Ministry of Health Research Proposal Guideline 1
Ministry of Health Research Proposal Guideline 2
Foreword
The well-known entity called R&D or Research and Development is a critical facet of any organizations
for its growth and continued relevance in the scientific world. Without research, there can be no
development. Without development, the organization remains static. And if an organization remains
static, it soon becomes irrelevant. Thus, research has to play a pivotal role for the future growth of the
any organisation.
With the dawn of the modern renaissance in Oman in 1970, great emphasis was placed in the domain
of Health and Education. They continue to be priority areas of the Government even to this date. In the
early decades of growth in Oman, health service was the main focus and it has paid rich dividends. By
all standards of measurement of health, Oman is now ranked along with the high income countries. A
clear understanding of the local situation, local needs and research priorities can be achieved only
through good quality focused research done within the country by the people that know it best. If the
health sector has to develop further and remain relevant to enhance the health and well-being of its
citizens, research has to be a priority.
Research within the health sector has been receiving increasing priority since the fifth 5-year plan.
Domains for research have been prioritized. Ways and means of encouraging, facilitating and
supporting research in health service and health system have been progressively increasing. The Health
Vision for 2050 has laid great emphasis on enhancing research within the health sector in Oman. But
health research does not happen just because of Governmental or Administrative initiatives. The
infrastructure and the human motivation have to enhance simultaneously. The Centre of Studies and
Research (CSR) and the Research and Ethics Review & Approval Committee (RERAC) have been
created exclusively to facilitate, encourage, support and monitor research within the Ministry of Health
in Oman. If these activities can be rendered using newer technologies that will improve efficiency, save
time and educe effort, it will prove to be beneficial in the long run.
I am glad that the Centre of Studies and Research has taken one more step in improving the situation
by initiating the process of online submission of research proposals on the MoH website. The website
was launched in December 2015 and now, all research proposals submitted for review by RERAC has
to be submitted online. Compared to the earlier system, this is more efficient in many aspects. The
research proposal forms have been upgraded and are now more comprehensive to cover different types
of research designs. This booklet is one more in a series of information that is designed to add some
more impetus to the system and process of administrative management of research activities within the
Ministry. It is designed to guide the researcher through the myriad of explanations and answers that are
required for compiling the research proposal form for submission to RERAC. Each form is designed in
a comprehensive and logical manner which will prompt the researcher to compile the form in a
Ministry of Health Research Proposal Guideline 3
methodical and systematic manner and submit it online which in turn will make it easier for the RERAC
Reviewers to evaluate and score the proposals as well as give constructive suggestions and feedback on
the proposal to the researcher. Through this process, the system of research proposal submission will
not only be made more efficient but also educational for the researcher and a gratifying experience.
No system should remain static. Continuous Quality Improvement (CQI) will be as much a need of this
enterprise as with any other health sector service. I am sure the team at CSR will strive towards CQI
and meet newer challenges as they emerge. This may be just another step in the right direction but I am
confident that all these endeavours that MoH is putting in place will collectively help to enrich research
in Oman.
Dr. Ahmed Mohamed Al-Qasmi
Director General of Planning & Studies
Chairman of Research and Ethical Review & Approval Committee
Ministry of Health Research Proposal Guideline 4
Task Force
Chairperson:
Dr Adhra Hilal Nasser Al-Mawali, Director, Centre of Studies and Research (Ministry of Health)
Ph.D. in Flow Cytometry and Molecular Genetics, University of Adelaide (Australia)
Members:
Dr John Idikula, Senior Specialist (Ministry of Health); MS; M.Med.Sci. in Epidemiology, University
of Newcastle (Australia)
Mr Avinash Daniel Pinto, Technical Manager of Health Information (Ministry of Health); M.Sc. in
Molecular Medicine, University of Sheffield (United Kingdom)
Mr Waleed Nasser Al-Shekaili, Head of Health Systems Research (Ministry of Health); M.Sc. in
Health Services and Public Health Research, University of Aberdeen (United Kingdom)
Ms Sultana Mohamed Saif Al-Sabahi, Head of the Department of Knowledge Translation and
Research Management (Ministry of Health); M.Sc. in Epidemiology and Medical Statistics, Sultan
Qaboos University (Oman)
Dr Brian Gunn, Senior Specialist Clinical Pharmacist & Section Head Research (Ministry of Health)
Ph.D., Heriot-Watt University (United Kingdom)
Prof. Gillian White, Advisor Directorate General of Education & Training (Ministry of Health)
Ph.D. in Community Health, University of Tasmania (Australia)
Acknowledgement
Members of the Research and Ethical Review & Approval Committee (RERAC)
Ministry of Health Research Proposal Guideline 5
Table of Contents Foreword ................................................................................................................................................ 2
Task Force ............................................................................................................................................. 4
Introduction ......................................................................................................................................... 10
Website of the Centre of Studies & Research ................................................................................... 13
Steps prior to Submission of a Research Proposal ........................................................................... 13
I. Ministry of Health (MoH) Staff as Principal Investigators ....................................................... 13
II. Non-Ministry of Health Persons as Principal Investigators ...................................................... 14
III. Non-Ministry of Health persons/institutions/organizations from outside Oman or non-
Omani researchers in Oman but not affiliated to any institution ...................................................... 16
Sensitive Data / Material .................................................................................................................... 19
Commensuration of Authorising Authority ..................................................................................... 20
Research carried out in Private Healthcare Establishments .......................................................... 21
Research Proposal Submission Process ............................................................................................ 22
Research Proposal System Timeline ................................................................................................. 24
Research Proposal Review Status/Decisions ..................................................................................... 25
RERAC Review Decision Appeals ..................................................................................................... 30
Common Section of all Forms ............................................................................................................ 32
1. Research Proposal Title ............................................................................................................ 33
2. Research Team Details.............................................................................................................. 33
3. Planned Contribution of Research Team Members .................................................................. 34
4. Research Proposal Summary .................................................................................................... 35
5. Background and Literature Review .......................................................................................... 36
6. What is the Reason for Conducting this Study?........................................................................ 37
7. Statements Related to the Problem ........................................................................................... 37
8. What Kind of Research Will be Conducted? ............................................................................ 39
Research Algorithm ............................................................................................................................ 40
Research Algorithm (Choosing the suitable Form to be filled) ........................................................ 41
Form A1: Clinical Trials .................................................................................................................... 42
9. Study Group Recruitment ......................................................................................................... 43
10. Sample Size Estimate of the Study / Experiment Group ...................................................... 44
11. Study / Experiment Group Allocation .................................................................................. 45
12. Control Group Recruitment .................................................................................................. 45
13. Sample Size Estimation of the Control / Comparison Group ............................................... 46
14. Control Group Allocation ..................................................................................................... 46
15. Baseline Characteristics Relevant to the Study ..................................................................... 47
Ministry of Health Research Proposal Guideline 6
16. Intervention ........................................................................................................................... 47
17. Informed Consent .................................................................................................................. 49
18. Blinding and Bias .................................................................................................................. 50
19. Co-intervention ..................................................................................................................... 51
20. Contamination ....................................................................................................................... 51
21. Confounders .......................................................................................................................... 51
22. Maintenance .......................................................................................................................... 52
23. Outcome ................................................................................................................................ 52
24. Outcome Measurement ......................................................................................................... 52
25. Data Synthesis and Management .......................................................................................... 53
26. Work Plan & Study Implications .......................................................................................... 54
27. Ethical considerations ........................................................................................................... 55
28. Additional Resource Utilisation ............................................................................................ 56
29. Pilot Study ............................................................................................................................. 56
30. Additional information .......................................................................................................... 56
31. Research Grant ...................................................................................................................... 56
32. Attachments .......................................................................................................................... 57
33. Declaration – To be signed by the Principal Investigator (P.I.) ............................................ 57
Form A2: Case-Control Studies......................................................................................................... 58
9. Study Group / Cases .................................................................................................................. 59
10. Target Population of Cases ................................................................................................... 59
11. Sample Selection of Cases .................................................................................................... 61
12. Sample Size Estimation of the Cases .................................................................................... 61
13. Study Group / Controls ......................................................................................................... 62
14. Selection of Controls ............................................................................................................. 62
15. Sample Selection of Controls ................................................................................................ 63
16. Sample Size Estimation of the Control ................................................................................. 63
17. Informed Consent ................................................................................................................. 65
18. Outcome Measuring Instrument ............................................................................................ 66
19. Exposure Factors ................................................................................................................... 66
20. Confounders .......................................................................................................................... 68
21. Exposure Measuring Instrument ........................................................................................... 68
22. Blinding................................................................................................................................. 68
23. Data Synthesis and Management .......................................................................................... 69
24. Work Plan & Study Implications .......................................................................................... 70
25. Ethical Considerations .......................................................................................................... 71
Ministry of Health Research Proposal Guideline 7
26. Additional Resource Utilisation ............................................................................................ 71
27. Pilot Study ............................................................................................................................. 72
28. Additional Information ......................................................................................................... 72
29. Research Grant ...................................................................................................................... 72
30. Attachments .......................................................................................................................... 72
31. Declaration – To be Signed by the Principal Investigator (P.I.) ........................................... 73
Form A3: Cohort Studies ................................................................................................................... 74
9. Study Cohort ............................................................................................................................. 75
10. Target Population of Cohorts ................................................................................................ 75
11. Sample Size Estimation of the Cohort Group ....................................................................... 77
12. Enrolment of the Cohort Participants .................................................................................... 77
13. Control / Comparison Cohort ................................................................................................ 77
14. Sample Size Estimation of the Control / Comparison Group ............................................... 78
15. Control Group Allocation ..................................................................................................... 79
16. Matching ............................................................................................................................... 79
17. Informed Consent ................................................................................................................. 80
18. Exposure Measuring Instrument ........................................................................................... 81
19. Outcome Measuring Instrument ............................................................................................ 81
20. Confounders .......................................................................................................................... 82
21. Modification and Follow-Up ................................................................................................ 82
22. Outcome Measures ................................................................................................................ 83
23. Attrition ................................................................................................................................. 84
24. Blinding................................................................................................................................. 84
25. Data Synthesis and Management .......................................................................................... 85
26. Work Plan & Study Implications .......................................................................................... 86
27. Ethical Considerations .......................................................................................................... 87
28. Additional Resource Utilisation ............................................................................................ 87
29. Pilot Study ............................................................................................................................. 88
30. Additional Information ......................................................................................................... 88
31. Research Grant ...................................................................................................................... 88
32. Attachments .......................................................................................................................... 88
33. Declaration – To be Signed by the Principal Investigator (P.I.) ........................................... 89
Form B: Qualitative Research ........................................................................................................... 90
Introduction ....................................................................................................................................... 91
9. Study Design ............................................................................................................................. 92
10. Research Strategy .................................................................................................................. 92
Ministry of Health Research Proposal Guideline 8
11. Data Collection Methods ...................................................................................................... 93
12. Sampling ............................................................................................................................... 93
13. Methodological considerations ............................................................................................. 93
14. Data Analysis ........................................................................................................................ 94
15. Pilot Study ............................................................................................................................. 94
16. Data Synthesis and Management .......................................................................................... 94
17. Quality Control of Data......................................................................................................... 95
18. Ethical Considerations* ........................................................................................................ 95
19. Informed Consent .................................................................................................................. 97
20. Anticipated Results, Beneficiaries and Dissemination ......................................................... 98
21. Work Plan & Study Implications .......................................................................................... 99
22. Research Grant .................................................................................................................... 100
23. Attachments ........................................................................................................................ 101
24. Declaration – To be Signed by the Principal Investigator (P.I.) ......................................... 101
Form C: Non-Clinical Quantitative................................................................................................. 102
9. Study Group ............................................................................................................................ 103
10. Sample Size Estimation of the Study .................................................................................. 104
11. Study Group Allocation ...................................................................................................... 105
12. Control / Comparison Group............................................................................................... 105
13. Sample Size Estimation of the Control / Comparison Group ............................................. 106
14. Control Group Allocation ................................................................................................... 106
15. Measuring Instrument ......................................................................................................... 106
16. Pilot Study ........................................................................................................................... 107
17. Data Collectors Training ..................................................................................................... 107
18. Informed Consent ................................................................................................................ 108
19. Attrition and Non-Compliance ............................................................................................ 109
20. Data Synthesis and Management ........................................................................................ 110
21. Work Plan & Study Implications ........................................................................................ 110
22. Ethical Considerations ........................................................................................................ 112
23. Additional Resource Utilisation .......................................................................................... 112
24. Research Grant .................................................................................................................... 112
25. Attachments ........................................................................................................................ 113
26. Declaration – To be Signed by the Principal Investigator (P.I.) ......................................... 113
Form D: Mixed/Other Research Designs ........................................................................................ 114
9. Research Design and Methodology ........................................................................................ 115
10. Study Population ................................................................................................................. 115
Ministry of Health Research Proposal Guideline 9
11. Sample Size Estimation ...................................................................................................... 116
12. Study Group Allocation ...................................................................................................... 117
13. Control / Comparison Group............................................................................................... 117
14. Measuring Instrument ......................................................................................................... 118
15. Gold Standard / Benchmark ................................................................................................ 119
16. Pilot Study ........................................................................................................................... 119
17. Data Collectors Training ..................................................................................................... 119
18. Informed Consent ................................................................................................................ 120
19. Attrition and Non-Compliance ............................................................................................ 121
20. Data Synthesis and Management ........................................................................................ 122
21. Work Plan & Study Implications ........................................................................................ 122
22. Ethical Considerations ........................................................................................................ 124
23. Additional Resource Utilisation .......................................................................................... 124
24. Additional Information ....................................................................................................... 124
25. Research Grant .................................................................................................................... 125
26. Attachments ........................................................................................................................ 125
27. Declaration – To be Signed by the Principal Investigator (P.I.) ......................................... 125
Minimum required standards .......................................................................................................... 126
Glossary of Research Terms ........................................................................................................... 126
Ministry of Health Research Proposal Guideline 10
Introduction
Reviewing research proposals to evaluate them for ethical and research acceptability is an
important responsibility and function of the Review Board of every institution that supervises
research. The elaborate process of Ethical and Research Review begins with the submission
of the research proposal by the Principal Investigator who represents the research team and
takes the responsibility for making all the interactive dealings with the Committee from
proposal submission to final reporting of the completed research project.
Each Review Board would have its own format for the forms that need to be filled. Both the
form and the process of submission would change over time to meet the demand and the
evolving technology. From paper forms that needed to be manually filled and physically
submitted a few decades ago through to submission by e-mail, the Research and Ethics Review
& Approval Committee (RERAC) has now reached a stage where research proposals can be
submitted online on the dedicated website of the Centre of Studies and Research (CSR) to be
reviewed as well as followed up electronically by RERAC. The evolution to reach this stage
was as much due to the necessity of keeping abreast with advancing technology as the need to
be economically efficient, judicious in time management and transparent in the review process.
The CSR Team also had to take into consideration that researchers in the Ministry of Health
range from novice researchers who are planning to do research for the very first time to expert
researchers planning multi-centric international trials and even postgraduate students
proposing to do dissertations for MSc or theses for PhD programmes registered at international
universities. This meant that the proposal forms that need to be submitted have to be specific,
educational, and comprehensive as well as simple and user-friendly. The CSR Team took all
these factors into consideration in the process of creating the revised research proposal form.
The revisions were also reviewed for suitability by members of the RERAC and their opinion
and views were taken into consideration in the creation of the revised Research Proposal forms.
Another important consideration is the fact that there are different research designs, each of
them being specific to address a particular type of research concept. There are qualitative
research that makes detailed evaluation of a particular situation, quantitative studies that
analyses a problem to find an explanation or a solution and even clinical studies on patients
that determines the effect of an experiment or an intervention. The research method that needs
to be applied in each situation is distinct in many respects. Hence, the concept “one research
Ministry of Health Research Proposal Guideline 11
proposal form fits all” is not apt. Keeping the distinct nature of different research in
consideration, six different proposal forms were designed that are suitable for each of the most
common types of research. The forms are designed so that it is easy to fill even by a novice
researcher yet detailed and thorough enough for any type of study design to be filled adequately
by an experienced researcher.
The website went through several revisions and upgrading before it was considered ready and
was launched in December 2015. Like all interactive websites, when end users start using it,
some of the deficiencies and “bugs” in the programme will become apparent. Arrangements
have been made to meet with such contingencies - to resolve them and to keep improving the
usability of the web site and the research proposal forms. The website has several uses and
applications but the purpose of this document is to introduce the research proposal submission
forms and the process connected with it. The reader is encouraged to also read other
information available on the CSR website that connects this material to other similar materials
relevant to research in the Ministry of Health (For example, the latest booklet titled ‘The
Guidelines for Responsible Conduct of Clinical Studies & Trials’). There are also several
educational materials like PowerPoint® presentations of lectures on research methodology and
biostatistics, e-library resources, links to useful sites like Free Medical Journals, Sample Size
Calculators and several other useful resources for the researchers.
The research proposal form posted on the website of the Centre of Studies and Research
consists of 2 sections. The first section is common for all types of studies while the second
section is specific for each of the six different research types. At the end of the first section, the
researcher who is filling the proposal has to select the form that is best suited for the research
design of the proposed study. An algorithm to help in selecting the appropriate form to fill is
given at the end of the Common Section of the electronic form. This booklet will also help as
it gives a complete view of all the forms, giving the reader a chance to see all the forms and to
identify the most appropriate form that is suitable for the proposed study.
Each of the forms consists of items that have to be filled in by typing the matter or by copying
from another document, into boxes designed for each item. Instructions on what should be
written in each box are indicated above each box. Useful suggestions and helpful examples are
also given for most items. As mentioned earlier, this booklet contains the common section of
the form that has to be filled by all: as well as the six individual forms designed for each type
of study design, one of which has to be selected and filled to complete the proposal form. In
Ministry of Health Research Proposal Guideline 12
addition to the website form reprinted as it appears on the website, there are some notes to
provide additional information that are useful to the researcher filling out this form (these are
extracted from standard text books on research methodology and best practice, and are shown
in the coloured boxes in this booklet). To avoid replication, some of the notes are given only
in the first form, the one designed for clinical trial. This booklet is not intended to replace text
books or monograms on topics in research methodology but as a guide to fill this research
proposal form. The researcher must familiarize himself/herself with adequate knowledge on
research methodology, basic biostatistics and bioethics pertinent to the proposed research
before filling up this form so that all sections can be correctly, clearly and explicitly filled.
Once the proposal form is submitted, it will be screened to determine if it is complete with all
the required documents attached, and then it will be forwarded to the RERAC reviewers for
reviewing and scoring after which a final decision on approval will be taken by the RERAC.
The details of the review process and scoring are beyond the scope of this booklet and are given
in another document which is also found on the website of CSR. This booklet will fill the
existing gap on the contents of the electronic version of the research proposal submission forms
that are to be submitted online.
Ministry of Health Research Proposal Guideline 13
Website of the Centre of Studies & Research
You can visit www.mohcsr.gov.om to enter the online presence of the Centre of Studies &
Research, a dedicated website to stay up-to-date with the research activities of the Ministry of
Health as well as to get your research proposal submitted, reviewed, and approved by the
RERAC/Regional Research Committee. The website can also be accessed through a link from
the main Ministry of Health website (www.moh.gov.om). The fully responsive website can
seamlessly switch between English and Arabic. The website also has a mobile-friendly
interface which means visitors and researchers can browse the website on mobile, tablet and
PC. The website offers you search filtering options along with content-based features and
research databases. Promoting connectivity through the website offers you a one-stop-location
for research. All research conducted in Ministry of Health institutions should have prior
approval from RERAC/Regional Research Committee. If you are a researcher with a research
proposal to be submitted for approval to RERAC/Regional Research Committee, the steps
outlined in the sections below should guide you on how to proceed. For additional information
pertaining to research in the Ministry of Health, kindly refer to the publications which can be
found on our website homepage.
Steps prior to Submission of a Research Proposal
I. Ministry of Health (MoH) Staff as Principal Investigators
a) Register through a registration form (found on
www.mohcsr.gov.om by clicking on New User
on the homepage) directed through your
respective regional focal person
b) Mention your Name, Staff ID number and your
institution in the form.
c) Provide a copy of your Ministry of Health
Institutional ID card which mentions your 5-digit
staff number.
Ministry of Health Research Proposal Guideline 14
d) After verification is complete, you shall receive your username and password through
the email you provided.
e) The username will be the MoH staff number of the Principal Investigator as this will
help in easy reference and identification for future correspondence/verification.
f) Researchers can login to the portal with the provided credentials to submit a research
proposal.
g) The submission must include letter(s) of provisional approval/authorization from the
institution(s) where the research will be carried out
II. Non-Ministry of Health Persons as Principal Investigators
Request for research to be carried out in any of the Ministry of Health institutions in Oman by
non-MoH persons would fall into one of the following categories:
a) Research carried out by students/staff of academic institutions in Oman
b) Research carried out by employees of a governmental or non-health private
organisation in Oman
c) Research carried out by Health professionals of non-MoH institutions in Oman (such
as private clinics, private hospitals etc.)
d) Research carried out by private citizens (Omani)
Such persons wanting to conduct research within MoH institutions have to contact
designated focal points within their particular region or the Centre of Studies & Research
at the MoH-Headquarters. The researcher should meet the criteria given below depending
on the nature of the study.
1) If the participants/subjects of the research/study include patients, clients or MoH staff
from MoH institutions and a competent MoH staff is included as a member of the
research team:
a. The username and password will be issued directly to the MoH staff for submission
of the research proposal
Note: MoH staff with Master’s/PhD research proposal submissions can request for
login credentials from their region or directly through ‘MoH Headquarters’.
Ministry of Health Research Proposal Guideline 15
b. The MoH staff member should ensure that the study is conducted as per the
approved protocol and health research guidelines of the Centre of Studies &
Research in the Ministry of Health
2) If the participants/subjects of the research/study include patients, clients or MoH staff
from MoH institutions and a competent MoH staff is not included as a member of the
research team:
a. The researcher will need to obtain a letter of provisional approval/authorization
from his/her parent institution as well as letter(s) of approval/authorization from the
institution(s) where the research will be carried out.
b. Username will be linked to the National ID card for submission of the research
proposal. Researchers will have to provide through email a scanned copy of their
national ID card along with their name, region, and institution (if applicable).
c. The proposal can then be submitted to obtain authorization from the respective
research committee (Regional or Central RERAC).
3) If the research/study does not involve using subjects such as patients, clients or MoH
staff, the research study will be assessed based on collection of any sensitive
data/material from MoH institutions*:
a. If it involves collection of sensitive data/material from MoH institutions*and a
competent MoH staff is included as a member of the research team:
i. The MoH staff can directly obtain credentials to submit the proposal online.
ii. The MoH staff member should ensure that the study is conducted as per the
approved protocol and health research guidelines of the Centre of Studies &
Research in the Ministry of Health.
b. If it involves collection of sensitive data/material from MoH institutions* and
the research team does not include an MoH staff:
i. The researcher will need to obtain a letter of recommendation/approval
/authorization from his/her parent institution as well as letter(s) of
provisional approval/authorization from the institution(s) where the
research will be carried out.
ii. The proposal can then be submitted to obtain authorization from the
respective regional research committee or central research committee.
Ministry of Health Research Proposal Guideline 16
iii. Username will be linked to the National ID card for submission of the
research proposal. Researchers will have to provide through email a scanned
copy of their national ID card along with their name, region, and institution
(if applicable).
c. If it does not involve collection of any sensitive data/material from MoH
institutions*:
i. The researcher will need to obtain a letter of recommendation/approval
/authorization from his/her parent institution
ii. The researcher can submit the proposal online to obtain authorization from
the respective regional research committee or central research committee.
iii. Username will be linked to the National ID card for submission of the
research proposal. Researchers will have to provide through email a scanned
copy of their national ID card along with their name, region and institution
(if applicable)
III. Non-Ministry of Health persons/institutions/organizations from outside Oman or
non-Omani researchers in Oman but not affiliated to any institution
For researchers outside of Oman (including non-Omani researchers residing in Oman but not
affiliated to any institution within Oman) wishing to do research within MoH institutions:
a) The researcher must get written permission from the Undersecretary for Planning
Affairs in the MoH
b) A competent MoH staff should mandatorily be included acting as a local supervisor/co-
ordinator of the research (who may be nominated by the approving authority in the
MoH)
c) The username and password will be issued directly to the MoH staff for submission of
the research proposal
*Sensitive data/material refers to information or material of any kind related to
patients/clients, confidential/personal information about staff, data or information
about health services or the health system of MoH and all such information that are not
in the public domain.
Ministry of Health Research Proposal Guideline 17
d) A letter of recommendation/authorization/approval should accompany the proposal
from the competent authority of the applicant’s parent institution abroad (where
applicable).
For quick reference, kindly refer the diagrammatic flowchart for the pathway for submitting
research proposals for non-MoH persons wanting to do research within MoH institutions.
Note: All approvals/authorizations from the institution(s) where the research will be
carried out are conditional subject to approval of the Central RERAC or Regional
Research Committee.
Ministry of Health Research Proposal Guideline 18
Flow Chart for Submitting Research Proposals by Non-MoH Persons Wanting to Do Research Within MoH Institutions
Academic research by a student/staff of an Academic
Institution in Oman #
Employee of a Governmental or
Private Organization in
Oman (#)
Contact Regional Focal Person or Administrator at CSR of MoH
Participants /subjects of the study includes patients/clients /MoH staff ?
Study involves collection of sensitive
data/material from MoH *
Obtain specific permission from a competent authority at the study
site/Directorate/MoH & applicants' parent institution
Username and password issued to the Applicant. Username linked to
National ID for submission of research proposal
A competent MoH staff is a Co-PI /
Local Supervisor for the research $
Non-MoH Health Professional in
Oman (#)
Private Citizen (Omani)
Non-Omani Person or
Institution/ Organization outside Oman
Approved by Competent Senior Authority in MoH
A competent MoH staff is a Local
Supervisor for the research $
Username and password issued to the MoH staff
connected with the study ($) for submission of Research Proposal & supervision
No
Yes
Yes
Yes
Yes
No
Yes
Yes
No
# Research Proposal should be accompanied by a letter of
recommendation/approval/authorisation from a competent
authority of the applicant’s parent institution.
* Sensitive data refers to information or any material related to
patient/clients, confidential/personal information about staff,
data or information about health service or the health system of
MoH and all such information that are not in the public domain.
$ The MoH staff should ensure that the study is conducted as
per the approved protocol using research guidelines of MoH.
Ministry of Health Research Proposal Guideline 19
Sensitive Data / Material
Sensitive data/material refers to information or material of any kind related to patients/clients,
confidential information about staff, data or information about health services or the health
system of MoH, and all such information that are not in the public domain.
Few examples of sensitive data / material are given below for clarification:
1. Examples of Sensitive Data (patient): Patient ID, Patient’s / clients personal profile, any
clinical data including diagnosis, results of investigations, treatment, clinical management
plan, case history, clinical findings, referral notes or any such information, including any
such information recorded in the case record of the patient. Any privileged communication
between patient and the managing health care provider – whether recorded or not; and
whether stored manually or electronically will all fall under the purview of sensitive data
for this purpose.
2. Examples of Sensitive Material (patient): Any blood, tissue or other biological samples
taken from the patient for testing including any left-over material, any biological material
that the hospital is entrusted by the patient for safe disposal such as expired blood from
blood bank, human placenta after delivery, expelled products of conception, amputated
body parts, medical waste that may contain body fluids or similar biological materials etc.
3. Examples of sensitive data (MoH staff): Staff profile, personal details and any
information stored in the personal record of any staff including but not limited to any
personal communication with the staff and any information or data that a staff may not wish
to disclose to an agent outside the MoH will all constitute as sensitive data for this purpose.
4. Examples of sensitive data (MoH Organization): Protected or secure information of any
of the organization or system within MoH including and not limited to official
communications, minutes of meetings and all other such administrative and policy matters
that are not in the public domain such as in the official MoH publication or MoH website
would be construed as sensitive material for this purpose.
Ministry of Health Research Proposal Guideline 20
Commensuration of Appropriate Authority
Letter of Recommendation from the parent institution of the researcher and the provisional
letter of acceptance at the study venue should be authorised by an appropriate functionary in
either organization and their designation should be commensurate with the nature and extent
of the study. For example, if a study is to be conducted at a Departmental or institutional level,
the corresponding Directors should be the recommending authority. If the study covers a
Governorate, the Director Generals should be the recommending authority. As described
earlier, the Principal Investigator should submit the research proposal to the appropriate
Research Committee along with the letters of recommendation or provisional acceptance of the
research for Approval by the respective Research Committee. The Committee may seek further
clarification, feasibility etc. from the concerned institutions as required before granting the
approval.
Ministry of Health Research Proposal Guideline 21
Research carried out in Private Healthcare Establishments
The scope of RERAC for research proposals coming out of private healthcare establishments
will fall under the following categories:
Clinical Trials/ Experimental Studies
Therapeutic Interventional Studies
Studies involving the use of therapeutic device or medication not currently approved
by MoH
Studies with international collaboration
Studies where tissue samples/fluids/other biological material is to be sent abroad
Any other situation that may arise on a case-by-case basis
Other research/audit being conducted in private healthcare establishments should get prior
approval from appropriate authority/Executive Director of the private hospital/institution.
Ministry of Health Research Proposal Guideline 22
Research Proposal Submission & Review Process
Using the login details (Username and Password), the researcher can log on to the website to
submit the research proposal. The unique username will help in locating the researcher for any
future reference and follow up. (The researcher may change the password but not the
Username).
Once logged in to the ‘Researcher Dashboard’, researchers can click on ‘Submit New Research
Proposal’ to begin a new submission. A common section of all forms has to be filled at the end
of which researchers will need to select the appropriate form to be filled specific to the study
design of the proposal. There is an algorithm provided which can be viewed to guide
researchers in choosing the right form. The PI should open the proposal form that is appropriate
to the type of study design and fill up the form completely. Each of these forms have been
tailored for even the novice researcher and in the process of filling up the form, the researcher
will be educated about the various facets and requirements of conducting a research using that
particular research method.
The spaces to be filled in each section of the form can be either typed in or copied from another
compatible electronic form (e.g. Word document). All relevant documents such as consent
form, participant information sheet, brief CV of researchers, signatures of researchers, approval
letter from parent institution, approval letter of supervisor if applicable etc. have to be attached
as electronic attachment in the prescribed format (e.g.: .jpg file for scanned images, or as PDF
file). When the proposal form has been completed and all enclosures have been attached, the
researcher should click “Submit” upon which the proposal will be delivered to the Technical
Focal Person (TFP). Once submitted, the research proposal will be locked from further editing.
The Technical Focal Person will screen the proposal to determine whether the proposal requires
to be forwarded to RERAC or can be approved by the Regional Research Committee based on
the guidelines for authorizing research. If the research fulfils criteria for approval by the
Regional Committee, the TFP will process the proposal through the Regional Committee
without submitting it to RERAC. If it is determined that, as per MoH guidelines, the proposal
needs to be reviewed by Central RERAC, the TFP will recommend and forward the proposal
to the RERAC electronically.
Ministry of Health Research Proposal Guideline 23
When the TFP has submitted the proposal to RERAC, the RERAC Administrator will be
alerted electronically. From then on, the RERAC Administrator will be able to communicate
with the PI directly. The research proposal will be screened to determine if it is complete with
all the required documents attached. If the submitted proposal is complete in all respects, the
RERAC Administrator will register the proposal. However, if the proposal is incomplete, the
Administrator will not register the proposal but will alert the PI about the deficiency and keep
the proposal submission process open till the deficiency is corrected and re-submitted. The PI
will be able to edit the submitted proposal during this phase.
The completed and registered proposals are forwarded electronically to the reviewers by the
RERAC Administrator. The reviewers will study the proposal in detail and make suggestions,
comments and remarks as needed and also give a score based on RERAC criteria. During this
stage, the PI will receive a notification/online alert that the proposal is under review. Once the
RERAC Administrator receives the reviewers’ remarks and recommendations, the same will
be sent anonymously to the PI for their perusal and feedback. The PI can now edit the proposal
if necessary and resubmit the proposal again which will be forwarded to the respective
reviewers for their perusal and final decision. Eventually, a final decision, based on the
reviewers’ feedback whether the proposal is Approved or not will be taken by RERAC by
voting for all members in a monthly meeting, and the PI will be informed accordingly.
The score given by the reviewers (at the first review of the proposal) will be collated and used
for approving research grants or research awards as per the criteria specified in the MoH
document “Health Research Funding Guideline”.
Ministry of Health Research Proposal Guideline 24
Research Proposal System Timeline
Task Step Duration Required (Days)
Screening proposals within 2 working days from date of proposal receipt
Registering proposals (if complete & correctly filled) within 2 working days from date of proposal receipt
Selecting & Sending to reviewers within 2 working days from date of registration
Reviewing period by reviewers ~22 calendar days
Preparing Agenda 5 working days before RERAC meeting
Committee Meeting 1 day (usually at the end of each month)
Sending feedback/update to researcher
(for ready proposals) 2 working days after the RERAC Meeting
Reviewers adding comments after meeting
(if required) 2 working days after the RERAC Meeting
Sending any pending feedback 1 working day of receiving additional comments by the
reviewers
Checking PI feedback of revised proposals with decision ‘Approval after
Minor Changes’ Maximum of 5 days from revised proposal receipt date
Checking PI feedback of revised proposals with decision ‘Approval after
Major Changes’ Maximum of 10 days from revised proposal receipt date
Ministry of Health Research Proposal Guideline 25
Research Proposal Review Status/Decisions
One of the important roles of the Centre of Studies & Research in the Directorate General of
Planning & Studies is to encourage, support, and facilitate research by health care professionals
in the Ministry of Health. RERAC is the central committee (under the Directorate General of
Planning & Studies) to review and approve research proposals. In as much as the Committee
critically reviews proposals, it would also offer suggestions to improve the quality of research
proposals so as to advance the quality of research overall in MoH. Members of the RERAC
have wide experience in research and can facilitate this role while reviewing and deciding on
the approvability of each research proposal.
The reviewers who review each research proposal will select a Review Status option which is
given in the Proposal Review form. Based on this selection of the Review Status by the
reviewers and the discussion among the Committee members at the monthly RERAC meeting,
a final decision on the approval status of the proposal will be finalised by the Committee. The
Status/Decision of the research proposal would be categorised to one of the following four
options:
1: Approved (as submitted)
2: Approval after MINOR changes
3: Approval after MAJOR changes
4: Disapproved
Ministry of Health Research Proposal Guideline 26
1: APPROVED (AS SUBMITTED)
The research proposal meets all the required standards in all aspects of the study. The
decision of the Committee will be intimated to the PI who can then proceed with the study
as per the approved protocol.
In some cases, there may be a few grammatical or spelling corrections or syntax changes that
may be required in the presentation. Also, the reviewers and the Committee in their wisdom
may offer some suggestions to further improve the study even though it can be approved
without incorporating those suggestions. In such situations also, the final decision can be that
of Approval. The PI can be informed of the Approved decision as well as the suggestions by
the reviewer(s) / Committee which may be incorporated during the course of the study.
Resubmission of the research proposal is not required in this case.
2: APPROVAL AFTER MINOR CHANGES.
The quality of the proposed study is deficient in certain aspects and requires modification
before it can be approved.
The deficiency is of a minor nature in the overall presentation and methodology. Criteria which
would lead to this decision include:
modification of inclusion/exclusion criteria
alteration of sample size calculation
minor errors in abstract and/or introduction sections
description of methodology that needs minor clarification and is clearly remediable
modification/addition/deletion of the allocation strategy of the samples
modification/addition/deletion of some of the dependent/independent variables
study implications and/or limitations are missing a point(s) which can be addressed
discrepancies within text, abstract, and other supporting information
minor listing/addition of references, especially an important article(s) that could impact
the proposal
Ministry of Health Research Proposal Guideline 27
references are not appropriately correlated to the text/subject of the proposal
references are in different citation styles making it difficult for the reviewer to follow
institutional pre-approval(s)/feasibility recommendations missing
other minor research points that could be addressed
The decision of the Committee will be sent to the PI along with the suggestions, comments
and clarifications required. The PI should revise the proposal in the light of the feedback from
the Committee and resubmit it to the satisfaction of the reviewer(s). The reviewer(s) may then
recommend that the study be approved (without bringing it again to the RERAC Committee)
and that decision can be conveyed to the PI who may commence the study as per the revised
protocol. However, if the reviewer(s) are not satisfied with the revision, the process may go
through another cycle till it meets the satisfaction of the reviewers.
3: APPROVAL AFTER MAJOR CHANGES
The quality of the proposed study is seriously deficient in certain aspects and requires
significant modification before it can be approved.
The deficiency is of a major nature in the overall presentation and methodology. Criteria which
would lead to this decision include:
hypothesis and objective not clearly worded/defined along with unclear methodology
incorrect sampling strategy
incorrect study design employed
description of methodology is unclear and needs major revision
several discrepancies within text, abstract, and other supporting information
lack of clarity, i.e. components are present but needs major rewriting to address it
incorporation of a pilot study needed to check validity/reliability of the instrument/tool
objectives and anticipated results are not matched but can be addressed by major
revision
Ministry of Health Research Proposal Guideline 28
significant number of objectives remained unanswered/unresearched
too many references are not appropriately correlated to the text/subject of the proposal
revision of any ethical issues that can be rectified
several points under minor changes occurring together in the opinion of the reviewer
The decision of the Committee will be intimated to the PI who should revise the proposal and
resubmit it. The reviewer(s) will then critically review the revised proposal and will take a
decision on the approvability of the revised proposal and that decision will be conveyed to the
PI. However, if the reviewer(s) is not satisfied with the revision, the process may go through
another cycle till it meets the satisfaction of the reviewers.
4: DISAPPROVED
This is a serious decision and will be taken only in extreme cases after due deliberation
by the Committee at the RERAC committee meeting. Few examples where such a decision
may be taken are listed below:
The quality of the proposed research is unlikely to reach the minimum required
standard even after major revision (e.g.: Master’s, PhD Thesis)
There are serious flaws in the research methodology and the research question
cannot be answered by the proposed research
The PI or members of the research team do not have the required professional
qualification or the technical competence to carry out their role in the study.
The health institution where the study is planned to be conducted lacks the
minimum infrastructure (including manpower, equipment, materials, finances or
any other) required for conducting the study and the items in the proposed budget
– even if approved for funding – will not make good the perceived deficiency. (non-
feasibility)
Unfixable flaws in data/research (number/selection of subjects; instruments/drugs
used)
Ministry of Health Research Proposal Guideline 29
Major discrepancies within text, abstract and other supporting information which
cannot be addressed by major revision
Serious Ethical issues
a. Any issues in the research that contravenes the law of the land or is in
conflict with accepted professional practice and professional ethics.
b. The research may create some sensitive/political issues
c. If the participants to the study are placed in any undue risk or if it
contravenes any of the International guidelines on human research.
d. The participants may be disadvantaged by the study (financially,
emotionally, physically or in any other way including an adverse labelling
effect) and is not adequately compensated or provided for within the scope
of the study.
e. Potential for misuse of any information or material (e.g.: biological samples)
collected as part of the study
If it is discovered that any of the research team members have undeclared and
serious conflict of interest or have been involved in conducting fraudulent research
in the past based on severity and circumstances
Any other issue that the Committee considers as a serious impediment to the proper
conduct of research as per the submitted proposal and which cannot be overcome
or circumvented even after suitable revision.
In this case, the PI will have to submit a new proposal which will be sent to reviewers, and
consequently be placed before the Committee to make a final decision on the approvability of
the proposal. However, if the Committee is still not satisfied with the proposal, the process may
go through another cycle till it meets a final review decision.
Ministry of Health Research Proposal Guideline 30
RERAC Review Decision Appeals
RERAC is committed to advancing high-quality research and ensuring that research activities
carried out as mentioned in research proposals meet minimum criteria for health, medical
ethics, rights, safety, and privacy of human participants and/or personal data. To ensure fairness
as part of this commitment, RERAC has established a procedure to allow appeals against
‘Disapproval’ decisions.
A researcher may not appeal against the decision of the Committee purely on the grounds that
he/she disagrees with the decision. The researcher may appeal the decision based on:
facts/circumstances which the Committee was not aware of and may have impacted on
the decision
demonstrable evidence of inadequate review
Appeal Process
A ‘Letter of Appeal’ should be addressed to the Chairman of the Research and Ethical Review
& Approval Committee within 10 days of being notified of the Committee’s decision. The
researcher must send the letter to [email protected] / [email protected] and notify the
rapporteur of the Committee by email or telephone on 22357274 / 22357280. Please write
‘Letter of Appeal’ in the subject line of the email.
The appeal request must include:
Title of the research proposal & Proposal ID
The reason for appeal
Any documentary evidence to support the appeal
The Committee will deal with appeal requests with reasonable expedition. The Committee will
appoint experts if deemed necessary. Following this, the Chairman will make an eventual
decision which will be final and binding. There is no further scope of appeal against this final
decision. However, the researcher may submit a new proposal avoiding the issues that were the
reason for disapproval.
Ministry of Health Research Proposal Guideline 31
Regional Technical Focal Person To Create Username & Password
Submit Proposal Online by PI & checked by Regional Focal Person
Researcher (PI) ready with Research Proposal
Focal Person Screens Proposal
& Forwards
To Regional Research Committee
Authorizes and forwards to RERAC the Proposal & all attachments
RERAC Administrator Checks Proposal
Incomplete
Incorrect
Return to PI Alert PI by e-mail
Updates / Appends / Modifies As necessary and Resubmits
Meets RERAC Submission Criteria
Meets Regional
Criteria
Complete and Correct
Register and Forward to selected
Reviewers in RERAC Committee
Reviewers Return to Admin with Score, Comments & Decision on the Proposal
Decision of Reviewer / Final Committee Decision (RERAC)
Needs Change
Minor or Major Admin Forwards comments to PI
PI makes needed modification to the proposal
Edited Version ready for submission
Rej
ecte
d b
y M
ajo
rity
of
Rev
iew
ers
/ C
om
mit
tee
Pri
nci
pal
Inve
stig
ato
r (P
I)
Info
rmed
DISAPPROVED
APPROVED
PI Informed by e-mail The Study may proceed as per
approved protocol
PI m
ay s
ign
ific
antl
y m
od
ify
Pro
po
sal a
nd
Res
ub
mit
Funds requested
Proposal and budget Forwarded to
FUNDING COMMITTEE
FLOW CHART SHOWING
THE RESEARCH PROPOSAL
SUBMISSION PROCESS
PATHWAY
DECISION OF THE FUNDING COMMITTEE
INCORRECT
T
Ministry of Health Research Proposal Guideline 32
Common Section of all
Forms
The first section in the research proposal form is a common section and all
researchers have to fill it regardless of the type of research. After that, based
on the research methodology and study type the researcher has to select one
of the study types and the system will direct the researcher to the appropriate
research form that has to be filled.
There are many parts in this section which will be listed along with some
guidelines and instructions.
Ministry of Health Research Proposal Guideline 33
1. Research Proposal Title
Research title (English):
Research title (Arabic):
2. Research Team Details
Role Name Qualifications Job Title Telephone Email
Principal Investigator
(PI)
Co-Principal Investigator
(Co-PI)
Add More
The title summarizes the main idea(s) of your study.
A good title contains the fewest possible words needed to adequately
describe the contents and/or purpose of your research.
Keep the title brief and clear. Use active verbs instead of complex noun-based
phrases, and avoid unnecessary details.
Good research titles (typically 10–12 words long) use descriptive terms and phrases
that accurately highlight the core content of the.
The title should not have abbreviations and jargon.
A catchy title posing a question or including an apparent contradiction may be
more easily remembered by a reviewer.
The title should address: what, why, who, how, when and where of the research.
It should catch the reader’s attention.
It should describe the contents accurately.
It should describe the subject specifically.
It should be easy to understand.
It should be suitable for indexing.
Ministry of Health Research Proposal Guideline 34
Name of the Affiliated Institution:
Institution address:
Governorate/Region:
Telephone number:
Fax:
E-mail:
Duration of study in months:
Proposed start date:
Study Area: {dropdown menu}
Specify the Hospital/Health Centre/Wilayats as applicable:
3. Planned Contribution of Research Team Members
z
Affidavit: It is the responsibility of the Principal Investigator to ensure that by signing/initialling for
the individuals listed above, the individuals have consented to be involved in this research.
S. No. Name of
Researcher Affiliation
Contribution of
Researcher Signature/Initials
Add more Remove Last
This is to indicate the planned contribution by each member in the research
team. A multidisciplinary team with relevant scientific expertise is often
required for most studies and should be listed here. It should be reported again
after completion of the study in the final report before dissemination by
indicating the factual contribution and time devoted by each of the team
members. The PI should be aware of the type of contribution and suitability
with each investigator’s qualifications and position.
[e.g. Conception of idea, Research design, Data collection/field work, Data
management, Analysis, Report writing, Interpretation of results, Critical
reviewing with intellectual input]
Ministry of Health Research Proposal Guideline 35
If the study is supervised or a Bachelor’s/Master’s/PhD (or other academic programme):
Supervisor’s name:
Position:
Institution:
Country:
Phone number:
Email address:
Declaration of supervisor:
I take responsibility for supervision and related aspects pertaining to this study.
Supervisor’s letter / signature: {Attach}
4. Research Proposal Summary
(Not more than 500 words in a structured format)
Please fill in this part only after completing your detailed proposal.
It must include the statement and importance of the research problem,
aims and objective(s), population under study, sample, sampling method,
sample size, data collection tool(s) and technique(s), data analysis methods,
expected results and implications for practice.
It should be a concise summary of the WHOLE project.
Use the abstract to identify the need for the research, state what
you intend to do, and how you intend to do it.
It should not include unnecessary detail.
It should contain key words for indexing.
It should stand on its own.
It should not contain references, abbreviations, citations, tables or
figures
It should avoid unsubstantiated conclusions
Ministry of Health Research Proposal Guideline 36
Research Summary / Abstract in English:
Research Summary / Abstract in Arabic:
5. Background and Literature Review
(Not more than 1500 words, please restrict to information directly pertaining to the research)
Literature Review:
Keywords:
References:
Background information [A brief description of the country/region,
socioeconomic, cultural characteristics, health status and health care system
with few illustrative statistics that are relevant to the research problem]. It
then includes the selection and analysis of the research problem, direct
determinants and the contributing factors. Please review critically the
already available information from relevant studies in Oman, from similar
countries and international studies. You must furnish references for all
quoted statements you make in the proposal.
Ten Simple Rules for Writing a Literature Review:
1. Define a topic and audience
2. Search and re-search the literature
3. Take notes while reading
4. Choose the type of review you wish to write
5. Keep the review focused, but make it of broad interest
6. Be critical and consistent
7. Find a logical structure
8. Make use of feedback
9. Include your own relevant research, but be objective
10. Be up-to-date, but do not forget older studies
Ministry of Health Research Proposal Guideline 37
Citation Search Strategy
6. What is the Reason for Conducting this Study?
o Partial fulfilment of PhD / Masters / other academic programme*
o Component of research methodology or other formal training programme
o Collaborating as part of a multicentre study or international study.
o Scientific curiosity / problem solving interest, etc.
o Professional (personal) advancement.
*Please specify the academic programme (Bachelor’s, Master’s, PhD)
7. Statements Related to the Problem
7.1 Statement of the problem that prompted the need to conduct this study (In 2-3 sentences):
How did you search for the background and foreground information on your research topic?
State the search terms/MeSH headings/Keywords and the internet search engines used to
acquire the reference material. (E.g.: PubMed, Google Scholar, MedlinePlus, UpToDate,
Embase, Cochrane Collaboration etc.)
Do not list individual web address from where references are cited.
The researcher should justify his selection of the research problem to convince
others about the importance of the problem or why the situation needs to be
investigated. For example, you may have observed that childhood diarrhea is
more common among children in one geographic area within the catchment area
covered by the health facility you are working in.
Ministry of Health Research Proposal Guideline 38
7.2 What is the primary research question?
7.2 State the scientific hypothesis.
7.3 What is the specific aim of this study? (State in one or two sentences)
7.4 What are the specific objectives of the study that will help to achieve the stated aim? (1 to
3 listing)
Research questions are posed when one wants to estimate a phenomenon in a
population, to compare a phenomenon in several populations, to evaluate the
effect of an intervention, to assess the expected relationships between two or more
variables or to determine risk factors for an outcome/disease. The research
question should be answerable by the planned research. It should be specific,
measurable, achievable, relevant and time bound (SMART).
Hypothesis is a statement about expected/conceptual relationships between two or
more independent variables and one dependent variable e.g. higher levels of field
health worker performance (independent variable) will lead to higher rates of
contraceptive acceptance among eligible couples (dependent variable)
Aim of a study is a general statement of what the study hopes to achieve within the
scope of the actual research. The aim should be clear and concise. For example in
the problem regarding childhood diarrhoea (mentioned earlier) the aim would be to
identify the common and preventable risk factors for the increased incidence of
childhood diarrhoea in that specific area. The specific objectives are the specific steps
taken to achieve the aim of the study.
Ministry of Health Research Proposal Guideline 39
7.5 Are there any secondary questions / hypotheses / aims that this research will attempt to
answer? If yes, list them out accordingly.
7.6 Are there any similar published studies locally, nationally, or internationally? If yes, justify
the need to replicate this study.
8. What Kind of Research Will be Conducted?
(The Applicant is advised to fill up the appropriate form. Click here (Algorithm is in the next
page) to view the algorithm to help guide you in the choosing the right form. If still in doubt,
the applicant is encouraged to preview each of the forms so that the most appropriate form that
will elicit suitable responses from the study to most of the items in the form can be used.)
8.0 What is the specific category to which the proposed Clinical Study can be classified?
(Check the most appropriate box.) {Logic based selection}
o A- Clinical Research
o B - Qualitative Research
o C - Non - Clinical Quantitative
o D - Mixed/Other Research Designs
8.1 Will the study group be subjected to an intervention as part of the research?
Yes (A1) No
e.g.: any therapy including medication, surgery, training, instruction etc. as part of the research
intervention?
8.2 Is your study a Case-control study or a Cohort Study?
Case-control (A2) Cohort (A3)
Case-control (retrospective observational) or Cohort study (prospective observational)?
Ministry of Health Research Proposal Guideline 40
Research Algorithm
The Applicant will have to choose the form most applicable to the design of
the proposed research study. This algorithm is a short guide to aid the
researcher in selecting the right form to be filled. It lists the most common
types of research and categorises it according to the main study designs.
Ministry of Health Research Proposal Guideline 41
Research Algorithm (Choosing the suitable Form to be filled)
Quantitative Qualitative/Quantitative
Qualitative
Interventional Observational
Clinical Trials
Form A1
Case-
Control
Studies
Form A2
Cohort
Studies
Form
A3
Non-Clinical Quantitative
Form C
Mixed / Other Research Designs
Form D
Pure qualitative design
Form B
Clinical trials of
investigational
medicinal
products
Clinical
investigations
or other studies
of medical
devices
Clinical trial of
a drug/device
combination
Other clinical
trials or clinical
investigations
Basic science
study involving
procedures with
human
participants
Studies to
determine aetiology
or causation of
diseases
Studies to
determine
prognosis after an
intervention or
exposure to an
agent or a factor
Study administering
questionnaires/interviews, KAP
studies for qualitative or
quantitative analysis
Exploratory Observational study –
involving patients /clients of health
service
Covert or overt observational
research/surrogate research with
analysis
Surveys and observations on
Clients, health professionals,
members of public or other persons
of interest
Clinical audit, audit of any service
through anonymous aggregate data
Observation or assessment of
health systems
Review and Analysis of stored
clinical data in Health records
without directly evaluating patients
(Use Form A-2 if clinical record
review is by Case-control or Form
A-3 if Cohort Study design)
Study incorporating aspects of
qualitative and quantitative
research, either simultaneously
or sequentially
Study limited to working with
human tissue samples and/or
analysis of data on them
Research confined to material in
blood or other tissue bank
Research or case records
database
Evaluation of a diagnostic test
Other research (not involving
direct human intervention)
Research using surplus or
existing samples unidentifiable
by the researcher
Economic Analysis
Decision Analysis
Study involving
qualitative methods
only:
Phenomenology
Ethnography
Grounded
Theory
Historical
Research
Critical Inquiry
Discourse
Analysis
Ministry of Health Research Proposal Guideline 42
Form A1: Clinical
Trials
This section is to be used if any intervention or experiments are to be
carried out on human participants as part of the research.
Note: Please refer to the ‘Guidelines for Responsible Conduct of Clinical
Studies & Trials’ booklet on the website homepage.
Ministry of Health Research Proposal Guideline 43
9. Study Group Recruitment
9.1 What is the source / reference / target Population for the purpose of this study?
9.2 Who are the accessible participants (to be drawn from the source / reference / target
population) who are under consideration for the study?
9.3: How will the potential study participants be accessed / invited to participate in the study
from the accessible population?
9.4: Specify the inclusion criteria.
9.5: Specify the exclusion criteria.
Target / Reference population: The group of people to whom we want our research
results to apply to
Study population: The people who meet our operational definition of the target
population
Research sample: The members of the study population from whom we collect our
data
Inclusion criteria: attributes of subjects that are essential for their selection to
participate. It should be broad enough to closely represent the target/reference
population. E.g. All persons living in a geographic area, all patients with a certain
disease or risk factor, all persons in a defined age group or gender or any such
specific attribute that are unique to the study
Exclusion criteria: attributes of subjects that warrants their non-inclusion in the
study. Such exclusion should not affect the generalisability of the study. Attributes
that can have a confounding effect on the study variables may be excluded. E.g.
extremes of age, presence of certain risk factors or disease or a physiologic state like
pregnant women, etc.
Ministry of Health Research Proposal Guideline 44
9.6 After applying the inclusion / exclusion criteria, does the selected study population closely
represent the source / reference / target population such that the study findings and conclusions
will apply to this population? (External validity). Briefly explain.
10. Sample Size Estimate of the Study / Experiment Group
10.1 What is the proposed sample size of the Study / Experimental group?
10.2 What is the basis for sample size calculation and how was it calculated? Indicate the
anticipated variability, margin of error, confidence level, effect size or other measures to justify
sample size.
10.3 Describe in detail the sampling process for the selection of Study / Experimental group
participants?
The extent to which a study's results (regardless of whether the study is descriptive or
experimental) can be generalized/applied to other people or settings reflects its external
validity. Typically, group research employing randomization will initially possess higher
external validity than will studies (e.g., case studies and single-subject experimental
research) that do not use random selection/assignment.
Ministry of Health Research Proposal Guideline 45
11. Study / Experiment Group Allocation
11.1 How will the eligible STUDY participants be enrolled / allocated to the study?
Random allocation Systematic
allocation
Convenient
allocation
All eligible
11.2 Describe briefly the allocation / randomization technique including any sub-categories
(block / strata etc.).
12. Control Group Recruitment
12.1 Will there be a Control or Comparison group?
12.2 What is the source / reference / target Population of Control or Comparison group?
12.3 Who are the accessible participants (to be drawn from the source / reference / target
population) who are under consideration for Control or Comparison group?
12.4 How will the potential Control or Comparison participants be accessed / invited to
participate in the study from the accessible population?
12.5 Specify the inclusion criteria.
12.6 Specify the exclusion criteria.
Ministry of Health Research Proposal Guideline 46
12.7 After applying the inclusion / exclusion criteria, does the selected Control or Comparison
group closely represent the source / reference / target population such that the study findings
and conclusions will apply to this population? (External validity). Briefly explain.
13. Sample Size Estimation of the Control / Comparison Group
13.1 What is the proposed sample size of the Control / Comparison group?
13.2 What is the basis for sample size calculation and how was it calculated? Will the number
be the same as in the Study / experiment group (1:1 ratio) or different? Explain / justify.
13.3 Describe in detail the sampling process for the selection of Control / Comparison group?
14. Control Group Allocation
14.1 How will the accessible control participants be enrolled / allocated to the study?
Random allocation Systematic
allocation
Convenient
allocation
All eligible
14.2 Describe briefly the allocation technique including any sub-categories (block/ strata etc.).
Ministry of Health Research Proposal Guideline 47
15. Baseline Characteristics Relevant to the Study
15.1 What are the baseline study factors (characteristics / parameters / variables) relevant to
the study that will be measured at the beginning of the study?
15.2 Should the study group and control group be similar at the beginning of the study? If yes,
what are the relevant measures of similarity (e.g.: age group, gender, severity of disease,
ethnicity, socio-economic status, BMI etc.)? Measure only those that can have a confounding
effect on the outcome factors.
15.3 Will there be more than one study group in this research? Describe in sufficient detail the
intervention in each study group that is planned to be carried out in this research.
16. Intervention
16.1 Is the intervention (medication, surgical procedure, training etc.) already in accepted
practice in the research location and / or approved as standard practice in the concerned
organization (e.g.: MoH)
Yes No
16.2 If No, justify its use. Include permission/approval from appropriate authority (including
ethical aspects for its use).
16.3 Describe in detail, the planned intervention in the experimental / study group.
Ministry of Health Research Proposal Guideline 48
16.4 Describe the intervention, if any, in the control group (e.g.: placebo, current therapy, other
intervention etc.).
16.5 Give the justification for the intervention, if any, in the control group.
16.6 What is the timeline / time gap / delay between randomization / allocation and starting of
intervention for each participant?
16.7 Is the intervention in the study group or control group likely to pose a potential risk to the
participant to any one of the following degree: - whether physical, psychological, spiritual,
social or economic?
Harm (including side effects or complication due to any intervention)
Discomfort (e.g.: pain, anxiety etc. from any intervention)
Inconvenience (including time, effort, finance etc. – either direct or indirect)
If yes, describe in detail the nature of the risk and how it will be taken care of in the study.
Ministry of Health Research Proposal Guideline 49
17. Informed Consent
17.1 Explain briefly how, when and by whom informed consent will be taken? How will it be
ensured that the consenter / participant has fully understood all the rights, duties and privileges
of consenting including the right to withdraw at any time and other inalienable rights that has
to be granted on account of the nature and process of the study?
17.2 Is there likely to be any perceived coercion / undue pressure (direct or indirect) or
incentive (material or otherwise) that may influence the participation in the study? Will there
be reimbursement for out of pocket expenses incurred by the participant? Will there be
compensation for any complication arising due to the participation in the study? Briefly explain
how these issues are addressed.
Informed consent is more than a form, it is also a process. Information must be
presented to enable persons to voluntarily decide whether or not to participate as
a research subject. Informed consent process must be a dialogue of the study’s
purpose, duration, experimental procedures, alternatives, risks, and benefits. The
process of consenting is ongoing and must be made clear to the subject that it is
his or her right to “withdraw” or “opt out” of the study or procedure at any time,
not just at the initial signing of paperwork. The location where the consent is
being discussed, the subject’s physical, emotional and psychological capability
must be taken into consideration when consenting a human subject. The
informed consent process should ultimately assure that the subject understands
and really “gets” what they are signing up for.
Ministry of Health Research Proposal Guideline 50
Note: Please attach a copy of the consent form and patient information sheet (in
‘Attachments’ section)
18. Blinding and Bias
18.1 Blinding and Masking: Will either the participant or the investigator know the
allocation? If blinding and masking are applied, describe briefly how it will be achieved. Who
and how will the allocation code be kept confidential?
18.2 Who will carry out the intervention? Will there be an intervention bias and how will it be
addressed?
A bias is a systematic error or deviation from the truth in results or inferences. Biases can
operate in either direction: different biases can lead to underestimation or overestimation
of the true intervention effect. Biases can vary in magnitude: some are small (and trivial
compared with the observed effect) and some are substantial (so that an apparent finding
may be entirely due to bias). Even a particular source of bias may vary in direction: bias
due to a particular design flaw (e.g. lack of allocation concealment) may lead to
underestimation of an effect in one study but overestimation in another study. It is usually
impossible to know to what extent biases have affected the results of a particular study
although there is good empirical evidence that particular flaws in the design, conduct and
analysis of randomized clinical trials lead to bias. Because the results of a study may in
fact be unbiased despite a methodological flaw, it is more appropriate to consider risk of
bias.
Ministry of Health Research Proposal Guideline 51
19. Co-intervention
Will there be any additional or associated intervention / therapy other than the principal
intervention in either the study group or control group (e.g.: other medication or any therapy
used concurrently for same or other clinical condition) that could influence the expected
outcome? If yes, how will it be monitored or its influence on the outcome be accounted for?
20. Contamination
Is the control participant likely to take a therapy intended for use by the study participant (e.g.:
self-medication, therapy from another practitioner etc.) or vice-versa? How will this be
monitored / controlled?
21. Confounders
Are there other known factors that could affect the outcome factors either directly or indirectly?
If yes, how will they be accounted or adjusted for?
Confounding: A situation in which the effect or association between an exposure and
outcome is distorted by the presence of another variable. Positive confounding (when
the observed association is biased away from the null) and negative confounding
(when the observed association is biased toward the null) both occur.
This can lead to erroneous conclusions about the relationship between the independent
and dependent variables. You deal with confounding variables by controlling them;
by matching; by randomizing; or by statistical methods.
Ministry of Health Research Proposal Guideline 52
22. Maintenance
What is the duration the participant will be followed up from intervention to outcome? What
is the follow up process? When will the participant be released from the study? Are there any
special adaptations in the study like cross-over design? Explain in detail.
23. Outcome
What are the main outcome factors that will be studied (as per the stated research question and
hypothesis)?
24. Outcome Measurement
24.1 Who will measure the outcome factors? Will the assessor be blind to the intervention
administered previously? How will potential measurement bias be managed?
24.2 Measuring instrument (Instrument used for outcome measurement): Describe how the
outcome of interest in the study will be gathered. Specify how the instrument will be evaluated
for Validity and Reliability.
24.3 Will there be an interim analysis? If yes, when and how will it become operational and
how will the result influence the further progress of the study?
Ministry of Health Research Proposal Guideline 53
24.4 Are all relevant clinical outcome being measured? Are any proxy measures used in place
of a clinical outcome? (e.g.: Reduction of serum lipid as a proxy for reduction in MI, smoking
cessation as a proxy for reduction of COPD or Lung cancer, compliance to taking medication
as a proxy for control of a chronic disease etc.) If yes, is that proxy measure a reasonable and
reliable measure of the true outcome? Explain.
24.5 Attrition: Indicate the measures to reduce attrition (drop outs / loss to or
incomplete follow up / failure to comply etc.) that may happen after
allocation or randomization to the study . How will these cases be
analyzed (e.g.: Intention-to-treat analysis, per protocol analysis, best
scenario response, worst scenario response, exclude from analysis etc.)
25. Data Synthesis and Management
Note: Please include a copy of the Data collection pro forma along with this proposal ( in
‘Attachments’ section)
25.1 Indicate the computer program that will be used for data entry and data analysis.
Attrition of the original sample represents a potential threat of bias if those who drop out
of the study are systematically different from those who remain in the study. The result is
that the remaining sample becomes different from the original sample, resulting in what is
known as attrition bias. However, if sample attrition over time is not systematic, meaning
that there are no unique characteristics among those who drop out, then there is no attrition
bias, even though the sample has decreased in size between waves of data collection. It is
important, then, for researchers who collect multiple waves of data to check for attrition
bias.
Ministry of Health Research Proposal Guideline 54
25.2 Indicate the likely statistical tests that will be performed in analysing the data (descriptive
and analytical tests as appropriate to the study and the nature of the collected data).
25.3 Quality Control Of Data: What steps will be taken to ensure quality control of the data
(data is properly collected, data entry is accurate, transcribed and decoded correctly, managed
appropriately etc.)?
25.4: How will the data analyst be blinded to the treatment allocation (triple blinding)?
26. Work Plan & Study Implications
26.1 Please describe your work plan / timetable / Gantt chart. (Alternatively, it can be attached
in ‘Attachments’ section)
26.2 What is the anticipated conclusion that may result from the study and how can it be used
to improve / enhance scientific knowledge, patient management, professional or administrative
practice or influence policy making? (Please note that conclusions from a study should be
entirely and exclusively based on the observed findings and results of the conducted study.
Conclusions should not extend into making recommendations that are subjective assumptions
that are not proven by the concluded study.)
Ministry of Health Research Proposal Guideline 55
26.3 Beneficiaries of the research: Who will be the potential beneficiaries of the study and its
application?
26.4 How will the conclusion drawn from the study be disseminated for use by the scientific /
professional / administrative community?
26.5 What are the potential shortcomings / limitations of the study?
26.6 Indicate the Priority and Importance of the study / research topic.
26.7 Is your chosen research topic part of the ‘Health Research Priorities’ as listed in the
booklet by the Ministry of Health? (Refer the booklet on the Home Page)
Yes No
If Yes, kindly mention to which priority topic your research is related to.
27. Ethical considerations
Highlight the ethical issues in the study and how they have been addressed. (Refer the ‘Ethical
Checklist’ for relevant particulars)
Ministry of Health Research Proposal Guideline 56
28. Additional Resource Utilisation
Will the research take up any additional resources of the department / hospital / health facility,
including but not limited to human resources, time, equipment, consumables, reagents,
investigations, bed occupancy, finances etc. If yes, list them. Has due permission been obtained
from the appropriate authority? (Please include letter of approval(s) in ‘Attachments’ section)
29. Pilot Study
29.1 Will a pilot study or pre-test be carried out prior to the main study? If yes, describe the
pilot study in sufficient detail and how it will help in the main study. If no pilot study is planned,
explain why a pilot study is not required / necessary.
30. Additional information
30.1. Any other additional information (if applicable)?
31. Research Grant
Are you planning to apply for a research grant through the Centre of Studies & Research of the
Ministry of Health?
Yes No
If Yes, please submit / attach the Budget Form. (For more details about research grants, refer
to the Health Research Funding Guideline on the homepage)
Ministry of Health Research Proposal Guideline 57
32. Attachments
Kindly attach all additional documents in this section (for multiple files in one section, kindly
zip the files and attach):
1. List of Abbreviations (if applicable)
2. Curriculum Vitae of the P.I.
3. Curriculum Vitae of the Co-P.I./s
4. Participation Information Sheet
5. Informed Consent for Research Participants
6. Letter of Endorsement for the Study / Institutional Approval
7. Letter from Supervisor (for supervised studies)
8. Letter from Sponsor (for sponsored studies)
9. Data Collection Tools / Instruments / Questionnaires
10. Sample Spreadsheet for data entry
11. Work plan / Timetable / Gantt chart
12. Other Information relating to the study
33. Declaration – To be signed by the Principal Investigator (P.I.)
If the research proposal is approved, I (we) declare that I (we) shall be actively engaged in,
control the project and agree to provide progress reports and the final report to the committee
for revision before final dissemination of it.
I (we) confirm that the details of this research proposal are a true representation of the research
to be undertaken. I (we) will ensure that the research does not deviate from the protocol
described. If significant protocol amendments are required as the research progresses, I (we)
shall submit these to the Research and Ethical Review & Approval Committee for final
approval.
I (we) shall ensure that only the analysis specified in the protocol will be performed on the
samples. If I (we) send patients’ blood, body fluids or tissues outside the country for analysis,
official permissions to do so will be obtained. Any unused or remaining samples will be
disposed as per laboratory guidelines for specimen disposal.
Signature: Date:
Ministry of Health Research Proposal Guideline 58
Form A2: Case-
Control Studies
Use this section if the research is a retrospective analytical study involving clinical
cases (e.g. patients) and controls. Case-control studies are usually employed to
estimate the strength of association between a clinical condition or an outcome of
interest with the prior exposure to a potential causal / risk factor.
If any of the items are not applicable to your study, please mention “NA” to indicate
Not Applicable in the corresponding response box. You should also add any
additional information that is pertinent or specific to your study in the section
provided for it.
Ministry of Health Research Proposal Guideline 59
9. Study Group / Cases
9.1 Specify the criteria used to define a CASE as a case in the study (e.g. clinical diagnosis, disease
specific characteristic, outcome of interest, etc.).
10. Target Population of Cases
10.1 What are the Source / Reference / Target population of CASES for the purpose of the study?
10.2 Who are the accessible participants (to be drawn from the source / reference population) who
are under consideration for the study?
10.3 How will the potential study participants (CASES) be accessed / invited to participate in the
study from the accessible population?
Target / Reference population: The group of people to whom we want our research results
to apply to
Study population: The people who meet our operational definition of the target population
Research sample: The members of the study population from whom we collect our data
Ministry of Health Research Proposal Guideline 60
10.4 Specify the inclusion criteria.
10.5 Specify the exclusion criteria.
10.6 After applying the inclusion / exclusion criteria, does the selected study population of CASES
closely represent the source / reference /target population such that the study findings and
conclusions will apply to the reference population? (External validity). Briefly explain.
Inclusion criteria: attributes of subjects that are essential for their selection to
participate. It should be broad enough to closely represent the target/reference
population. E.g. All persons living in a geographic area, all patients with a certain
disease or risk factor, all persons in a defined age group or gender or any such specific
attribute that are unique to the study
Exclusion criteria: attributes of subjects that warrants their non-inclusion in the study.
Such exclusion should not affect the generalisability of the study. Attributes that can
have a confounding effect on the study variables may be excluded. E.g. extremes of
age, presence of certain risk factors or disease or a physiologic state like pregnant
women, etc.
The extent to which a study's results (regardless of whether the study is descriptive or
experimental) can be generalized/applied to other people or settings reflects its external
validity. Typically, group research employing randomization will initially possess higher
external validity than will studies (e.g., case studies and single-subject experimental research)
that do not use random selection/assignment.
Ministry of Health Research Proposal Guideline 61
11. Sample Selection of Cases
11.1 How will the required sample be selected from eligible CASES?
Random sample Systematic sample Convenient sample All eligible cases
11.2 Describe briefly the sampling technique including any sub-categories.
12. Sample Size Estimation of the Cases
12.1 What is the proposed sample size?
12.2 What is the basis for sample size calculation and how was it calculated? Indicate the
anticipated variability, margin of error, confidence level, effect size or other measures to justify
sample size.
12.3 What are the baseline study factors (characteristics / parameters / variables) relevant to the
study that will be measured at the beginning of the study?
Ministry of Health Research Proposal Guideline 62
13. Study Group / Controls
Specify the criteria used to define a Control as a control in the study. (e.g. healthy individuals,
relatives of patients, persons/patients with different outcome or health conditions, etc.)
14. Selection of Controls
14.1 What is the Source / Reference / Target population of Controls for the purpose of the study?
14.2 Who are the accessible control participants (to be drawn from the source / reference
population) who are under consideration for the study?
14.3 How will the potential study participants (Controls) be accessed / invited to participate in the
study from the accessible population?
14.4 Specify the inclusion criteria.
14.5 Specify the exclusion criteria.
Ministry of Health Research Proposal Guideline 63
14.6 After applying the inclusion / exclusion criteria, does the selected study population of Controls
closely represent the source / reference /target population such that the study findings and
conclusions will apply to the reference population? (External validity). Briefly explain.
15. Sample Selection of Controls
15.1 How will the required sample be selected from eligible Controls?
Random sample Systematic sample Convenient sample All eligible controls
15.2 Describe briefly the sampling technique including any sub-categories.
16. Sample Size Estimation of the Control
16.1 What is the proposed sample size of the Control?
16.2 What is the basis for sample size calculation and how was it calculated? Indicate the
anticipated variability, margin of error, confidence level, effect size or other measures to justify
sample size.
Ministry of Health Research Proposal Guideline 64
16.3 What are the baseline study factors (characteristics / parameters / variables) relevant to the
study that will be measured at the beginning of the study?
16.4 How many controls will be selected for each case (e.g.: 1 Case to 4 Controls, 1: 1 etc.).
Indicate the justification and feasibility.
16.5 Is the study group and control group similar except for the outcome factor (e.g.: disease)?
What are the relevant measures of similarity that are to be matched between Cases and Controls
(e.g.: age group, gender, severity of disease, ethnicity, socio-economic status, BMI etc.)? Measure
only those that can have a confounding effect on the association between the study factors.
Ministry of Health Research Proposal Guideline 65
17. Informed Consent
17.1 Explain briefly how, when and by whom informed consent will be taken? How will it be
ensured that the consenter / participant has fully understood all the rights, duties and privileges of
consenting including the right to withdraw at any time and other inalienable rights that have to be
granted due to the nature of the study?
Note: Please attach a copy of the consent form (in ‘Attachments’ section)
17.2 Is there likely to be any perceived coercion / undue pressure (direct or indirect) or incentive
(material or otherwise) that may influence the participation in the study? Briefly explain how this
issue is addressed.
Informed consent is more than a form, it is also a process. Information must be
presented to enable persons to voluntarily decide whether or not to participate as a
research subject. Informed consent process must be a dialogue of the study’s
purpose, duration, experimental procedures, alternatives, risks, and benefits. The
process of consenting is ongoing and must be made clear to the subject that it is his
or her right to “withdraw” or “opt out” of the study or procedure at any time, not just
at the initial signing of paperwork. The location where the consent is being
discussed, the subject’s physical, emotional and psychological capability must be
taken into consideration when consenting a human subject. The informed consent
process should ultimately assure that the subject understands and really “gets” what
they are signing up for.
Ministry of Health Research Proposal Guideline 66
18. Outcome Measuring Instrument
Measuring instrument (Instrument used for determining OUTCOME [e.g.: disease] measurement):
Describe how the outcome of interest in the study will be gathered. Specify how the instrument
will be evaluated for Validity and Reliability.
19. Exposure Factors
19.1 What are the EXPOSURE factors that are to be studied (as specified in the hypothesis /
research question)?
19.2 What is the time period between exposure and outcome? Is it biologically reasonable?
19.3 Who will assess/evaluate exposure factors? How will exposure factors be estimated?
Ministry of Health Research Proposal Guideline 67
19.4 What are the potential biases in the estimation of the exposure? How will bias such as Recall
Bias be reduced?
A bias is a systematic error or deviation from the truth in results or inferences. Biases can
operate in either direction: different biases can lead to underestimation or overestimation of
the true intervention effect. Biases can vary in magnitude: some are small (and trivial
compared with the observed effect) and some are substantial (so that an apparent finding
may be entirely due to bias). Even a particular source of bias may vary in direction: bias
due to a particular design flaw (e.g. lack of allocation concealment) may lead to
underestimation of an effect in one study but overestimation in another study. It is usually
impossible to know to what extent biases have affected the results of a particular study
although there is good empirical evidence that particular flaws in the design, conduct and
analysis of randomized clinical trials lead to bias. Because the results of a study may in fact
be unbiased despite a methodological flaw, it is more appropriate to consider risk of bias.
Ministry of Health Research Proposal Guideline 68
20. Confounders
Are there other known risk factors that could affect the outcome factors either directly or
indirectly? If yes, how will they be accounted for?
21. Exposure Measuring Instrument
Measuring instrument (Instrument used for detrmining / estimating EXPOSURE [Risk factor]
measurement): Describe how the exposure/risk factors in the study will be gathered. Specify how
the instrument will be evaluated for Validity and Reliability.
22. Blinding
Will the person evaluating the Exposure be aware of the outcome status of the participant? How
will blinding of the Exposure evaluator to the outcome be achieved?
Confounding: A situation in which the effect or association between an exposure and
outcome is distorted by the presence of another variable. Positive confounding (when the
observed association is biased away from the null) and negative confounding (when the
observed association is biased toward the null) both occur.
This can lead to erroneous conclusions about the relationship between the independent
and dependent variables. You deal with confounding variables by controlling them; by
matching; by randomizing; or by statistical methods.
Ministry of Health Research Proposal Guideline 69
23. Data Synthesis and Management
Note: Please include a copy of the Data collection pro forma along with this proposal (in
‘Attachments’ section)
23.1 What are the important variables that will be collected & what are the nature/characteristics
of the variables (ordinal, nominal, continuous, categorical etc.)?
23.2 Indicate the computer program that will be used for data entry and data analysis.
23.3 Indicate the likely statistical tests that will be performed in analysing the data (Odds Ratio,
multivariate analysis, confidence levels, level of significance etc. to be used in analysing the data).
23.4 Quality Control of Data: What steps will be taken to ensure quality control of the data (data
is properly collected, data entry is accurate, transcribed and decoded correctly, managed
appropriately etc.)?
Ministry of Health Research Proposal Guideline 70
24. Work Plan & Study Implications
24.1 Please describe your work plan / timetable / Gantt chart. (Alternatively, it can be attached in
‘Attachments’ section)
24.2 What is the anticipated conclusion that may result from the study and how can it be used to
improve / enhance scientific knowledge, patient management, professional or administrative
practice or influence policy making? (Please note that conclusions from a study should be entirely
and exclusively based on the observed findings and results of the conducted study. Conclusions
should not extend into making recommendations that are subjective assumptions that are not
proven by the concluded study.)
24.3 Beneficiaries of the research: Who will be the potential beneficiaries of the study and its
application?
24.4 How will the conclusions of the study be disseminated for use by the scientific / professional
/ administrative community?
24.5 What are the potential shortcomings/limitations of the study?
Ministry of Health Research Proposal Guideline 71
24.6 Indicate the Priority and Importance of the study / research topic.
24.7 Is your chosen research topic part of the ‘Health Research Priorities’ as listed in the booklet
by the Ministry of Health?
Yes No
If Yes, kindly mention to which priority topic your research is related to.
25. Ethical Considerations
25.1 Highlight the ethical issues in the study and how they have been addressed. (Refer the ‘Ethical
Checklist’ for relevant particulars)
26. Additional Resource Utilisation
Will the research take up any additional resources of the department / hospital / health facility,
including but not limited to human resource, time, equipment, consumables, reagents,
investigations, bed occupancy, finances etc. If yes, list them. Will the research adversely affect
any of the normal services of the health facility? Has due permission been obtained from the
appropriate authority to use the resources of the health facility? (Please include letter of
approval(s) in ‘Attachments’ section)
Ministry of Health Research Proposal Guideline 72
27. Pilot Study
27.1 Pilot Study / Pre-test: Will there be a Pilot Study or a Pre-test of the questionnaire (data
gathering instrument) that will be used in this study. If yes, how, when, where and by whom it will
be done and how it may help the study. If no, justify why it is not required / necessary.
28. Additional Information
28.1 Any other additional information (if applicable)?
29. Research Grant
Are you planning to apply for a research grant through the Centre of Studies & Research of the
Ministry of Health?
Yes No
If Yes, please submit / attach the Budget Form. (For more details about research grants, refer to
the Health Research Funding Guideline)
30. Attachments
Kindly attach all additional documents in this section (for multiple files in one section, kindly zip
the files and attach):
1. List of Abbreviations (if applicable)
2. Curriculum Vitae of the P.I.
3. Curriculum Vitae of the Co-P.I./s
4. Participation Information Sheet
5. Informed Consent for Research Participants
6. Letter of Endorsement for the Study / Institutional Approval
Ministry of Health Research Proposal Guideline 73
7. Letter from Supervisor (for supervised studies)
8. Letter from Sponsor (for sponsored studies)
9. Data Collection Tools / Instruments
10. Sample Spreadsheet for data entry
11. Work plan / Timetable / Gantt chart
12. Other Information relating to the study
31. Declaration – To be Signed by the Principal Investigator (P.I.)
If the research proposal is approved, I (we) declare that I (we) shall be actively engaged in, control
the project and agree to provide progress reports and the final report to the committee for revision
before final dissemination of it.
I (we) confirm that the details of this research proposal are a true representation of the research to
be undertaken. I (we) will ensure that the research does not deviate from the protocol described. If
significant protocol amendments are required as the research progresses, I (we) shall submit these
to the Research and Ethical Review Committee for final approval.
I (we) shall ensure that only the analysis specified in the protocol will be performed on the samples.
If I (we) send patients’ blood, body fluids or tissues outside the country for analysis, official
permissions to do so will be obtained. Any unused or remaining samples will be disposed as per
laboratory guidelines for specimen disposal.
Signature: Date:
Ministry of Health Research Proposal Guideline 74
Form A3: Cohort
Studies
Use this section if the research is a prospective study involving participants who already
have an exposure of interest (risk factor) and who are to be followed up for a specified
period of time to determine if they manifest the anticipated outcome (e.g.: disease). Ideally,
a comparison cohort (control cohort) which does not have the exposure factor is also
followed up for the same period. Cohort studies are usually employed to estimate the
strength of association between an exposure / risk factor and the outcome.
If any of the items are not applicable to your study, please mention “NA” to indicate Not
Applicable in the corresponding response box. You should also add any additional
information that is pertinent or specific to your study in the section provided for it.
Ministry of Health Research Proposal Guideline 75
9. Study Cohort
Specify the criteria used to define the exposure or risk factor of the study cohort.
10. Target Population of Cohorts
10.1 What are the Source / Reference / Target population of cohorts for the purpose of the study?
(e.g. exposed people in a community/locality/region)
10.2 Who are the accessible participants (to be drawn from the source / reference / target
population) who are under consideration for the study? (e.g. people from the source population
attending an institution/service)
10.3: How will the potential study participants (cohort) be accessed / invited to participate in the
study from the accessible population of participants having the exposure / risk factor?
Target / Reference population: The group of people to whom we want our research results
to apply to
Study population: The people who meet our operational definition of the target population
Research sample: The members of the study population from whom we collect our data
Ministry of Health Research Proposal Guideline 76
10.4: Specify the inclusion criteria.
10.5: Specify the exclusion criteria.
10.6: After applying the inclusion / exclusion criteria, does the selected study population closely
represent the source / reference population such that the study findings and conclusions will apply
to the reference population? (External validity). Briefly explain.
Inclusion criteria: attributes of subjects that are essential for their selection to
participate. It should be broad enough to closely represent the target/reference
population. E.g. All persons living in a geographic area, all patients with a certain disease
or risk factor, all persons in a defined age group or gender or any such specific attribute
that are unique to the study
Exclusion criteria: attributes of subjects that warrants their non-inclusion in the study.
Such exclusion should not affect the generalisability of the study. Attributes that can
have a confounding effect on the study variables may be excluded. E.g. extremes of age,
presence of certain risk factors or disease or a physiologic state like pregnant women,
etc.
The extent to which a study's results (regardless of whether the study is descriptive or
experimental) can be generalized/applied to other people or settings reflects its external
validity. Typically, group research employing randomization will initially possess higher
external validity than will studies (e.g., case studies and single-subject experimental research)
that do not use random selection/assignment.
Ministry of Health Research Proposal Guideline 77
11. Sample Size Estimation of the Cohort Group
11.1: What is the proposed sample size of the COHORT group?
11.2 What is the basis for sample size calculation and how was it calculated? Indicate the
anticipated variability, margin of error, confidence level, effect size or other measures to justify
sample size.
12. Enrolment of the Cohort Participants
12.1 How will the cohort of eligible participants be enrolled / allocated to the study?
Random sample Systematic sample Convenient sample All eligible
12.2 Describe briefly the sampling technique of the study cohort (if applicable).
13. Control / Comparison Cohort
13.1 Will the study include a CONTROL / COMPARISON group of participants who do not have
the EXPOSURE factor under study?
Ministry of Health Research Proposal Guideline 78
13.2 What is the source / reference / target Population for the purpose of Control or Comparison
group?
13.3 Who are the accessible participants (to be drawn from the source / reference / target
population) who are under consideration for Control or Comparison group?
13.4 How will the potential Control or Comparison participants be accessed / invited to participate
in the study from the accessible population?
13.5 Specify the inclusion criteria.
13.6 Specify the exclusion criteria.
13.7: After applying the inclusion / exclusion criteria, does the selected Control or Comparison
group closely represent the source / reference / target population such that the study findings and
conclusions will apply to this population? (External validity). Briefly explain.
14. Sample Size Estimation of the Control / Comparison Group
14.1 What is the proposed sample size of the Control / Comparison group?
Ministry of Health Research Proposal Guideline 79
14.2 What is the basis for sample size calculation and how was it calculated? Will the number be
the same as in the cohort group (1:1 ratio) or different? Explain / justify.
14.3 Describe in detail the sampling process for the selection of Control / Comparison group?
15. Control Group Allocation
15.1 How will the accessible control participants be enrolled / allocated to the study?
Random allocation Systematic allocation Convenient allocation All eligible
15.2 Describe briefly the allocation technique including any sub-categories (block/ strata etc.).
16. Matching
Is the study cohort and control cohort similar except for the exposure / risk factor? What are the
relevant measures of similarity that are to be matched between study cohort and control cohort
(e.g.: age group, gender, severity of exposure, ethnicity, socio-economic status, BMI etc.)?
Measure / match only those that can have a significant confounding effect on the association
between exposure and outcome factors.
Ministry of Health Research Proposal Guideline 80
17. Informed Consent
17.1 Explain briefly how, when and by whom informed consent will be taken? How will it be
ensured that the consenter / participant has fully understood all the rights, duties and privileges of
consenting including the right to withdraw at any time and other inalienable rights that has to be
granted on account of the nature and process of the study?
Note: Please attach a copy of the consent form (in ‘Attachments’ section)
17.2 Is there likely to be any perceived coercion / undue pressure (direct or indirect) or incentive
(material or otherwise) that may influence the participation including retention in the study?
Briefly explain how this issue is addressed.
Informed consent is more than a form, it is also a process. Information must be
presented to enable persons to voluntarily decide whether or not to participate as a
research subject. Informed consent process must be a dialogue of the study’s
purpose, duration, experimental procedures, alternatives, risks, and benefits. The
process of consenting is ongoing and must be made clear to the subject that it is his
or her right to “withdraw” or “opt out” of the study or procedure at any time, not just
at the initial signing of paperwork. The location where the consent is being
discussed, the subject’s physical, emotional and psychological capability must be
taken into consideration when consenting a human subject. The informed consent
process should ultimately assure that the subject understands and really “gets” what
they are signing up for.
Ministry of Health Research Proposal Guideline 81
18. Exposure Measuring Instrument
18.1 (Instrument used for EXPOSURE / RISK measurement): Describe how the exposure factor
of interest in the study will be gathered. Specify how the instrument will be evaluated for Validity
and Reliability.
18.2 What are the outcome factors / disease that are to be studied?
19. Outcome Measuring Instrument
(Instrument used for OUTCOME / DISEASE): Describe how the disease / outcome of interest in
the study will be gathered. Specify how the instrument will be evaluated for Validity and
Reliability.
Ministry of Health Research Proposal Guideline 82
20. Confounders
Are there other known risk factors that could affect the outcome factors either directly or
indirectly? If yes, how will they be accounted for?
21. Modification and Follow-Up
21.1 Exposure Modification: If the risk / exposure being studied is on-going through the study
period, can a change in the magnitude or nature of the exposure / risk after recruitment and group
allocation, result in effect modification? How will this be taken care of in assessing the association
between exposure and disease? (e.g. smoking and lung disease, diet and ischaemic heart disease
etc.)
21.2 Effect Modifier: During the period of follow up / observation, could there be any intervention
/ therapy in either the study group or control group (e.g.: medication or any therapy used
concurrently for any clinical condition) that could influence the expected outcome? If yes, how
will it be monitored or its influence on the outcome be accounted for?
Confounding: A situation in which the effect or association between an exposure and
outcome is distorted by the presence of another variable. Positive confounding (when the
observed association is biased away from the null) and negative confounding (when the
observed association is biased toward the null) both occur.
This can lead to erroneous conclusions about the relationship between the independent
and dependent variables. You deal with confounding variables by controlling them; by
matching; by randomizing; or by statistical methods.
Ministry of Health Research Proposal Guideline 83
21.3 What is the duration of follow-up of each study participant? Is it a biologically reasonable
time period for the exposure or risk factor to cause the disease or the outcome under consideration?
22. Outcome Measures
22.1 Will the beneficial final outcome measure be substituted by a proxy measure (e.g. reduction
of serum lipid as a proxy for reduction in MI, smoking cessation as a proxy for reduction of COPD
or lung cancer, compliance to taking medication as a proxy for cure from a chronic disease etc.).
If yes, is that proxy measure a reasonable and reliable measure of the outcome? Explain.
22.2 When, How and by whom will the outcome factors be estimated?
A bias is a systematic error or deviation from the truth in results or inferences. Biases can
operate in either direction: different biases can lead to underestimation or overestimation of
the true intervention effect. Biases can vary in magnitude: some are small (and trivial
compared with the observed effect) and some are substantial (so that an apparent finding may
be entirely due to bias). Even a particular source of bias may vary in direction: bias due to a
particular design flaw (e.g. lack of allocation concealment) may lead to underestimation of an
effect in one study but overestimation in another study. It is usually impossible to know to
what extent biases have affected the results of a particular study although there is good
empirical evidence that particular flaws in the design, conduct and analysis of randomized
clinical trials lead to bias. Because the results of a study may in fact be unbiased despite a
methodological flaw, it is more appropriate to consider risk of bias.
Ministry of Health Research Proposal Guideline 84
22.3 What are the potential biases in the estimation of the outcome? How will measurement bias
be reduced?
23. Attrition
Indicate the measures to reduce attrition (drop outs / loss to or incomplete follow up) that may
happen after allocation to the study. How will these cases be analysed?
24. Blinding
Will the person evaluating the outcome be aware of the exposure status of the subject? How will
blinding of the outcome evaluator to the exposure be achieved?
Attrition of the original sample represents a potential threat of bias if those who drop out of
the study are systematically different from those who remain in the study. The result is that the
remaining sample becomes different from the original sample, resulting in what is known as
attrition bias. However, if sample attrition over time is not systematic, meaning that there are
no unique characteristics among those who drop out, then there is no attrition bias, even though
the sample has decreased in size between waves of data collection. It is important, then, for
researchers who collect multiple waves of data to check for attrition bias.
Ministry of Health Research Proposal Guideline 85
25. Data Synthesis and Management
Note: Please include a copy of the Data collection pro forma along with this application (in
‘Attachments’ section)
25.1 Indicate the computer program that will be used for data entry and data analysis.
25.2 Indicate the likely statistical tests that will be performed in analysing the data (Relative Risk,
multivariate analysis, confidence levels, level of significance etc.) to be used in analysing the data.
25.3 Quality Control of Data: What steps will be taken to ensure quality control of the data (data
is properly collected, data entry is accurate, transcribed and decoded correctly, managed
appropriately etc.)?
25.4 When analysing the potential association between exposure and outcome, how will the data
analyst be blinded to the exposure status (Study cohort or control cohort)?
Ministry of Health Research Proposal Guideline 86
26. Work Plan & Study Implications
26.1 Please describe your work plan / timetable / Gantt chart. (Alternatively, it can be attached in
‘Attachments’ section)
26.2: What is the anticipated conclusion that may result from the study and how can it be used to
improve / enhance scientific knowledge, patient management, professional or administrative
practice or influence policy making? (Please note that conclusions from a study should be entirely
and exclusively based on the observed findings and results of the conducted study. Conclusions
should not extend into making recommendations that are subjective assumptions that are not
proven by the concluded study.)
26.3 Beneficiaries of the research: Who will be the potential beneficiaries of the study and its
application?
26.4 Dissemination of the study findings and recommendations: How will the outcome of the
study be disseminated for use by the scientific and professional communities?
26.5 What are the potential shortcomings / limitations of the study?
Ministry of Health Research Proposal Guideline 87
26.6 Indicate the Priority and importance of the study / research topic.
26.7 Is your chosen research topic part of the ‘Health Research Priorities’ as listed in the booklet
by the Ministry of Health? (Refer to the booklet in the Home Page)
Yes No
If Yes, kindly mention to which priority topic your research is related to.
27. Ethical Considerations
Highlight the ethical issues in the study and how they have been addressed. (Refer the ‘Ethical
Checklist’ for relevant particulars)
28. Additional Resource Utilisation
Will the research take up any additional resources of the department / hospital / health facility,
including but not limited to human resource, time, equipment, consumables, reagents,
investigations, bed occupancy, finances etc. If yes, list them. Will the research adversely affect
any of the normal services of the health facility? Has due permission been obtained from the
appropriate authority to use the resources of the health facility? (Please include letter of
approval(s) in ‘Attachments’ section)
Ministry of Health Research Proposal Guideline 88
29. Pilot Study
29.1 Pilot Study / Pre-test: Will there be a Pilot Study or a Pre-test of the questionnaire (data
gathering instrument) that will be used in this study. If yes, how, when, where and by whom it will
be done and how it may help the study. If no, justify why it is not required/necessary.
30. Additional Information
30.1 Any other additional information (if applicable)?
31. Research Grant
31.1 Are you planning to apply for a research grant through the Centre of Studies & Research of
the Ministry of Health?
Yes No
If Yes, please submit / attach the Budget Form. (For more details about research grants, refer to
the Health Research Funding Guideline)
32. Attachments
Kindly attach all additional documents in this section (for multiple files in one section, kindly zip
the files and attach):
1. List of Abbreviations (if applicable)
2. Curriculum Vitae of the P.I.
3. Curriculum Vitae of the Co-P.I./s
4. Participation Information Sheet
5. Informed Consent for Research Participants
Ministry of Health Research Proposal Guideline 89
6. Letter of Endorsement for the Study / Institutional Approval
7. Letter from Supervisor (for supervised studies)
8. Letter from Sponsor (for sponsored studies)
9. Data Collection Tools / Instruments
10. Sample Spreadsheet for data entry
11. Work plan / Timetable / Gantt chart
12. Other Information relating to the study
33. Declaration – To be Signed by the Principal Investigator (P.I.)
If the research proposal is approved, I (we) declare that I (we) shall be actively engaged in, control
the project and agree to provide progress reports and the final report to the committee for revision
before final dissemination of it.
I (we) confirm that the details of this research proposal are a true representation of the research to
be undertaken. I (we) will ensure that the research does not deviate from the protocol described. If
significant protocol amendments are required as the research progresses, I (we) shall submit these
to the Research and Ethical Review & Approval Committee for final approval.
I (we) shall ensure that only the analysis specified in the protocol will be performed on the samples.
If I (we) send patients’ blood, body fluids or tissues outside the country for analysis, official
permissions to do so will be obtained. Any unused or remaining samples will be disposed as per
laboratory guidelines for specimen disposal.
Signature: Date:
Ministry of Health Research Proposal Guideline 90
Form B: Qualitative
Research
Use this form if the proposed research is a purely QUALITATIVE study. Observation
methods could be qualitative but the results can also be analysed statistically.
Please fill in all the responses that are applicable to your specific study. If any of the
items are not applicable to your study, please mention “NA” to indicate Not
Applicable in the corresponding response box. You should also add any additional
information that is pertinent or specific to your study in the section provided for it.
Ministry of Health Research Proposal Guideline 91
Introduction
A summary of the major qualitative philosophies, methodologies and approaches
Philosophy Methodologies Methods of Data Collection
Interpretivism
(Seeks to
understand)
Phenomenology
(Seeks to understand people’s
individual experiences and
interpretations of their world)
Interviews
Focus Group Discussions (FGDs)
Ethnography
(Seeks to understand the social
meaning of activities, rituals and
events in a culture)
Participant Observations
Interviews
Grounded Theory
(Seeks to develop theory based on
both an inductive [creative] and a
deductive [logical or empirical]
approach. Data is collected and
analysed, and then a theory is
developed that is grounded in the
data)
Participants Observations
Interviews
Historical Research
(Seeks not only to discover the events
of the past but to relate these past
happenings to the present and to the
future. Historical studies concern the
identification, location, evaluation,
and synthesis of data from the past.
Historical research Primary sources
should be used in historical research
when possible. There are many
examples of primary sources: oral
histories, written records, diaries,
eyewitnesses, pictorial sources, and
physical evidence)
Private letters
Personal and professional journals
Books, magazines, newspapers
Ministry of Health Research Proposal Guideline 92
Critical
Inquiry
(Seeks to
change)
Action Research
(Seeks action to improve practice and
study the effects of the action that
was taken. The purpose action
research is to identify facilitators and
barriers)
Participative group work
Interviews
Reflective Journals
(Quantitative methods may be
added)
Feminist Research
(Seeks to create social change
specifically to benefit women from a
feminist perspective)
In-depth interviews
Focus groups
(Quantitative methods may be
added)
Discourse Analysis
(Assumes that language constructs
what we think about ourselves, our
experiences, our world, and how we
relate to each other)
Study of written text and
communications such as policies
9. Study Design
Describe the research design that is specific to this study. Provide details about the research
approach that will be employed and list the procedural steps which will be used in the study.
Strengths and weaknesses of the design should also be discussed in this section.
10. Research Strategy
Specify the research strategy which will be used in the study. Provide details about the
characteristics and the selection of participants, how access to the participants will be done and
describe the setting in detail, and how the data will be collected (including need for training of data
collectors).
Ministry of Health Research Proposal Guideline 93
11. Data Collection Methods
Provide a description of any interview schedules, observation check lists, focus group discussions
(FGDs), or documentation to be collected along with examples attached. Intention to tape
record/videotape or use photographs must be stated.
Note: Please include a copy of the Data collection pro forma / Instrument along with this
proposal (in ‘Attachments’ section)
12. Sampling
What is the sampling technique used? (e.g: Snow ball; Homogenous; extreme deviant; maximum
variation; intensity or criterion (standard))
13. Methodological considerations
Indicate aspects of trustworthiness in qualitative research methods which are essential (such as
Credibility, Transferability. Dependability and Conformability).
Ministry of Health Research Proposal Guideline 94
14. Data Analysis
Specify how qualitative content analyses will be applied.
15. Pilot Study
Will there be a Pre-test / Pilot study? If yes, describe how it will be done (giving type and
number of participants, the data collection tool, the setting, what will be done with the results, and
whether it will be included or not in the main study).
16. Data Synthesis and Management
16.1 Provide explanations about tape recording/videotaping management including the
management of written transcripts, photographs, or field notes which will be done in the study.
The secure handling of multiple documents including use of computer software packages (if used
such as Nvivo) to manage the data for transcription and coding should be described. The plan for
destroying the data (hard and soft copies) should be given.
16.2 Based on the available data if any descriptive and/or analytical tests can be done as
appropriate for the purpose of the study, kindly indicate in the box below. (N/A if not applicable)
Ministry of Health Research Proposal Guideline 95
17. Quality Control of Data
In addition to trustworthiness, what steps will be taken to ensure the quality of the data including
transcription of tape/video recordings? Statements of how the accuracy of the transcripts will be
checked, how the data will be verified, analysed, synthesized, interpreted, and how the
interpretations will be validated should be mentioned.
18. Ethical Considerations*
18.1 In this section, ethical issues must be critically considered including confidentiality and
anonymity, informed consent, the researcher – participant relationship (power, exploitation and
coercion), sensitive issues including support put in place if the participants are disturbed the
nature of the research. Please refer to the guidelines below.
Topic Guiding questions Yes No
Phenomenon
of interest
1. Is the research study relevant, important and
best studied using a qualitative method?
2. Is there any aspect of the research that could
be misleading?
3. Are there benefits in doing this research?
Review of the
literature
1. Has all the available literature been
reviewed?
2. Are all citations accurate in terms of quoting
and referencing?
3. Has the reason for including the article been
made explicit?
Participants 1. Is the well-being of the participants protected
(physically and psychologically)?
Ministry of Health Research Proposal Guideline 96
2. Is there evidence that informed consent has
been obtained and freely given?
3. If the participants are vulnerable is there
adequate explanation of how they were
recruited and protected?
Sampling
1. Will the confidentiality of the participants be
assured?
2. Is there evidence of coercion or deception?
3. Is there any payment or compensation being
paid to participants?
Data
generation
1. Will all the data collectors be trained and
prepared?
2. Is the credibility of the data assured?
3. Is there any evidence of bias in data
collection?
4. Is any data being collected covertly i.e. not
openly shown or hidden?
5. Is there evidence that the participants will be
clear about what the data will be used for?
6. Is there a clear mechanism for ensuring
authenticity and trustworthiness of the data?
Data
Analysis
1. Will data analysis be undertaken by more
than one person?
2. Is there evidence to ensure there will be no
data manipulation?
Conclusions
1. Is there a clear process describing how the
findings (interpretations) will be validated?
2. Is there a clear process to ensure that
confidentiality will be maintained when the
findings are presented?
Ministry of Health Research Proposal Guideline 97
*You should use the guideline for assistance however you must ensure you have
explained all the above further either in your full proposal or below in this section
18.2 Highlight the ethical issues in the study and how they have been addressed. (Refer the
‘Ethical Checklist’ for relevant particulars)
19. Informed Consent
Explain briefly how, when and by whom informed consent will be taken? How will it be
ensured that the consenter / participant has fully understood all the rights, duties and privileges
of consenting including the right to withdraw at any time and other inalienable rights that have
to be granted due to the nature of the study?
Informed consent is more than a form, it is also a process. Information must be
presented to enable persons to voluntarily decide whether or not to participate as a
research subject. Informed consent process must be a dialogue of the study’s
purpose, duration, experimental procedures, alternatives, risks, and benefits. The
process of consenting is ongoing and must be made clear to the subject that it is his
or her right to “withdraw” or “opt out” of the study or procedure at any time, not just
at the initial signing of paperwork. The location where the consent is being
discussed, the subject’s physical, emotional and psychological capability must be
taken into consideration when consenting a human subject. The informed consent
process should ultimately assure that the subject understands and really “gets” what
they are signing up for.
Ministry of Health Research Proposal Guideline 98
20. Anticipated Results, Beneficiaries and Dissemination
20.1 What are the anticipated results that may result from the study? The relevance of the research
findings to action in practice or policy change should also be mentioned. (Anticipated results
means what the end point of the research will be, for example – themes related to the phenomenon
will be presented; an exhaustive description will be presented; theory will be developed;
description of a culture will emerge, etc.)
20.2 Beneficiaries of the Research Results: Who will be the potential beneficiaries of the study
and its application?
20.3 Dissemination of findings, conclusions and recommendations: How will the outcome of the
study be disseminated for the benefit of the scientific and professional community? (For example
– a report, a conference presentation (national/international), a workshop, peer reviewed
publication. Mention should also be made about managing dissemination of the findings to the
participants)
Ministry of Health Research Proposal Guideline 99
21. Work Plan & Study Implications
21.1 Please describe your work plan / timetable / Gantt chart. (Alternatively, it can be attached
in ‘Attachments’ section)
21.2 How will the administration and monitoring of research activities be carried out? (The
names of the administering, monitoring and supervising agencies/people should be given, for
example, University, College, School, Ministry, Hospital, mentors, advisors and/or supervisors.)
21.3 What are the potential shortcomings / limitations / constraints of the study?
21.4 Indicate the Priority and Importance of the study/research topic.
Ministry of Health Research Proposal Guideline 100
21.5 Is your chosen research topic part of the ‘Health Research Priorities’ as listed in booklet by
the Ministry of Health? (Refer the booklet on the Home Page)
Yes No
If Yes, kindly mention to which priority topic your research is related to.
21.6 Will the research take up any additional resources of the department / hospital / health facility,
including but not limited to human resource, time, equipment, consumables, reagents,
investigations, bed occupancy, finances etc. If yes, list them. Will the research adversely affect
any of the normal services of the health facility? Has due permission been obtained from the
appropriate authority to use the resources of the health facility? (Please include letter of
approval(s) in ‘Attachments’ section)
21.7 Any other additional information (if applicable)?
22. Research Grant
Are you planning to apply for a research grant through the Centre of Studies & Research of the
Ministry of Health?
Yes No
If Yes, please submit / attach the Budget Form. (For more details about research grants, refer to
the ‘Health Research Funding Guideline’)
Ministry of Health Research Proposal Guideline 101
23. Attachments
Kindly attach all additional documents in this section (for multiple files in one section, kindly zip
the files and attach):
1. List of Abbreviations (if applicable)
2. Curriculum Vitae of the P.I.
3. Curriculum Vitae of the Co-P.I./s
4. Participation Information Sheet
5. Informed Consent for Research Participants
6. Letter of Endorsement for the Study / Institutional Approval
7. Letter from Supervisor (for supervised studies)
8. Letter from Sponsor (for sponsored studies)
9. Data Collection Tools / Instruments
10. Sample spreadsheet for the Data entry
11. Work plan / Timetable / Gantt chart
12. Other Information relating to the study
24. Declaration – To be Signed by the Principal Investigator (P.I.)
If the research proposal is approved, I (we) declare that I (we) shall be actively engaged in, control
the project and agree to provide progress reports and the final report to the committee for revision
before final dissemination of it.
I (we) confirm that the details of this research proposal are a true representation of the research to
be undertaken. I (we) will ensure that the research does not deviate from the protocol described. If
significant protocol amendments are required as the research progresses, I (we) shall submit these
to the Research and Ethical Review Committee for final approval.
Signature: Date:
Ministry of Health Research Proposal Guideline 102
Form C: Non-Clinical
Quantitative
Please fill in all the responses that are applicable to your specific study. If
any of the items are not applicable to your study, please mention “NA” to
indicate Not Applicable in the corresponding response box. You should also
add any additional information that is pertinent or specific to your study in
the section provided for it.
Ministry of Health Research Proposal Guideline 103
9. Study Group
9.1 Define and briefly describe the population you plan to study (the source population who have
the characteristic of interest that is to be studied and not the general / national population).
9.2 Who are the accessible participants (to be drawn from the source / reference / target population)
who are under consideration for the study?
9.3 How will the potential study participants be accessed / invited to participate in the study from
the accessible population? (e.g.: Outpatient visits, home visits, telephone / letter /e-mail invitation,
website announcement etc.)
Target / Reference population: The group of people to whom we want our research results
to apply to
Study population: The people who meet our operational definition of the target population
Research sample: The members of the study population from whom we collect our data
Ministry of Health Research Proposal Guideline 104
9.4 Specify the inclusion criteria.
9.5 Specify the exclusion criteria.
10. Sample Size Estimation of the Study
10.1 What is the proposed sample size?
10.2 What is the basis for sample size calculation and how was it calculated? Indicate the
anticipated variability, margin of error, confidence level, effect size or other measures to justify
sample size.
Inclusion criteria: attributes of subjects that are essential for their selection to
participate. It should be broad enough to closely represent the target/reference
population. E.g. All persons living in a geographic area, all patients with a certain
disease or risk factor, all persons in a defined age group or gender or any such specific
attribute that are unique to the study
Exclusion criteria: attributes of subjects that warrants their non-inclusion in the study.
Such exclusion should not affect the generalisability of the study. Attributes that can
have a confounding effect on the study variables may be excluded. E.g. extremes of age,
presence of certain risk factors or disease or a physiologic state like pregnant women,
etc.
Ministry of Health Research Proposal Guideline 105
10.3 Describe in detail the sampling process (e.g.: sampling method, sample cluster, sample frame,
sampling unit etc. as applicable).
11. Study Group Allocation
11.1 How will the eligible participants be enrolled / allocated to the study?
Random sample Systematic sample Convenient sample All eligible
11.2 Describe briefly the sampling technique.
12. Control / Comparison Group
12.1 Will there be a control / comparison group? If yes, how will they be selected?
12.2 How will the potential control / comparison participants be selected from the accessible
population?
12.3 Specify the inclusion criteria for controls.
12.4 Specify the exclusion criteria for controls.
Ministry of Health Research Proposal Guideline 106
13. Sample Size Estimation of the Control / Comparison Group
13.1 What is the proposed sample size of the Control / Comparison group?
13.2 What is the basis for sample size calculation and how was it calculated? Will the number be
the same as in the Study / experiment group (1:1 ratio) or different? Explain / justify.
13.3 Describe in detail the sampling process for the selection of Study group participants?
14. Control Group Allocation
How will the accessible control / comparison participants be enrolled / allocated to the study?
Random sample Systematic sample Convenient sample All eligible
15. Measuring Instrument
Note: Please include a copy of the Data collection pro forma/ Instrument along with this
proposal (in ‘Attachments’ section)
15.1 How will the required data / information be collected with details? (e.g.: Interviewer
administered, self-administered, case records, other documents etc.)
Ministry of Health Research Proposal Guideline 107
15.2 Give details on who will collect the data / information?
15.3 Where (setting / location) and when (time-period) will the data be collected?
Where and when will the data be collected
15.4 Specify how the instrument will be evaluated for Validity and Reliability?
16. Pilot Study
Will there be a Pilot Study or Pre-test of the instrument? If yes, describe how it will be done (please
include target, number, purpose, what will be done with the results, and whether it will be included
or not in main study).
17. Data Collectors Training
Will the data collectors be trained on data collection? If yes, explain the process.
Ministry of Health Research Proposal Guideline 108
18. Informed Consent
18.1 Explain briefly how, when and by whom informed consent will be taken? How will it be
ensured that the consenter / participant has fully understood all the rights, duties and privileges of
consenting including the right to withdraw at any time and other inalienable rights that has to be
granted on account of the nature and process of the study?
Note: Please attach a copy of the consent form (in ‘Attachments’ section)
18.2 Is there likely to be any perceived coercion / undue pressure (direct or indirect) or incentive
(material or otherwise) that may influence the participation including retention in the study?
Briefly explain how this issue is addressed.
Informed consent is more than a form, it is also a process. Information must be
presented to enable persons to voluntarily decide whether or not to participate as a
research subject. Informed consent process must be a dialogue of the study’s purpose,
duration, experimental procedures, alternatives, risks, and benefits. The process of
consenting is ongoing and must be made clear to the subject that it is his or her right
to “withdraw” or “opt out” of the study or procedure at any time, not just at the initial
signing of paperwork. The location where the consent is being discussed, the
subject’s physical, emotional and psychological capability must be taken into
consideration when consenting a human subject. The informed consent process
should ultimately assure that the subject understands and really “gets” what they are
signing up for.
Ministry of Health Research Proposal Guideline 109
19. Attrition and Non-Compliance
19.1 Indicate the measures to reduce attrition / non-participation (drop outs / loss to
or incomplete data procured) or non-compliance or non-response that may
happen after allocation of the participant to the study. How will these instances be dealt with?
A bias is a systematic error or deviation from the truth in results or inferences. Biases can
operate in either direction: different biases can lead to underestimation or overestimation of
the true intervention effect. Biases can vary in magnitude: some are small (and trivial
compared with the observed effect) and some are substantial (so that an apparent finding may
be entirely due to bias). Even a particular source of bias may vary in direction: bias due to a
particular design flaw (e.g. lack of allocation concealment) may lead to underestimation of an
effect in one study but overestimation in another study. It is usually impossible to know to
what extent biases have affected the results of a particular study although there is good
empirical evidence that particular flaws in the design, conduct and analysis of randomized
clinical trials lead to bias. Because the results of a study may in fact be unbiased despite a
methodological flaw, it is more appropriate to consider risk of bias.
Attrition of the original sample represents a potential threat of bias if those who drop out of
the study are systematically different from those who remain in the study. The result is that the
remaining sample becomes different from the original sample, resulting in what is known as
attrition bias. However, if sample attrition over time is not systematic, meaning that there are
no unique characteristics among those who drop out, then there is no attrition bias, even though
the sample has decreased in size between waves of data collection. It is important, then, for
researchers who collect multiple waves of data to check for attrition bias.
Ministry of Health Research Proposal Guideline 110
19.2 Adjustment for potential bias: Identify potential bias (if any) that could affect the study.
How will they be avoided or reduced at the various stages in the study? (e.g.: Selection bias,
Measurement bias, Recall bias, etc.).
20. Data Synthesis and Management
20.1 Indicate the computer program that will be used for data entry and data analysis.
20.2 Indicate the likely statistical tests that will be performed (descriptive and analytical tests as
appropriate to the study and the nature of the collected data).
20.3 Quality Control Of Data: What steps will be taken to ensure quality control of the data (data
is properly collected, data entry is accurate, transcribed and decoded correctly, managed
appropriately etc.)?
21. Work Plan & Study Implications
21.1 Please describe your work plan / timetable / Gantt chart. (Alternatively, it can be attached in
‘Attachments’ section)
Ministry of Health Research Proposal Guideline 111
21.2 What is the anticipated conclusion that may result from the study and how can it be used to
improve / enhance scientific knowledge, professional or administrative practice or influence policy
making?
21.3 Beneficiaries of the research: Who will be the potential beneficiaries of the study and its
application?
21.4 What are the potential shortcomings / limitations of the study?
21.5 Dissemination of the study findings and recommendations: How will the outcome of the study
be disseminated for the benefit of the scientific and professional communities?
21.6 Indicate the Priority and Importance of the study / research topic.
21.7 Is your chosen research topic part of the ‘Health Research Priorities’ as listed in the booklet
by the Ministry of Health? ( Refer the booklet on the Home Page)
Yes No
If Yes, kindly mention to which priority topic your research is related to.
Ministry of Health Research Proposal Guideline 112
22. Ethical Considerations
22.1 Highlight the ethical issues in the study and how they have been addressed. (Refer the ‘Ethical
Checklist’ for relevant particulars)
23. Additional Resource Utilisation
23.1 Will the research take up any additional resources of the department / hospital / health facility,
including but not limited to human resource, time, equipments, consumables, reagents,
investigations, bed occupancy, finances etc. If yes, list them. Has due permission been obtained
from the appropriate authority? (Please include letter of approval(s) in ‘Attachments’ section)
23.2. Any other additional information (if applicable)?
24. Research Grant
Are you planning to apply for a research grant through the Centre of Studies & Research of the
Ministry of Health?
Yes No
If Yes, please submit / attach the Budget Form. (For more details about research grants, refer to
the Health Research Funding Guideline)
Ministry of Health Research Proposal Guideline 113
25. Attachments
Kindly attach all additional documents in this section (for multiple files in one section, kindly zip
the files and attach):
1. List of Abbreviations (if applicable)
2. Curriculum Vitae of the P.I.
3. Curriculum Vitae of the Co-P.I./s
4. Participation Information Sheet
5. Informed Consent for Research Participants
6. Letter of Endorsement for the Study / Institutional Approval
7. Letter from Supervisor (for supervised studies)
8. Letter from Sponsor (for sponsored studies)
9. Data Collection Tools / Instruments
10. Sample Spreadsheet of Data entry
11. Work plan / Timetable / Gantt chart
12. Other Information relating to the study
26. Declaration – To be Signed by the Principal Investigator (P.I.)
If the research proposal is approved, I (we) declare that I (we) shall be actively engaged in, control
the project and agree to provide progress reports and the final report to the committee for revision
before final dissemination of it.
I (we) confirm that the details of this research proposal are a true representation of the research to
be undertaken. I (we) will ensure that the research does not deviate from the protocol described. If
significant protocol amendments are required as the research progresses, I (we) shall submit these
to the Research and Ethical Review & Approval Committee for final approval.
I (we) shall ensure that only the analysis specified in the protocol will be performed on the samples.
If I (we) send patients’ blood, body fluids or tissues outside the country for analysis, official
permissions to do so will be obtained. Any unused or remaining samples will be disposed as per
laboratory guidelines for specimen disposal.
Signature: Date:
Ministry of Health Research Proposal Guideline 114
Form D: Mixed/Other
Research Designs
Use this section if the research is a mixed research incorporating aspects of qualitative and
quantitative research, either simultaneously or sequentially in the proposal. This form can
also be used if the study is proposed to be done in sequential phases. Studies of Diagnostic
tests, Economic analyses, Decision analyses etc. may also be used in this form; but if there are
any components that are specific to the study which are not covered in this form, it can be
brought out separately in the space provided.
Please note that if the study is done in phases and if any phase involves an intervention on
human participants, Form A1 should be used instead of this Form D.
Please fill in all the responses that are applicable to your specific study. If any of the items are
not applicable to your study, please mention “NA” to indicate Not Applicable in the
corresponding response box. You should also add any additional information that is pertinent
or specific to your study in the section provided for it.
Ministry of Health Research Proposal Guideline 115
9. Research Design and Methodology
Specify the research strategy (research design and methodology) that is unique / specific to this
study.
10. Study Population
10.1 Define and briefly describe the Population you plan to study (the source population who
have the characteristic of interest that is to be studied and not the general / national population)
10.2 Who are the accessible participants / study items to be drawn from the Source / Reference
/ Target population) who are under consideration for the study (e.g.: case records, disease registers,
telephone directory, tissue samples etc.)?
10.3 How will the potential study participants/items be accessed / invited to participate in the study
from the accessible population? (e.g.: Outpatient visits, home visits, telephone / letter / e-mail
invitation, website notification, case records, registers etc.)
Target / Reference population: The group of people to whom we want our research results
to apply to
Study population: The people who meet our operational definition of the target population
Research sample: The members of the study population from whom we collect our data
Ministry of Health Research Proposal Guideline 116
10.4 Specify the inclusion criteria.
10.5 Specify the exclusion criteria.
11. Sample Size Estimation
11.1 What is the proposed sample size?
11.2 What is the basis for sample size calculation and how was it calculated? Indicate the
anticipated variability, margin of error, confidence level, effect size or other measures to justify
sample size.
11.3 Describe in detail the sampling process (e.g.: sampling method, sample cluster, sample frame,
sampling unit etc. as applicable)
Inclusion criteria: attributes of subjects that are essential for their selection to
participate. It should be broad enough to closely represent the target/reference population.
E.g. All persons living in a geographic area, all patients with a certain disease or risk
factor, all persons in a defined age group or gender or any such specific attribute that are
unique to the study
Exclusion criteria: attributes of subjects that warrants their non-inclusion in the study.
Such exclusion should not affect the generalisability of the study. Attributes that can have
a confounding effect on the study variables may be excluded. E.g. extremes of age,
presence of certain risk factors or disease or a physiologic state like pregnant women, etc.
Ministry of Health Research Proposal Guideline 117
12. Study Group Allocation
12.1 How will the eligible participants/study items be enrolled / allocated to the study?
Random sample Systematic sample Convenient sample All eligible
12.2 Describe briefly the allocation / randomization technique.
13. Control / Comparison Group
13.1 Will there be a Control / comparison group? If yes, how will they be selected?
13.2 How will the potential control / comparison participants be selected from the accessible
population?
13.3 Specify the inclusion criteria for controls.
13.4 Specify the exclusion criteria for controls.
13.5 How will the accessible control / comparison participants be enrolled / allocated to the study
Random sample Systematic sample Convenient sample All eligible
Ministry of Health Research Proposal Guideline 118
14. Measuring Instrument
14.1 How will the required data / information be collected with details? (e.g.: Interviewer
administered, self-administered, case records, laboratory tests, clinical images, financial records
etc.)
14.2 How and by whom will the data / information be collected?
14.3 Where (setting / location) and when (time-period) will the data be collected?
14.4 Specify how the instrument that will be used for data collection will be evaluated for Validity,
Reliability and Applicability.
Ministry of Health Research Proposal Guideline 119
15. Gold Standard / Benchmark
15.1 Will there be a comparison with a known standard or gold standard or benchmark? If yes,
describe.
16. Pilot Study
16.1 Will there be a Pilot Study or Pre-test of the instrument? If yes, describe how it will be done
(please include target, number, purpose, what will be done with the results, and whether it will be
included or not in main study).
17. Data Collectors Training
17.1 Will the data collectors be trained on data collection? If yes, explain the process.
Note: Please include a copy of the Data collection pro forma/ Instrument along with this
proposal (in ‘Attachments’ section)
Ministry of Health Research Proposal Guideline 120
18. Informed Consent
18.1 Explain briefly how, when and by whom informed consent will be taken? How will it be
ensured that the consenter / participant has fully understood all the rights, duties and privileges of
consenting including the right to withdraw at any time and other inalienable rights that has to be
granted on account of the nature and process of the study?
Note: Please attach a copy of the consent form (in ‘Attachments’ section).
18.2 Is there likely to be any perceived coercion / undue pressure (direct or indirect) or incentive
(material or otherwise) that may influence the participation including retention in the study?
Briefly explain how this issue is addressed.
Informed consent is more than a form, it is also a process. Information must be
presented to enable persons to voluntarily decide whether or not to participate as a
research subject. Informed consent process must be a dialogue of the study’s
purpose, duration, experimental procedures, alternatives, risks, and benefits. The
process of consenting is ongoing and must be made clear to the subject that it is his
or her right to “withdraw” or “opt out” of the study or procedure at any time, not just
at the initial signing of paperwork. The location where the consent is being
discussed, the subject’s physical, emotional and psychological capability must be
taken into consideration when consenting a human subject. The informed consent
process should ultimately assure that the subject understands and really “gets” what
they are signing up for.
Ministry of Health Research Proposal Guideline 121
19. Attrition and Non-Compliance
19.1 Indicate the measures to reduce attrition (drop outs / loss to or incomplete
response) or non-compliance or non-response that may happen after allocation
of the participant to the study. How will these instances be dealt with?
A bias is a systematic error or deviation from the truth in results or inferences. Biases can
operate in either direction: different biases can lead to underestimation or overestimation of
the true intervention effect. Biases can vary in magnitude: some are small (and trivial
compared with the observed effect) and some are substantial (so that an apparent finding may
be entirely due to bias). Even a particular source of bias may vary in direction: bias due to a
particular design flaw (e.g. lack of allocation concealment) may lead to underestimation of
an effect in one study but overestimation in another study. It is usually impossible to know
to what extent biases have affected the results of a particular study although there is good
empirical evidence that particular flaws in the design, conduct and analysis of randomized
clinical trials lead to bias. Because the results of a study may in fact be unbiased despite a
methodological flaw, it is more appropriate to consider risk of bias.
Attrition of the original sample represents a potential threat of bias if those who drop out of
the study are systematically different from those who remain in the study. The result is that the
remaining sample becomes different from the original sample, resulting in what is known as
attrition bias. However, if sample attrition over time is not systematic, meaning that there are
no unique characteristics among those who drop out, then there is no attrition bias, even though
the sample has decreased in size between waves of data collection. It is important, then, for
researchers who collect multiple waves of data to check for attrition bias.
Ministry of Health Research Proposal Guideline 122
19.2 Adjustment for potential bias: Identify potential bias that could affect the study. How will
they be avoided or reduced at the various stages in the study (e.g.: Selection bias, Measurement
bias, Recall bias, etc.)?
20. Data Synthesis and Management
20.1 Indicate the computer program that will be used for data entry and data analysis.
20.2 Indicate the likely statistical tests that will be performed (descriptive and analytical tests as
appropriate to the study and the nature of the collected data).
20.3 Quality Control Of Data: What steps will be taken to ensure quality control of the data (data
is properly collected, data entry is accurate, transcribed and decoded correctly, managed
appropriately etc.)?
21. Work Plan & Study Implications
21.1 Please describe your work plan / timetable / Gantt chart. (Alternatively, it can be attached in
‘Attachments’ section)
Ministry of Health Research Proposal Guideline 123
21.2 What is the anticipated conclusion that may result from the study and how can it be used to
improve / enhance scientific knowledge, professional or administrative practice or influence policy
making? (Please note that conclusions from a study should be entirely and exclusively based on
the observed findings and results of the conducted study. Conclusions should not extend into
making recommendations that are subjective assumptions that are not proven by the concluded
study.)
21.3 Beneficiaries of the research: Who will be the potential beneficiaries of the study and its
application?
21.4 Dissemination of the study findings, and recommendations: How will the outcome of the
study be disseminated for the benefit of the scientific and professional communities?
21.5 What are the potential shortcomings / limitations of the study?
21.6 Indicate the Priority and Importance of the study / research topic.
Ministry of Health Research Proposal Guideline 124
21.7 Is your chosen research topic part of the ‘Health Research Priorities’ as listed in the booklet
by the Minstry of Health? (Refer to the bboklet in the Home Page)
Yes No
If Yes, kindly mention to which priority topic your research is related to.
22. Ethical Considerations
Highlight the ethical issues in the study and how they have been addressed. (Refer to the ‘Ethical
Checklist’ for relevant particulars)
23. Additional Resource Utilisation
Will the research take up any additional resources of the department / hospital / health facility,
including but not limited to human resource, time, equipment, consumables, reagents,
investigations, bed occupancy, finances etc. If yes, list them. Has due permission been obtained
from the appropriate authority? (Please include letter of approval(s) in ‘Attachments’ section)
24. Additional Information
Are there any specific processes in this study that need further elaboration in terms of the research
methodology or any other additional information? If yes, please highlight them in the following
box.
Ministry of Health Research Proposal Guideline 125
25. Research Grant
Are you planning to apply for a research grant through the Centre of Studies & Research of the
Ministry of Health?
Yes No
If Yes, please submit / attach the Budget Form. (For more details about research grants, refer to
the Health Research Funding Guideline)
26. Attachments
Kindly attach all additional documents in this section (for multiple files in one section, kindly zip
the files and attach):
1. List of Abbreviations (if applicable)
2. Curriculum Vitae of the P.I.
3. Curriculum Vitae of the Co-P.I./s
4. Participation Information Sheet
5. Informed Consent for Research Participants
6. Letter of Endorsement for the Study / Institutional Approval
7. Letter from Supervisor (for supervised studies)
8. Letter from Sponsor (for sponsored studies)
9. Data Collection Tools / Instruments
10. Sample Spreadsheet of Data entry
11. Work plan / Timetable / Gantt chart
12. Other Information relating to the study
27. Declaration – To be Signed by the Principal Investigator (P.I.)
If the research proposal is approved, I (we) declare that I (we) shall be actively engaged in, control
the project and agree to provide progress reports and the final report to the committee for revision
before final dissemination of it.
Ministry of Health Research Proposal Guideline 126
I (we) confirm that the details of this research proposal are a true representation of the research to
be undertaken. I (we) will ensure that the research does not deviate from the protocol described. If
significant protocol amendments are required as the research progresses, I (we) shall submit these
to the Research and Ethical Review & Approval Committee for final approval.
I (we) shall ensure that only the analysis specified in the protocol will be performed on the samples.
If I (we) send patients’ blood, body fluids or tissues outside the country for analysis, official
permissions to do so will be obtained. Any unused or remaining samples will be disposed as per
laboratory guidelines for specimen disposal.
Signature: Date:
Ministry of Health Research Proposal Guideline 127
Minimum required
standards
This section provides a reference for the minimum required standards in a research
proposal.
Ministry of Health Research Proposal Guideline 128
MINIMUM REQUIRED STANDARDS
- The proposal is clear and coherent
- All aspects and components of the proposal are adequate and consistent with international best
practices and good research methodology
- The literature review is concise, comprehensive and up-to-date
- The yield of the proposed research will generate useful information / outcome at both the national
and scientific level to improve the efficiency of the health system, raise the level of health services
or improve the knowledge and health behaviour at the level of the community and the individual
- The research topic is preferably within the list of research priorities of the Ministry of Health
- The research plan is feasible with sufficient time to complete the proposed research and with
sufficient resources (human, material and monetary).
- The research team is capable & professionally competent for project implementation (skills,
scientific qualification & experience)
- Potential Ethical issues are addressed in the proposal
- Procedures for informed consent are provided (if required)
- Adequate measures are taken to ensure confidentiality, privacy, participant safety, data protection
and other factors that are consistent with Good Research Practice.
- The researchers have obtained due pre-approval (feasibility/administrative approval) or has
evidence of “No objection” from the appropriate authorities or supervisors to facilitate the study
if approval is granted by the respective research committee.
Ministry of Health Research Proposal Guideline 129
Glossary
of Research Terms
This glossary provides definitions of common research terms used and is intended as
a guide in understanding the terms and concepts within the context of health
research.
Ministry of Health Research Proposal Guideline 130
GLOSSARY
Aim(s): It is a general statement(s) of what the study hopes to achieve within the scope of the
actual research.
Attrition rate: The rate of drop-out (loss to or incomplete follow up / failure to comply etc.)
among participants/subjects in a research study.
Attrition The ‘wearing away’ or progressive loss of data/participants in research. Attrition occurs
when cases are lost from a sample over time or over a series of sequential processes.
Bias: It is a systematic error or deviation from the truth in results or inferences.
Blinding: It refers to the concealment of group allocation from one or more individuals involved
in a clinical research study to prevent bias. Blinding can be single-blinded, double-blinded, or
triple-blinded.
Case-control Study: It is a type of research design usually employed to estimate the strength of
association between a clinical condition or an outcome of interest with the prior exposure to a
potential causal / risk factor.
Clinical Trial: Any research study that prospectively assigns human subjects to one or more
health-related interventions to evaluate the effects on health outcomes.
Cohort Study: A research study (usually prospective) involving participants who already have an
exposure of interest (risk factor) and who are to be followed up for a specified period of time to
determine if they manifest the anticipated outcome (e.g.: disease).
Confidence interval: A whole interval of acceptable values for the parameter instead of a single
value.
Confidence level: The likelihood that the value for a parameter will be within the confidence
interval.
Ministry of Health Research Proposal Guideline 131
Confounding: A situation in which the effect or association between an exposure and outcome is
distorted by the presence of another variable.
Control/Comparison group: It is a group of subjects which closely resemble the
treatment/population-of-interest group in many demographic variables but do not get the
treatment/procedure being studied in the study. It will be used as a baseline and
allows researchers to eliminate and isolate confounding variables and bias.
Convenient allocation: It is the process whereby sample participants are allocated into groups
based on the investigator's convenience or primarily because they were available at a convenient
time or place.
Exclusion criteria: Attributes of subjects that warrants their non-inclusion in the study. Such
exclusion should not affect the generalisability of the study.
External Validity: The extent to which a study's results (regardless of whether the study is
descriptive or experimental) can be generalized/applied to other people or settings.
Hypothesis: Hypothesis is a statement about expected/conceptual relationships between two or
more independent variables and one dependent variable.
Inclusion criteria: Attributes of subjects that are essential for their selection to participate. It
should be broad enough to closely represent the target/reference population.
Informed Consent: A process whereby the subject voluntarily agrees to participate in the research
after provision of sufficiently detailed information on the research (including potential risks and
benefits).
Intervention: A systematic change in conditions or an action that produces an effect or is intended
to alter the course of a pathologic process.
Margin of error: It expresses the maximum expected difference between the true population
parameter and a sample estimate of that parameter.
Ministry of Health Research Proposal Guideline 132
Matching: The deliberate process of making a study group and a comparison group comparable
with respect to factors that are extraneous to the purpose of the investigation but which might
interfere with the interpretation of the study's findings.
Mixed Research: A research study type incorporating aspects of qualitative and quantitative
research, either simultaneously or sequentially in the proposal.
Objectives: The specific steps/measures taken to achieve the aim(s) of the study.
Qualitative Research: A research study which is primarily exploratory and involves data
collection methods such as interviews, focus group discussions. It is used to further understand
underlying reasons, opinions, and motivations.
Random allocation: It is a process in which identified sample participants are randomly assigned
to a treatment/procedure/group and each participant has the same probability of being assigned to
any particular treatment/procedure.
Random selection: It is the process of drawing a sample from a population where the sample
participants are not known in advance.
Research sample: The members of the study population from whom we collect our data.
Sample size: The number of subjects included in a sample.
Sampling: It is the process of selecting a number of study units from a defined study population
of interest.
Sensitive Data/Material: It refers to information or material of any kind related to patients/clients,
confidential/personal information about staff, data or information about health services or the
health system (of the Ministry of Health) and all such information that are not in the public domain.
Stratified allocation: It is the process in which identified sample participants are assigned to a
particular group based on baseline variables (potential confounding factors) thought to be
associated with the outcome.
Study population: The people who meet our operational definition of the target population.
Ministry of Health Research Proposal Guideline 133
Systematic allocation: It is the process in which identified sample participants are assigned to a
particular group based on a specific system (alternately, based on time, date of birth etc.).
Target / Reference population: The group of people to whom we want our research results to
apply to.
Ministry of Health Research Proposal Guideline 134
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