AMSRA - Responsible Conduct of Research

AMSRA in brief

AMSRA “Ainshams Medical Students Research Association” is a non-profit entity

founded in May 2012 to mark and create a revolutionary change in the field of medical

research.

Science … Procession … Excellence

These are not just words, but rather a mission; a reflection of a vision and a dream of an

outstanding medical future, nourished by a strong determination to reach new horizons.

This is not just an idea or a thought, AMSRA “Ainshams Medical Students Research

Association ” is a non-profit entity founded in May 2012 to mark and create a revolutionary

change in the field of medical research.

Our goal is to escalate clinical research education among medical students, enabling them to

keep pace with the constantly increasing scientific breakthroughs over the world.

We aim at nourishing the energy and creativity of Ain-sham students by providing

them with the appropriate research training, as well as collaborating with international

scientific societies and universities. We believe that improving students' skills and exposing

them to different settings and experiences will help raise their capabilities, thus creating

bridges between them and their professors, allowing the latter to better convey and share

their expertise with those students.

By improving clinical research we are cultivating and refining a better healthcare system in

Egypt.

With science we do not only contribute in the development our country, but we also build a

new life for us and for the generations to come.

Why so enthusiastic?

We witness a critical time for our country, our people and our civilization. For a quite long

interval of time, Egypt has been pushed out of the field of scientific research delaying us and

preventing us from coping with the international trend. If AMSRA is going to be the first/only

trial to change the current situation, we will be satisfied, and if it is going to be an ignition

point for other projects, we will be delighted but, either way we are proud of taking

initiative.

Edited by Ibrahim M. Abdelmone’m Sha'arawi Medical student – Ain Shams university Mohamed Yousef Saad Medical student – Ain Shams university Mohamed M. Hany Medical student – Ain Shams university Yosif Mohamed Ali Medical student – Ain Shams university

Ghada Moharam Mohemed Medical student – Ain Shams university Omar M. ElTawansy Medical student – Ain Shams university Marwa Hosni Bedair Medical student – Ain Shams university Karim Osama Ibrahim Medical student – Ain Shams university

Designed By Mahmoud Mohamed AbdelWahab Medical student – Ain Shams university Mahmoud Montaser Medical student – Ain Shams university

Supervised By Dr. Mohamed El Sayed El Shinnawi AMSRA Chairman Associate Professor of General Surgery - Ain Shams university.

Reviewed & Granted by :

“It is a non-profit organization in the

United States. Members serve pro bono as "advisers to the nation on science, engineering, and medicine". As a national academy, new members of the organization are elected annually by current members, based on their distinguished and continuing

achievements in original research.”

Preface

Although filled with great minds and brilliant ideas,

developing countries -like Egypt- face a substantial problem

that lies in the fact that undergraduates in the scientific field

have superficial knowledge about the RCR (Responsible Conduct

of Research). Little or no teaching about the topic occurs in the

different scientific schools around the country. Consequently, it

is our hope that one day such knowledge could be available for

every student in the field, and that it could be further

implemented in the curricula of all scientific schools in Egypt.

Yousef A. Fouad

Medical Student – Ainshams University

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Acknowledgment

This booklet would not have been possible without the help of

many people. The editors wish to express their gratitude to Reham Salah-

Eldin, Our AMSRA Great Fundraising Coordinator and her Team members;

Amira El Shamy , Mahmoud Shokri , Ibrahim Osama , Mohamed Fouda

and Omar El-Mokhtar .

AMSRA on stage mission wouldn't be accomplished without the

vision and guidelines of PR Coordinator, Salma M. Gouda and PR

members ; Arwa Hazem , Mai Adel , Reem Sultan , Nouran Sorour ,

Omar Tag , Mohamed Tag , Mohamed Nabil , Amr Abdelmone'em and

Hend Ibrahim . Thank you for sharing your efforts and invaluable

assistance.

We can't say thank you enough for Belal N. Mahfouz and Karim

Osama our AMSRA Cofounder/CEOs for tremendous support and help. Not

forgetting to Mention Dr. Mohamed El-Shinnawy who always been there

and for providing the financial means to accomplish this event, and all

members who work in different positions in AMSRA

we would like to Convey our gratitude to Mohmoud Abdel-wahab IT

member and Coordinator for the event , Ahmed Maged Kassab the IT

Coordinator of AMSRA and the members who are always behind the

scene; Aya Osama Kassem , Mohamed Osama El-Arrosi , Mahmoud

Montaser and Mohamed Abo El-Fadl.

Finally, an honorable mention goes to our AMSRA Members in Each

Committee

Objectives

[1] To conduct research projects without plagiarism, falsification or fabrication.

[2] To execute research projects in a way that protects the human subjects and respects their rights.

[3] While performing a research on animal subjects, the executive personnel become able to achieve reasonable beneficence for the human being, and animals as well.

[4] To write the authors of a research project in a correct manner

[5] To be able to manage the data used in a research project and the result obtained.

[6] To build a clear, correct and righteous relationship between mentor and trainees or between members in collaborative teams while conducting a research project.

[7] To solve any conflict either financial, work commitments or intellectual and personal matters while conducting a research project.

[8] To act efficiently while submitting research paper in a journal for

peer reviewing by being aware of this process.

Table of contents :

1. Research Misconduct: 4

2. Protecting human subjects in research 8

3. Animal Welfare 10

4. Authorship 12

5. Data management 13

6. Mentor and trainee responsibilities 16

7. Conflict of interests and Commitment 17

8. Peer Review 18

9. Collaborative Science 20

10. Dual use of Research 22

11. Special issues concerning Responsible Conduct of

Research 21

Responsib le Conduct o f Research

1 Ainshams Medical Student Research Association

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Ainshams Medical Student Research Association 2

Overview of Research Values:

Responsible conduct in research is based on many of the

same human values that apply in daily life, but these values have

specific implication in research context.

These values are:

Honesty: when doing research, you must be honest about the research when

communicating it with others, about research results and its applications without

deception.

Fairness: Be fair whether in citing a colleague’s idea or when mentoring a

student in the proper conduct of research

Objectivity: Look beyond your preconception and biases to the evidence that

justifies the conclusion.

Reliability: Research communities over years have developed methods to

enhance the reliability of their results

Skepticism: Allegiance to empirical evidence requires that researchers

maintain a degree of toward research results and conclusions so that results and

explanations are continually reexamined and improved.

Accountability: Researcher is accountable to other researchers, the society

and the nature, the must demonstrate that their results or statement are reliable

Openness: Researcher must be opened with others, he must consider “what if I

am wrong” so he must convey o others their conclusions and their evidence so

that those conclusion could be examined and extended, this require a good

storage of data and making it available to others.

Trust: It is a fundamental characteristic of the research enterprise. Researchers

expect that their colleagues will act in accord with these values. When a

researcher violates one of the values, that person’s trustworthiness is diminished

among other researchers. In addition, the public’s trust in research can be

damaged.



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Definition of RCR

It’s the awareness and application of norms and ethical principles in all

aspects of scientific research.

What started all that? (The Beginning)

After World War II, Nazi doctors committed a series of crimes against

humanity. They tortured, maimed, and even led to the killing of war prisoners by

conducting deadly experiments on them in the name of science. The Nuremberg

trials were conducted afterwards to convict those doctors.

In order to do that the Nuremberg Code, the first ethical guidelines for

conducting research, came to light followed by Helsinki declaration which

addressed the vulnerabilities of human subjects involved in clinical research

project, and Belmont report focusing on the concepts of informed consent,

beneficence, and justice.

Topics covered by RCR:

1. Research Misconduct

2. Research on human subjects

3. Research on animal subjects

4. Authorship

5. Data management and collection

6. Mentoring

7. Conflict of interests

8. Peer Review

9. Collaborative Science

10. Dual use of research


Research Misconduct: Research misconduct is defined as fabrication, falsification, or plagiarism in

proposing, performing, or reviewing research, or in reporting research results.

1. Fabrication

Is making up data or results and recording or reporting them.

Examples of Fabrication:

• Creating a data set for an experiment that was never actually conducted. • Adding fictitious data to a real data set collected during an actual

experiment for the purpose of providing additional statistical validity; and • Inserting a clinical note into the research record to indicate compliance

with an element of the protocol. • Completing a questionnaire for a fictitious subject that was never

interviewed.

2. Falsification

Is a manipulating research material, equipment, or processes, or changing or

omitting data or results such that the research is not accurately represented in the

research record. Falsification also includes the selective

omission/deletion/suppression of conflicting data without scientific or statistical

justification.

Examples of Falsification:

• Altering data to render a modification of the variances in the data.

• Falsifying dates and experimental procedures.

• Misrepresenting results from statistical analysis.

• Misrepresenting the methods of an experiment such as the model (e.g., cell line) used to conduct the experiments.

• Falsifying research accomplishments by publishing the same research results

in multiple papers (self-plagiarism).



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• Misrepresenting the materials or methods of a research study in a published

paper.

• Providing false statements about the extent of a research study in an abstract submitted for publication and oral presentation at a professional society meeting.

• Falsifying telephone call attempts to collect data for a survey study.

Examples of Falsification in Clinical Studies:

• Substituting one subject's record for that of another subject.

• Falsely reporting to a data coordinating center that certain clinical trial staff, who was certified to perform the procedures on the subjects, had done so, when they had not.

• Altering the dates and results from subjects' eligibility visits.

• Altering the dates on patient screening logs and/or submitting the same log with altered dates on multiple occasions;

• Failing to update the patients' status and representing data from prior contacts as being current.

• Altering the results of particular tests on blood samples to show that the test

accurately predicted a disease or relapse.

• Backdating follow-up interviews to fit the time window determined by the study protocol

Research misconduct does not include honest error or

differences of opinion.


3. Plagiarism

Is the appropriation of another person’s ideas, processes, results, or

words without giving appropriate credit, Plagiarism is the theft of intellectual

property and is not unlike stealing from a commercial business? A special case of

plagiarism is the unacceptable practices of "self-plagiarism" in which an author

will use segments of his/her own

published material (e.g., the

methods section of a scientific

paper) in a new publication

without reference.

Plagiarism-Fabrication - the act of

taking an unrelated figure from an

unrelated publication and

reproducing it exactly in a new

publication (claiming that it

represents new data). Recent

papers from the University of

Cordoba have come to light

showing how this can go

undetected and unchallenged for

years.

What Causes Research Misconduct?

Why would a person that is considered top in his/her field fabricate results or

falsify data? This is a hard question to answer.

Pride may be a primary motivator. Perhaps the researchers pride is such that they

just have to be right. It may be that they so believe in the hypothesis and believe

that it should be an accepted theory that they are willing to risk their career on it.

Money is also a huge motivator, funding is normally based on results,

unfortunately. If the researcher feels that funding may be cut if the results cannot

be proven in the favor of the financer of the project this may promote dishonesty

in reporting.



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The researcher may perceive that falsifying data may not impact the overall study.

It may also be perceived that falsifying evidence that supports the actual outcome

does not actually impact the outcome and is not truly dishonest but more of a

means to ramp up the actual findings.

There may even be instances where the researcher is dependent upon assistants

for valid reporting and this information may be falsified. If the head researcher

doe not check the data as presented and uses that data to report the findings, and

the data is not accurate, this too is considered scientific falsification.

How to avoid Misconduct?

1. Understand why students cheat.

2. Educate yourself about plagiarism

3. Educate your students about plagiarism

4. Discuss the benefits of citing sources.

5. Make the penalties clear.

Researchers have an obligation to themselves, their colleagues, and society to avoid both the egregious transgressions of falsification, fabrication, and

plagiarism and the other forms of irresponsible conduct that can undermine the research enterprise.


Protecting human subjects in research

According to the US department of health and human services, human

research subject is a living individual about whom a research investigator

(whether a professional or a student) obtains data through:

1) Intervention or interaction with the individual, or

2) Identifiable private information

Human subject rights

Voluntary, informed consent

Respect for persons: treated as autonomous agents

The right to end participation in research at any time

Right to safeguard integrity

Benefits should outweigh cost

Protection from physical, mental and emotional harm

Access to information regarding research

Protection of privacy and well-being



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Ethical guidelines in protecting the human subjects

a. Nuremberg code: The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War

b. Belmont report: The purpose of The Belmont Report is to protect participants and subjects in the clinical trials and research studies involving ethics and health care research. The Belmont Report consists of 3 principles which are justice which is the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy, beneficence and respect for persons

Requirements for approval of research with human subjects

Categories of research that may receive Exempt Status

Procedures for working with minors and other protected populations

The content and documentation of informed consent

Ongoing review policies

What are the researcher’s responsibilities?

In carrying out any research work with human subjects, it is the

responsibility of the researcher to:

Know, understand and adhere to the ethical principles and applicable local

and institutional regulations, relating to research activities with human

subjects.

Train and supervise research staff in all aspects of the ethics and individual

responsibilities of research involving human subjects

Fully inform potential subjects of the purpose and nature of the research

work in which they are being asked to participate (what will be involved in

participation, that under all circumstances participation is fully voluntary,


and that participants are entitled to protection of their privacy) and ensure

appropriate consent for all subjects.

Animal Welfare Animal research is carefully regulated as human researches, Animals

may benefit from the information gained through animal experimentation and some research with animals is conducted specifically for the purpose of improving animal health. But most animal research is conducted primarily for the benefit of humans, not animals. And because you can’t get a consent from animals it’s important before the start , familiarize yourself with your responsibilities and check with someone in a position of authority before making any plans.

RULES, POLICIES& GUIDELINES

1. Guide for the Care and Use of Laboratory Animals (1996)

The purpose of the Guide is to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate. The Guide is also intended to assist investigators in fulfilling their obligation to plan and conduct animal experiments in accord with the highest scientific, humane, and ethical principles.

2. US Government Principles for the Utilization and Care of Vertebrate

Animals Used in Testing, Research, and Training

Researchers should:

a. Follow the rules and regulations for the transportation, care, and use of animals.

b. Design and perform research with consideration of relevance to human or animal health, the advancement of knowledge, or the good of society;

c. Use appropriate species, quality, and the minimum number of animals to obtain valid results, and consider non-animal models;

d. Avoid or minimize pain, discomfort, and distress when consistent with sound scientific practices.

e. Use appropriate sedation, analgesia, or anesthesia;



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f. Painlessly kill animals that will suffer severe or chronic pain or distress that cannot be relieved.

g. Feed and house animals appropriately and provide veterinary care as indicated;

h. Assure that everyone who is responsible for the care and treatment of animals during the research is appropriately qualified and trained; and

i. Defer any exceptions to these principles to the appropriate IACUC.

3. Broader responsibilities

Even with all of the care and review that currently is used to assure the responsible use of animals in research, animal research is still controversial and raises concerns that cannot easily be set aside.

4. Pain and suffering

Some experimental information cannot be gained without subjecting animals to pain and suffering.. This can be done by administering mild electric shocks, forcing animals such as rats to swim until they reach exhaustion, or subjecting them to other traumatic treatments.

5. Concern for different species

There is widespread agreement that some animals, such as primates and household pets, deserve more protection than other animals, such as worms and clams. What moral considerations set one species apart from another when making decisions about the use to which it can be put in experiments?

6. Unnecessary experiments

Animals are used to test the safety of experimental drugs, but should they also be used to test the toxicity of chemicals or cosmetics (as once was common, but has largely been abandoned)?


Authorship Authors names are found in the beginning of each paper, they refer to

who have conducted the research. They tell us who is responsible for the research and whom we can ask for an interpretation for anything in the paper.

Is anyone has contributed to the paper called an author?

Actually not every contributor to the paper is called an author, an author is the one who has a significant contribution, and this significance varies from one journal to the other, for less contribution the name is listed under acknowledgments.

International Committee of Medical Journal Editors

ICMJE Statement on Authorship

An “author” is generally considered to be someone who has made substantive intellectual contributions to a published study, Authorship credit should be based on

1) Substantial contributions to conception and design or acquisition of data or analysis and interpretation of data.

2) Drafting the article or revising it critically for important intellectual content.

3) Final approval of the version to be published.

- Authors should meet conditions 1, 2, and 3.

- All persons designated as authors should qualify for authorship, and all those who qualify should be listed.

- Each author should have participated sufficiently in the work to take

public responsibility for appropriate portions of the content.



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In what order are the authors names listed

Author names are usually listed according to importance; also both the first and the last names of the authors are special. Some journals have their rules in determining the order of names; however there are no specific rules and the order of names is only the coauthors' responsibility

Corresponding or primary author

Some journals require a corresponding or a primary author who is responsible for the accuracy of data in the paper and the names listed, also for responding to any inquiry concerning the paper.

Honorary authorship

Honorary authorship is putting a person's name as an author while not deserving that. It is considered a type of misconduct. A department chair or someone who provided fund for the research may ask to put his name as an author, putting the name of one of those as an author could be done only if they have a significant contribution (as previously mentioned) otherwise, it is considered a misconduct.

Data management

Data management issues are integral to all core areas of Responsible Conduct of

Research (RCR) instruction, and everyone involved in research-related activities

should be aware of these issues to conduct and support research responsibly.

What constitutes research data can often be discipline-specific, but in general

“data management issues” refer to the way you deal with any information related

to your research including data selection, collection, analysis, handling, reporting

and publishing, and data ownership issues.


Data Selection

Issues should be aware of when selecting data include:

● The appropriate type and sources of data which permit investigators to

adequately answer the stated research questions

● suitable procedures in order to obtain a representative sample

● There should be compatibility between the type/source of data and the

mechanisms to collect it.

Data Collection

• Accurate data collection is essential to maintaining the integrity of

research.

• Issues related to maintaining integrity of data collection:

The primary rationale for preserving data integrity is to support the

detection of errors in the data collection process, whether they are made

intentionally (deliberate falsifications) or not (systematic or random errors).

Two approaches that can preserve data integrity and ensure the

scientific validity of study results. Each approach is implemented at different

points in the research timeline (Whitney, Lind, Wahl, 1998):

1 Quality assurance - activities that take place before data collection begins

2 Quality control - activities that take place during and after data collection.

Data Analysis

Data analysis issues include:

● Having the necessary skills to analyze

● Concurrently selecting data collection methods and appropriate

analysis

● Following acceptable norms for disciplines

Data Handling

Issues that should be considered in ensuring integrity of data handled

include the following:



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● Type of data involved in the research.

● Type of media containing data and its storage capacity, handling and

storage requirements, reliability etc...

● Data handling responsibilities/privileges, that is, who can handle which

portion of data, at what point during the project, for what purpose, etc.

Data handling procedures that describe how long the data should be

kept, and when, how, and who should handle data for storage.

Data Reporting & Publishing

Issues in data reporting and publishing

There are often factors in research settings that can result in

compromises to data integrity due to irresponsible act of publishing

data or information that is not yet well reviewed , such factors may

include Publication pressure ,Professional competition ,Lack of formal

mentoring ,Lack of penalties ,Little chance of getting caught and Bad

examples from mentors (Price, Drake, Islam, 2001).

Data Ownership

Data ownership is important for responsible data sharing which in turn

is important for the science and society; for example ; shared data may be used

for,

a. Reanalysis to verify or refute reported

results.

b. Alternative analyses to refine results.

c. Analyses to check if the results are

robust to varying assumption.

d. The general consensus of science

emphasizes the principle of openness

(Panel Sci. Responsible. Conduct Res.

1992). Thus, sharing data has a number

of benefits to society in general and protecting the integrity of scientific

data in particular.


Along with the mentioned topics, Proper conceptualization of a

research project and the use of appropriate research methods along with

adequate training of all those staff directly and indirectly involved in the research

project will ensure data integrity. Those who are new to a research area or

particular research methods can unintentionally commit mistakes or misuse

research methods that can impact the integrity of research data along with every

other aspect of a project. But issues related to conceptualization of research and

research methods are difficult to cover in the core modules of RCR instruction due

to the project-specific nature of such issues.

Mentor and trainee responsibilities

Mentor: is a person who helps another person to develop knowledge at area of

interest. Mentor may be a doctor, fellow student, or a friend.

Trainee: is the one learning from the mentor.

This relationship is important and useful for both, though it’s complex and brings

many conflicts into play, so there must be basic rules to prevent such problems.

What you need to know as a trainee?

Rights:

How much time they will be expected to spend on their mentor’s

research?i

The criteria that will be used for judging performance and form the basis

of letters of recommendation?

How responsibilities are shared or divided in the research setting?

Standard operating procedures, such as the way data are recorded and

interpreted?

How credit is assigned, that is, how authorship and ownership are

established?

The mentor should also provide good research environment to emphasize

collaboration and competition with Provision of equal treatment, also he

should Train and educate in the responsible conduct of research.

And for the final aim of this relationship to be achieved the mentor should

make sure the trainee develops into a responsible researcher.



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Duties:

Do assigned work in a conscientious way.

Respect the authority of others working in the research setting.

Follow research regulations and research protocols.

Live by agreements established for authorship and ownership.

Conflict of interests and Commitment It’s a situation in which in which financial or other personal

considerations can compromise person’s professional judgment, objectivity and

obligations in a particular research project. Conflict of interests could present in 3

important forms: Financial gain, work commitment, personal and intellectual

matters

Financial gain

Researchers are permitted to benefit financially from their work. In 1980, a

congressional law known as the Bayh-Dole Act stated that researchers and

research institutions are allowed to use copyrights, and licenses to put research

ideas to use for the good of the public. Prior to this act, there were no uniform

policies regulating the ownership of ideas developed with public funding.

Financial interests should not influence the research’s obligation to truth and

honesty, but they may if they were significant e.g. a university researcher, who

owns stocks at a certain pharmaceutical company, might be conflicted if he was

asked to report accurate data that might harm the stocks prices.

Work commitment:

At any time, a researcher may be asked to work on one or more funded projects,

serve as a consultant or employee in a private company, teach and advice

students, etc. Researcher should be careful that these commitments do not

inappropriately interfere with one another.


Personal and Intellectual matters:

Researchers should be careful to avoid making judgments or presenting

conclusions based solely on personal opinion or affiliations rather than on

scientific evidence

Personal conflicts are usually the easiest to identify and resolve. Generally,

researchers should not serve as reviewers for grants and publications submitted

by close colleagues and students

On the other hand, intellectual conflicts are more difficult to identify; if a

researcher holds strong personal views on the importance of a particular area of

research or strong moral convictions that could influence a researcher’s scientific

opinions, they should be disclosed so that others can take them into consideration

when judging the researcher’s statements

Managing significant conflicts

It means finding a way to assure that the interests do not adversely influence the

research

This could be achieved by: - Requiring full disclosure of all

interests. - Monitoring the research or

checking research results for accuracy and objectivity.

- Removing the person with the

conflict from crucial steps in the

research process.

Peer Review

Although peer review have existed for more than 300 years, people didn’t know

much about it until December 2005, South Korean scientist Dr. Hwang Woo Suk



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stunned the world by admitting that his stem cell research that was supposed to

revolutionize health care by helping to cure diseases ranging from diabetes to

Parkinson's used fabricated data, although it has been published in the prestigious

U.S journal “Science”. So there were a lot of reports not only questioning

Dr.Hwang, his research and the journal but also the way of conducting science. To

define peer review, it is a process whereby a scientist's research is assessed for

quality before it is funded or published.

The "peer" in peer review means that the scientist in question will submit his work

to other experts in the field to comment on the quality, significance and originality

of the research. Reviewers aren't the ultimate arbiters about whether research

should be funded or published, but their comments inform the decision makers.

It all starts with a scientist and his research. When the research is completed, the

scientist writes a paper describing the experimental procedure and the results. He

then submits it to a journal that publishes papers in his field. Then the path to

acceptance begins with the journal editors. They first review the submission to

make sure it fits both the journal's subject-matter focus and its editorial platform.

Then after passing the editors initial evaluation the research is passed to a team of

reviewers who read it closely and provide individual critiques, usually within two

to four weeks.

Peer review could be single blinded, where the reviewers know who is the editors

but not vice-versa, or double blinded in which the identities of both author and

reviewers are hidden. Some journals have adopted the open peer review model

where there are no hidden identities to force the reviewers to give more

thoughtful critiques.

Peer review is a quality-control system. When a team of reviewers gives a green

light to a particular paper, they are saying the science described in the paper is

valid and trustworthy.

- For authors, peer review provides a patina of respectability on their

work. A scientist who publishes in his field's most prestigious journal

gets to bask in the glow of the publication's reputation.

- For journal editors, peer review informs their decision-making process.

An editor can publish a paper with much greater confidence.


- For other scientists, peer review acts as a mechanism to help prioritize

what they read.

However, peer review has some limitations. Studies on it have proved that

Reviewers are much more likely to find and flag plagiarism than falsified data. Also

peer review is accused of slowing down advances in scientific and medical

knowledge. It can take a year for an article to move through the peer-review

system and become published.

Researchers have a responsibility to participate in the review of research

proposals and not to abuse the trust on which the review process is based. They

should disclose conflicts of interest and treat colleagues fairly in reviewing their

ideas. Research sponsors should use international reviewers where feasible.

Collaborative Science

Collaboration is “working together”. in

contrast to mentor/trainee relationship

,collaboration means a group of

researchers who are all more or less

equal partners working on a common,

“collaborative” project.

While collaboration in research is

essential, it may raise many problems

between researchers, so roles must be

established as early as possible.

Roles for effective collaboration:

Role of each partner must be established.

Goals and outcomes of the research must be discussed.

Criteria for ranking authors.



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Who will draft the publication, speak in public. Also, good management is

essential for effective collaboration, management of financial issues,

compliance, and adequate training of research staff.

Formal agreements may be needed to establish this collaborative

research.

Many of these points seem clear and obvious, but they easily get missed in every

day research practice.

Special situations concerning international collaboration:

There are two cases: - The first case, when a research team invites a foreign colleague,

and in such case, the guest must follow the research conduct rules of the host institute.

- The second one, when there is collaboration between two teams of different countries, here the professional codes of ethics or governmental regulations may contradict, so the codes and legal standards they will follow must be determined first.

Dual use of Research

What is Dual-Use?

The concept is that “the same piece of scientific research can be used for bad as

well as good purposes”. This means that well-intentioned research with beneficial

outcomes may end up being misused for malicious purposes by third party.

How to prevent dual use?

1. Develop appropriate Policies and Bio-risk Management Plans that

include Dual Use Research of Concern.

2. Develop screening methods for early detection of researches that is

potential for misuse.


Dual use example :

Mouse pox experiment:

Aim of the study:

- Induction of infertility in mice to control mouse population in Australia. - Insertion of the IL-4 gene into mousepox virus created super-virulence that

could kill vaccinated mice.

Dual-use implications:

- Potential application of knowledge to human viruses such as Smallpox.

Researchers should bear in mind the possible consequences of their

work, including harmful consequences, in planning research projects.

Special issues concerning Responsible Conduct of Research

How to respond to an act of Irresponsible Research Practices?

Irresponsible practices done by a member in a research team must be

reported, this is done by talking to someone else in the team who is

responsible for that.

Some institutions have independent ombudsmen, offices, individuals

responsible for dealing with irresponsible practices.

If someone is accused of doing such practices, they must be treated fairly.

Many institutions cover up such incidents of misconduct, but it is better to

deal with them openly, and that makes the institution stronger.

Communicating with Policy Makers and the Public

Research has a great influence over the society, so public communication

with those who are outside the field is essential. Researchers must be open

and honest in communicating the results to the public and policy makers.



23

Researchers should provide their advice to the government and other policy

makers in documents that differ from research articles but still based on

evidence and peer reviewed either formally or informally.

Research ideas and fair accreditation:

Research ideas have many sources, some emerge logically from the

forward progress of a research program or it could be the product of long

and careful individual thought about how to solve a problem.

However, when research ideas are discussed in public, they become part of

the collective knowledge of the research community. But fairness dictates

that individual researchers be acknowledged for their contributions.

On the other hand, discussions in private communications as grant proposals

or meetings of a research group. Generally deserve to remain privileged as

researchers work out the difficult problems associated with gaining reliable

knowledge. In particular, the reviewers of grant applications are expected to

maintain confidentiality.

References

[1] http://www.virtualsalt.com/antiplag.htm

[2] http://uresearch.miami.edu/?p=175

[3] http://ori.hhs.gov/education/products/ucla/chapter2/page00.htm

[4] Responsible conduct of research by adile.shamoo and david b. resnik, oup

2009

[5] Steneck, N. H. (n.d.).Introduction to the Responsible Conduct of Research.

[6] http://ori.dhhs.gov/education/products/n_illinois_u/datamanagement/dotopic.

html

[7] ORI Introduction to the Responsible Conduct of Research/ Mentor and

Trainee Responsibilities.

[8] http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/

GuidancesInformationSheetsandNotices/ucm113709.htm

[9] http://www-

personal.umich.edu/~nsteneck/researchintegrity/RCRintro_Spanish/c04/b5c4

.html

[10] http://www.gradstudies.fsu.edu/Academics-Research/Research-and-

Scholarly-Integrity/Info-by-Topic-Area/Conflicts-of-Interest

[11] Hwang WS, Ryu YJ, Park JH, Park ES, Lee EG, Koo JM. Evidence of a

Pluripotent Human Embryonic Stem Cell Line Derived from a Cloned

Blastocyst. Science 12 March 2004: 303 (5664), 1669-1674.Published online

12 February 2004 [DOI:10.1126/science.1094515]

[12] Smith R. "Peer review: reform or revolution?" BMJ. Sept. 27, 1997;315:759

[13] Ware M. Peer review: benefits, perceptions and alternatives .Publishing

Research Consortium. Dec 2, 2008

[14] White C. Little evidence for effectiveness of scientific peer review. BMJ.

Volume 326, February 2003. (Dec. 2, 2008)

[15] ORI Introduction to the Responsible Conduct of Research/collaboration.

[16] Willy K. Tonui, Role of Biosafety Professionals in Dual Use Research of

Concern

[17] Responsible Conduct in the Global Research Enterprise/ A Policy Report -

InterAcademy Council / IAP – the global network of science academies.

Illustrations used in this booklet from:

Illustrations by David Zinn/ Introduction to the Responsible Conductof Research

Nicholas H. Steneck August 2007.

http://www.virtualsalt.com/antiplag.htm

http://uresearch.miami.edu/?p=175

http://ori.hhs.gov/education/products/ucla/chapter2/page00.htm

http://ori.dhhs.gov/education/products/n_illinois_u/datamanagement/dotopic.html

http://ori.dhhs.gov/education/products/n_illinois_u/datamanagement/dotopic.html

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm

http://www-personal.umich.edu/~nsteneck/researchintegrity/RCRintro_Spanish/c04/b5c4.html



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AMSRA - Responsible Conduct of Research

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