GENERAL RESEARCH ETHICS APPLICATION SJHH REB Version – REVISED MARCH 2008

For use by investigators performing research* to be reviewed by the Research Ethics Boards (REBs) of: St. Joseph’s Healthcare Hamilton; and Hamilton Health Sciences / McMaster University Faculty of Health

Sciences; and their affiliated institutions.

*NOTE: There are separate application forms for research that falls into the following distinct categories: Retrospective Chart Review; Tissue Study (for HHS/FHS only); and Prospective Database Study. Forms and further information for

these 3 categories are located at: http://www.fhs.mcmaster.ca/csd/ethics/reb/forms.htm If in doubt as to which form to use, contact Alison van Nie x-22057, Research Ethics Officer for SJHH REB and HHS/FHS REB; or Deborah Mazzetti x-

42013 for HHS/FHS REB; or Leigh Mahan x-33099 for SJHH REB

Complete the application in NO smaller than 10 point font; handwritten submissions are NOT acceptable

Please refer to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans prior to completion of this form: http://pre.ethics.gc.ca/english/policystatement/policystatement.cfm

Project # (assigned by REB) SECTION A – GENERAL INFORMATION

1. FULL STUDY TITLE:

KEYWORDS – List up to 5 keywords that describe this project: i) ii) iii) iv) v)

2. RESEARCH PERSONNEL

Is this a student/trainee project? If YES, specify: Post-doc PhD Master’s* Undergrad* Resident/Fellow

NOTE re HHS/FHS REB: * For ethics applications being submitted to the HHS/FHS REB, all FHS undergraduate and Master’s applications (if minimal risk) must be sent to the Student Ethics Review Committee for review http://www.fhs.mcmaster.ca/csd/ethics/reb/faculty_hhsreb.htm

All PhD, Post Doc, Resident and Fellows’ projects and all non-minimal risk studies should be sent to the full HHS/FHS REB for review. NOTE re SJHH REB: * For ethics applications being submitted to the SJHH REB, all applications, including student/trainee research which will take place at SJHH must be sent to the SJHH REB using this form. A. LOCAL PRINCIPAL INVESTIGATOR (LPI): LPI must have an appointment at the institution where the REB application is being

submitted for review. LPI may not be a student, fellow, or resident. Title: First Name: Surname: Institution: Dept: Program: Division: Street Address: Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

B. PRINCIPAL INVESTIGATOR (PI), IF DIFFERENT FROM LPI ABOVE: If this is a student project, one student must be named as the PI. If PI is a student/trainee, specify: Post-doc PhD Master’s Undergrad Resident/Fellow Title: First Name: Surname: Institution: Dept: Program: Division: Street Address:

2

Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

C. CO-INVESTIGATOR(S) (CO-I): CO-I #1: If CO-I is a student/trainee, specify: Post-doc PhD Master’s Undergrad Resident/Fellow Title: First Name: Surname: Institution: Dept: Program: Division: Street Address: Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

CO-I #2: If CO-I is a student/trainee, specify: Post-doc PhD Master’s Undergrad Resident/Fellow Title: First Name: Surname: Institution: Dept: Program: Division: Street Address: Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

CO-I #3: If CO-I is a student/trainee, specify: Post-doc PhD Master’s Undergrad Resident/Fellow Title: First Name: Surname: Institution: Dept: Program: Division: Street Address: Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

FOR ADDITIONAL CO-INVESTIGATORS, COMPLETE AN ADDITIONAL SHEET (see Appendix 2) AND ATTACH

D. Study Coordinator for this Application (if not the applicant): Not Applicable Title: First Name: Surname: Institution: Dept: Program: Division: Street Address: Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

3. STUDY PERIOD:

Expected Start Date: (dd/mmm/yy) Anticipated End Date: (dd/mmm/yy)

4. STUDY LOCATIONS PERTAINING TO THIS APPLICATION:

3

STUDY LOCATIONS (Check all applicable): Hamilton Health Sciences CHEDOKE HAMILTON GENERAL JURAVINSKI CANCER CENTRE HENDERSON HOSPITAL MUMC/HEALTH SCIENCES CENTRE OTHER (specify): St. Joseph’s Healthcare Hamilton

SJH

CMHS CAHS OTHER (specify): McMaster University MAIN CAMPUS (i.e. not MUMC) OTHER (specify): St. Peter’s Hospital SPH OTHER (specify): Community Specify: Other Specify:

5. IS THIS AN INVESTIGATOR-INITIATED STUDY? *YES NO

*If YES, attach a copy of Certificate of Good Clinical Practice Training for the LPI (eg. SJHH/ClinCoach on-line GCP course, National Institutes of Health/National Cancer Institute on-line GCP course, etc). ATTACHED

6. MULTI-SITE STUDIES (a) Is this a multi-site study (i.e. conducted at locations other than those identified in Q4 above)? YES NO (b) Other Ethics/Scientific/Scholarly Review:

ETHICS REVIEW AND APPROVAL STATUS (Check all that apply and indicate date where applicable)

In order to facilitate the REB review process through harmonization and coordination of REB activity, identify if any of the REBs below have received and/or approved the study outlined in this application (check all that apply)

REB Study #

Application to be Submitted

Applied with Review Pending

Reviewed

Approved

HHS/FHS REB

SJH REB

McMaster REB

Juravinski Cancer Centre PRC

Other (e.g. UWO Health Sciences REB, UHN REB, etc.) Specify:

Attached

Include all relevant correspondence related to ethics and scientific review (e.g. REB review letter, replies, approval letter). ATTACHED TO FOLLOW

4

(c) Has the study been denied approval by any other REB? *YES NO *If YES, you must attach REB letter. ATTACHED 7. SOURCES OF STUDY FUNDING OR IN-KIND SUPPORT

(a) In the table below, identify all sources of financial or in-kind support for this study (i.e.. include both internal and external, public and private sources, e.g. funding sponsors, agencies, departmental, hospital or university sources). If funding or support is not required, check: NA and go to Q9

FUNDING SOURCES AND IN KIND SUPPORT: (Check all that apply)

Name

Funding Status

If Funding Pending, Expected Date of Decision

Local Budget Total Budget

Applied Received In-Kind

(specify: )

$ $

Applied Received In-Kind (specify:

)

$ $

(b) Budget:

You must attach a Budget Summary (You must use the template found in Appendix 1) ATTACHED

Indicate where funds will be administered (check one only): Hamilton Health Sciences St. Joseph’s Healthcare Hamilton McMaster University – Faculty of Health Sciences McMaster University – Office of Research Services Other (specify):

8. FUNDING AGREEMENT:

NOTE: Agreements must be reviewed and signed by authorized institutional officials

Will there be a signed contract/agreement with a study-related funding source? YES NO NA If YES, will it in any way limit your access to the research data, or limit your right to publish the study results?

*YES NO *If YES, please explain.

9. CONFLICT OF INTEREST:

Will any investigators, members of the research team, and/or their partners or immediate family members: (a) Function as an advisor, employee, officer, director or consultant for a study-related

sponsor(s) or funding source (i.e. identified in Q7)? *YES NO NA (b) Have direct or indirect financial interest in the drug, device or technology employed

including patents or stocks) in this research study? *YES NO NA (c) Receive any personal benefit, e.g., a financial benefit such as remunerations,

intellectual property rights, rights of employment, consultancies, board membership, share ownership, stock options, honorarium, or other benefits from the sponsor (apart from fees for service) etc. as a result of, or connected to this study? *YES NO NA

5

*If YES to questions a, b or c above, you must describe the conflict of interest and explain how it will be managed to ensure that participant rights and welfare are not affected.

10. CLINICAL TRIALS: NOTE: If this is not an application for a clinical trial, please skip to 10(b))

Definition of clinical trial (World Health Organization): *“any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.” (a) Health Canada Requirements:

(i) Is this a clinical trial involving a new investigational drug, device, natural health product, or a drug, device or natural health product used for an indication outside the parameters of the approved Health Canada Notice of Compliance (NOC) or Drug Identification Number (DIN) application or Medical Device Licence, as applicable?

YES NO NA

(ii) If YES, does this study require Health Canada approval? YES NO

(iii) If YES, indicate who submitted the Clinical Trial Application for approval to Health Canada as the Sponsor of the study (i.e. will take responsibility for the initiation and management of the study as per Health Canada regulations and GCP guidelines)?

Local Principal Investigator Principal Investigator Funding Source (i.e. industry/pharma/biotech) – Specify Name: Other – Specify:

(iv) Attach a copy of the Health Canada “No Objection” Letter (NOL).

ATTACHED TO FOLLOW

Specify: NOL Control #: Date:

NOTE: NOL must be received prior to final approval. Study may NOT commence without Health Canada approval.

(b) Trial Registration

The REB strongly supports the recommendations of the International Committee of Medical Journal Editors (ICMJE) regarding the requirement for registration of all clinical trials (* see WHO definition above) on a publicly accessible and recognized registry. (For info: http://www.fhs.mcmaster.ca/csd/registration.htm )

Please specify the registry name and registration identifier number: NOTE: Study may not commence without registration. Observational studies do not require registration. Check if applicable

11. Dissemination of Study Results

The REB feels that every effort should be made to make trial results public, but also recognizes that not all submissions get accepted for publication or presentation. Is there an intention to make the results of this trial publicly available through one of some of the following methods? (select all that apply)

YES – peer reviewed journal publication and/or presentation at conference or scientific meeting YES – report to study participants YES – clinical trial registry OTHER (describe)

6

12. INTERNAL APPROVALS:

(a) Does this study involve a Medical Directive(s)? Formal Medical Directives affecting clinical care require approval by a sub-committee of the Medical Advisory Committee (MAC) of the hospital (e.g. RNs giving routine post-op analgesia on behalf of the physician). If this research proposal contains similar delegated responsibilities for members of the research team, it is the responsibility of the Local Principal Investigator to ensure that appropriate approval has been obtained from the MAC. (Refer to College of Physicians & Surgeons of Ontario: http://www.cpso.on.ca/policies/delegation.htm ) *YES NO

*If YES, briefly describe the order/procedure(s):

(b) Does this study involve an infectious agent? YES NO

(c) Does this study involve a biosafety hazard? YES NO

(d) Does this study include genetic testing? *YES NO

*If YES, attach a separate consent form addressing the special concerns related to genetic testing. NOTE: See Informed Consent Checklist attached and sample Genetic Consent Form on web: http://www.fhs.mcmaster.ca/csd/ethics/reb/faculty_hhsreb.htm

SECTION B – DESCRIPTION OF PROPOSED RESEARCH

PART I: 1. LAY SUMMARY (A lay summary is a statement that is suitable for general readers and must not include

jargon or complicated language/ideas or be copied from the research protocol – if the statement is not clear your application will be returned to you):

Provide a summary (10 lines maximum) of the research proposal in language suitable for a press release or for inclusion as minutes in a document aimed at lay personnel (e.g. the Board of the Hospital or the University). DO NOT use jargon or medical short forms. UNDER THE FOLLOWING HEADINGS PLEASE INDICATE: (a) Main Research Question(s): (b) What is being studied? (c) Why is this research important?

2. Describe the rationale and a summary of the methodology, including the anticipated outcomes/objectives

(primary and secondary if applicable) and how these outcomes will be measured (250 word limit): 3. PLAN FOR DATA ANALYSIS: Briefly explain how data will be analyzed. 4. SAMPLE SIZE:

(i) Indicate how the sample size was determined (if a convenience sample, please describe also): (ii) The anticipated number of participants locally: (iii) The total number of participants anticipated study-wide (for multi-centered studies):

5. MONITORING NOTE: Monitoring is a requirement

Please describe your monitoring plan (For minimal risk undergrad/Masters applications, please indicate that the Supervisor will monitor the conduct of the study. For all other studies, please indicate the plan for monitoring the conduct of the study to ensure participant safety and confidentiality, and the integrity of the conduct of the student and data collection). Additionally:

7

Is there a steering committee? YES NO NA Is an interim analysis planned? YES NO Is there a data safety monitoring board/data monitoring committee (DSMB/DSMC)?*

YES NO NA If YES, is it independent of the sponsor? YES NO

*DATA MONITORING COMMITTEES: The World Health Organization...has issued a report “Operational Guidelines for the Establishment and Functioning of Data Safety Monitoring Boards”. These Guidelines describe the constitution, role, responsibilities, and operating framework for DSMBs: http://www.sidcer.org/new_web/index.php?group=main&open=guidelines.php The FDA (US Food & Drug Administration) has issued a guidance document that discusses the roles, responsibilities, and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) or Data and Safety Monitoring Committees (DSMCs) that may carry out important aspects of clinical trial monitoring. This guidance is intended to assist clinical trial sponsors in determining when a DMC may be useful for study monitoring, and how such committees should operate. To view the complete document, visit the FDA website .

PART II: 1. PROTOCOL #: and DATE: (Required – please assign # and date to your protocol) 2. DESCRIPTION/TYPE OF STUDY:

A. STUDY DESIGN (Select all that apply, e.g. if study is a clinical trial that incorporates the use of health records and a genetic component, then check #1, 2 & 4 below):

1. Clinical Trial - indicate phase (select all that apply):

Pilot Phase I Phase II Phase III Phase IV Randomized Double Blind Single Blind Open Label Other (please describe): Active Comparator:

• If an active comparator is used, is this the standard of care? YES NO • Provide justification that the active comparator is the standard of care and that a state of

clinical equipoise* exists regarding the merits of the regimens to be tested: *NOTE: Clinical equipoise means a genuine uncertainty on the part of the expert medical community about the comparative therapeutic merits of each arm of a clinical trial. The tenet of clinical equipoise provides a clear moral foundation to the requirement that the health care of subjects not be disadvantaged by research participation. http://www.ncehr.medical.org/english/code_2/sec07.html - Note2

Placebo Controlled. If a placebo is used, how is this justified (e.g. no alternative standard treatment available)? Include any provisions in place to reduce the risks to subjects assigned to placebo (e.g. increased monitoring, rescue medication):

2. Review of Health/Education Records or other records: YES NO Please indicate sources of data records (select all that apply):

Health Records/Chart Review (e.g. Sovera, Provider Portal) Electronic Database (specify): Outside Institution (specify): Educational Records* (specify): Other (specify):

*NOTE: Requirement to complete Agreement re access to student records and submit to Registrar’s Office 3. Collection of Tissue: YES NO

If YES, indicated: Retrospective Prospective

4. Genetic Component to Study YES NO

5. Observational Study YES NO

8

6. Qualitative Study: (attach the interview guide, questionnaire, survey, etc.) YES NO Questionnaire Survey Focus Groups Interviews Other (specify):

Interview Guide/Questionnaire/Survey attached: YES NO

7. Other (describe): YES NO

B. Setting (check all that apply):

Outpatient Inpatient ICU Community Emergency Dept. Campus Other (specify):

C. Participants: 1. Provide a brief description of participants: 2. Will you be seeking third party/surrogate consent: *YES NO

NOTE: TCPS reference re subjects not legally competent to consent – TCPS 2.5 *If YES, please justify:

3. If any of the following populations are the primary target of this research, please check all that apply:

Healthy Volunteers Children Aboriginal persons Elderly persons

Persons Incompetent to Consent Cancer patients Mental Health patients Incarcerated persons Nursing Home Residents Persons with Incurable disease Persons in emergency situations Unemployed/impoverished persons

4. Inclusiveness: Are there any age, ethnicity, language, gender or race-related inclusion or exclusion criteria?

*YES NO *If YES, please justify:

D. STUDY INTERVENTIONS (i.e. what will happen to the participant as a result of this study)

Check all that apply:

1. Diagnostic Test: Imaging Lab Other:

2. Intervention/Treatment Type: Chemotherapy Radiotherapy Surgery Medical Device Gene therapeutic Physiological Interview/survey/focus group/questionnaire Cognitive/Behavioural Drugs Observational Natural health product Other (specify):

3. List all the drugs* to be used in this study. Please include brand name and generic name and/or investigational designation. (*This includes the study drugs PLUS any other medications specified in the protocol that the participant will receive while on this study).

Investigational Drug

Generic Name

Brand Name

Manufacturer Dose Frequency Route of Admin

Duration

9

SECTION C – DESCRIPTION OF THE RISKS AND BENEFITS OF THE PROPOSED RESEARCH

1. What are the proposed benefits to the participants, the scientific community or society that would justify

asking individuals to participate? 2. Specify the risks to participants involved in this study (e.g. physical risks such as pain, discomfort, injury, side

effects; psychological risks such as participants feeling demeaned, worried, upset, or embarrassed); social or economic risk such as invasion of privacy or breach of confidentiality).

3. How will you manage and minimize the risks? 4. Payments to participants:

(a) Will participants be reimbursed for expenses? *YES NO *If YES, please provide amount(s) and item(s) covered:

(b) What other inducement or compensation is offered to participants?

SECTION D – INFORMED CONSENT Complete the attached “Informed Consent Checklist” prior to completing this section. NOTE: Patients may not be approached directly by research staff: they must first be approached by someone within their ‘circle of care’ for permission for the research staff to speak to them about the research and prior to review of their medical record. 1. Identifying Participants:

(a) Indicate how potential participants will be identified, through one or more of the following (Check all that apply):

a. From the investigator’s own patients/students b. From patients proposed by another healthcare provider (with the patient’s consent) c. From lists of patients identified by Health Records Dept (initial contact must be made by

the patient’s attending physician or another member of the patient’s healthcare team)*

d. From databases of participants who have previously given consent to be approached for research studies (consent forms must be archived and accessible)*

e. From REB approved internal advertising within this institution f. From REB approved external advertising outside the institution. Specify: g. By REB approved direct approach of the public (e.g. random digit dialing, direct approach

in public places, snowballing, etc.). Specify:

h. From access to educational records, e.g. students in the institution i. Other. Specify:

* NOTE: If accessing participants through the use of an existing database, the custodian of the database must obtain the patient’s or participant’s permission to provide his/her name to the researcher unless prior consent has been given at the time the data was entered into the database.

(b)How will potential participants be approached/recruited (i.e. initial contact/approach)?

2. Describe the procedures for obtaining consent from participants (i.e. consent process):

10

3. Who will obtain consent? 4. Are you requesting a consent waiver (e.g. anonymous questionnaire with no identifiers)? *YES NO

NOTE: TCPS reference re waiver of consent – TCPS 2.1(c)

*If YES, please justify: 5. Describe the relationship between the investigator(s) and the participant(s). If the investigator is in a position of

authority or power in relation to the participants (e.g. supervisor/treating physician/professor), how will you avoid undue influence?

6. Consent Requirements

(i) Are ALL participants competent to consent? YES *NO NOTE: TCPS reference re authorized third party -TCPS 2.5

*If NO, describe the alternate source of consent

(ii) Are participants minors (i.e. ages 0 to 15)? *YES NO

NOTE: Refer to REB Assent Procedures *If YES, describe the procedure to be used and describe how you will obtain assent / consent (attach assent/consent form).

(iii) How will you assure ongoing consent from research participants or authorized third party?

(iv) What procedures will be followed for participants who wish to withdraw their consent, either during

or after the study? NOTE: Ensure the procedure is described in the consent/assent form.

7. Will you be contacting participants either by telephone or letter during the project? *YES NO

*If YES, you must append a copy of the letter/telephone script or list of questions with the research protocol. APPENDED

SECTION E – STEPS TO BE TAKEN TO ENSURE CONFIDENTIALITY OF DATA

1. Indicate all person level data you collecting:

DIRECT IDENTIFIERS INDIRECT IDENTIFIERS Full Name (recommend initials) Initials Address Full Date of Birth (day/month/year) Full Postal Code (recommend first 3 digits only)

Age at time of data collection or year of birth

Telephone number First 3 Digits of Postal Code OHIP # Healthcare Provider (recommend type of

provision, e.g. Family Physician, VON)

Social Insurance Number Discharge Date Email Address Other date (e.g. date of service) Medical Record Number Fax Number Full Face Photograph Medical Device Identifier OTHER- Certificate/License Number Vehicle Identification* OTHER -

11

* NOTE: Vehicle Identification numbers (VIN) and serial numbers including license plates. PRIVACY BEST PRACTICES: Investigators should plan to collect person level data at the lowest level of identifiability necessary to achieve the study objectives. We recommend using only initials and the first 3 digits of postal codes. Even a dataset without direct identifiers may present risk of indirectly identifying data subjects if the dataset contains sufficient information about the individuals concerned. For advice, consult the “CIHR Best Practices for Protecting Privacy in Health Research”: http/www.cihr-irsc.gc.ca/e/29138.html If you are collecting person level data, you are required to: 1. segregate/strip all direct identifiers from other clinical data 2. assign a unique study identifier (ie. randomly generated or meaningless ID number) 3. if direct identifiers must be retained, they should be isolated on a separate dedicated

server/network without external access 4. ensure that Master list is locked and password protected

2. If you are collecting any of the above personal identifiers, you must justify why each item is required. Justification:

3. Attach data collection form or list of fields to be collected. ATTACHED NOTE: Data collection forms must not include personal identifiers. If you are collecting data in a Case Report Form please attach the first 2 data pages of the CRF

4. Do you plan to link the locally collected data with any other dataset(s) (e.g. OHIP data, census tract data)?

*YES NO *If YES, identify the dataset, identify how the linkage will occur, and provide a list of data items contained in it.

5. Indicate the steps to be taken to ensure security of data. Please check all that apply.

NOTE: Data with direct or indirect identifiers must not be saved on personal devices including laptops or memory sticks unless adequate security procedures are in place (IT consultation required).

PROCEDURAL MEASURES Data without

identifiers Data With identifiers

Data access to the segregated/identified data will be limited to a “need to know” basis* (authentication measures)

There will be an audit trail of access to electronic records to document the person, time and nature of data access with flags for aberrant use and abort algorithms to end inappropriate access

PHYSICAL If direct identifiers are collected, encryption software is required and a protocol for encryption must be attached.

Encryption protocol attached

Electronic data with personal identifiers is stored on a separate server without external access and separate from anonymous data

Paper data records with personal identifiers are stored in a locked filing cabinet separate from related non-identified data records – Specify institutional location (NOTE: Data must not be stored at ‘home’):

Completed data abstraction forms will be stored in locked filing cabinets in secure location – Specify institutional location (NOTE: Identifying data must not be stored at ‘home’) :

Computers will be housed in locked secure location – Specify institutional location (NOTE: Computer with identifying data must not be located at ‘home’):

12

Data file backup will be stored in a separate, locked secure location – Specify institutional location (NOTE: Data back-up must not be stored at ‘home’):

Audio tape/video tape data will be stored in a secure, locked location – Specify institutional location (NOTE: Tapes must not be stored at ‘home’):

Other – Specify: TECHNICAL Data will be stored on a computer which is password protected Data will be stored in a computer file which is password protected Frequent backups of data will occur Data will be stored on computer systems with virus protection Data will be stored on computer systems with uninterrupted power source

*REMINDER: All changes to previously approved research plans require approval, including any change in persons given access to the data.

6. (a) Will data be sent outside of the institution where it was collected and/or will you be receiving data

from other sites (for example, in the case of a multi-site study where you are the coordinating site receiving data)? *YES NO

*If YES: i. is it de-identified data? YES NO ii. is it data with direct/indirect identifiers? YES NO iii. explain why it is necessary to send/receive data outside of the institution where it was collected.

iii. Specify the names and affiliations of persons outside of your research team (e.g. technical service providers, other researchers, sponsor/CRO representatives) who will have access to the data. *NOTE: Data with direct/indirect identifiers sent or received by the institution will require that the parties enter into an information transfer agreement before the data transfer takes place.

iv. Where will data be sent? *NOTE: For data with direct/indirect identifiers being transferred outside of Ontario, the receiving party must provide documentation that specifies they are in compliance with security and privacy legislation as it relates to the Ontario Personal Health Information & Protection Act. ALSO NOTE that data going to the U.S. will be open to access by U.S. Regulatory Bodies, e.g. Dept of Homeland Security, and researchers are obligated to notify study participants of this possibility.

(b) How will the data be sent or received?

Transmission of data via: Sent? Rec’d?Fax - Describe security at the receptor site: Email (Attach encryption protocol) Private Courier (Must be able to trace delivery) Canada Post Xpresspost or Priority Courier (Regular mail may not be used) Other – Specify:

7. Will the data be entered into an ongoing electronic database for future use in another research study?

NOTE: Any secondary analysis must be approved by the REB prior to implementation. *YES NO *If YES, specify where it will be stored, who will be the custodian (i.e. the person responsible for data storage and integrity), who will have access to it, and security measures.

8. (a) How long do you plan to keep the data? Specify:

13

NOTE: You are required to destroy identifiers or links at the earliest possible time. ALSO NOTE that Health Canada Drug, Device or Natural Health Products studies require 25 year study-related record retention. Otherwise, there are no defined regulations or standards for other research trials. However, institutional or sponsor standards for record retention may apply. The REB recommended minimum standard is ten (10) years. (b) Will data be: destroyed, anonymized (e.g., the key identifying the link between data and the individual’s

identity is deleted)? REMINDER: For Questions 6, 7 and 8 above, where Computer Information Technology support and consultation is required, please ensure IT needs are identified in Section F – Resource Utilization.

14

SECTION F – RESOURCES UTILIZATION PAGE FOR ST. JOSEPH’S HEALTHCARE HAMILTON NOTE: Please note that if you are conducting your research at a site/location (e.g. educational facility, private clinic/programme site, retirement home, community location) this is not affiliated with HHS, SJHH or McMaster University, you will need to provide a letter of permission from the individual(s) responsible for that site/programme indicating permission for you to conduct your study/recruit participants, etc. For non-clinical research that involves access to students, staff or faculty, and which may include requiring access to contact information and records at HHS, SJHH or McMaster University, please obtain permission from the appropriate School/Programme/Department and ensure that signatures are completed (see below under #8 Other). Requirements: • It is the responsibility of the applicant to ensure that all areas from which resources will be required have been

consulted and have indicated agreement by signing this form. • Approval of the project is conditional upon satisfactory completion of this section. • A separate resources form must be filled in for St. Joseph’s-based and for Hamilton Health Sciences-based research. Institutional Services, Staff or Equipment: • If your participant will be admitted to hospital and/or will require any hospital services as a requirement of this study,

which are over and above standard treatment, you must obtain appropriate signatures in areas listed below. • If the study involves more than one unit or service in the hospital, signatures must be obtained from all areas

involved. • In all cases, budgets should cover institutional costs (e.g. nursing time for data collection, incremental costs

associated with drugs being used in study) for Hospital/Centre participation in research, unless agreed upon by the appropriate Director/Administrator.

• All applications for studies involving drug administration, even if dispensed directly to participants by the Investigator, require the appropriate Pharmacy signature. (NOTE: Application will not be reviewed until signature is obtained)

Human Resources: • When budgeting for research personnel, the applicant is advised to contact the Human Resources Office to ensure

that all necessary calculations for personnel costs are included. McMaster: employ@mcmaster.ca HHS: recruitment@hhsc.ca SJH: jnikpal@stjosham.on.ca

Space: • Investigators are expected to accommodate all features of research in their present space allocation (staff, records,

materials storage, etc). Approval from the REB does not constitute approval for additional space. The following individuals may be contacted to facilitate negotiation of additional space at the following locations: - Faculty of Health Sciences: Marie Townsend, 905-525-9140, x22515, townsend@mcmaster.ca - Hamilton Health Sciences: Deidre Henne, 905-521.2100, x74862, henne@hhsc.ca - St. Joseph’s: Dori Kazimer, 905-522-1155, x34916, dkazimer@stjosham.on.ca

Information Computer Technology Support Services: • What support services do you require from SJHH IT for this research project? (see signature required below #9)

Software installation Database setup Storage space Server space Web access Data security services Remote Access Hardware Installation Encryption protocols Other (specify):

The following individual may be contacted to ensure that all necessary costs for IT support are included: o Doug Campbell, St. Joseph’s: 905-522-1155, x34913, dcampbell@stjosham.on.ca

CHECK AREAS BELOW WHERE RESOURCES OR AUTHORIZATIONS ARE REQUIRED ( ) # AREA Type Name of Authorized

Official OR Designate Signature

1 Health Records

Rose Iannone, Manager OR

2 Laboratory Services

Matthew McQueen OR

3 Medication/Drugs (Pharmacy) Carolyn Gosse, Director OR

15

Shamim Jamal-Rajan, Research Pharmacist

4 Radiology/Diagnostic Imaging Mary Ann Breitigam, Research Coordinator OR

5 Nuclear Medicine Resources

Betty Ng, Manager

6 Radiation Safety

Rhonda Buchy, Radiation Safety Officer

7 Information Computer Technology Support Services

Doug Campbell, Research IS Analyst

8 Other – specify (i.e. Social Work Services, Coroner’s Office, Schools of Rehab Science, Nursing, or Medicine, BHSc Programme, etc):

FOR RESEARCH INVOLVING PATIENTS AT SJHH - APPROVALS ARE REQUIRED FROM INDIVIDUALS RESPONSIBLE FOR NURSING AND CLINICAL CARE OF EACH PATIENT AREAS TO BE UTILIZED

Inpatient Area(s) – Specify area(s) and provide signature(s) as applicable Area 1

Name

Signature

Area 2

Name

Signature

9

Area 3

Name

Signature

Outpatient/Clinic Area(s) – Specify area(s) and provide signature(s) as applicable Area 1

Name

Signature

Area 2

Name

Signature

10

Area 3

Name

Signature

16

SECTION G –SIGNATURE PAGE FOR REB APPLICATION ST. JOSEPH’S HEALTHCARE HAMILTON SIGNATURE OF LOCAL PRINCIPAL INVESTIGATOR: • I assume full responsibility for the scientific and ethical conduct of the study as described in this REB application and

submitted protocol and agree to conduct this study in compliance with the Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans and any other relevant regulations and guidelines. I certify that all researchers and other personnel involved in this project at this institution are appropriately qualified and experienced or will undergo appropriate training to fulfill their role in this project.

• I have obtained all necessary resource utilization signatures as noted above and all costs associated with the use of

these resources have been declared. • On behalf of my research team, I recognize the importance of maintaining the confidentiality of all personal

information, including personal health information, and the privacy of individuals with respect to that information. I will ensure that the personal information is used only as necessary, to fulfill the specific research objectives and related research questions described in this application and approved by the REB. This includes all conditions and restrictions imposed by the REB governing the use, security, disclosure, return or disposal of the research participants’ personal information. I agree to take any further steps required by the REB and/or the institution to ensure that the confidentiality and security of the personal information is maintained in accordance with the Personal Health Information Protection Act (PHIPA), its accompanying regulations and the Tri-Council Policy Statement (TCPS)..

___________________________________________________ Signature of the LPI Date Print LPI Name: NOTE: If this is a student project, then the supervisor must sign above where indicated for LPI and the student signs below as the PI. ___________________________________________________ Signature of the PI (if different from above) Date (If PI is not local, a faxed signature is permitted – please attach) Print PI Name:

17

ST. JOSEPH’S HEALTHCARE HAMILTON

REB Application Signature Page For Director, Clinical Services / Vice President

COMPLETE THIS PAGE FOR EACH CLINICAL DEPARTMENT/PROGRAM/SERVICE INVOLVED

The signature of the Director, Clinical Services OR the Vice President is required to indicate that the hospital has sufficient resources within the department/service/program to support the study. 1, 2 Director, Clinical Services / Vice President’s Review: I have reviewed the attached protocol and confirm that the Department of (or) Program of has the resources (space, personnel, patient population) necessary to support this research. I have taken into consideration any research which is planned or already in progress in the Department/Program in making my assessment. Printed Name: Director, Clinical Services _________________________________________ Signature Date OR Printed Name: Printed Name: Vice-President2 AND Director/Manager2 __________________________________________ __________________________________________ Signature Date Signature Date 1 Hamilton Regional Laboratory Medicine Program exempted – only the signature of the Chief of Laboratory Medicine is required in Section F of this application. 2 For those diagnostic/therapeutic services (e.g. Pharmacy, Social Work) and/or institutes and centres (e.g. CMAS, CEM) which report directly to a Vice-President, signatures of the appropriate Vice-President AND the Director/Manager of the service or institute must be obtained; for those programs/clinics/services (e.g. Emergency, CTU, OPD) reporting to a Director, Clinical Services, the signature of that Director must be obtained.

18

ST. JOSEPH’S HEALTHCARE HAMILTON

REB Application Signature Page For Chief of Department / Professional Practice Leader

Only one signature is required (either the Chief of Department OR the Professional Practice Leader).

(a) If the Local Principal Investigator is a member of the Medical, Dental, Midwifery and Special Professional staff, the signature of the Chief of Department must be obtained.

(b) If the Local Principal Investigator is a member of an allied health profession, the signature of the Professional Practice Leader must be obtained.

This signature is required to confirm that the local principal investigator is qualified to conduct the study, and that (for the Chief’s signature) the clinical department has sufficient resources to support the study. Chief of Department Review: CHECK [ ]:

I have reviewed this protocol.

I confirm that is a member in good standing of the medical staff of St. Joseph’s Healthcare Hamilton.

I confirm that s/he has the credentials/expertise to conduct the research being proposed in this application.

I agree that the Department of has the resources (space, personnel and patient population) to support this research. Printed Name: Chief of Department _______________________________________ Signature Date OR Professional Practice Leader Review: CHECK [ ]:

I have reviewed this protocol.

I confirm that is a member in good standing of the discipline of , St. Joseph’s Healthcare Hamilton.

I confirm that s/he has the credentials/expertise to conduct the research being proposed in this application. Printed Name: Professional Practice Leader _______________________________________ Signature Date

19

Research Ethics Board

CHECKLIST THIS FORM MUST BE COMPLETED & AFFIXED TO THE FRONT OF YOUR PACKAGE

Check [ ] all that apply: Affiliation

If the Principal Investigator is not a staff member of SJHH, there must be named as Locally Responsible Investigator a staff member who will be responsible for the conduct of the research at SJHH.

Required Signatures The Principal Investigator must sign and date the application form in the space provided. Chief of Dept / Director, Clinical Services / Professional Practice Leader must sign and date the application form

in the space provided. If the study uses the following services, corresponding signatures must be on the application:

Health Records – The Manager, Health Records. Laboratory Services --- The Director, Laboratory Services. Pharmacy --- The Director, Pharmacy or delegate. Radiology/Diagnostic Imaging Services --- The Research Coordinator or delegate. Nuclear Medicine Resources --- The Manager. Radiation Safety --- The Radiation Safety Officer. Information Computer Technology Support Services --- Research IS Analyst In Patient / Outpatient Services - the relevant Administrative Director.

Lay Statement

Readability should be at a Grade 8 level.

Forms/Attachments/# of Copies Required Provide three copies of the application (including one with original signatures plus two photocopies)

consisting of the: Typed Application for Review by Research Ethics Board with all applicable sections complete; Consent form/Information documents and recruitment advertisements/posters; Research Protocol (include see Guidelines for content); Letters of approval from hospital/university REBs in other jurisdictions, if applicable; Approval Letters from Health Canada, if applicable (see Sec A.10); Two copies of the product monograph or investigator’s brochure if the study includes an investigational

agent not yet approved by Health Canada; Approval Letters from Infection Control or Biosafety Committee, if applicable (see Sec A.11); Budget Summary (Appendix 1); and Informed Consent Checklist (Appendix 3).

If the protocol contains a total of 26 pages or more, then 22 copies of the protocol must be submitted.

In addition to the above materials, please forward via email attachment (email to: lmahan@stjosham.on.ca ) an

electronic copy of the Application for Review and the Information/Consent form(s).

Administrative Fee for REB Review of Industry-Sponsored Studies $2,000 (Cdn) administration fee payable to “McMaster University” included for all industry-sponsored research

projects. Questions regarding payment details may be directed to the CSD office (905-525-9140, ext. 22258). Projects must be submitted by 1600hrs on the last Monday (or Tuesday if Monday is a holiday) of the month to Mrs. Anna Hoover, Rm H307, St. Joseph’s Healthcare, 50 Charlton Ave E, Hamilton, ON L8N 4A6 (905-522-1155, ext. 33357) for consideration at the Research Ethics Board meeting held on the 3rd Monday of the following month.

Projects not conforming to the ABOVE requirements will be returned to the Investigator.

APPENDIX 1 RESEARCH ETHICS BOARD

BUDGET TEMPLATE Estimated Itemized Cost Per Participant

# Visits X Cost = Total

History & Physical (or other remuneration to investigators)

X =

X-rays X = Ultrasound X = Bone Scans X = CT Scans X = MRI X =

Imaging:

Other – specify

X =

Haematology X = Chemistry X = Urinalysis X =

Lab Work:

Other – specify

X =

ECG X = Endoscopy/OR X =

Medication Costs – Mandatory: list all drugs being used (if free, enter “0”)

X = Pharmacy:

Admin Costs Reimbursements and other payments to participants

X =

Total cost per participant = (a) Total Participant costs:

participants X (a) = (b)

PERSONNEL COSTS 1. Nurse/Coordinator @ $ /hr x hrs/patient x patients = 2. Nurse/Coordinator @ $ /hr x hrs/patient x patients = 3. Nurse/Coordinator @ $ /hr x hrs/patient x patients =

Total Personnel: = (c) EQUIPMENT COSTS

Specify Equipment - = Total Equipment: = (d)

ADMINISTRATIVE AND INFORMATION TECHNOLOGY COSTS Administrative (meetings, telephone, stationery, etc.) = Information Technology (software install, dbase setup, storage/server space, data security, web access, remove access, etc.)

=

Total Administrative Costs: = (e) INDUSTRY-SPONSORED STUDIES

Overhead for Industry-sponsored studies = REB Admin Fee for Industry-sponsored studies ($2,000) =

Total Indirect Costs: = (f) Total Cost for Complete Study: =

(b+c+d+e+f) N.B. If your budget is reported as cost/patient enrolled, be sure to provide a detailed justification of what is included in the cost/patient (i.e. how many hours of nursing time, etc.). Remember to contact Human Resources when budgeting for personnel costs.

APPENDIX 2 ADDITIONAL CO-INVESTIGATORS (CO-I)

CO-I #4: If CO-I is a student/trainee, specify: Post-doc PhD Master’s Undergrad Resident/Fellow Title: First Name: Surname: Institution: Dept: Program: Division: Street Address: Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

CO-I #5: If CO-I is a student/trainee, specify: Post-doc PhD Master’s Undergrad Resident/Fellow Title: First Name: Surname: Institution: Dept: Program: Division: Street Address: Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

CO-I #6: If CO-I is a student/trainee, specify: Post-doc PhD Master’s Undergrad Resident/Fellow Title: First Name: Surname: Institution: Dept: Program: Division: Street Address: Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

CO-I #7: If CO-I is a student/trainee, specify: Post-doc PhD Master’s Undergrad Resident/Fellow Title: First Name: Surname: Institution: Dept: Program: Division: Street Address: Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

CO-I #8: If CO-I is a student/trainee, specify: Post-doc PhD Master’s Undergrad Resident/Fellow Title: First Name: Surname: Institution: Dept: Program: Division: Street Address: Building/Office/Room #

City: Province/State: Postal/Zip: Country: Phone/ext: Pager: Email: Fax:

APPENDIX 3

HHS/FHS & SJHH RESEARCH ETHICS BOARD CONSENT CHECKLIST Version March 2008

This form is available in MS WORD & WP formats and can be downloaded at: http://www.fhs.mcmaster.ca/csd/ethics/reb/forms.htm

INFORMED CONSENT CHECKLIST GENERAL REQUIREMENTS: Check[ ] all applicable

• Print the Information sheet and Consent form on appropriate letterhead (e.g. St. Joseph’s Healthcare, Hamilton; McMaster University; Hamilton Health Sciences; or Hamilton Regional Cancer Centre), with the title of the study, names of the Principal/Local Principal Investigator and funding Sponsor (also identify internally funded sources/sponsors) at the top, pages numbered appropriately and current version date included. Ensure use of the proper names of institutions, sites, sponsors, etc. avoiding use of acronyms or abbreviations. • The Information sheet should begin with the phrase “You are being invited to participate in a research….” • Ensure the Information sheet is written consistently in the second person (“You”/”your”) • The Consent portion should be written in the first person singular (“I”, “me”, “my”) and should indicate that the participant understands and agrees to participate in the research. • Ensure a thorough check for spelling, punctuation and grammar (including consistency in the use of “you/I”). Also ensure that all consent materials are printed in a suitable type-size for easy reading by participants. • Avoid use of acronyms on information/consent materials that form actual words while abbreviating the study title. To avoid any possibility of unduly influencing participants, do not use acronyms that may give participants the expectation of a favourable outcome (e.g. the “W.O.N.D.E.R. D.R.U.G.” study). • Research participants must be informed if their physician will receive a fee for enrolling them in a study. • A sentence identifying the person that participants should contact with any questions concerning the rights of trial participants:

○ FOR ST. JOSEPH’S HEALTHCARE STUDIES: “If you have any questions regarding your rights as a research participant, you may contact the Office of the Chair of the Research Ethics Board, St. Joseph’s Healthcare Hamilton, 905-522-1155, Ext. 33537.” ○ FOR HAMILTON HEALTH SCIENCES/FHS McMASTER UNIVERSITY STUDIES: “If you have any questions regarding your rights as a research participant you may contact the Office of the Chair of the Hamilton Health Sciences / Faculty of Health Sciences Research Ethics Board at 905-521-2100, Ext. 42013.”

• Ensure sufficient space is provided for both the printed name and signature of each person completing the Consent portion, i.e. participant, person obtaining consent, witness (if required) and investigator, together with the date of each signature and (recommended for Division 5 Drug trials) that initials are on each page of the consent form. • If the participant is a minor,(7 – 15) the participant should sign to give assent to the research in addition to the guardian’s consent. • Include a sentence in the Consent Form stating that “I will receive a signed copy of this form”.

READABILITY: • Ensure the Information sheet and Consent form are at a Grade 8 reading level.

o To check readability of consent materials using Microsoft Word, go to “Tools” ”Spelling & Grammar” ”Options” ”Show Readability Statistics”. When Word finishes checking spelling and grammar, it displays information about the reading grade level.

CONFIDENTIALITY: • Describe procedures to ensure confidentiality of data and anonymity of participants. Provide information on length of retention and security of data. If information will be released to any other party for any reason, state the person/ agency to whom the information will be furnished, the nature of the information, and the purpose of the disclosure. • If activities are to be audio- or videotaped, describe the participant’s right to review the tapes, who will have access, if they will be used for educational purposes, and when they will be erased.

MEDICAL ACTS: • If investigators propose to include their own patients in a study, the invitation to participate should be made and the informed consent should be obtained by persons on whom the participant has no dependency. • That a physician is a co-investigator and signs the Consent form if medical intervention is part of the study.

GENETICS: • For studies involving genetic research or banking of tissue, inform the participant how long the sample will be stored; explain that the sample will be used for genetic research; explain who has control and ownership of the sample (e.g. “The analysis of your DNA sample may contribute to the creation of commercial products from which you will receive no financial benefit”); inform participant whether they will have access to genetic information; and indicate whether there may be a future secondary use of sample. • For protocols containing sub-studies involving genetic research or banking of tissue, a separate consent is required, either as a separate section following the main study consent form, or as a stand-alone consent form.

HHS/FHS & SJHH RESEARCH ETHICS BOARD CONSENT CHECKLIST Version March 2008

The following elements are REQUIRED for clinical trials that fall under ICH-GCP Guidelines Excerpts from Section 4.8 “Informed Consent of Trial Subjects”

ICH Good Clinical Practice: Consolidated Guidelines adopted by Health Canada 4.8.4 None of the oral and written information concerning the trial, including the written informed consent form, should contain any language that causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence. 4.8.6 The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness, where applicable. 4.8.10 Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following: (a) That the trial involves research. (b) The purpose of the trial. (c) The trial treatment(s) and the probability for random assignment to each treatment. (d) The trial procedures to be followed, including all invasive procedures. (e) The subject's responsibilities. (f) Those aspects of the trial that are experimental. (g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant. (h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this. (i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important

potential benefits and risks. (j) The compensation and/or treatment available to the subject in the event of trial-related injury.

(k) The anticipated prorated payment, if any, to the subject for participating in the trial. (l) The anticipated expenses, if any, to the subject for participating in the trial. (m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled. (n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such access. (o) That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject's identity will remain confidential. (p) That the subject or the subject's legally acceptable representative will be informed in a timely manner if information

becomes available that may be relevant to the subject's willingness to continue participation in the trial. (q) The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury.

(r) The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated. (s) The expected duration of the subject's participation in the trial. (t) The approximate number of subjects involved in the trial.