RESEARCH ETHICS SUBMISSION FORM
Please complete ALL information. Forms with incomplete information will not be reviewed. Submissions
MUST be typed in an easy-to-read font. Any questions related to this form should be directed to the
Administrative Assistant to the VP Medicine at 538-3432.
For Office Use:
Date Received:
_______________________
DREC File #:
_______________________
INSTRUCTIONS: Please complete the entire checklist (with either a  or ‘N/A’) to indicate that the
appropriate number and format of all required documentation has been submitted. As indicated, please
submit one (1) original, eleven (11) copies and/or one (1) electronic copy of documentation listed below.
ALL PHOTOCOPIES MUST BE COLLATED for distribution. If submissions are not complete, they will not
be reviewed and will be returned to the Principal Investigator for resubmission.
Documentation Checklist:
Original
E-copy
11
Copies
For Admin
use:
Administrative Approval Documents:
Identification of AVH Departments Checklist
Impact Analysis for each Affected Area of AVH
Letter(s) of Support for each Affected Area of AVH
District Research Ethics Board Documents:
Ethics Approval Submission Form
1-2 page Research Summary
Study Protocol
Informed Consent Form(s)
Copy of Contract with Funding Agency
Questionnaires / Instruments to be Used
Advertisements for Recruitment of Study Subjects
Results from Previous Ethics or Peer Review Process
Curriculum Vitae for Principal and Associate Investigators
Research Budget
Statement of Disclosure of Conflict of Interest
ONLY For Studies involving investigational Drugs/Devices:
Investigator’s Brochure or Product Monograph
Copy of No Objection Letter from Health Canada
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A. Project
1. Project Title:
1. (a) Title for Release (if different from above):
B. Project Team
1. Print Name of Principal/Qualified* Investigator:
Institution, Department and Division:
Mailing Address:
Phone:
Fax:
Email:
*Note: According to Division 5 Health Canada regulations, one “qualified investigator” must be identified as medically
responsible for a clinical trial. A QI refers to a physician or dentist (in the case of a drug to be used for dental purposes only) in
good standing of a professional medical or dental association.
*Note: By signing below the Principal Investigator certifies that he/she has read the protocol and agrees to conduct the study
following all applicable regulations and guidelines including ICH-Good Clinical Practices Guidelines, Health Canada Division 5
Food and Drug Regulations, Tri-Council Policy Statements, Titles 21 and 45 of the Code of Federal Regulations, and all
Annapolis Valley Health policies and procedures.
Signature:
Date:
(Principal/Qualified Investigator)
(yyyy/mm/dd)
2. Associate Investigators (if applicable):
*Note: By signing below, the Associate Investigator(s) certifies that they have read the protocol and the Principal Investigator
has fully explained their responsibilities in conducting the study following all applicable regulations and guidelines (e.g. ICHGood Clinical Practices Guidelines, Health Canada Division 5 Food and Drug Regulations, Tri-Council Policy Statements, Titles
21 and 45 of the Code of Federal Regulations, and all Annapolis Valley Health policies and procedures).
Name
Affiliation
Div/Dept.
Signature*
3. If the PI is not an Annapolis Valley Health staff member or physician, identify an Annapolis
Valley Health staff member or physician who is an associate investigator and who has
accepted overall responsibility for risks related to the research.
Print Name:
(AVH Staff Member / Physician / Associate Investigator)
Signature:
Date:
(AVH Staff Member /Physician / Associate Investigator)
(yyyy/mm/dd)
4. If PI is a trainee, identify associate investigator at Annapolis Valley Health who has reviewed
the protocol and accepted overall responsibility to supervise the trainee during conduct of the
research.
Print Name:
(AVH Staff Member / Physician /Associate Investigator)
Signature:
Date:
(AVH Staff Member / Physician / Associate Investigator)
(yyyy/mm/dd)
5. Name of contact research coordinator (if applicable):
Mailing address:
Phone number:
Fax number:
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Email:
6. Site(s) where research will be conducted:
7. Study Sponsor (if other than the Principal Investigator):
8. Funding Agency (if funded):
9. Does the study involve the use of an investigational drug, biologic or natural health product
that is not approved for use in Canada or will be used in a way that is different from the
approved use?
YES
NO
If YES, then a copy of the “Letter of No Objection” from Health Canada is required as part of the
submission.
10. Does the study involve the use of an investigational device that is not approved for use in
Canada?
YES
NO
If YES, then a copy of the “Letter of Authorization” from the Medical Device Bureau is required before
full approval will be granted.
11. Does your study require the services or support of any department/division other than the
PI’s own?
YES
NO
If YES, provide a letter of support from the Manager and Head of the impacted department/division.
C. Compensation
1. Will subjects be provided with any compensation (financial or other) over and above
reimbursement for expenses?
YES
NO
If YES, please detail. If subjects are to receive amounts beyond simple reimbursement of expenses
(based on receipts), please explain why you think that the amount is not enough to induce individuals
to participate for monetary reasons.
D. Financial Interest and Disclosure of Conflict of Interest
1. Will any fee (e.g. finder’s fee) be paid to individual(s) or organization(s) for finding subjects
for this study?
YES
NO
If YES, please provide details:
2. Does any investigator or AVH have a financial or proprietary interest in the research and/or
the product under investigation, or in the company sponsoring the research?
YES
NO
If YES, please provide details:
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E. Research Protocol Information
1. Planned start date:
Planned end date:
2. Subjects: Provide number of subjects to be studied (both local and in total). Also provide
justification here for any exclusion criteria that appear to violate the principle of inclusiveness
(e.g., upper or lower age limits, exclusion of women):
3. Standard of Care: For research involving therapies, procedures and interventions, what is
the standard of care at AVH for the patient population?
4. How will participation in this project potentially change or add to the standard of care for a
patient?
5. Identify any additional visits, procedures, or data collected for the purposes of the research
project only.
6. Safety monitoring: Is there an independent Data and Safety Monitoring Board?
YES
NO
7. When are safety analyses planned by the DSMB or by the sponsor?
8. When will summary reports be available to the Annapolis Valley Health Research Ethics
Board?
*Note: In addition to SAEs, all safety summary reports should be provided to the REB. A summary report is requested on at least
an annual basis, at the time of annual approval.
9. Follow-up care: In the case of treatment studies, what procedures are planned to
ensure provision of follow-up care at the end of the study or if the study is terminated
prematurely?
10. Has (or Will) this protocol been/be submitted to another local Research Ethics Board for
approval?
YES
NO
If YES, provide the Board’s name, date of submission, and a copy of the final approval letter:
11. Has this protocol been peer reviewed and approved by external agencies outside of
Annapolis Valley Health?
YES
NO
If YES, provide the name of the agency, date and copies of any written comments:
12. Does anything in the protocol or the contract limit your ability to notify research subjects,
other investigators, physicians, the REB, regulatory agencies or the scientific community of
newly identified risks during the conduct of the study?
YES
NO
If YES, please provide details:
13. Does anything in the protocol or the contract limit your ability to publish the results?
YES
NO
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If YES, please provide details:
F. Informed Consent Process
Please provide a description of the informed consent process including the following
information:
1. Who is the proposed subject population?
2. How will potential subjects be identified?
3. Who will initially approach the potential subjects for informed consent to participate? Note:
Patients should not be approached by ‘strangers’ who know their health care circumstances.
4. Who will be involved in the consent procedure?
5. In the identified subject population, do you anticipate any limitations to the procedure for
consent (e.g., blindness), or to the capacity to consent, (e.g., dementia)?
YES
NO
If YES, please describe the informed consent method you will use to take any limitations into account.
If participants may lack the competency to consent, or the capacity to consent may change during the
course of the study:
5. (a) How will the participant’s competency be determined?
5. (b) Who will be approached for consent?
6. What will occur should the capacity of the participant to give informed consent change
during the study? Note: The consent procedure should be reflected in the consent form.
G. Other Issues:
1. Is this a placebo-controlled study?
YES
NO
If YES, provide a justification for using a placebo instead of a standard therapeutic agent with
reference to Article 7.4 of the Tri-Council Policy Statement on the Ethical Conduct for Research
Involving Humans:
There is no standard treatment.
Standard therapy has been shown to be no better than placebo.
Standard therapy has been shown to provide no net therapeutic advantage.
Effective treatment is not available due to cost constraints or short supply.
A population of patients is refractory to standard care and no standard second-line therapy exists
for them.
The treatment being tested is an “add-on” treatment to standard therapy that all subjects in the trial
will receive.
Patients have provided an informed refusal of standard therapy for a minor condition that will not
lead to any undue suffering or irreversible harm.
Please justify your above selection(s):
H. Privacy and Confidentiality:
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Definition of Personal Information (from the TCPS and FOIPOP legislation)
Identifiable personal information means information relating to a reasonably identifiable who has a
reasonable expectation of privacy. It includes information such as name, address, telephone number,
race, national or ethnic origin, colour, religious or political affiliations, age, sex, sexual orientation,
marital or family status, identifying number or symbol assigned to an individual, fingerprints, blood
type, inheritable characteristics, health care history (including physical and mental disability),
educational/financial/employment histories, opinions about the individual and the individual’s opinions
(except if they are about someone else).
Collection, Use and Disclosure
1. What type of personal information will be collected during the study? (for example: name,
address, telephone number, diagnostic history, full patient record, etc.)
2. What will be the source of personal information? (for example: patients, the general public, third
party organizations, etc.)
3. How will the personal information be collected? (for example: from patient themselves,
databases, forms, etc.)
4. What will the personal information be used for? If the information is being disclosed to third
parties, to who is it being disclosed and why?
Security and Access
5. Where, how and for how long will this information be stored? (for example: central data
repository, electronically on user terminals, physical location, etc.)
6. Who will have access to the personal information? Why will s/he have access and will there
be any limits on access?
7. Describe the administrative security safeguards in place to protect the personal information:
(for example: external contracts with privacy provisions, staff confidentiality agreements, staff privacy
and confidentiality training, restrictions on access, privacy/confidentiality policies, internal policies and
procedures, etc.)
8. Describe the technical security safeguards in place to protect the personal information being
collected, used and/or disclosed: (for example: encryption, password protection, remote access,
monitoring and auditing of access, system testing, etc.)
Maintaining Personal Information
9. Please describe mechanisms (if any) in place to ensure the continued accuracy of personal
information that has been collected:
10. Is the information going to be de-identified prior to disclosure to third parties? If so, please
describe the method for de-identification for the personal information:
11. Please provide details of or attach as an appendix the retention schedule for the personal
information collected and the methods of destruction of the personal information.
Consent and Access
12. Please identify any consent issues with respect to the personal information that is being
collected, used and/or disclosed: (for example: Will consent be obtained from the individual? Will
the study participants be notified of any change in the collection, use or disclosure of their personal
information?)
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13. Will the study participants be given the right to access his or her personal information? If
so, please describe any limitations on access:
14. Will any personal information be stored or accessed outside of Canada? Are there any
contracts in place to limit access and report disclosure of personal information? Are there
specific confidentiality requirements in the contract?
I. Conflict of Interest Disclosure:
1. Does any member of the research team have any financial interests in conducting this
study?
YES
NO
If YES, please indicate the member(s) and the conflict of interest:
2. Are any honoraria being provided to the research team or other departments involved in the
study?
YES
NO
If YES, please list the honoraria being provided:
A copy of the research budget must be provided to the REB.
In order to facilitate the REB’s ability to make conflict of interest determinations, if the
following details are not provided in questions I.1. and I.2. above, please attach a separate
document outlining:
 commercial and financial interests (e.g., stock or share holdings or future options with the
sponsoring company, travel benefits, per capita payments, etc.);
 consultative relationships;
 the relationship between the researcher and the proposed research subjects; and
 any other information that may be relevant.
J. Other Potential Ethical Issues
Please identify any other potential ethical issues in the design or conduct of the project and
provide an explanation for how you have found a resolution for these issues. (for example,
justification of safeguards and benefits if it is a high risk project; any deviation from standard scientific
methodology)
K. Research Summary
Please attach a 1-2 page summary in non-expert terminology of the research project. The
summary must address the following areas:
1. Background and rationale of the research project. Why is this research important?
2. Hypothesis to be tested or question to be asked:
3. Methods of the study (including the design):
4. Outcome measures and how they will be analyzed to test the hypothesis:
5. What are the proposed benefits? What are the potential harms? How do the benefits
outweigh the harms?
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