MONTREAL NEUROLOGICAL INSTITUTE AND HOSPITAL RESEARCH ETHICS BOARD (REB)

APPLICATION FOR INITIAL REVIEW

The following are the requirements for a complete submission to the REB. Incomplete submissions will not be
considered. Please complete this form for your submission.

When printing the consent documents, make certain that the study site, protocol title and version date appear on
every page.

Fifteen (15) copies are to be provided to the Coordinator of the REB, Lisa Jones (Acting Coordinator) Room 686, Tel:
(514) 555-1046, fifteen (15) days prior to the meeting at which it is to be reviewed.

(Approval letters from the Magnetic Resonance Research Committee or the PET Working Group should be delivered
at least eight (8) days prior to the scheduled meeting.)

Investigators are requested to verify the date of upcoming meetings with Lisa Jones (Acting Coordinator)
[email protected] or on the web at http://www.mni.mcgill.ca/staff/research_services/reb

1. a) Official title of project:

b) Does this protocol involve any patient population? If so, state type:
□ Yes □NO

c) Does it involve the administration of therapy?

□ Yes □NO

d) Is this an imaging study? □Yes □NO

If so, state type:
□ MRI □ MRI Approval letter attached
□ PET □ PET Approval letter attached

2. Principal Investigator
Coordinates (room # & tel #):

a) Associate investigator(s) at the MNI/MNH:

b) Full names, titles and affiliations of other associate investigators:

3. Is the PI the author of the protocol? If not, who is?

4. MNH physician, if any, to be involved in this project:

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5. Letters of agreement and support from individuals or departments whose facilities are to be used:

5.a. McGill University Health Centre/ Montreal Neurological Institute departments or facilities (eg.
Director of professional Services (DPS), Neurological Services Operations Committee, etc)

5.b Regulatory Compliance

A clinical trial involving human subjects planned for conduct in Canada must comply with the regulations
stipulated by the Food and Drugs Act including the Food and Drug Regulations, and be authorized by Health
Canada (HC) via a No Objection Letter (NOL).

A clinical trial regulated by the US Food and Drug Administration (FDA), conducted at a non-US site must
conform to the laws and regulations of the country in which the research is conducted (attestation). Refer to
the US DHHS and FDA document entitled “Guidance for Industry: Acceptance of Foreign Clinical Studies”.

Research activities involving human subjects sponsored in whole or in part by the US federal government
including the Public Health Service is conducted at the MUHC in compliance with a Federal Wide Assurance
(FWA) for International Non-US Institutions.

For a clinical trial involving an investigational drug and/or biological, or a new indication for a marked
product, was a Clinical Trial Application (CTA) filed with Health Canada (HC) seeking regulatory approval to
conduct the study?

Health Canada No Objection Letter must be appended.

Yes, Health Canada reviewed the study and issued a “No Objection Letter” (NOL). Yes, but

the Health Canada review determined the study does not require a CTA.

If NOL is not required append HC correspondence to justify.

NO, Health Canada “NOL” is not required

6. Synopsis of scientific background of the project, how you will proceed with statistical analysis, and a very
brief summary of goals/aims:

7. Drug studies protocol:

8. Detailed description of procedures to which patients, control and/or normal subjects will be
subjected:

9. Does your protocol involve subjects who are part of a “special population”?
(Definition): Patients diagnosed with psychiatric, neurological or other medical disorders known potentially
to affect competency, or juvenile subjects or mentally challenged subjects pursuant to the terms of Article 21
of the Quebec Civil Code.)

Form version 2006.07.12

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(a) If yes, how will you assess the competence of the subjects to consent to being involved in the
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study?

(b) If yes, what measures have you taken to ensure the immediate availability of medical assistance, if
necessary, during the participation of subjects in the protocol?

(c) If yes, please consult the Guidelines for Protocols Involving Special Populations.

10. Outline any anticipated risks, e.g., medical, psychological, privacy and confidentiality, and the specific
measures contemplated to ensure that any potential risk to the subject is being avoided.

11. Informed Consent documents bearing version dates. Please indicate whether the granting agency
specifically requires REB approval of the consent documents.

12. Proposed number of subjects for the entire duration of the study (please specify the number of
patients, controls and/or normal subjects) and estimated duration of the study:

(a) Number of subjects to be studied in the first year:

13. Granting agency to which project is to be submitted:

(Please provide also the grant number & McGill Fund # if known)

14. If not being submitted to a granting agency, information regarding source of funding:

15. Has the project been peer-reviewed? (indicate yes□ or no□);

16. Source and method of recruitment of subjects:

17. Copy of any advertisement in recruiting volunteers for the study:

18. If the protocol arises from a grant submission, please attach one final copy of the grant submission.

19. For resubmissions only, please clearly indicate all changes made since the original submission. Whenever
submitting protocol amendments or revisions, please provide a brief statement indicating the significance, if
any, of the changes made and whether the consent documents need to reflect these changes.

20. Signature of principal investigator(s)

Date:

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Assessment and verification of subject’s competence:
a) Does the subject have factual understanding of the protocol as described in the consent document?
b) Does the subject have full cognizance of risks and benefits of participation?
c) Cite and attach any additional sources of information the subject may be given:
d) Is the subject able to understand [manipulate rationally] the terms of the consent s/he is signing and to
collaborate safely in the protocol in view of her/his medical condition(s):
e) Is the subject aware that experimentation is proceeding in a research facility and not a primarily medical care
Form version 2006.07.12
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Form version 2006.07.12