Appendix C

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Scientific Peer review of a Research Project Involving Human Participants

Note

A scientific peer review should be undertaken prior to submitting an application for ethics review and approval to the Health Canada and Public Health Agency of Canada’s Research Ethics Board (REB).

Conflict of Interest

This is to confirm that I have no conflict of interest and that I am also free of any biases that would prevent me from giving my best independent scientific opinion on this participant.

Reviewer's Name:
Title:

Address:
Telephone:
Facsimile:
E-mail:

Signature:
Date:

Part A: General

Name of Applicant(s):
Division/Department:
Project Title:
Funding Agency:
Deadline:

1. Brief Description of Project (To be completed by reviewer)
2. Budget:
   1. Approximate Budget - Year 1:
   2. Is it justified in the application?:
   3. Are the sums requested adequate?:
   4. Is there a project contract?:

Part B: Review

1. Is there a reasonable hypothesis?
2. Is there an appropriate literature review?
3. Is the research protocol clearly described?
4. Is the significance of the study explained?
5. Are the summary pages well prepared?
6. Is this study feasible?
   If not, why?
7. Is the study likely to yield publishable results?
8. Does this study require a safety monitoring committee?
   If no, what monitoring mechanism would you recommend?
9. What is your overall assessment of the application?
   Please list any specific recommendations (Attach an additional page if necessary)

Part C: Human Participants

1. Are participant inclusion and exclusion criteria carefully delineated?
2. Is the study comparative?
3. Are the study numbers discussed and justified? If yes, are the study numbers sufficient to provide likelihood of an interpretable result?
4. Is the study descriptive?
   If yes, is the information to be derived likely to be unique?
5. Does the study involve disruption of schedules (including school) for participants/parents?
   If yes, is the disruption justified?
6. Is statistical analysis required?
   If yes, is there a discussion of statistical methods and are they appropriate?
7. Is the potential harm vs. potential benefits appropriate?
8. If this is a clinical trial comparing two or more treatment regimens, are the risk - benefit ratios of each regimen well balanced so that the average expert would not favor one regimen over the other (that is, does equipoise exist)?  Yes  No  Don't Know
9. Are there any major changes that need to be made before this proposal should be submitted for ethics review?
10. Is scientific merit including significance of the study adequate to justify its ethics consideration?

Part D: Ranking

Two ratings are to be determined; the proposal as is, and the proposal if the proposed revisions are made.

Please use the rating system from 0 to 4:
(0-reject / 1-fair / 2-good / 3-very good / 4-outstanding)

• Proposal As Is:
  • 1
  • 2
  • 3
  • 4
• Proposal if Revisions are Made:
  • 1
  • 2
  • 3
  • 4

Signature of Reviewer:
Date of Review:

Part E: Itemized Response

An itemized written response to all the issues raised by the reviewers noting where revisions were made in the revised protocol must be provided to the Research Director for final approval and signoff prior to submission to the REB for ethics approval.

Final Branch Approval:

Signature:
Date:

All research involving humans at Health Canada and the Public Health Agency of Canada must be reviewed and approved by the Research Ethics Board. Approval must be obtained in writing before the research begins.

This form should accompany the Principal Investigator's application as well as all supportive documents and submit these to:

Manager, Research Ethics Board Secretariat
Holland Cross Building, Tower A
11 Holland Avenue,
Suite 511, Address Locator #3005B
Ottawa, Ontario, K1A 0K9
Phone number: 613-941-5199
Fax : 613-948-6781

Email: REB-CER@hc-sc.gc.ca

The Research Ethics Board (REB) aims to adhere to the principles and practices stated in the Canadian Tri-Council Policy Statement (1998) and the Declaration of Helsinki.