Application Categories

This content was archived on June 24, 2013.

Application for Health Canada and the Public Health Agency of Canada's Research Ethics Board (REB) Review

• Full review
  The REB Application - Appendix A
  must be submitted for review and approval by the REB if the research involves human subjects.

  The REB application must be accompanied by the required documentation. All signatures must be original. An approval letter from the REB must be obtained in writing before the research begins.

• Expedited review
  To qualify for expedited review, research must involve no more than minimal risk to human subjects and fall within one of the Criteria for Expedited Review. If there is uncertainty that research falls within the criteria, please contact the Research Ethics Board Secretariat.
• The REB Application - Appendix B
  must be submitted for an expedited review and approval by the Chair of the Board or the delegate. The REB application must be accompanied by the required documentation. All signatures must be original.

  If the Chair does not agree that the research qualifies for expedited review, the researcher will be asked to resubmit the application for full review.

• Reviewed by another REB
  Research that has been previously reviewed and approved by another REB that is guided by the ethical principles found in the Tri-Council Policy Statement (TCPS), must still be submitted for REB review. REB Application - Appendix I has been developed for this purpose.

  This form must be accompanied by the required documentation. All signatures must be original.

• Grants and contributions
  Grants and contributions funded research that involves humans, must have a REB review before the funds are released. The researcher must submit REB Application - Appendix M to the REB Secretariat.
• Supplemental Services
  Health Canada or Public Health Agency of Canada (PHAC) officers, due to their highly specialized expertise, are often requested by a Principal Investigator (PI) from another institution to provide analytical services to a specific project, for example where a Health Canada or PHAC officer analyzes anonymous or anonymized human biological material samples without engaging in their collection.

  The PI must obtain an ethics review from his/her institution's REB, before the research begins. Once the PI has obtained the approval to proceed by his/her institution's REB, the Health Canada or PHAC officer is now required to obtain an ethics review by the Health Canada and PHAC REB by completing the Appendix N and submitting a copy to the REB Secretariat for an ethics review. REB approval must be obtained in writing before the Health Canada or PHAC official takes possession of the data or biological material and begins the analysis thereof.

• Scientific Peer Review
  In order for research to be ethically acceptable, it must be scientifically sound. If research does not have sufficient scientific merit, generalizable knowledge cannot be anticipated and the reason for undertaking the research vanishes. Even a negligible risk of harm resulting from research that may not yield meaningful results is inherently unethical. Therefore, before the research can be reviewed by the REB, it must be reviewed to ensure scientific validity. In addition to including a copy of the completed Scientific Peer Review Report - Appendix C, an itemized response to issues raised and research director signoff is also required prior to submission to the REB.

Consent Forms

The REB reviews each consent form to ensure that the information that is being presented to participants is clear and accurate.

Specifically, consent forms and information sheets should meet the following criteria:

• Generally the REB tries to ensure that consent forms are presented at a Grade 8 reading level.
• The use of medical jargon should be minimized. If technical wording is used, an explanation should also be presented.
• The font size used should not be too small.
• Be sure to be consistent in the subject person ("I" or "You") used throughout the consent form.
• Ensure that the document is checked for grammar and spelling before submitting to the REB Secretariat.
• Use standard clauses and format that are presented in the sample consent forms and recommended format.

Protocol Amendments

If there are any changes to the original application, before the annual review date, the researcher must notify the REB. Researchers must submit an Amendment Request Form - Appendix D to the REB Secretariat. A REB Certificate from the Chair of the Board must be obtained prior to implementing any changes.

This includes changes to an approved consent form and/or information document. Be sure to include the appropriate revised documents. If there are changes required to the Participant Information and Consent Form because of the amendments, include a copy of the last approved documents, a copy of the documents with all changes highlighted, and a clean final version of the revised documents printed on original letterhead. These amendments may only be used by the researcher, once they have been reviewed and approved by the REB and a letter of approval from the Decisional Authority of Health Canada or PHAC.

Annual Progress Report

If research is ongoing, it is the responsibility of the researcher to seek REB re- approval before the year ends. An Annual Progress Report Research Form - Appendix K should be submitted approximately two months prior to the expiry date.

Adverse Event Reports

Adverse effects or unexpected events resulting from the research must be reported by completing the Adverse Event Report Form - Appendix J.

If there are changes required to the Participant Information and Consent Form because of these adverse events, include a copy of the last approved documents, a copy of the revised documents with all changes highlighted, and a clean version of the revised document printed on original letterhead.

Termination/Completion Reports

Upon completion or termination of the research, the researcher must submit a Completion/Termination Form - Appendix L.

If participants undergo continued, periodic assessment after completion of a study intervention, or if continued correspondence about the research is anticipated (Ex.: adverse event reports) the research is ongoing. Participant follow-up should be complete before the termination is submitted.