All research involving human subjects at Health Canada or the Public Health Agency of Canada (PHAC) must be reviewed and approved by the Research Ethics Board (REB). Approval must be obtained in writing before the research begins.
Applications to the Health Canada and PHAC REB must include the following:
- a signed and dated application form;
- a completed and signed scientific peer review and all correspondence pertaining to the review (see Appendix C - Scientific Peer Review of a research project involving human participants);
- the protocol of the proposed research (clearly identified and dated) together with supporting documents and annexes;
- a summary (in non-technical language), synopsis, or diagrammatic representation (Ex.: flowchart) of the protocol;
- a description (usually included in the protocol) of the ethics considerations involved in the research;
- case report forms, diary cards and other questionnaires intended for research participants;
- researcher(s) curriculum vitae (updated, signed and dated);
- material to be used (including advertisements) for the recruitment of potential research participants;
- a description of the process used to obtain and document consent;
- written and other forms of information for potential research participants (clearly identified and dated) in the language(s) understood by the potential research participants and, when required, in other languages;
- informed consent form (clearly identified and dated) in the language(s) understood by the potential research participants;
- a statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants;
- a description of the arrangements for indemnity, if applicable;
- a description of the arrangements for insurance coverage for research participants, if applicable;
- a statement of agreement to comply with ethical principles set out in relevant guidelines;
- all significant previous decisions (for example : those leading to a negative decision or modified protocol) by other REBs or regulatory authorities for the proposed study (whether in the same location or elsewhere) and an indication of the modification(s) to the protocol made on that account. The reasons for previous negative decisions should be provided.
Research Involving Aboriginal people
The Canadian Institutes of Health Research (CIHR), in conjunction with its Institute of Aboriginal Peoples' Health, have recently released the Guidelines for Health Research Involving Aboriginal People. These Guidelines have been produced to assist researchers and institutions in carrying out ethical and culturally competent research involving Aboriginal people.
The intent is to promote health through research that is in keeping with Aboriginal values and traditions. The Guidelines will assist in developing research partnerships that will facilitate and encourage mutually beneficial and culturally competent research. The Guidelines will also promote ethics review that enables and facilitates rather than suppresses or obstructs research.
There is a need for researchers to involve Aboriginal communities when doing research involving Aboriginal people.
- The researcher needs to ensure the involvement of Aboriginal communities in the development of the proposed research project;
- The Principal Investigator, when submitting an application for an ethics review to the Health Canada and PHAC REB, should include the following:
- The results of the consultation undertaken with the Aboriginal communities and a copy of the exchange of correspondence with these communities;
- The recruitment processes to be undertaken in these communities;
- The consent processes for obtaining informed consent from both these communities and the individuals;
- The communication of the report of findings to these communities and the individuals.
All research involving human subjects at Health Canada or PHAC must be reviewed and approved by the Research Ethics Board. Approval must be obtained in writing before the research begins.
Please submit 1 original hardcopy, 8 photocopies and 1 electronic version of:
- The complete ethics application;
- The research protocol;
- Scientific peer reviews;
- Sign-off by research director for those projects reviewed by research forums;
- The information sheet and the consent/assent forms on the required letterhead;
- Documentation for the recruitment of potential participants; and
- Contract (if applicable).
Submit by mail or e-mail to the Research Ethics Board Secretariat.
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