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1.0 PURPOSE

This standard operating procedure (SOP) describes the Research Ethics Board’s (REB) communication with research participants.

2.0 SCOPE

This SOP pertains to REBs that review human participant research in compliance with applicable regulations and guidelines.

3.0 RESPONSIBILITIES

All REB members and REB Office Personnel are responsible for ensuring that the requirements of this SOP are met.

4.0 DEFINITIONS

See Glossary of Terms.

5.0 PROCEDURE

Research participants should be able to confidently voice their concerns and questions, and request information regarding their participation or potential participation in research to an informed individual on the REB or in the REB office.

5.1    Communication with Research Participants

5.1.1    Research participants are encouraged to contact (by telephone or, in writing electronically) the REB Office with questions and concerns using the contact information provided in the informed consent document(s). The identity of the participant will be shared with the REB Chair and with the organization’s appropriate representative, if applicable, and if the participant provides their consent.

5.1.2    The REB Office Personnel must document all communication with the research participant.

5.1.3    The REB Office Personnel will communicate participant concerns to the REB Chair or designee.

5.1.4    The REB Chair or designee works to resolve participant issues, which may include a follow-up with the Researcher or the Researcher’s supervisor or other organizational representative and with appropriate federal agencies, as applicable.

5.1.5    The REB Chair or designee documents all communication with the research participant, and a de-identified record of this communication is maintained securely and in the relevant research file.

6.0 REFERENCES

See References.