The membership and conduct of the Research Review Board Inc. operates with policies and procedures that are compliant with the composition, operation, and responsibilities as defined in Section 3.2 of the Therapeutic Products Directorate (TPD) Health Canada and with the US Food and Drug Administration requirements defined in 21 CFR (Code of Federal Regulations) Parts 50 and 56. This REB carries out its functions in a manner consistent with Section 3 of the ICH (International Conference on Harmonization) guidance relating to GCPs (Good Clinical Practice).
The RRB:
- Membership consists of the appropriate number of members, including community membership, gender variation, and appropriate areas of expertise all without conflict of interest;
- Membership curriculum vitae are maintained current and supplied with approvals and other communications as necessary;
- Meetings consist of correct representation and proceedings are documented, communicated as necessary and stored safely for the time periods recommended;
- Follows all guidelines regarding the review and approval of all documentation and information submitted;
- Follows all recommendations and procedures regarding expedited reviews and keeps all RRB members apprised of such reviews and outcomes;
- Ensures that risk is minimized and fully disclosed to subjects, that the research has benefit, that subject selection is equitable, that consent is sought and documented, that confidentiality is upheld and that the rights and welfare of subjects are safeguarded;
- Reviews serious adverse events (SAE's) and ongoing research activities at approved sites and has the right to suspend or terminate that research if site activity is inappropriate or subjects are deemed to be at risk above the value of the research;
- Obtains knowledge of the culture of a community in which active research is conducted via an appropriate mechanism to be assured that the research is in harmony with that areas culture and laws;
- Enables study subjects to contact the chair of the RRB directly with questions or concerns;
- Communicates with the study sites as needed and requests or supplies information to the sites so that all information is current and reports to the RRB members etc can be made.
