Background Information about the Research Review Board Inc.
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, community membership,
gender variation, appropriate areas of expertise and membership is
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
written policies and procedures regarding new applications, ongoing
review of research, reporting to the RRB and reporting to the sponsors;
- 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.
|
