Clinical Trials Committee | Membership
The HREBA Clinical Trials Committee is constituted and operates in accordance with the:
– Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2, 2014);
– Alberta Health Information Act (HIA);
– Good Clinical Practice (GCP) Guidelines of the International Conference on Harmonization (ICH);
– Health Canada’s Food and Drug Regulations (FDR), Part C, Division 5.
The committee is registered with the U.S Department of Health and Human Services, Office for Human Research Protections (OHRP), IRB # 00001209.
The HREBA-CTC is one of three committees which comprise the HIA-designated Health Research Ethics Board of Alberta. Since the three committees operate as one Research Ethics Board, members from one committee may attend another committee’s meeting when their expertise is required. This ensures that members in attendance have the specific expertise, relevant competence and knowledge necessary to provide an adequate research ethics review of the proposals under consideration.
The majority of the committee members are Canadian citizens. Any member of the committee who is a Principal Investigator or a Co-Investigator on a study that is under review abstains from any discussion, voting, or approval of that study. This also applies to initial and continuing reviews.
Clinical Trials Committee Composition 2018
Lawyer (2-F) (1 is Chair)
Pediatric Hematologist (1-M) (Vice Chair)
Clinical Ethicist (2-M, 1-F)
Community Member (3-F) (1 has expertise in alternative/complementary health)
“F” denotes female and “M” denotes male.
The majority of the HREBA – Clinical Trials Committee members are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act.
The Clinical Trials Committee Composition