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 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 (F) (Chair)
Pediatric Hematologist (M) (Vice Chair)
Clinical Ethicist (2-M)
Community Member (3-F)
General Practitioner (1-F)
Physician – Infectious Diseases (1-F)
“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