Report from David Brisco on the Ethics Board’s activities as the UOHI Patient Alumni’s representative

One of the things that make our Heart Institute the great institution that it is, is the ongoing program of research carried out by both specialized researchers, and the medical staff of the HI. The quality of this work has advanced medical knowledge, and has directly served we patients of the HI.

In the past, medical research involving humans has been subject to some controversy, but following the Second World War, international agreements to protect volunteer participants in medical research, became part of the newly evolving system of international law.

In Canada, all research that includes human participants is governed by the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). A key statement from the policy is as follows:

“Respect for human dignity requires that research involving humans be conducted in a manner that is sensitive to the inherent worth of all human beings and the respect and consideration that they are due. In this Policy, respect for human dignity is expressed through three core principles – Respect for Persons, Concern for Welfare, and Justice. These core principles transcend disciplinary boundaries and, therefore, are relevant to the full range of research covered by this Policy.”

In practical terms, the result has been the mandatory establishment; at all institutions carrying out research with human participants, of Research Ethics Boards (REB), to vet proposed experimental projects, to ensure that they meet the high standards of the TCPS 2.

In the case of the UOHI, research is conducted under the umbrella of the University of Ottawa Heart Institute Research Corp (OHIRC), the research arm of the UOHI. Ethical review and approval may come from the UOHI/TOH local board, the Ottawa Health Science Network Research Ethics Board (OHSN-REB) with panels at UOHI, Civic and General Campuses, or through a qualified Board of Record with the Clinical Trials Ontario (CTO) Stream process.  The OHSN-REB is a qualified board with CTO Stream, so in addition to local protocols, our members review studies on behalf of other centres in the province.

The REB consists of members drawn from the medical, research and administrative areas of the UOHI, as well as outside volunteers from the Ottawa legal community, and community members drawn from the general population.

For a number of years, it has been my privilege to represent the Alumni on our Heart Institute’s REB.  The REB meets monthly to consider new research applications, and to deal with issues such as renewals and study closures.  At each meeting, the REB considers 3-4 submissions, receiving in-person presentations from researchers.  Board members with their diverse backgrounds consider such issues as the adequacy of consent forms, conflict of interest and the general ethical approach of the researchers.  The work requires voluminous background reading; reading that is complicated, for me at least by my frequent need to try to understand sometimes arcane medical issues.

I consider my work with the REB to be of real value to our HI, and I hope to continue to represent the Alumni on this vital board for some time to come.

Prepared by David Brisco

December 2018