Ethics Practitioners on Research Ethics Boards
Have you ever wondered about ethics in scientific research? Specifically, about the ethical treatment of human participants in research?
There have been instances of high-handed treatment of human research subjects in the past that are nothing short of disgusting. In Canada and elsewhere. For instance, accounts of nutrition and health experiments on Aboriginal people in Canada, mainly children, in the 1940s and 50s, hit the news in 2013. They included near starvation diets and withholding of dental treatment. This happened without the participants’ awareness or consent.
Such ethical aberrations are less likely nowadays, thanks to Research Ethics Boards (REB). You can offer your help to an REB to ensure proper ethical consideration of proposed research. It’s a valuable contribution to science and society – and it’s fascinating too.
Since 1998, much of the publicly-funded medical, scientific and social research in Canada has been subject to prior ethics review. The policy and guidelines were devised jointly by the three federal research granting councils: the Social Sciences and Humanities Research Council, the Natural Sciences and Engineering Research Council, and the Canadian Institutes of Health Research. Together they issue the Tri-Council Policy Statement: Ethical Conduct for Research Involving Human Subjects. (The short-hand name is TCPS2.) It reflects an international consensus that every research project involving human subjects must be reviewed and approved by a duly constituted and functioning ethics review committee before any potential subjects are invited to participate. The third edition appeared in 2014.
To protect research participants and ensure their ethical treatment, the TCPS2 covers many areas: physical and psychological safety, privacy of personal information, free and informed consent, and decision-making on behalf of vulnerable persons and children. The most recent edition also covers cultural matters, particularly in research in Aboriginal populations. A tutorial on the TCPS2, called CORE (Course on Research Ethics), is available at https://tcps2core.ca/welcome.
Who ensures that research proponents have considered these matters? It must be done by a Research Ethics Board (REB) that is independent in its decision-making, even if attached to the institution that performs the research. Without the OK of an REB, funding will not proceed.
Every university, hospital, or government laboratory or other entity that wishes to apply to any of the three federal granting councils must sign an MOU committing it to have an ethics review done of all its research projects involving human subjects (not only of those projects for which it is seeking tri-council support).
In addition, any entity that seeks Health Canada approval to market a product in Canada must show that the product’s research was approved from a human ethics viewpoint by an REB.
The current guidelines require an REB to have at least five members, and at least one of these must be a community member with no affiliation to the institution. Also required are members with specialized scientific, legal and ethics knowledge.
The primary role of community members “is to reflect the perspective of the participant. This is particularly important when participants are vulnerable and/or risks to participants are high.” They are also expected to “broaden the perspective and value base of the REB,” and thus advance “dialogue with, and accountability to, relevant communities.” (For more on the REB and community members see http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter6-chapitre6/.)
At least three EPAC members serve on REBs. One of them is Dr. Richard Walker, a retired Major who served as the Canadian Army Ethics Officer. He has had one year’s experience as a community member with the Queen’s University General Research Ethics Board. Why “General”? There are up to 400 research proposals per year, so the university has a decentralized REB system that has the various faculties or programs deal with routine proposals in their own sub-committees.
“We see a lot of complex issues in thesis-based or equivalent research projects,” he says. “Consider that students or faculty might delve into topics that are geo-political in nature, or highly controversial in public perception. There may be legal liability concerns for the safety of the researchers or for the well-being of children at risk of abuse. There can be strong associated incentives – perceived or inherent conflicts of interests, cash payments or course grade increases for students. The list goes on.
“As a community member, I find myself acting as an honest broker who brings a reasonable person, unbiased perspective to these matters.”
Another community member of an REB is Robert Czerny, who now serves as the chair of EPAC. Czerny learned about REBs at lunchtime ethics round-tables in Ottawa.
The work of the National Research Council REB, on which he has been a community member for three years, is varied – a wide range of subject matter, and dealings with researchers in government, academia and industry. “It’s fascinating to be exposed to leading, innovative researchers in many areas of science,” he says. “At the same time, a good deal of my contribution comes from reading documents from a non-specialist’s viewpoint. Will a prospective research participant really understand the consent form?”
He also focusses on how participation in a research project might affect workplace relationships and families. “Let’s say a family is asked to test something for a month. What happens after? The children don’t understand why they must give up the new equipment or routines that they like. Treating individuals and families with consideration is part of the ethical outlook that a community member can bring.”
Mark Audcent, EPAC’s Secretary, has been on the Science and Health Sciences REB of the University of Ottawa for about ten years, as a community member, a member with legal expertise and the Board’s Vice-Chair since 2010. He estimates that he spends 8 to 12 hours a month reading and commenting on submissions for ethical review. “Depending on the nature of the proposed research and the associated risks, the Board will either conduct a delegated review on a minimal risk basis or a full Board review. Two Board members are assigned to evaluate every submission: in the case of a minimal risk review, the evaluators submit their comments in writing; in the case of a full Board review the evaluators lead a discussion of the submission. A submission for full Board review is studied by all of the Board members.”
If you want to volunteer for REB service, as a community member or as an ethicist, check with the likely institutions in your area such as universities; or ask EPAC for help. And if you are interested in similar topics regarding the use of animals in research, check http://www.ccac.ca/en_/, the site of the Canadian Council on Animal Care.
By Robert Czerny, with help from Francis Rolleston, originator and a key editor of the TCPS statements.
Comment
Well written and comprehensive article on “Ethics Practitioners on Research Ethics Boards” coupled with practical information. It was an interesting read as I too serve as a community member on McMaster’s REB. I concur with author’s comments about participating in a REB is not only a “valuable contribution to science and society” but most definitely a “fascinating” experience. If I may add, to me it has been adventurous. Working with a board comprising of legal, IT and subject experts has been invaluable. During full board reviews, I have been exposed to a totally new phenomenon that results in raising critical questions in an effort to mitigate any potential harm to participants. Being a community member and not being familiar with the topic is an advantage in some ways. Community members are able to raise valuable questions that contribute to improving the study. In the process, I have also become accustomed to new phenomena in the context of cultural, social or technological innovation. I highly recommend REB experience to any open-minded inquirer as there are learning opportunities including conferences along the way.
Sadhna Jayatunge; July 13, 2016
