Major changes proposed for research that involves humans

It took seven years and several rounds of consultations with researchers across the country, but a contentious piece of Canada’s research ethics regime is on the verge of an update that largely accommodates decade-old concerns from many researchers in social sciences and humanities.

At stake is a comprehensive amendment to the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (or TCPS), a policy adopted by all three federal granting councils in 1998. The original policy has served as the standard set of guidelines used by research ethics boards at Canadian universities to approve, or ask for changes to, research proposals for research involving humans.

The original policy statement was borne out of a desire by the Medical Research Council – now the Canadian Institutes of Health Research – to establish strict ethical guidelines for biomedical research. Because of the weight carried by the Medical Research Council and other health-research stakeholders in developing the TCPS, many social science researchers felt the policy didn’t take into account the qualitative approach to research that is normal in their disciplines, and quite distinct from biomedical methods.

The amended policy makes this distinction crystal clear: “Qualitative research approaches are inherently dynamic and are grounded in different assumptions than those that shape the biomedical model of research,” it states at the start of a completely new chapter on qualitative research.

The amended policy, called the Draft 2nd Edition of the TCPS, was developed by an advisory panel to Canada’s three major granting councils and is now open for public consultation (at www.pre.ethics.gc.ca.).

The draft includes two entirely new chapters, one on research involving aboriginal Canadians and one on qualitative research, as well as copious notes on how to apply each guideline. The guidelines on qualitative research removes the need for research ethics board review for the exploratory phase and for research involving public observation, among many other changes. (See “Profound changes” below).

The chapter on research involving aboriginal peoples was a dramatic amendment of the “best practices” outlined in the 1998 TCPS, and it involved extensive consultations with First Nations, Métis, and Inuit communities. The new section emphasizes the importance of responsible community engagement and requires researchers to make clear to research ethics boards exactly how they plan to work in aboriginal communities.

Tony Porter, a political science professor at McMaster University who has followed Canadian research ethics governance over the last decade, said that it probably wasn’t apparent at first “exactly how problematic” the original policy statement would be for social sciences and humanities research. “I think an accumulation of frustration over many years is what it’s taken to come up with a second draft.”

Lacking specific guidance from TCPS on social science research practices, universities’ research ethics boards sometimes have applied biomedical guidelines to social science research, says Dr. Porter. For example, the boards might demand that researchers acquire written consent from participants – a process seen by many qualitative researchers as too cumbersome given their normal practice of using verbal consent, questionnaires, or even inferred consent from research subjects.

The Interagency Advisory Panel on Research Ethics was the body established by the granting councils in 2001 to interpret, examine and revise the TCPS. Susan Zimmerman, its executive director, said she agreed with some of the criticisms levelled at the original document from the social sciences and humanities community, for example, that the terminology and references weren’t sufficiently inclusive.

“This was always intended to be a living document,”” she said, pointing to the working committees – including the social sciences and humanities working committee – that were set up to consult within their own communities on how to improve it.

Glenn Griener, an ex-officio member of the social sciences and humanities working committee, said the updated document fills many of the gaps in the original, but he cautioned that some researchers might remain unsatisfied – in fields like criminology, for example, where researchers say “that information that researchers collect ought to be protected from the police, from the courts.”

Dr. Porter added that draft statement’s guiding principles still use strong language about protecting research participants, and that could be a concern for researchers whose work might not intend to reach that outcome. He pointed to studies in public policy that, in their conclusions, might paint a powerful public figure in a negative light.

Ms. Zimmerman said that the current consultation lasts through March. Then the advisory panel will integrate the feedback into the draft and forward it to granting councils for approval. She expects the revised TCPS could be approved by all three councils as early as the fall.

Profound changes to REB review

Some of the important new guidelines and applications in the chapter on qualitative research include the following:

• under a variety of circumstances, written consent is not required in qualitative research;
• informed consent can be inferred by the participant’s agreeing to interact with the researcher and no further verification is needed;
• research ethics board (REB) review isn’t needed for observing people in public places, nor for doing web-based research that uses only publicly available information;
• REBs should use delegated review when considering research using observation, including web-based research that collects personal, identifiable information;
• REBs should focus on projects above the threshold of minimal risk;
• REBs should acknowledge that in some cases, subjects may want to be identified for their contribution;
• REB review isn’t required for the initial exploratory phase when the researcher is developing the research design.