New guidelines released on ethics for research involving humans


After a two-year process involving public consultations in 17 cities across the country, Canada’s three major research granting agencies have issued their final version of a comprehensive, updated policy and guidelines governing research involving people.

The second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans revises and augments the initial policy adopted in 1998. It governs researchers – faculty, staff and students – and institutions receiving grants from the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council, known collectively as the Tri-council.

The new edition was welcomed by some of the social science researchers who had criticized the previous document for being too heavily weighted towards biomedical research. “There’s a much bigger recognition of the distinctive challenges facing social sciences and humanities researchers in the most recent document,” said Tony Porter, a political scientist at McMaster University who participated in the consultations.

He pointed to a new chapter on qualitative research (Chapter 10), which recognizes that social scientists and humanists, unlike their peers in the natural sciences, cannot formulate all their questions before beginning a project for pre-review by universities’ research ethics boards. The new document states: “Qualitative research approaches are inherently dynamic and may be grounded in different assumptions than those that shape quantitative research approaches.”

The chapter also acknowledges that some issues of consent, confidentiality and privacy will arise during the conduct of the research itself, not just in the design phase. The guidelines recommend that researchers “informally” consult their institution’s research ethics board, or REB, if ethical issues arise during the course of their work when they are engaging with communities.

Chapter 10 also allows researchers doing some types of observational studies to seek an exemption to the general requirement that they need the consent of participants. The chapter distinguishes between the need for signed consent when vulnerable participants, like children, are being interviewed and the need for verbal consent from public figures or others who are used to being interviewed for research purposes.

These distinctions have practical implications for social science researchers, said Dr. Porter. As well, he said, parts of the policy concerning the governance of REBs were improved and the appeals process clarified.

Another new chapter in the updated policy, Chapter 9, concerns research involving Aboriginal Peoples. The new chapter is “definitely an improvement” over previous guidelines, said Scot Nickels, director of the Inuit Knowledge Centre, the research arm of the national association representing Inuit in northern Canada, Inuit Tapiriit Kanatami.

The chapter describes the “apprehension or mistrust” with which Aboriginal Peoples regard research, which often has not benefited their communities. Other requirements in this chapter include the following:

  • researchers must engage with the aboriginal community their research is likely to affect, including its formal leadership;
  • First Nations, Inuit and Métis representatives should be represented on ethical review bodies, where appropriate;
  • researchers and REBs should also engage community members who don’t have a voice in formal leadership;
  • researchers must ensure the research benefits – and the results are shared with – the participating community.

Dr. Nickels praised the consultation approach taken by the Interagency Advisory Panel on Research Ethics, but added that he still has concerns about whether the words will translate into action. He also urged the granting councils to change their processes to include calls for proposals that would fund researchers in the preliminary stages of projects, so they can identify communities’ own research priorities.

The final policy document follows on a draft version of the second edition, released in 2009. The draft sparked close to 2,000 pages of written comments from the research community and the general public. Susan Zimmerman, executive director of the interagency secretariat for the Tri-council’s panel on research ethics, said public comments influenced, in particular, the chapter about Aboriginal Peoples, sections involving intellectual property and Chapter 11 on clinical trials.

Chapter 11 now stresses the need for researchers to “promptly” report to REBs any new safety information that may affect the consent of participants, and to monitor participants’ safety and share that information during trials. The chapter also instructs institutions and research ethics boards to take “reasonable measures” to ensure interpretation of clinical trials is disseminated in a timely manner and without undue restrictions.

The policy is intended to address concerns that negative research outcomes, particularly in biomedical fields, are not always published or are even suppressed, as documented in some court cases involving pharmaceutical companies.

The secretariat is now revising an online tutorial that was to be launched in February. It plans to hold regional workshops to help researchers and REB members work through case studies so they learn how to apply the guidelines, Ms. Zimmerman said.