On September 12, 2013, the Canadian government’s Panel on Research Ethics published proposed revisions to the 2nd edition of the TCPS (Tri-Council Policy Statement), called “TCPS 2.” This is the Panel’s first set of changes proposed to the TCPS 2 since its official release on November 29, 2010. Comments to the proposed revisions were due by January 15, 2014. Now that the comment period is over, those conducting or reviewing human subject research in Canada must continue waiting to see the finalized revisions. Based on the proposed revisions and those comments available online, here is an overview highlighting what to expect (chapter by chapter):
- An added definition of disciplined inquiry (a.k.a. research): “Disciplined inquiry refers to an inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community.”
- Clarification of a child’s capacity to consent and the distinction between capacity and the age of majority in a province or territory.
- Clarification of the term “incidental findings” and emphasis on determining whether such findings are “Material.” Material incidental findings are those that have been interpreted as having significant welfare implications for the research participant.
- Guidance for handling material incidental findings and specific criteria for when researchers have an obligation to disclose to the participant any material incidental findings discovered in the course of research.
- Updated guidance and limitations on partial disclosure or deception in research.
- Removal of a significant barrier to obtaining a waiver of consent. A Research Ethics Board (REB) may grant a waiver of consent even if the research involves a therapeutic intervention or other clinical or diagnostic interventions.
- Clarification that the assessment of whether personal information is identifiable is to be made within the context of a specific research study.
- Clarification that even anonymous information can present risks of re-identification.
- Clarification that thesis-based study research involving human participants generally meets the TCPS 2’s definition of research and, therefore, should be reviewed by an REB.
- Expanded circumstances in which delegated review may be used to conduct continuing review. Such review may be used for more than minimal risk research where the phase or intervention that is more than minimal risk is complete, and the remaining phase(s) is only minimal risk. Such review may also be used for more than minimal risk research, so long as:
- the REB Chair remains responsible for determining that the delegated review process is appropriate; and
- there have been no significant changes to the research and no increase in risk to (or other ethical implications for) the participants since the initial review by the full REB.
- Guidance for institutions on how to determine the point after which REB review would no longer be required.
- Direction that Chapter 9, involving First Nations, Inuit and Métis Peoples of Canada, may also serve as useful guidance when conducting research in other distinct communities.
- Additional examples of “public spaces” possibly appropriate in which to conduct observational studies.
- Clarification of the extent of access to trial data by researchers depending on their role in the research.
- Clarification of the responsibility of the REB in reviewing potential conflicts of interest in clinical trial budgets.
- An added requirement for researchers to complete all required WHO Trial Registration Data Set fields.
- An added requirement for researchers to update trial registries with changes to the research protocol, decisions to prematurely end a trial, and new information impacting the welfare of participants.
- An added requirement to disclose in subsequent publications new information discovered at, or after, the end of research if that information impacts the welfare of participants.
- An added requirement for researchers to disseminate findings of their clinical trials in the publicly available trial registry.
- Clarification of the definition of fetal tissue and revised guidance regarding research involving a fetus or fetal tissue.
- Full integration of the Canadian Institutes of Health Research (CIHR) Updated Guidelines for Human Pluripotent Stem Cell Research. These Guidelines are currently incorporated by reference in TCPS 2 and the proposed revisions would accomplish the Tri-Council’s goal of providing a single reference document for the ethics of all research involving humans.