The new draft Canadian federal guidelines: Is there more to say?

Our Canadian readers will be well aware that right now, the Interagency Advisory Panel on Research Ethics (PRE) is in the middle of doing cross country town-hall style discussions on the new draft of the Tri-Council Policy Statement (TCPS). Officially launched in December 2008, this new draft is the result of a great deal of ongoing consultation with stakeholders across Canada. For the most part, it reads very well. The kinds of changes people said that they wanted appear in the document. There is increased clarity about previously confusing issues. There is more said about research in the social sciences and humanities, about qualitative and emergent research methods. Aboriginal research is discussed in much more detail. Risk is approached in a much more realistic manner. All of these are very good things and those attending the town-halls and focus groups are echoing these sentiments.

In the spirit of keeping the TCPS a living document as was always intended, PRE is open to continuing feedback — thus the cross-country discussions. One interesting thing that came up at the Toronto focus group for research ethics board Chairs and administrators (which I attended) was that more needs to be said about what kinds of things are exempt from research ethics review. This is something with which ethics review boards are grappling more and more, and yet the TCPS says little. Here is an excerpt:

Article 2.4 Quality assurance and quality improvement studies, program evaluation, and performance reviews or testing within normal educational requirements are not subject to research ethics board review. Application Studies related directly to assessing the performance of an organization or its employees or students, within the mandate of the organization or according to the terms and conditions of employment or training, do not require REB review. Activities other than research as defined in this Policy may still raise ethical issues that would benefit from careful consideration by a body capable of providing some independent guidance, other than an REB.

Here are three points that came up in our discussion, and that hopefully PRE will take forward:

1. The number of projects that fall into one of these categories (quality assurance and quality improvement studies), and that end up coming across the desk of most ethics review board Chairs, is growing. The TCPS is clear about one thing: If there is doubt about whether a project requires research ethics review or not, it needs actually to come before the board for assessment. This is problematic for two reasons. First, it is a significant additional workload for already overworked Chairs. Second, we’re all doing it differently! So multi-centre projects are deemed to require review at one centre and then deemed to be exempt from review at another. For researchers, this looks like inconsistent application of the federal guidelines. Inconsistencies are acceptable, as reasonable people might disagree on whether a project requires review or not. However this really isn’t inconsistent application of guidelines per se, because the TCPS provides too little guidance when it comes to how to decide the difference between a quality improvement project or program evaluation and a research project.

2. The TCPS indicates that those projects that are not deemed to require research ethics review could be “covered” by discipline-specific best practices documents, codes of ethics or professional codes of conduct. But many disciplines either don’t have such a code or if they do, those documents don’t relate to the ethical conduct of “research”. So many researchers conducting program evaluations or quality improvement projects as their “research” aren’t sure where to go to have an expert body give their project the “ethical thumbs up” so to speak. As a result, they are asking ethics review boards to overstep their jurisdiction and review their projects. This is a new phenomenon and one that most boards are, understandably, more than a little hesitant to do. And it’s not just about hesitation to take on extra work or to overstep a boundary. The TCPS simply doesn’t address any specific issues related to quality assurance or improvement projects or program evaluations.

3. PRE is correct in stating that it isn’t only research projects that should be carried out in an ethically sound manner. Few would disagree with the assertion that program evaluations and quality improvement projects should also be done with integrity, protecting the rights and autonomy of participants without exposing them to an undue risk of harm while producing benefit.

Most ethics review board Chairs share the same three concerns related to the issue of assessing and reviewing these kinds of projects: First, it represents additional responsibilities for Chairs who are in positions most institutions view as simply an “additional duty”. Second, it is clearly overstepping the jurisdiction of ethics review boards to review projects deemed exempt according to federal guidelines. Finally, there are significant inconsistencies between ethics review boards in their decision-making about what is exempt in the first place.

PRE is conducting further discussion of the new document at their half-daypre-conference session one day prior to the NCEHR 2009 Annual Conference in Ottawa from February 21-22.

~ by Nancy Walton on February 7, 2009.

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