Moving Ethics Review Out of the institution: Are We Throwing Caution to the Wind?
There is a debate out there in the research ethics world about “outsourcing” research ethics review responsibilities. In other words, taking the (Research Ethics Board) REB from the University or hospital and situating it outside of the institution. For those of you not familiar with Canadian research ethics review processes, we use a fairly common “local model of review” standard as articulated in our federal guidelines, found in the Tri Council Policy Statement for the Ethical Conduct for Research Involving Humans (TCPS). The model of local review implies that research must be reviewed by multidisciplinary, independent local ethics review boards who apply both the national norms or guidelines (as outlined in the TCPS) and local interpretations of the guidelines as outlined in institutional ethical standards for research. Boiled down, this means that Universities and hospitals, along with other kinds of research-generating institutions, have local ethics review boards to review research conducted at their institution and by those affiliated with their institution. The current question is whether or not to take these ethics review boards out of the institution and create a different kind of ethics review model.
It’s an interesting debate and one that, I’m sure, we have not heard or seen the end of quite yet.
Why even suggest taking the ethics review board outside of the institution?
Well, there are a few reasons. First, there is a claim that it would create a kind of “arms-length” board that can fulfill the need for ethics review for research without, presumably, the worry over potential conflicts of interest, special treatment of certain researchers or bias against others. Of course, this is a pretty difficult claim to make. The world of research and research ethics is much smaller than you’d think. The act of situating an ethics review board outside of an institution doesn’t necessarily take away the worry that board members might be faced with a potential conflict of interest.
Second, ethics review boards that are not situated directly within an institution might well be better able to coordinate ethics review for multi-centre research projects. Without a clear institutional affiliation, such a Board may be able to approve a project that could be carried out at a number of institutions right away, instead of what happens now. Currently, researchers must apply to every local review board within institutions where the research may be conducted (as well as any institution with which they are affiliated). For many researchers involved in multi-centre projects, this can be burdensome and frustrating. Case in point: Recently, for my own low-risk research, I had to apply to 17 separate Ontario Research Ethics Boards. Each had different local norms and requirements for recruitment and consent, thus requiring me to “reinvent the wheel” with almost every application. Some Research Ethics Boards did not allow an expedited review (typical for already-approved low risk research) even when the project had clearly been previously approved by 15 other Boards. With outsourcing, some institutions might agree to regional reviews or something of the like — where a “regional” external ethics review Board could approve a study once for a number of local institutions.
Third, getting faculty members, students and clinicians to serve as Board members is a notoriously difficult task. It’s not like some committee work at Universities that involves simply attending an occasional meeting with no “homework”. Compared to most committee work (required by most higher educational institutions as part of the service requirements for tenure-track faculty), it’s a great deal more work and effort. However, it’s clearly not a priority for many institutions who don’t recognize or promote the importance of these kinds of processes nor are those involved in the work rewarded or supported as well as they should be. Old news.
Outsourcing that work to an external Board would eliminate, to some degree, the need to recruit busy professors and clinicians from within the institution. However it would likely involve increased costs. Currently, many ethics review board Chairs and members essentially “work for free”. They might perhaps be provided with a course release or a merit increment in pay for their ethics review work. Outsourcing ethics review responsibilities would mean direct costs for institutions, who would have to pay for external Board members and their work.
Which leads us to the clear downsides of a move to outsource research ethics review. But, really, shouldn’t we just be glad to offload this work?
Well, the model of local review works — at the very least, it helps ethics review boards with their primary mandate of protecting participants. A local board, situated within an institution or community, has special knowledge of that community, the populations, etc. That “insider” knowledge not only helps to maintain the protection of potential participants from within the community but also it helps researchers. At the end of the day, knowledge of community-held local norms and offering advice on such communities can help researchers to gain appropriate access into certain institutions and participants.
Local norms help protect institutions with “special” populations or considerations. Here’s how. A pediatric hospital or a community mental health centre may have very different local norms for ethics review than a large academic acute care hospital. In turn, a small arts college may have much different norms than those of a large University with emphases on biomedical research programs. These kinds of local norms are, for the most part, based on local interpretations of the federal guidelines for the ethical conduct of research. These kinds of variations in, for example, approaches to recruitment or requirements for a consent form, are vitally important in helping to protect participants, especially those “special” populations that may be more vulnerable.
Additionally, the issues of responsibility and liability are unclear when a Board that is external to the institution approves a study. Detailed agreements would need to be in place and would require ongoing revision, almost on a case-by-case basis for large centres with highly varied research being carried out. Again, the issue of the competing priorities of academic research centres comes up. It would require a great deal of dedicated vigilance to work with an external body to ensure that local standards for the ethical conduct of research are being upheld. If the support for research ethics work isn’t in place now, how will support for that dedicated vigilance and ongoing coordination, required with an external board, ever become a reality?
This isn’t an easy question to answer. It also isn’t one that will be answered by a “one size fits all” kind of solution. Clearly, the model of local review has particular attributes that are situated in important values and principles for how the Canadian community feels that research participants should be protected. Whether those values and principles can be upheld by taking the REB completely out of the institution remains to be seen.
Here’s an older, but still very interesting article on this issue, which also puts forth some suggestions for alternative models:
Debate Over Institutional Review Boards Continues as Alternative Options Emerge