Millions of higher education and Canadian tax dollars are invested in campus-based Research Ethics Boards (REBs) and the Interagency Advisory Panel on Research Ethics each year. In fact, untold millions have been spent on REBs across Canada in the last 10 years since the first Tri-Council Policy was launched. What evidence do we have that this money has been well spent? In short, how do Canadian researchers evaluate whether or not human research participants are any safer now than they were 10 years ago when the first Tri-Council Policy and Research Ethics Boards were implemented across Canada?
Recently, a group of ethics experts, lead by the Secretariat on Research Ethics, have been touring the country to spread the word about Dec 2008, TCPS Draft 2nd Edition of the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans, and to gather feedback through community consultation. There must be a healthy budget for Research Ethics -- unlike many other meetings I have attended in the past few weeks since the 0% budget was handed down on this campus, at least people were offered a drink and a muffin.
I attended the meeting held on my campus, entitled "Chart the Course of Ethics in Research Involving Humans". There were many good questions asked and issues raised by the three dozen or so participants. Among the issues raised were: (i) the imbalance of power between the REBs and researchers, REBs and graduate students; (ii) accountability of the REB - to whom does the REB chair report, what are they required to report, and the autonomy of the board; (iii) changing the view of the Tri-Council Policy as "minimum standards"; and, (iv) the role of REBs in the scholarship of teaching. A few copies of the 150+ page draft policy were available, and can also be downloaded from the Panel on Research Ethics (PRE) website.
First, two quotes will provide context for my questions to the chair of this consultation session.
From Draft 2, on balancing risks and benefits: "Modern research ethics, for instance, requires a favorable risk-benefit balance - that is, the anticipated benefits should outweigh the foreseeable harms." (p. 14).
From Kim, Ubel & De Vries (2009). Pruning the regulatory tree: For human-subjects research, maximum regulation does not mean maximum protection. Nature, 457, 534-535. "It is unethical to support a system that creates a significant financial, scientific, clinical and ethical burden with virtually no counterbalancing good" (p. 535).
My question to the Susan Zimmerman, who chaired the consultation session, was three-fold:
1. In the context of a consideration of the risks-benefits of REBs, what evidence do we have that human research participants are any safer than they were 10 years ago before we started to review every proposal to do research? In short, what evidence do we have of benefit? The Answer: None.
2. More importantly, in the context of faculty researchers and graduate students who have to submit all protocols for review, a somewhat time-intensive and resource intensive process, what evidence do we have of the type and scope of harms that have resulted from the current Tri-Council Policies and their implementation by campus-based REBs? In short, what have we LOST by the present process?
3. What are the chances that a protocol designed to evaluate the harms inflicted on researchers and graduate students would be approved by a campus-based REB? Not likely...
The discouraging reality is that Canadian researchers (and tax payers) have NO evidence that the research ethics review policies and systems that have been created are any more or less effective in protecting human research participants than doing nothing. There has been no data collected on the benefits and harms of research ethics boards and research ethics policies. No data - no evidence. One might think that the government would want some form of accountability in place to ensure that these dollars for research ethics were well spent...
On some campuses, mine included, there is some record keeping about number and type of protocols reviewed, the approval and refusal rates, and how long this process takes. This information does not tell us anything about benefits and harms. What this type of assessment does NOT capture is the harm to graduate student research, to junior faculty tenure trajectories, to senior faculty's promotion plans, and so on. We do not know the extent or depth of emotional, financial, professional, and academic freedom impacts of the REBs on researchers and graduate students. We do not know how many junior faculty and graduate researchers have been counseled to "avoid that type of research because it will never be approved by the REB". We have no reliable measure of the harmful impact or the benefits of the current system of autonomous REBs on the research culture, the research innovativeness and the research productivity on campus. We simply do NOT know the extent, nature or scope of the benefit-harm relationship.
However, for the past decade, REBs have handled and judged hundreds of thousands of research ethics proposals. Hundreds of thousands of researchers and graduate students have had their proposed research scrutinized and dissected and pronounced upon as "ethical or unethical".
So, Canada's Interagency Advisory Panel on Research Ethics is traveling the country gathering feedback and views on its latest draft. I think it is well past time that we institute a thorough and indepth program evaluation; Canadian researchers need to collect and collate meaningful data from researchers and graduate students about the burdens and benefits of REBs, and the impact of same on the conduct of research with human participants across disciplines. Researchers have to design and implement an ethical and effectiveness review of REBs to determine whether there is significant counterbalancing good from the significant burdens of ethical review.
I was encouraged by the attendance and tone of today's research ethics consultation on campus. The consultation was a great opportunity to hear from the many voices on campus who are holding the Advisory Panel and the current REB to account; I just hope that the right people are listening and this good momentum translates into positive action for research ethics on campus.