Thursday, December 18, 2008

Seeking Ethics Review of Ethics Review

Our campus desperately needs to review the current approach to ethics review. Please let faculty researchers who are forced to comply with this often unnecessary bottleneck scrutinize the purpose of these social and biomedical ethics review boards. Perhaps if we use our impressive research and evaluation skills, we can gain some insight into secretive ethics review boards and institute some form of accountability and control.

Currently, faculty and graduate student researchers in the social sciences, who conduct human subjects research that is no or very low risk, are overly delayed and overly scrutinized by an opaque ethics review board. Anonymous reviewers get to criticize research protocols well beyond their own area of expertise, and/or request whatever changes, deletions and additions that they dream up for the protocol under scrutiny -- even if these changes, deletions and additions make absolutely no sense and have no discernible impact on subject safety.

A graduate student of mine once had her research held up for 3 weeks because she refused to change a word in her title -- a reviewer objected to a term in her TITLE - eventually the ethics review board backed down from this "strong suggestion" when I sent a letter with three references citing the terminology as used in our discipline. Blind ethics reviewers, who wring their hands and dream up potential unforeseen risks and fantasy phantoms, do not help the research objective of the university nor do they keep human subjects safe.

I ask that ethics reviewers be named and known to the researchers being scrutinized -- let's level the playing field. Researchers need to know the credentials and background and qualifications of those who seek to fiddle with their research plans and protocols -- just as the reviewers know the credentials and name of the researcher. The reviewers should have to defend their requests for changes, and researchers should be given an opportunity to respond.

Currently, if a researcher disagrees with a "strong suggestion" from the REB, they have to argue their case to the ... REB. Researchers must appeal their case to the same board that denied their request. Big conflict of interest here. Researchers need an opportunity to engage in meaningful discourse with peer reviewers and the REB rather than their only option being to capitulate to unnecessary and often unreasonable demands.

One of the purposes of a University is RESEARCH. At my university, faculty and students have to submit ALL PROTOCOLS to an onerous, nit-picking and timely review process. Like many of my colleagues, and like many of our graduate students, I have become "encultured" in the new politically correct approach to vetting research proposals. Any kind of research about sex or religion or death or learning is automatically subjected to "zero tolerance" for ANY risk whatsoever -- even if the research will benefit the groups involved. Note, I do not believe the current ethics review process is methodologically or philosophically or ethically defensible. What I do believe is that our current ethics review process is nothing more than an intellectual exercise for some reviewers and chairs who seem to be drawn to questions about ethics in research and studying lint in navels.

I do believe that Ethics Review Boards are largely a legal, "protectus thy butticus" industry of the university -- ethics review often has less to do with protecting human subjects from any harm involved in the research itself, and more to do with "finding fault" and justifying the ethics review process and protecting the university from imaginary threats. The uni and ethics review boards want to protect their interests and shore themselves up against any legal threats -- the review process is the point, and gives the uni leave to abandon the researcher to his or her own defense -- after all, the uni did everything in its power to protect the human subjects from the researchers, right?

In early December, my research team submitted a research proposal for ethics review concurrently at my university and the sister institution up North (where members of the team work). In a few days, our team had approval from the sister university. That is, we had APPROVAL in a few days. Ethics APPROVAL with no revisions or changes of any kind. I repeat: "ethics approval with no changes" because it is such a foreign concept at my university. So far, all I have received from my campus Ethics Review Board is a series of nit-picking questions about this or that detail - totally unrelated to the research methods and questions and plans.

I expect to wait several weeks, perhaps 1 -2 months, to get approval for my low to no risk RESEARCH at my RESEARCH INTENSIVE university. Hah. Bah humbug.

At some future point, I will submit to the VP Research, at my Research Intensive University (RIU), a comparison between the ethics review and approval time at the sister university (a few days) and mine (probably several weeks or even months), and the process at the sister university (no changes), and mine (nitpicking, detailed changes and requests for more detail and requests for minute changes and revisions) for comparison and consideration. There may just be a reason why the sister university gets more research funding and conducts more research than my institution...

Let me connect the dots: a reasonable and quick ethical review & approval of research that conveys a commitment to the research objective, and conveys a trust of researchers at the sister institution; versus, a chilling, bureaucratic and overly scrutinized and numbingly arcane bottlenecked ethics revivew process at my university.

A few days versus a few weeks or months for ethical review: The defensive position I anticipate from the REB at my RIU is that "our" ethics review process is of "higher quality" - well, I want proof. I want proof of return on investment -- after all, the Ethics Industry is now a significant budget line item. I want proof that the Ethics Review Board has resulted in some benefit to the University, some benefit to researchers, and any benefit to research. In fact, I suggest we bring our social science research skills to bear on evaluating the processes for ethics review, and demonstrate whether this onerous and timely and nitpicking process has any impact whatsoever on human subject safety, and determine the very real impact on slowing down and limiting the type of research that gets conducted at my "research intensive" university.

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