Vander Putten, who chaired his university's IRB for six years, complains that IRBs fail to make decisions consistently. He accuses them of both under- and over-protection, and then offers two suggestions for reform.
Under-Protection
Vander Putten's case for under-protection concerns two invitations to take online surveys, both of them aimed at university administrators and faculty. He is upset about their lack of informed-consent apparatus:
Although these were low-risk social and behavioral science studies, IRBs should not be absolved from ensuring that researchers will fully inform prospective participants about specifics of the research tasks. I deserve to know the answers to a number of questions before I decide whether to participate in a study: What is the nature of my involvement? Will survey completion take 5 minutes of my time or 35 minutes? How (not just if) will my identity be protected and confidentiality maintained in this study? In a web-based survey, am I required to respond to each question before proceeding to the next? Perhaps most importantly, what will researchers do with my responses if I decide to cease participation before completing the research task? Will they be kept or discarded? Do I have a voice in the matter? As a result of the absence of this information, I declined to participate in both studies.
There are certainly some nasty online surveys out there, that fail to screen for minors or that ask highly personal questions midway through the survey. And when I am asked to participate in a survey, I often appreciate an estimate of the time it will take. But I can't share Vander Putten's outrage about the two invitations he received to participate in surveys specifically aimed at university professionals. Without any IRB intervention, he proved capable of deciding for himself not to answer the surveys.
Consider that Vander Putten's own e-mail to me failed to warn me how long it would take to read his essay (5 minutes of my time or 35 minutes?), whether I was required to read each paragraph before proceeding to the next, or how (not just if) would my identity be protected and confidentiality maintained should I reply to his message. Instead of infantalizing me with such precautions, Vander Putten respected me as an autonomous adult.
Over-Protection
The case for over-protection is stronger:
A few years ago, another faculty member and I conducted a qualitative research study at five different Doctoral/Research institutions in the Southeast. As a professional courtesy, we informed each institution of our plans to interview faculty and staff on their campuses, and noted that the study had already been approved by our institution’s IRB. I was surprised when each institution required us to submit 'Exempt From Full Board Review' IRB proposals for review and approval as a precursor to conducting the research on their campuses. With my knowledge and expertise as a sitting IRB Chair, I volunteered to complete the proposals to increase the likelihood of IRB approval upon first review.
You can imagine my surprise when several of the IRBs rejected the proposals on the basis of an inconsistent array of style issues, such as consent forms not cumulatively paginated (e.g., 1 of 3, 2 of 3, etc) and either written or not written in the past tense. The time delays associated with revision and re-submission of these IRB proposals (some of which were rejected a second time) were measured in months, and would have been even longer had we been required to complete each institution’s responsible conduct of research training program. These delays began a chain reaction of subsequent delays in data collection, research conference proposal submissions and presentations, and manuscript submissions for publication consideration. For untenured faculty, these delays can present formidable obstacles to meeting institutional expectations for scholarly productivity leading to tenure and promotion.
Multi-campus projects like this one and those conducted by J. Paul Grayson and Linda Thornton are particularly good at exposing the arbitrary nature of much IRB decision-making. When one IRB insists on the past tense and another forbids it, you know that at least one board, if not both, has no idea what makes for good informed consent, yet it is willing to impose its guesswork on researchers.
Reform
Vander Putten concludes with two suggestions for reform.
The first is an endorsement of the Illinois White Paper's call for a national clearinghouse for IRB best practices. He writes, "Based on my experiences as an IRB Chair, researcher, and research study participant, this would be a useful development and should include guidance on consistent expectations for the use of informed consent documents regardless of research risk, data collection method, or funding source to provide optimal protection for prospective research participants."
There are two parts to this recommendation. One is for a clearinghouse, which is all to the good. The second part is for specific practices, which he recommends using the same guesswork that produced the inconsistent responses to his study proposal. Just as one board guessed that consent documents should be written in the past tense and another guessed that they should be written in the present, Vander Putten guesses that that every study should use informed consent documents, as opposed to unscripted explanations, or simple reliance on the context of the study. Such universality produces bad results. I hope, for example, that he would not expect researchers to hand out informed consent documents to people being observed in a public place.
Best practices cannot be determined a priori; they need research. If Vander Putten is serious about the clearinghouse idea, he needs to hold off on specific prescriptions for IRBs until competing proposals have been gathered and compared.
Vander Putten's second recommendation calls for
the expansion of federal regulations requiring researchers to complete training in the responsible conduct of human participants research before conducting research. This expansion should include minimum requirements for researchers to actually implement the ethical practices regarding informed consent that they learned in their institution’s training program. In education terms, it is inappropriate to train researchers on the history of informed consent and methods to incorporate specific elements of informed consent into their research, and then decline to hold researchers accountable for doing so. If a specified set of minimum requirements are implemented nationwide, then IRB review would begin to approximate peer review systems that are the bedrock of scholarly quality and integrity.
Though Vander Putten begins his essay with several links to IRB-related reportage in the Chronicle of Higher Education and Inside Higher Ed, he apparently missed David Glenn's November 2008 story, Scholars Mull Rules for Training in Research Ethics," and my own reportage about the replies received in response to OHRP's call for comments. Those replies showed significant frustration, among institutions and individual researchers, about the quality of existing training programs, making a regulatory mandate seem unwise.
While well intended, both of Vander Putten's recommendations show a lack of familiarity with the existing debates over IRB inconsistency. More reading might produce more nuanced suggestions for reform.
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