Comments submitted to HHS today on the Advanced Notice of Proposed Rulemaking (ANPRM) for Revisions to the Common Rule (10/26/2011)
My views on the subject of Institutional Review Boards (IRBs) have been shaped by my experiences.
In the 1980s, I majored in writing during college, then worked briefly as a journalist before becoming a public librarian who believed it was my responsibility to uphold the First Amendment. When I took a position as a college librarian in 2007, I discovered that there was much interest on campus in the college's history, which sparked my interest in exploring the past. I was accepted into a graduate school in the history department at the University of Maine, and studied oral history.
I had loved interviewing people as a journalist; I found oral history equally engaging. As with journalism, the questions we asked were simply starting points for two people to have a conversation--to share thoughts, observations, remembrances, and history. It was impossible to predict what might be created between two people talking with each other, with the wonderful result that we would enrich the human record.
During the course of my studies, I was astonished to discover that in the two decades I'd been absent from academia, IRBs--originally created in an effort to protect human subjects of biomedical research, the sort of activity that could cause serious physical harm to people--had developed and spread to become powerful committees on some college campuses which could (if they wished) even require that journalism or oral history students submit their precise questions for prior review and fill out significant paperwork before they would be allowed to talk with people. I observed situations that would significantly delay and at times even completely discourage time-pressed faculty and students wanting to engage in seemingly harmless conversations about campus history, or distribute anonymous opinion polls on such topics as campus pet policies. IRBs, I was told, had the complete and final authority to decide what had to be reviewed and what didn't; they were under no obligation to exempt anything whatsoever; and there was no oversight or appeals process.
In other words, if I wished to study oral history on a university campus, an IRB could determine whether or not I would be allowed to engage in activities which, until now, I had assumed would be considered constitutionally-protected speech. Topics which librarians would fight to keep on the shelves after the books had been published, could now be effectively banned before the books were even written.
Furthermore--at least in part, I believe, because claiming an exemption might mean that a scholarly pursuit would not be considered "research"--I discovered that many people who would otherwise be opposed to prior restraint of speech were reluctant to forego IRB review. Many people who had worked with an IRB on a project seemed to feel validated by the experience and were reluctant to criticize. They accepted and even endorsed the proposition that IRBs are needed to educate people about ethics.
However, surely there are better ways to educate college students and professors about ethics than making them go through long applications processes. I'm not the first to suggest that we could require all colleges and universities to teach and train in ethics. We could implement processes that make it easier for people to complain if they have concerns about a researcher, and publicize them well. Educating the entire population about their rights is more likely to be effective in the long run anyway, because IRB review cannot really prevent anyone from behaving unethically; it can only ensure that someone has filled out an application properly.
While I was a public librarian, I learned that legal efforts to prevent people from giving or receiving expression on potentially upsetting topics must be clearly proven dangerous before they'd pass constitutional muster, because the public's right to know--because creating new knowledge--is essential, and hence prioritized in a free society. This principle is vital in higher education, because democracy cannot flourish in an environment where college students are discouraged from asking questions that enrich their educational experience.
This is why I hope that the regulations will be changed to explicitly and unequivocally exclude all language-based scholarly activities that do not physically impact human subjects (including interviews and surveys) from IRB review.
Under the circumstances, I believe that expanding the funding requirement to include any organization that receives federal funds for any purpose (such as community colleges, where biomedical research is seldom undertaken) would simply compound the problem.
And finally, as a librarian, I believe that making already-collected data subject to ongoing IRB review would seriously impair the ability of libraries, archives, and other repositories to provide information. It would create such a chilling atmosphere that resource-sharing would be significantly undermined and curtailed, to the detriment of civilization.
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