Evan D. Morris is a professor of biomedical imaging at Yale University who has conducted research with human subjects for 35 years.
Scientists cannot conduct research involving human subjects until they secure approval from a body of concerned citizens whose role is unfamiliar to most Americans: an institutional review board.
At universities, hospitals and research institutes, these boards evaluate the ethics of any proposed scientific research or clinical trial. Who could be against an ethics review? Unfortunately, the review process has become so unwieldy and burdensome that it impedes medical science and advances the public has paid for.
The ethics of human experimentation in the United States are set out in the Belmont Report. First published in 1979 to govern human-subject research funded by the National Institutes of Health, it was eventually adopted broadly by federal agencies.
“Ethics” in IRB review has a specific meaning. The Belmont Report’s principles are “autonomy,” “beneficence” and “justice.”
Autonomy holds that an individual is entitled to know all the risks and can then decide whether to participate. Beneficence means that the risks to participants must be weighed against the potential benefits of the research. Justice ensures that all populations have an equal chance to reap the rewards.
IRBs have “at least five members and include at least one scientist, one non-scientist,” and one member not affiliated with the institution.
Regrettably, the IRB’s mission has grown well beyond its authority. In recent years, paperwork has spiraled, reviewers have asked questions beyond their mandate, and some have made demands that violate the principles themselves. Ask any researcher and you will get a horror story.
My colleague Lee Jussim at Rutgers University is a social scientist whose experiments are merely to ask survey questions. Participants can decline to answer any question. He has been audited three times by the Rutgers IRB. Each time, the audit revealed no violations of his approved protocol, but the paperwork for the three audits exceeded 3,000 pages and caused six months of delay.
Peggy Mason at the University of Chicago studies someone with a rare disease. This participant readily takes part in studies but insists that publications use her full name to draw attention to her condition and humanize her experience. The university’s IRB insisted that the volunteer be identified only as “AA.” This is “hyper-paternalism,” Mason replied, and is itself a violation of the subject’s autonomy.
At Yale University, I recently made a request to the IRB to approve a trivial amendment to one of my ongoing research protocols. My request sought only to adjust the schedule of already-approved brain scans. Yet, it was met with a demand by the Yale IRB for additional scientific rationale. There could be no additional risk since the scan in question was approved by the IRB, and its timing does not alter in any way what happens to the subject. What should have been a routine approval delayed my time-sensitive research.
The bureaucracy has become soul-crushing, yet few believe the increased regulatory burden has made research subjects safer. As my Yale colleague Deepak Cyril D’Souza lamented to me in an email after a public discussion on IRB mission creep, “The mounting paperwork [has] not made my drug administration studies safer than 25 years ago. The studies are safe because I understand the risks and am in the trenches making sure the studies are safe.”
The IRB is an all-powerful body without adequate checks and balances. IRB committees face no consequences for delays because the people who care most about speed — scientists eager to start and the public waiting for results — have no real voice in the process.
To address structural deficiencies, my colleagues and I have proposed that IRB deliberations include a science advocate — a lawyer or scientist who would speak in defense of the potential scientific value of the proposal and against unwarranted delays, extraneous questions or demands.
In addition to calling for an advocate, we have published new guiding principles to help the IRB achieve its mandate while maintaining its mission, namely ethical and timely biomedical research. The principles are collected into the “Mudd Code,” named, like the Belmont Report, for the building in which it was proposed.
In short, IRB review must be more transparent. It must justify each of its demands on an ethical principle and recognize that its goal is not to eliminate all risk. Transparency could be achieved through the publication of yearly performance stats. (How long is the turnaround time? How much documentation is required?) Justification of any demand would need to be tied to autonomy, beneficence or justice. Finally, the IRB must refrain from reviewing scientific choices which are the purview of the researcher.
What can others do? Scientists must speak out. Donors should ask universities and hospitals to adopt the Mudd Code before making bequests. Congress and the administration could tie NIH funding to IRB performance. My colleague David Kareken from the Indiana University School of Medicine told me that his IRB “avoids unwarranted scientific review while striving to be timely.” So, IRBs can do better if they choose to curtail mission creep while prioritizing science along with ethics.
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