"Do you have an IRB?" is often the first question anyone asks when a new research idea is proposed. It shouldn't be the last.
Despite the personal frustrations of surgeons who deal with them, institutional review boards (IRBs) maintain a revered status within our profession. For instance, the perceived necessity of IRB review is so ubiquitous that most readers will know to ask the above question even if they do not know why. In this paper, we review the historical evolution of IRBs, argue that IRB review of minimal-risk research is problematic, and highlight proposed solutions. Though scholars from other disciplines have argued similar points extensively, not much has been written about IRB regulation in the surgical literature. We hope to provide surgeons greater context into the overregulation of essentially harmless research.
Within the United States (U.S.), the desire to regulate human subjects research arose in the aftermath of the atrocities of the Nazi regime abroad and the Tuskegee study at home. The U.S. government initially debated between a centralized national review board and a decentralized authority that would advise and oversee local review boards. The latter won, culminating in the passage of the National Research Act of 1974 and the publication of The Belmont Report, a document which outlined the ethical principles of respect for persons, beneficence, and justice but did not provide specific guidelines for how research should comply with those principles. Early IRBs comprised faculty volunteers collegially discussing research proposals. However, two high profile research scandals in the 1990s created the demand for a sweeping regulatory response. Absent any meaningful central authority, the U.S. government had only one tool with which to exact such a response – the specter of shuttering federal funding at "non-compliant" institutions. Institutions responded defensively by creating rigid and "hypercompliant" protocols aimed at minimizing their own exposure, regardless of the consequences. And so, IRBs evolved into massive, unregulated bureaucracies. Initially established to regulate federally-funded biomedical research, IRBs today claim jurisdiction over all human-subjects research (including social sciences research) regardless of funding. IRBs even require review of research deemed exempt from review by the government, even though the government does not explicitly prohibit researchers from self-determining exemption and encourages the use of checklists to that end.1–3
Others have argued that IRB regulation of clinical studies is onerous and may harm more people than it helps by delaying life-saving research.3 Here, we adopt a much narrower argument: that IRB review of minimal-risk social sciences research is unnecessary. Specifically, the rise of fields like surgical education and surgical innovation as academic disciplines means that surgeons and trainees are more frequently pursuing methodologies such as surveys and interviews. It is clear that such methodologies pose no real risk to human subjects. This point is perhaps best stated in a document published by American Association for Public Opinion Research: "There is no known case of any person sustaining any lasting physical or psychological harm from a survey interview".4 In fact, Schuwirth and Durning previously outlined a utilitarian case that IRBs create more harm than good in regulating medical education research specifically.5 Despite minimal risk, survey protocols often require the same review process as clinical trials. One study found that several well-funded institutions imposed overly onerous processes for exempt research beyond what the law required.2 Moreover, IRB review undermines the flexibility that is inherent to social sciences research. For example, IRBs require pre-approval of survey instruments and interview guides. Often, researchers are using these methods to study new and unexplored topics, and the exact questions they wish to ask may be fluid and evolve as the study progresses.
Through a time-consuming and burdensome review process, IRBs essentially impose a "tax" on research. Undoubtedly, well funded researchers with their own administrative staffs can pay this tax more easily than junior investigators, students, and trainees who lack the necessary support to comply with the review. For a trainee working 80 hours per week, unnecessary paperwork can make the difference between a first-author publication and forfeiting the idea completely. Outside of protecting subjects, some even argue that this tax may be beneficial in other ways – such as by reducing research fatigue.6 While the idea seems noble, the role of IRBs is to protect human subjects from actual harm. Such thinking is predicated on the notion that to have safe research, we should have less research. Two-time Nobel laureate Linus Pauling, who once said "in order to have good ideas, have lots of ideas" would disagree.
Perhaps the most pointed criticism of IRBs is that they restrict curiosity. When distilled, current IRB policy essentially affords a distant administrator, often without subject matter expertise, the power to censor research. This seems unethical, and is likely a regulatory overreach that violates the spirit, if not the letter, of free expression. Moreover, universities have long been considered bastions of free expression and independent inquiry. As the renowned social scientist Ithiel de Sola Pool wrote, "If universities are to be thus responsible for studies that occur on their premises, they must convert their students and faculty into disciplined agents, instead of what they always have been: independent thinkers guided by individual curiosity."7
The U.S. Government, likely sympathetic to these concerns, has proposed changes that would simplify the exemption process and reduce the workload on IRBs themselves, freeing them to focus on higher risk research. Among these changes is a computer-logic based web form that researchers can use to self-determine whether their research is exempt. Despite being last proposed in 2015, the form has yet to be rolled out. If it ever is, institutions will still be able to opt out of it. On the other hand, there is nothing preventing institutions from adopting similar tools on their own today.2
We advocate for the elimination of IRB review of survey and interview research and for the ability for researchers to determine exempt status based on automated checklists. We also believe that the requirement at some institutions that IRB submission requires faculty approval be removed. It does not appear to have any basis in the law, and there is no evidence that faculty surgeons are more ethical in administering surveys than trainees. Unfortunately, such policy decisions are largely in the hands of governments and institutions. What surgeons can realistically do today is ensure that our research groups and academic journals do not manufacture restrictions where none exist in the law - for example by preventing the initiation or publication respectively of minimal-risk survey studies without IRB documented exemption.
In conclusion, IRBs were developed to address the real need to protect human subjects. However, current IRB policy is not a manifestation of strong human subject regulations but rather an inflammatory response to the absence of such regulations. It imposes a tax on research that disadvantages junior and unfunded researchers, possibly worsening academic disparities. For a subset of minimal risk social sciences research, it is, at best, an administrative nuisance, and at worst, a censor on scientific creativity and free inquiry. Creative solutions in technology and policy are needed to ensure that IRBs can protect human subjects without stifling scientific innovation and progress.
References
1. Babb SL. Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy. Stanford University Press; 2020. https://play.google.com/store/books/details?id=IJnrwQEACAAJ
2. Loe JD, Winkelman DA, Robertson CT. An Assessment of the Human Subjects Protection Review Process for Exempt Research. J Law Med Ethics. 2016;44(3):481-491. doi:10.1177/1073110516667944
3. Schneider CE. The Censor’s Hand: The Misregulation of Human-Subject Research. MIT Press; 2015. https://play.google.com/store/books/details?id=aNB7CAAAQBAJ
4. American Association for Public Opinion Research. Protection of Human Participants in Survey Research: A Source Document for Institutional Review Boards. Published online November 2005. https://www.nmt.edu/research/docs/irb/aapordoc.pdf
5. Schuwirth LWT, Durning SJ. Ethics approval for health professions education research: are we going too far down the barrel? Med Educ. 2019;53(10):956-958. doi:10.1111/medu.13942
6. Ashley F. Accounting for research fatigue in research ethics. Bioethics. 2021;35(3):270-276. doi:10.1111/bioe.12829
7. De Sola Pool I. Prior Restraint. The New York Times. https://www.nytimes.com/1979/12/16/archives/prior-restraint.html. Published December 16, 1979. Accessed March 3, 2024.