Abstract
Pulling back the veil on Institutional Review Boards.
Just like the ghoulish dementors of the Harry Potter series, IRB committees are typified as the foulest of creatures who feed on the happiness of unsuspecting researchers. An institutional review board, or IRB, is comprised of a diverse group of individuals tasked with reviewing research proposals and monitoring ongoing studies in their community to ensure compliance with ethical standards designed to protect the rights of human participants in research. Alternatively, some would suggest that the mission of the IRB is to drain the hopes and dreams of investigators while stymieing research progress. Are IRB staff and committee members truly evil beings or are they just misunderstood?
In my professional career, I have been a graduate student in sociology and an IRB Administrator at several institutions. IRB administration is neither a traditional nor sought-after career path for sociologists. Yet, I have found it to be a rewarding profession. My primary role is to facilitate research (as bureaucratic as that sounds) while advocating for the rights and welfare of research participants. IRBs regularly receive questions and complaints from research participants and potential research participants. Inquiries range from clarification questions about the research to egregious complaints, which may reveal instances of serious and ongoing scientific misconduct that would otherwise go unnoticed and unreported.
I am not at liberty to disclose examples of researcher misconduct, but I can tell you that it happens. When it does, it is never fun. Sometimes research misconduct is unintentional and thoughtless. Other times, research misconduct is premeditated and self-serving.
There is a false perception that social science research cannot result in “serious harm” to research participants. In reality, research on the complex dimensions of social life can pose legitimate risks to participants from emotional discomfort to social harms. Privacy violations and threats to participant confidentiality are especially challenging for today’s researchers and IRBs who must consider data security measures and creative alternatives to recording participant identifiable information. My best advice to researchers is, “You can’t lose what you don’t have.” By choosing not to retain any personally identifiable information about a participant, you are not only protecting them but you are protecting yourself against the possibility of an accidental breach or data hack.
Ironically, irresponsible researchers are not subject to nearly as much daily scrutiny as IRB administrators. I have been stopped at lunch, on the bus, and in line at Starbucks for the occasional IRB update, “What is the status of my submission? Did you review my consent form yet? What is the hold up? Why is this whole thing taking so long?”
IRB staff navigate a winding road between helping the researcher to perfect their IRB submission and working through the review process with the assigned reviewer and/or the full IRB committee. Yes, the process can be slow and no one’s research comes first. You have to take a number, just like at the deli.
Thus, it comes as no surprise that many researchers, particularly social scientists, have had disappointing and frustrating experiences with IRBs. In 2012, Janice Irvine analyzed self-reports from sociological researchers to suggest that IRB committees are uninformed obstructionists who cannot successfully balance the risks and benefits of proposed sex research in her Contexts article “Can’t Ask, Can’t Tell: How Institutional Review Boards Keep Sex in the Closet.” There are certainly others who share Irvine’s opinion. Insults like “research amateurs” and “meddling interlopers” have been directed at myself and other well-intentioned IRB staff.
While name-calling is never appropriate, I can certainly understand why researchers may feel defensive toward IRBs. Having anyone review your research methods can be stressful, and no one wants their important research to be delayed by layers of bureaucracy and seemingly obtuse federal and institutional regulations. Additionally, IRBs are widely understaffed, undertrained, and underfunded, especially at smaller institutions. This problem is consistently documented by the annual IRB workload and salary survey conducted by the organization Public Responsibility in Medicine and Research (primr.org) as well as in scholarly research. Moreover, IRBs vary in structure and efficiency, particularly when accounting for other factors such as organizational culture, committee membership, and the categories of research prevalent within the organization (i.e., clinical versus nonclinical, federally-funded versus non-funded, etc.).
IRBs may enforce different policies based upon their institutional goals and the needs of their research community. Yet, all IRBs (with federal-wide assurances) must be guided by the regulations outlined in the Common Rule (45 CFR 46). Institutions may impose additional research regulations as needed. For instance, the Common Rule does not require that IRBs retain “back translations” of translated documents (a back translation is a translation of a translation done to ensure accuracy). However, some IRBs require a third party back translation to ensure that translations are accurate and culturally appropriate. In the age of “google translate,” this is not always a bad idea.
No, this is not how your Institutional Review Board makes their decisions.
Jeff Hitchcock, Flickr Creative Commons
I may be incredibly fortunate, but my experience as an IRB administrator has been more rewarding than traumatizing. In fact, I think I’ve made life a bit easier for many investigators especially social scientists. My academic background in sociology has prepared me to apply federal regulations appropriately to sociological research. In fact, the sociological imagination is extremely relevant when applying the guiding ethical principles of the Belmont Report (respect for persons, beneficence, and justice) to sociological investigations involving living individuals. Why? Because most of us sociologists genuinely care about equality and our research should reflect this—no matter which population is being recruited to participate.
Over the years, I developed some IRB survival tips intended to reduce the pain and suffering associated with IRB review. I share these tips with you, the reader, as an extension of the olive branch across the IRB board room.
IRB Survival Tip 1—Slow and Steady Wins the Race
If you are submitting to the IRB for the first time, schedule a face-to-face appointment with your IRB office. Bring your final research proposal and a draft of your completed IRB application. Ask the IRB administrator to give you feedback on the application, even before you submit. Make sure that any supplemental documents (such as consent forms and recruitment materials) are included in your application and reviewed by the administrator. Their feedback and suggestions might save you time, while an incomplete submission will definitely delay your approval, result in multiple rounds of revisions, and reduce confidence in your project. Take your time and do it right—speed kills.
IRB Survival Tip 2—Know thy Self, Know thy Enemy
Anticipate the kind of ethical questions that may arise from your proposed research and directly address those concerns in your application. Offer solutions for mitigating risks to participants. Arm yourself with knowledge about your own project and how federal regulations may apply to it.
Take advantage of any free trainings or IRB “office hours” offered by your local IRB office. Ask your department to invite IRB staff to offer a monthly Q&A session, or more personalized IRB training with your faculty and students. Many institutions and academic departments do not offer comprehensive training on human-subjects protections. Its value cannot be overstated for crafting a thoughtful IRB submission. A free training resource offered by the National Institutes of Health (NIH) on conducting research on human subjects can be found at phrp.nihtraining.com.
If you really want to “get inside” your IRB’s head, read the Institutional Review Board Member Handbook by Amdur and Bankert (now in its third edition). This handy reference guides you through the practical steps taken by IRB staff and committee members when reviewing applications and applying federal regulations and international guidelines for research with human participants. The more familiar you are with human subjects protections, the more prepared you will be to craft thoughtful study procedures with your future participants.
IRB survival tip 3—If You can’t Beat ‘Em, Join ‘Em!
If you are experienced with IRB submissions and feel that your IRB is not functioning in an acceptable or efficient way, ask to attend a meeting or volunteer to become an IRB member. Even students can volunteer. In my experience, such student members are reliable attendees and thoughtful reviewers of research protocols.
Your IRB may not hold meetings open to the public due to long agendas and time constraints, but you can always ask to attend a meeting as a guest or observer. Some IRBs post meeting minutes on their website. If your IRB does not publicly post minutes, you can request meeting minutes by contacting your IRB office and/or submitting an open-records request (if required by your institution).
By expressing interest in the IRB and offering to get involved, you will be able to communicate your concerns to the committee and understand how the committee functions at your institution. You will also become the new best friend of the entire IRB office, as it is terribly challenging to recruit new IRB members from busy college campuses and research institutions.
History is full of well-intentioned but ultimately misguided science, which means IRBs must ask the difficult question “Who really benefits from this research?” They do it to prevent potential exploitation and protect participants’ rights, dignity, and wellbeing. The IRB is not a group to be feared, but a resource to actively engage so as to ensure your research safeguards its participants. Respecting and enforcing ethical research guidelines as a community affirms our commitment to our community. The process for this safeguarding is complex, and yes, sometimes frustrating to navigate, but, by taking the proactive steps described above, you too can learn to stop worrying and love your local IRB.