IRBs Strive to Improve Consistency of Study Protocol Decisions
Is a study protocol OK to go forward? Or are many changes needed for recruitment, consent, or other processes? IRB decisions often are inconsistent on these points — even at the same institution, and sometimes at the same IRB. “Different IRBs have different people on them with different opinions,” explains Andrew Hedrick, MPA, CIP, senior IRB protocol analyst at The Ohio State University.
A common example is the language used in informed consent documents. “Some IRBs will look at a consent document and say, ‘This is fine.’ A week later, another IRB member may say, ‘This isn’t detailed enough. We want more,’” Hedrick reports.
IRB members might take contrary views on criteria for waiving consent for records review studies, or on research that involves deception of some kind. Some IRBs just look strictly at the criteria and grant a waiver as long as the study protocol meets the bare minimum. Other IRB members push back, challenging researchers on why they really need a consent waiver. “If a needed waiver is not granted, it’s sometimes only an inconvenience. But other times it can affect how a [principal investigator] wants to do their study,” Hedrick says.
Some IRB decisions made years earlier may no longer reflect current realities. “Technology is ever-evolving. Things that we don’t worry about now might be a big deal five years from now,” Hedrick observes.
Confidentiality and data are good examples. Certain IRB members consider data “anonymous” since no names or addresses are involved, even though other demographic information is involved. For example, in the context of a national survey of hospital patients conducted online, the IRB might consider the information to be anonymous if the only demographics collected are age, gender, ethnicity, and number of children.
“However, if you added something like a ZIP code into that same list, anonymity may go out the window for a lot of respondents, depending on how diverse the population is in a ZIP code and how many people live there. More savvy IRB reviewers would say it’s absolutely identifiable,” Hedrick says.
Studies involving children also tend to provoke strong opinions on subjective issues, regardless of whether regulatory criteria are met. “The IRB will ask: ‘Is it appropriate? Is it ethical? Should parents be involved?’” Hedrick says.
There can be heated discussion on all those questions. “You can never eliminate inconsistency completely, even within the same IRB,” Hedrick says.
Still, IRBs should monitor for inconsistent decisions. It is troublesome if IRBs decide on a study protocol without realizing the same issue arose previously and the panel made a different decision. Usually, investigators will alert IRB staff to the issue. Researchers will complain (perhaps heatedly) if the IRB asks for major changes the board did not request with a previous similar study (either their own or one by a colleague).
“In some cases, investigators are doing very similar types of research, but the devil is in the details,” Hedrick says.
In that situation, this gives the IRB a chance to explain to the researcher the two studies were not the same.
Hedrick tries to offer researchers guidance on how to comply with IRB requests so their work can go forward. “Ultimately, we want to promote research. We try to be researcher-focused and customer service-oriented to help the researchers do the research they want to do while keeping them inside the lines, so to speak, of regulatory frameworks. That’s the reason we’re all here,” Hedrick says.
Ohio State’s IRB Policy Committee (IPC) serves as a forum for deciding how boards will approach various issues. Occasionally, inconsistent decisions are a topic of discussion. “If we notice widespread inconsistencies, we put it on the agenda so the committee can decide how to address this going forward,” Hedrick reports.
If one IRB approves a study with no questions asked, but another board asks for many changes, it raises some important questions. “Do we have one IRB approving research that’s riskier than we should be approving?” Hedrick asks. “It means there’s a difference of opinion. That’s something we definitely want to look at.”
Using templates with language that investigators use for consent forms, instead of creating a unique consent form for every study, is one way to avoid issues. “To the extent you can standardize things, there is less guesswork for the IRB,” Hedrick says.
At the University of Pennsylvania, the Consortium to Advance Effective Research Ethics Oversight (AEREO) conducted a pilot project to understand whether IRB decisions could be summarized in a way that would allow them to be used as precedent for future decisions.1 “We were motivated by the analogies between IRB decisions and judicial decisions,” says Holly Fernandez Lynch, JD, MBe, co-chair of AEREO.
Courts are expected to rely on previous rulings to inform current decisions, and justices write opinions summarizing the rationales for their key opinions. In contrast, IRBs often rely on institutional memory to make decisions. “IRBs strive for consistency. But formal approaches to looking back at previous decisions are rare,” Fernandez Lynch explains.
IRBs lack a mechanism to index and search those prior decisions in a systematic way. “That’s what we were looking to address. IRB precedent has been discussed before, but we wanted to see what it would take to do in practice,” Fernandez Lynch explains.
AEREO members started by focusing on protocols and decisions for comparative effectiveness research. The team developed and tested several methods of summarizing prior IRB decisions on protocols. “We assessed the summaries on the basis of whether they were efficient to produce, valid, searchable, and comprehensive,” Fernandez Lynch reports.
Ultimately, none of the methods tested satisfied all these criteria. This led the team to identify a new approach. “We learned that for this to work, we need to find a way to support IRB decision summaries being written up in real time as protocols are reviewed,” Fernandez Lynch says.
This approach is more likely to be efficient and accurate since decision summaries can be produced as IRBs are reviewing them.
The team’s next step will be to test the feasibility of this prospective approach, a project on which they are about to embark. Once AEREO identifies mechanisms of developing IRB precedent, the next step is finding ways to make those precedents searchable so they can be used as a routine part of board deliberation. “In the future, we hope institutions will consider sharing these decision summaries with each other to improve learning more broadly,” Fernandez Lynch says.
For researchers, the benefit of a more systematic approach to using IRB precedent will be greater predictability and consistency. “Hopefully, there will be more clarity around how IRBs will interpret discretionary regulatory and ethical standards,” Fernandez Lynch says.
- Seykora A, Coleman C, Rosenfeld SJ, et al. Steps toward a system of IRB precedent: Piloting approaches to summarizing IRB decisions for future use. Ethics Hum Res 2021;43:2-18.
Is a study protocol OK to go forward? Or are many changes needed for recruitment, consent, or other processes? IRB decisions often are inconsistent on these points — even at the same institution, and sometimes at the same IRB.
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