Calls for IRB Transparency in a Closed-Door System
Transparency ‘benefits would outweigh the cost’
By Gary Evans
It is a common critical observation in human research that IRBs operate in a sort of “black box,” making decisions that could greatly affect a general public that remains largely oblivious of their role and function.
“The default rule — permitted by the regulations governing IRBs and demonstrated by the practices of many — has been for IRBs to be closed-door, relatively secretive bodies, making determinations with substantial impact on a wide variety of stakeholders without robust explanation, justification, or transparency,” the author of a paper on the subject noted.1
This default ought to change toward transparency, both for the good of the research community and to be in line with the increasing calls for publishing research results, reporting all clinical trial data, and sharing consent forms, says Holly Fernandez Lynch, JD, MBe, John Russell Dickson Presidential Assistant Professor of Medical Ethics and Health Policy at the University of Pennsylvania. Although her background is in law, Lynch is less interested in indicting IRBs than extolling the benefits of a new age of transparency.
“I don’t think anybody is non-transparent because they are trying to hide things,” she tells IRB Advisor. “They end up being nontransparent because the focus is on regulatory compliance, doing what you need to do to satisfy the rules, following your procedures, and moving things along. Anything that could take longer is kind of frowned on, and that’s understandable. People get frustrated when IRBs are slow. Setting up systems of transparency takes some effort.”
For example, releasing more thorough documentation of the proceedings beyond the cursory regulatory requirements of meeting minutes may necessitate redacting information for confidentiality protections, she says.
By the same token, “if you open your IRB meetings, you might have people come and ask questions that may be uninformed,” Lynch says. “That happens, but that is part of the educational function that IRBs can help serve. I don’t suggest that being transparent would be costless, but I think the benefits would outweigh those costs. On top of that, I think it is hard to justify nontransparency in decisions that have huge public relevance about what type of research can proceed or not.”
Lynch concludes her paper with the bottom line that “IRBs are rarely required to explain or justify their decisions. Investigators must be given some information, institutions and regulators have full access — to the extent that IRBs record their rationales — but everyone else can be left in the dark.”
IRB Advisor asked Lynch to comment further on this issue in the following interview, which has been edited for length and clarity.
IRB Advisor: While you are not accusing IRBs of trying to hide anything, it seems intuitive that closed proceedings could increase the risk of ethical lapses and heighten participant risk.
Lynch: I’m sure you have heard the phrase “sunshine is the best disinfectant.” I don’t think there is necessarily something that needs to be disinfected, but when you know your records are open, people tend to behave a little bit differently. IRBs may not necessarily agree with this, but I think IRBs have a lot in common with government regulators. For example, they are often at private universities or for-profit companies but they are the ones who get to decide whether research can proceed. That is a huge responsibility that I really think should not happen behind closed doors.
IRB Advisor: You note that probably the most common pushback is not against IRB transparency itself, but the cost of achieving it?
Lynch: IRBs often indicate that they have a lack of resources. They are trying to do everything they can to keep their head above water, maintaining regulatory compliance, and trying to protect human research participants however they can. Anything that is not actively required of them is likely to fall by the wayside. If there is no regulatory requirement to be transparent about a wide variety of things, it is not going to rise to the top of priority list.
The other thing is, frankly, nontransparency can be a way to avoid having people peek into your affairs in a way that might cause trouble down the road. I don’t mean to suggest that this is some purposeful and nefarious thing that IRBs do because they are engaged in shady activities. But if you think anecdotally about IRB minutes, they don’t often really allow you to piece together exactly what was discussed in the room. They satisfy the regulatory requirements and often provide the bare minimum of the information to do so.
IRB Advisor: Is there a concern that more complete documentation of discussions and decisions could raise legal liability?
Lynch: That’s part of it. If you write things down and then something negative happens, your records [can] get “discovered” in the legal sense. It’s probably “better” from the litigation perspective to not have written down a lot of things. But we don’t want IRBs to engage in activity that is preparatory to litigation all the time. That is not the best way of doing business, but it is a reasonable worry. It gets to this idea of IRBs being criticized for being more for institutional protection than [research] participant protection. I’m not saying that I endorse that view, but non-transparency kind of falls into that category. [The mindset] is “Don’t share information that you don’t have to share because it could cause you a headache later.”
Change Must Come From Within
IRB Advisor: You mention that regulations requiring more transparency would be one approach, but of course any regulatory changes would certainly proceed slowly.
Lynch: I don’t think the regulators are going to be pushing this [transparency] movement if it ever gets some legs under it. I think it is going to have to be driven by the human research community. There are a lot of benefits to transparency. Our default approach ought to be transparency because we have all of these stakeholders in our system. We have investigators that we are beholden to, research participants, and the public. In terms of cost, I think eventually it would be more efficient to be transparent.
If you could share information across institutions that would be huge. As it stands, each institution often has to reinvent the wheel because it is difficult to find policies that you could rely on from other institutions. If you are dealing with a problem at your institution and you have to write a policy about it, chances are some other institution already has that policy. You could use someone else’s policy as a jumping-off point. There are some informal mechanisms that have been built up to allow IRBs to share with one another, and that’s a great thing. It indicates that the community appreciates the value of transparency, at least with one another. They can build on that, and I would encourage them to go even further and think about how can we be more transparent with our investigators.
IRB Advisor: How can IRBs promote transparency for researchers?
Lynch: I know many IRBs are thinking about, for lack of a better term, “user satisfaction.” For researchers, it could be having a better understanding of how IRBs make their decisions. Open your IRB meetings. Have them come see what is discussed and how things work. Make your decision letters more robust and give reasons for your decisions. IRBs are not arbitrary. They have reasons for the decisions that they make, but if you don’t explain those to investigators you allow them to concoct reasons that they might disagree with. It is better to explain clearly the IRB’s rationale. Then, if the investigator disagrees, there can be a discussion. It doesn’t put the investigators in the position of getting frustrated over something that may not actually be true about the IRB position.
The other thing is that often, if I have a conversation with somebody and they ask my opinion on something, I will give my off-the-cuff opinion. Then, I think later “that’s interesting, maybe I should write something about that.” But when I start writing, I can’t justify [my opinion] in the same way I did in the conversation. In the process of justifying something in writing, you are thinking about whether your argument flows logically, or whether there are inconsistencies or holes. This is something that is really important that is not built into the IRB system. We have meetings where people are talking, having conversations, and mostly work off a consensus model. I wonder a lot whether IRB decisions would necessarily be the same if they had to be written down and justified.
IRB Advisor: Can you elaborate on the idea of establishing a repository of IRB “precedents,” past actions that could inform future decisions if they are in some searchable format?
Lynch: I have launched an organization called Advancing Effective Research Ethics Oversight (AEREO). We are trying to come up with ways to figure out not only how to make IRBs more efficient, but how can we be sure what IRBs are doing is actively promoting the goals they were created to promote? One of the projects our group has been working on is to think about whether a system of IRB precedents is plausible. You don’t have to necessarily be transparent to develop a system of precedents within an institution. You don’t have to share the information with anybody else; you could just have internal precedents. But ideally, you would share information across institutions with all the various stakeholders.
Of course, it is easier said than done, but we are trying to think about coming up with some kind of a summary, after an IRB makes a decision, of the key things it decided and then putting that into a kind of taxonomy. We could sort IRB decisions according to what they were about; for example, whether a study was minimal risk or what was decided about an informed consent waiver. You could build these taxonomies in search categories that would allow you to figure out what your institution had done previously, or ideally, what other institutions have done. We are trying to build on the transparency concept, and one of the things AEREO does is create this safe space for institutions to share information and ideas with one another.
- Lynch HF. Opening closed doors: Promoting IRB transparency. J Law Med Ethics 2018;46:145-158.
It is a common critical observation in human research that IRBs operate in a sort of “black box,” making decisions that could greatly affect a general public that remains largely oblivious of their role and function. This default ought to change toward transparency, both for the good of the research community and to be in line with the increasing calls for publishing research results, reporting all clinical trial data, and sharing consent forms, experts say.
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