Benefits of IRB Transparency Solved
Benefits of IRB Transparency Solved
Benefits of IRB Transparency Solved
While this rationale may suggest caution with regard to who is allowed to attend IRB meetings (which could at least partially be addressed via confidential- ity agreements), there is a relatively simple solution when it comes to IRB minutes and decisions: redact them. This is precisely what FDA does when releas- ing the materials supporting its decisions to approve new drug applications. Any member of the public is able to download robust portfolios from the Drugs@ FDA website, including correspondence between sponsors and the agency, scientific analyses, and deci- sion memos; certain information may be redacted, but enough remains to allow stakeholders to better understand the agency’s rationale, the issues at stake, and how they were resolved. Granted, this compari- son may not be apples to apples with the IRB context — for example, once FDA grants approval, the spon-
sor may be protected by various marketing exclusivi- ties, rendering competition less worrisome, and FDA does not publish the same information about applica- tions that were denied (although perhaps it should).73 Nevertheless, court decisions often deal with various types of sensitive information, and redaction or selec- tive inclusion is possible in those contexts. Similarly, IRB decisions can be written in such a way to focus on rationales and outcomes without necessarily shar- ing information that is best kept confidential.74 More- over, this sort of confidentiality concern is no reason not to be more transparent about IRB policies, rather than protocol-specific decisions, nor is it a reason not to be entirely forthcoming and direct with investiga- tors themselves about the IRB’s decision and rationale related to their own submissions.
There are other potential confidentiality concerns, for example when IRBs are reviewing politically sen- sitive research, such as that involving abortion, but those special cases should not be allowed to wag the dog, nor is it necessarily the case that fear of backlash is adequate reason to avoid transparency. And there may be another type of free-rider concern beyond issues related to competition between sponsors or investiga- tors, which is that if some IRBs are more transparent than others, they will bear the burdens while others learn from them without reciprocal benefits.75 The answer to that concern, though, is not to avoid trans- parency, but rather to make it more universal.
It is possible that greater IRB transparency could have a range of unintended consequences. As noted above, perhaps IRBs would become even more con- servative if they fear that their activities will be sub- ject to outside scrutiny or if they discover that their board is not as conservative as others, or perhaps the candor of IRB deliberations would be negatively affected on a more transparent approach.76 IRBs may actually be inclined to document and disclose less if
they fear opening themselves up to litigation.77 And it is also possible that increased transparency will result in more “IRB shopping” by sponsors and investigators seeking the most lenient boards.
These are reasonable worries, but they need not be insurmountable. First, given the general benefits of IRB transparency described above, possible bad out- comes seem inadequate to support the status quo. In particular, with regard to litigation, there have been relatively few lawsuits stemming from research stud- ies,78 and there is so much discretion in the applicable regulations that IRBs likely need not worry so long as they are behaving reasonably. Moreover, transparency can even help build an IRB “standard of care” based on what others are and have been doing in similar contexts. Second, these are empirical questions: we could pilot test different approaches to transparency
Probably the most important argument against IRB transparency is not that transparency itself is undesirable, but rather that it is costly. Many IRBs are
already woefully under-resourced, so asking them to write out and share robust determinations and policies is an added burden, which could ultimately result
in delay. Nonetheless, if this is the argument against transparency, there are even greater concerns — namely that IRBs are inadequately resourced to even render justifiable determinations in the first place. Clearly, this cannot stand.
Lynch
the future of informed consent • spring 2018 155 The Journal of Law, Medicine & Ethics, 46 (2018): 145-158. © 2018 The Author(s)
to see how they work and what impact they have, before accepting the status quo of nontransparency. And third, it is also possible that IRB transparency will have the salutary effect of facilitating more liberal approaches as IRBs see others adopting creative solu- tions to facilitate research. Most likely, transparency would facilitate some “regression to the mean,” with comparably conservative IRBs becoming less so as they gain insight into the approaches taken by other boards, and vice versa for some comparably liberal IRBs, which would minimize any concerns about IRB shopping. Since transparency is distinct from prec- edent, however, justifiable differences in approach could stand, so long as adequate care is taken to avoid inflexible “groupthink.”
Probably the most important argument against IRB transparency is not that transparency itself is undesir- able, but rather that it is costly. Many IRBs are already woefully under-resourced,79 so asking them to write out and share robust determinations and policies is an added burden, which could ultimately result in delay. Nonetheless, if this is the argument against transpar- ency, there are even greater concerns — namely that IRBs are inadequately resourced to even render jus- tifiable determinations in the first place. Clearly, this cannot stand.
Resolving the IRB resource problem is beyond the scope of this article, but one possibility is to include IRB costs in grant awards and contracts as a line item akin to a user fee, rather than as generalized “overhead” or “indirects,” to help ensure that funds are directed to this specific purpose. User fees raise ethical concerns of their own,80 but IRB services are not costless and the fee-for-service model is precisely that utilized by external IRBs not affiliated with any research institution and run as for-profit businesses. These IRBs pride themselves on customer service and efficiency, and being adequately resourced is part of how they are able to deliver. With appropriate protec- tion against conflict of interest, IRB user fees may be a part of the solution, as some institutions have rec- ognized, at least for industry-sponsored research.81 It is also possible that new requirements for single-IRB review of multi-site research will lead to certain effi- ciency gains and more resources for reviewing IRBs. Finally, note that some types of IRB transparency will be less costly than others, such as making existing pol- icies more freely available, such that cost cannot be an unqualified defense of nontransparency in all cases.
