To Whom?

The most obvious type of transparency in the IRB context refers to accessibility to and openness with investigators whose research protocols are under review, as they are the individuals in closest contact with IRBs, and whose work hangs in the balance. The same is generally true of research sponsors, particularly those with a financial interest in the research. Other stake-holders also have a clear interest in IRB decisions and decision-making, including the research participants whose interests IRBs are charged with protecting and the institutions hosting research studies who will bear the legal brunt of any IRB shortcomings. IRBs at other institutions may also have an interest in transparency among their peer boards, because they are engaged in collaborative research or because they are interested in benchmarking behavior of other IRBs as a learning exercise. Regulators, of course, need to know what IRBs are doing and how well they are doing it for compliance purposes, and the same is true for voluntary IRB accreditors, such as the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

The public in general also has a claim to transparency on a variety of grounds. IRBs are often deciding whether and how publicly-funded research may proceed, they are overseeing compliance with public laws and regulations, and they may play an important role in promoting public trust in the research enterprise (to the extent the public knows they exist). Sometimes, they are situated within public institutions (e.g., public universities) subject to government transparency requirements. And they may be approving research that the public will be affected by, and may even consider participating in, a potentially distinct role from protecting individuals who are already enrolled as participants.

A final stakeholder group is comprised of researchers who wish to study IRBs, analyzing for example how they are composed, how members engage with one another, how they make decisions and set policy, what hurdles they face, how they might be affected by certain types of reform, and a variety of other important questions. As others have recognized, the transparency needed to conduct such research has traditionally been lacking,¹⁶ but is sorely needed.^{Reference Nicholls17}

About What?

Each of these stakeholders may have a desire (or need) for transparency regarding different aspects of IRB operations and outcomes. At a foundational level, transparency as to the source of IRB authority, whether regulations, agency guidance, or institutional policy, as well as transparency — or education — about the historical ethical rationale for IRBs, can help enhance the perceived legitimacy of board actions, while minimizing perceptions of arbitrary or senseless imposition of burden.¹⁸ Indeed, at least some complaints that get leveled at IRBs seem upon closer examination to be complaints about the regulations they are charged with administering.

Beyond this, investigators need transparency about IRB determinations regarding their protocols, which they receive via approvals, disapprovals, and requests for modifications. In addition to bare determinations as to whether or not research can proceed, however, it is helpful to have transparency about various underlying determinations as well, for example, the IRB's assessment regarding a protocol's risk level and its ratio of benefit to risk, on what grounds it agreed to waive informed consent, which exemption category a study was deemed to fall under, and why certain payment amounts were accepted or rejected. Knowing how and why decisions were reached can be important for compliance purposes, crafting amendments, and designing future research such that it will be approved as expeditiously as possible. This may come in the form of conversations with the IRB chair or administrative staff, for example, or in written form such as a determination letter, although the level of detail provided can vary substantially — and in some cases, no detail is provided at all.¹⁹

Investigators, institutions, and regulators are not the only ones with an interest in this information, as noted above, but at present, it is typically not accessible to others. Indeed, the more extensive details regarding rationale may be inaccessible beyond the IRB itself. It is important to note here that information about IRB approvals and deferrals (outright disapprovals are exceedingly rare) can be equally valuable. Both provide insight into the IRB's overarching philosophy, its interpretation of relevant regulations, how it is likely to behave in the future, what should be emulated or avoided, and potentially what should be protested and changed. In fact, shedding light on IRB deferrals can be particularly important since, unlike protocols that are approved and proceed, deferred proposals will not be available as a teaching tool unless active steps are taken. In this regard, there are strong analogies to arguments for transparency of all clinical trial results, both positive and negative.^{Reference Hudson and Collins20}

In addition to the outcome and basis for IRB determinations regarding specific protocols, transparency regarding IRB procedures and policies is also important. Investigators need to know what to submit, to whom, about what, and by when. They also need to understand how IRBs are interpreting various regulatory requirements that leave them with substantial discretion, as well as any institutional policies that may exceed what regulations require. It is in no one's interest to hide the ball on these matters — IRBs want and need investigators to comply. That said, IRBs vary in the extent to which they facilitate investigators' protocol development and submissions, with the best (and typically most well-funded and institutionally-supported) boards providing easy-to-navigate websites, training sessions, and the like. While some IRBs have a robust library of formal policies covering a wide range of circumstances, it is also often the case that there will be informal policies that have developed over time,^{Reference Dickert, Emanuel and Grady21} which can be difficult to track, circulate, and understand. In some contexts, decisions may be “driven by tacit, unwritten practices that are neither standardized nor subjected to adequate critical scrutiny.”^{Reference Henry, Romano and Yarborough22} There is also wide variability as to whether written IRB policies and procedures are available on an institution's public website — thereby available for all to see, learn from, and analyze — or whether they are made available only via password within an institution or available only to IRB members and staff (and those responsible for institutional or regulatory oversight). IRB policies provide an important mechanism for institutions to learn from one another and potentially avoid unnecessarily reinventing the wheel,²³ and may also be of interest to research participants and others.

Finally, IRBs may have and maintain a variety of information about their own work, for example how many protocols they review, on what timeline, and of what nature. They may have built search functions and other data analysis components into their protocol submission templates and review software. And they may generally have mechanisms in place for self-assessment, quality improvement, and the like. Ideally, IRBs will analyze the data across these various parameters on a systematic basis, use it to adjust their own approaches, and publish it for the benefit of others. This is not technically within the IRB's regulatory purview, however, and many boards may simply lack adequate resources to conduct these additional activities. Nonetheless, transparency about these details — whether the analysis is done by IRBs themselves or the data is simply shared for analysis by others — is critically important to permit ongoing assessment of the current IRB system and evidence-based policymaking.

By What Mechanisms?

In terms of the mechanisms of IRB transparency, this can be achieved in a variety of ways depending on the goal to be achieved and stakeholder of interest. Some information may be provided verbally, for example through informal conversation between investigators and IRB staff or responses to questions raised by research participants via phone call to the contact person listed on research consent forms. While better than nothing, in general, written communication is preferable for transparency purposes, creating a record that can be referred to later and shared with others. Another mechanism might be to open IRB meetings, either a little bit — at least to the team of investigators whose protocol is under review (as some IRBs already do) — or a lot — to any investigator at the institution, to other IRBs, to researchers interested in studying IRBs, to potential or current participants, or to members of the public more generally. Alternatively or in addition, IRBs might share their meeting minutes with any of these stakeholders (ideally, with sufficient detail to understand what actually transpired at the IRB meeting),²⁴ perhaps upon request or even as a matter of course. And similarly, IRBs could choose to make their determinations available beyond the affected investigator, ideally including robust rationales. As with IRB policies, this information could be shared only within an institution or via an open-access public website, with a range of options in between. Of course, in any of these scenarios, appropriate confidentiality requirements would need to be established, as discussed below.

Current Regulatory Requirements

So far, we can see that IRB transparency is a broad concept, encompassing a range of stakeholders, types of information, and mechanisms of disclosure. But what must IRBs actually do when it comes to transparency? At present, not very much.

The Declaration of Helsinki provides that IRBs (“research ethics committees”) “must be transparent in [their] functioning,”²⁵ and the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Health-related Research Involving Humans states that IRBs must conduct reviews “according to clear and transparent procedures.”²⁶ Both of these sources offer aspirational principles, rather than regulatory requirements, and not much specificity regarding the transparency particulars described above.

With regard to U.S. regulatory requirements, the Federal Policy for the Protection of Human Subjects (the “Common Rule”), which governs most research conducted or supported by federal agencies, and regulations for research under the purview of the Food and Drug Administration (FDA) do offer a bit more specificity, although still leaving wide latitude for IRBs. IRBs are required to have (but not necessarily publish or share) a variety of written procedures for review and oversight of research, including policies for “reporting its findings and actions to the investigator and the institution.”²⁷ Beyond policies, the regulations require IRBs to “notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.”²⁸ Similarly, in the event an IRB suspends or terminates a protocol's approval, it must provide the “investigator, appropriate institutional officials, and the department or agency head” with a statement of reasons.²⁹

Figure 1

Defining IRB Transparency Parameters

There are a few important points to distill from these regulations. First, the regulations require that IRBs provide a statement of reasons — a rationale — for their decisions only when they are disapproving research or suspending or terminating their prior approval. When IRBs approve a protocol, however, they must simply report the decision, without reference to reasons. As between the two, it certainly makes sense to provide a justification when IRBs preclude a study from proceeding, so that investigators can make appropriate changes to strengthen the protocol or clarify and resolve elements of misunderstanding or concern. But importantly, IRBs rarely flat out disapprove a protocol, and instead frequently defer a decision until amendments are made. The regulations do not appear to account for this possibility. Moreover, providing clear reasons need not be a zero sum game. Explaining a rationale for disapproving a protocol in no way impedes an IRB's ability to provide a similar explanation in the context of protocol approvals; reasons are not a scarce resource to be allocated judiciously. Even when the IRB's decision is favorable, investigators and others can learn from the IRB's reasons; what did it find convincing and why did it deem the relevant criteria to be satisfied? As noted above, both sides of the coin are important.

A second point is that the regulations provide no hint as to what might count as an adequate statement of reasons, when one is required. Is it necessary or sufficient to simply point to the regulatory provisions not satisfied by a protocol, or must the statement of reasons be more fleshed out to explain why those regulatory sections or institutional policies preclude approval? Unfortunately, examination of regulatory guidance and agency enforcement letters sheds no light on the parameters of this requirement. Third, and related, although IRB determinations must be provided in writing, the regulations do not specify their scope or content more precisely. Ultimately, the regulations require transparency about the bare outcome of the IRB's deliberation in all cases and transparency about the IRB's rationale in some cases. However, even that required transparency is limited at most to the investigator, institution, and regulators.

By comparison, sharing IRB meeting minutes could generate more substantial transparency. By regulation, minutes must be “in sufficient detail to show… actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.”³⁰ Regulatory guidance further specifies that meeting minutes include documentation of findings, “including protocol-specific information justifying each IRB finding,” regarding specific regulatory provisions governing consent waiver and documentation and research with special populations.³¹ Although regulatory guidance acknowledges that IRB minutes are intended to “provide information to persons not present at the meeting (e.g., investigators, institutional officials, regulators, IRB members who could not attend),”³² meeting minutes are not required to be shared with anyone, including the investigator. Instead, they must simply be maintained with IRB records and made available for review by regulators.

To summarize, the bottom line is that “IRBs are rarely required to explain or justify their decisions.”^{Reference Coleman33} 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.

General Benefits of Transparency

Consider, for example, the litigation system and court decisions, agency rule-making through notice-and-comment processes, and agency review decisions, such as those made by FDA in approving new medical products. All entail processes that are more transparent than IRB oversight of research, and have in common not only analysis of applicable issues and arguments, but also detailed written evaluations that are made available to the public beyond the immediate parties at issue to explain the outcome and rationale. This forces development of articulable and defensible reasons, helps to provide a foundation for future analyses (and potentially for a system of precedent), and facilitates external oversight.⁴⁵ These are each important generalized benefits of a transparent system of decision-making, which the current IRB system fails to capitalize on. By contrast, when decisions are not made transparently, there is not only a lack of accountability, but also the possibility of confusion and uncertainty for affected parties, inconsistency between decision makers, ad hoc decision-making and poor reasoning, and even abuse of power (or at least not much to prevent it).^{Reference Swenson46} These are each risks facing IRBs. There are also more specific justifications for transparency to particular stakeholders.

Benefits of Transparency to the Public

Beyond these baseline considerations in favor of transparency, it is important to recognize the impact of IRB decisions on the public. As noted above, IRBs have the power to allow research to proceed on the basis of their determination of compliance with federal regulations, or to withhold approval when — in their estimation — applicable requirements are not met. Given this gatekeeping authority, IRBs can play a critical role in promoting scientific advancement, for example facilitating and speeding the approval of useful research. Conversely, however, they can stand in the way and slow things down, beyond the appropriate impediment of scientifically or ethically unsound projects. Both approaches have real implications for the public, such that it is appropriate for the public to demand to be given access to understand the how and why of IRB determinations — just as they have an interest in understanding the behavior of other gatekeepers, from FDA and the Patent and Trademark Office to government research funders and others. This allows the public to gauge whether the gatekeeper is striking the right balance and promoting the right priorities, and to call for change where needed. Relatedly, given that much of what IRBs review is government-funded research, the public has an interest in understanding the impact of IRB review on their tax dollars, and is aggrieved by being shut out of the process.

There is also one more way in which the public has an interest in IRB transparency, and that has to do with the public's interest in the transparency of government entities. The Department of Health and Human Services has never taken the position that IRBs are themselves arms of the government, absent some other factor, even though their existence is mandated by regulation and despite their role in overseeing research according to regulatory terms.⁴⁷ Nonetheless, some IRBs are located within government agencies or are part of public universities, and as such could be subject to a full slate of transparency responsibilities under federal and state laws.⁴⁸ These might include open meeting requirements,⁴⁹ records requests under freedom of information acts,⁵⁰ notice-and-comment rulemaking under various administrative laws,⁵¹ ethics and conflict of interest rules, and the like.⁵² In light of the quasi-governmental impact of IRBs as regulatory gatekeepers, it may be reasonable to extend these public transparency features often expected of government agencies to IRBs more generally.

Benefits of Transparency to Investigators

Investigators have a more direct interest in IRB transparency, on at least two grounds. First, there is some indication that the present lack of transparency, real or perceived, can lead investigators to distrust IRBs, or even to “demonize” them.⁵³ This can result in a variety of problems, ranging from failure to engage IRBs about research questions early on to rejection of the resources that IRBs may make available to facilitate research compliance to dismissal of the IRB process as illegitimate, which in the extreme may spur disrespect of ethical rules. If investigators are helped to understand the goals of IRBs, why certain questions are asked, on what grounds modifications are requested, the ways in which IRBs can help support research, timelines for review, IRB processes, and the like, this can avoid misunderstandings, assuage feelings of arbitrariness and powerlessness, and improve investigator trust in IRBs.⁵⁴ This is even more likely if IRBs can transparently demonstrate to investigators that they are being treated fairly and consistently in relation to other investigators and projects. There are numerous “horror stories” about IRBs, but transparency on all these fronts can help separate fact from myth, and with regard to fact, can offer explanation of why certain IRB actions have been taken. Ultimately, transparency should improve the essential relationship between IRBs and investigators, and facilitate weeding out IRB activities that are irrational or overly conservative.

The second basis for investigator interest in IRB transparency is simple efficiency. When investigators are uncertain why the IRB is imposing various requirements or reaching particular outcomes, they are obviously in a poor position to submit approvable protocols from the start or to make appropriate adjustments, particularly in light of IRB discretion in interpreting and implementing the relevant regulations. Similarly, when investigators are unclear as to how previous protocols have fared (and why), they may undertake unnecessarily duplicative work, for example justifying methods that the IRB may already be familiar or comfortable with, tracking down new approaches that the IRB might have already decided to be problematic, or developing mechanisms for things like recruitment, informed consent, results return, or confidentiality protection that the IRB might be able to offer guidance on given prior experience, saving investigators valuable time and effort. In short, “[w]ell-considered, thoughtful reviews could… serve as exemplars and educational tools.”⁵⁵

Relatedly, to the extent that investigators fear that IRBs will slow down their research or behave conservatively,^{Reference Whitney56} likely rooted in the “horror stories” noted above, they may self-censor what they submit for review in hopes of getting approval as quickly and painlessly as possible. While substantial empirical evidence of such behavior is lacking, anecdotal evidence is abundant.^{Reference Kempner, Merz and Bosk57} In so doing, investigators may sometimes make unnecessary sacrifices via wrong guesses about how their IRB is likely to behave. For example, investigators may fail to adopt a more scientifically appropriate study design, a speedier mechanism of recruitment, a fairer approach to paying participants out of concern that their IRB would not approve. If, rather than guessing, investigators had a better sense of what really would impede IRB approval, and what would not, such detrimental self-censoring could be minimized or avoided.

Benefits of Transparency to IRBs

These efficiency concerns are also relevant in support of IRB transparency in relation to other IRBs, as well as systems to promote transparency within IRBs over time, i.e., preservation of institutional memory via easily accessible and searchable records of prior decisions. As Professor Carl Coleman has explained, failure to work together to share information and insight results in a scenario in which “IRBs are regularly challenged by issues of first impression — not necessarily issues that are new to the world of research, but issues that have never previously come before the particular IRB.”⁵⁸ When IRBs are unable to learn from each other (and themselves), at the very least in terms of identifying relevant considerations and offering guideposts for their own decisions, the research enterprise suffers; resources may be wasted and research slowed.

A related concern is that a lack of transparency between IRBs, including failure to share policies, determination letters, and meeting minutes, for example, can contribute to variability between them. Sharing these materials and rationales will not automatically lead to consistency — courts do not necessarily reach the same outcome simply because they have access to the decisions rendered in other jurisdictions (to which they are not bound by precedent) — but it can help minimize thoughtless or ill-conceived variation.⁵⁹ This is not to suggest that IRBs should blindly “go with the crowd” once it becomes apparent what others are doing.⁶⁰ Sometimes, independent judgment will be needed, and just as there may be majority and minority rules in different legal jurisdictions, it may be that there is no obvious “right” answer when it comes to certain issues raised before IRBs, even with transparency. The key is to have sufficient grounding to know whether differences are considered and purposeful, and to avoid accidental difference simply out of ignorance to the behavior and decisions of peers. In this way, transparency can help lay the foundation for a system of IRB precedent, formally or informally,⁶¹ or at the very least generation of best practices.

The self-reflection that is likely to arise from transparency between IRBs may also help IRBs overcome unnecessary conservatism and fears that may be associated with risking “first mover” status in approving something unfamiliar.⁶² On the other hand, transparency might cause IRBs to discover that they have been more progressive than their peers, potentially resulting in increased conservativism in some instances.

Benefits of Transparency to Research Participants

When considering the benefits of IRB transparency, we cannot overlook a primary beneficiary: research participants. While participants would indirectly benefit from the various advantages already described, transparency regarding IRB processes and standards could have a more direct impact on participant trust. Given that participants may not be aware that IRBs even exist at present, or that they exist to help protect participant interests, or that the entire research enterprise is heavily regulated in a way that is skewed dramatically toward participant protection, disclosure of these features and education regarding the IRB's role may be an untapped resource to promote participant recruitment and retention. IRBs are sometimes concerned about language being included in informed consent materials indicating explicitly that a study has been IRB approved, on the grounds that this could appear to be an endorsement or encouragement to participate.⁶³ But helping participants understand why an IRB found the regulatory criteria to be satisfied could reasonably be relevant to the decision whether to participate.⁶⁴ And in the event that an IRB determines the regulatory criteria have not been satisfied, this may be relevant to patient communities who stand to benefit from research, who may help provide the IRB with additional information or help researchers address IRB concerns, for example.^{Reference Stark65} Other than potential information overload, which can be addressed and avoided, there seems to be little downside to greater transparency with research participants regarding the IRB process and outcomes. Empirical study of this question would be valuable.

Additional Benefits

There are at least two additional benefits to IRB transparency that span a variety of stakeholders. First, under the status quo of nontransparency, it is difficult to hold IRBs accountable for their decisions. This is most obviously because many stakeholders may simply not know what IRBs are doing, and therefore may not know to object, appeal, or push for change. But at a more subtle level, when IRB materials are not shared or available, and in particular, when IRB decisions are not presented in written form with analysis, IRBs can more easily fall back on “gut feelings” or intuition.⁶⁶ In an alternate scenario in which IRB activities are made accessible to others, IRBs are more likely to be compelled to articulate reasons and provide precise (or any) justifications for their decisions. And when reasons are provided, they can be assessed, analyzed, critiqued, praised, adjusted, and the like.⁶⁷ Moreover, the process of articulating reasons may cause IRBs to reassess their own views; perhaps they are less well-supported than initially “felt,” and alternative approaches are warranted.^{Reference Reynolds and Richman68} Ultimately, IRB transparency should improve the quality of IRB decisions, just as publication of judicial decisions has been correlated with higher quality.⁶⁹

A second benefit of IRB transparency is that transparent decisions, policies, and practices can be studied empirically. Empirical evaluation of IRBs is essential, given the resources devoted and impact on scientific advancement, and important work has been done already.⁷⁰ But this sort of work can be challenging, with important limitations, for example relying on IRBs to voluntarily provide information, which some may deny, or relying on investigators to pass along their correspondence, which maybe incomplete. More robust analysis via greater IRB transparency will provide important insights into the bases for IRB decisions (e.g., regulations, institutional policy, ethical principles, etc.); areas of focus (e.g., informed consent, trial design issues, privacy, etc.); goals (e.g., participant protection, institutional liability avoidance, etc.); consistency (e.g., within and between IRBs); and overall approaches (e.g., helpful or detached). It will allow assessment of whether IRBs are being too conservative, too permissive, too bureaucratic, too conflicted, too resource-intensive — and what they are doing well, adding value to the research enterprise and participant protection. Evidence-based policymaking, in turn, will allow the IRB system to focus its energies on areas where it can be most effective.