Roles of Institutional Review Boards (IRBs)

Roles of Institutional Review Boards (IRBs)

Roles of Institutional Review Boards (IRBs)

Researchers seeking to collect data through “intervention or interaction” with living human beings, through the use of their “iden-

tifiable private information,”1 or as part of “clinical investigations”2 will typically find their work subject to oversight by one or more Institutional Review Boards (IRBs). IRBs are responsible under various federal regulations, and often under institutional policies, to oversee research with human participants funded by U.S. government dollars or for submission to U.S. reg- ulatory authorities; many other countries have similar systems. IRBs review and have authority to approve, require modifications to, or disapprove research activ- ities.3 They are charged with ensuring that risks to research participants are minimized and reasonable in relation to anticipated benefits, selection of partici- pants is equitable, informed consent is appropriately obtained, data is appropriately monitored to protect participants’ safety, and adequate provisions are in place to protect participant privacy and confidential- ity, among other criteria.4Roles of Institutional Review Boards (IRBs)

Despite this hefty responsibility and its potential impact on researchers, participants, and the public,5 IRB processes are largely ensconced in a black box — conducted, as one author explained, “behind closed doors.”6 Meetings are often closed, sometimes even to the researcher whose protocol is under review, and minutes are typically not disclosed other than to regu- lators and accreditors.7 Decisions are provided to the

researcher and maintained in institutional records, but are usually not published or otherwise shared;8 IRB members themselves may even find it difficult to review prior board determinations and materials rel- evant to their current decisions because the records that are kept generally are not curated, indexed, or easily-searchable by topic or type of issue raised. There are few parameters demanding robust explanation of IRB decisions, whether favorable or unfavorable, and recent evidence suggests that IRBs frequently fail to justify the stipulations they impose on research as a condition of approval, often leaving ethical and regu- latory concerns implicit.9 This opacity makes it diffi- cult to assess how well reasoned (or not) board deter- minations may be. While there have been studies of IRB processes, including decision times, approval rates, and other generalized statistics,10 nothing in the regulations requires that IRBs transparently provide such data, or conduct such analysis themselves.

Against this backdrop, there have been calls for greater IRB transparency in the research ethics litera- ture. However, they have been short on analysis and often embedded in calls to establish a system of IRB precedent to address inconsistency in IRB approaches and outcomes.11 While transparency and precedent are important and related concepts, they are distinct: transparency will not automatically result in a system of decision-making-by-precedent among IRBs or a commitment to consistency, nor is transparency a nec- essary prerequisite. Boards, or even individual mem- bers, could share their decisions with no one else, but still bind themselves (by policy or informally) to their own prior determinations — and vice versa. That said, as will be discussed below, transparency can facili- tate consistency by exposing the rationales behind

Opening Closed Doors: Promoting IRB Transparency Holly Fernandez Lynch

Holly Fernandez Lynch, J.D., M.B.E., is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics and Assistant Faculty Director of Online Education, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Senior Fel- low, Leonard Davis Institute of Health Economics, University of Pennsylvania.

 

 

146 journal of law, medicine & ethics

INDEPENDENT

The Journal of Law, Medicine & Ethics, 46 (2018): 145-158. © 2018 The Author(s)

IRB decisions, both strong and weak, and promoting learning from the experiences of others.

Transparency itself has received little direct atten- tion in the IRB context, although its virtues have been extolled in many other settings, from court decisions12 to allocation of health resources13 to clinical trial data14 to the FDA approval process.15 Is transparency an independent good that we ought to demand of IRBs? In this article, I argue that the answer is yes.

In what follows, I provide the first comprehen- sive taxonomy of what transparency means (or could mean) for IRBs; this descriptive enterprise is essen- tial to assessing the ethical sufficiency of the status quo and the proper scope of needed change. With that conceptual foundation in place, I then describe cur- rent regulatory requirements and practices, and pro- vide arguments in favor of greater IRB transparency, from the perspective of several different stakeholders. In closing, I offer recommendations for improvement.

What Do We Mean By Transparency? When thinking about IRB transparency, it is impor- tant to be specific: transparency to whom, about what, and by what mechanisms? Recognizing what it is not — namely, a mandate to use or do anything with the information obtained — is also helpful. In this regard, transparency is best viewed as a means to other ends, such as trust, efficiency, and quality, as explored below.

To Whom? The most obvious type of transparency in the IRB con- text refers to accessibility to and openness with inves- tigators 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 trans- parency 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 transpar- ency on a variety of grounds. IRBs are often deciding whether and how publicly-funded research may pro- ceed, 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., pub- lic universities) subject to government transparency requirements. And they may be approving research that the public will be affected by, and may even con- sider participating in, a potentially distinct role from protecting individuals who are already enrolled as participants.

A final stakeholder group is comprised of research- ers 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 impor- tant questions. As others have recognized, the trans- parency needed to conduct such research has tradi- tionally been lacking,16 but is sorely needed.17

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,

In what follows, I provide the first comprehensive taxonomy of what transparency means (or could mean) for IRBs; this descriptive enterprise

is essential to assessing the ethical sufficiency of the status quo and the proper scope of needed change. With that conceptual foundation in place, I then describe current regulatory requirements and practices, and provide

arguments in favor of greater IRB transparency, from the perspective of several different stakeholders. In closing, I offer recommendations for improvement.

Roles of Institutional Review Boards (IRBs)