The American Journal of Bioethics | 2019
The Limitations of “Boilerplate” Language in Informed Consent: Single IRB Review of Multisite Genetic Research in Military Personnel
Abstract
Informed consent forms have commonly included standardized language, often referred to as “boilerplate” language, that has been vetted by institutional officials. The implicit goal is to ensure that all participants have adequate explanations of critical information. However, sometimes this language is included even if it does not clearly make sense in the context of a specific study, because it is more expedient for the investigator and the institutional review board (IRB) to include it. More recently, single IRB review of multisite trials has been an additional mechanism that is intended to improve efficiency and consistency for investigators and IRB while ensuring the quality of the content and presentation of information. The case presented here illustrates the challenge related to how a single IRB considers different boilerplate language from different institutions. This case is quite nuanced and is related to language about privacy and discrimination related to research about genetic risks for myositis in participants who are active-duty military personnel. However, the underlying concern in this case challenges the conceptualization of both the role of informed consent and role of institutions. Thus, this case is salient for anyone thinking about the role and expectations of consent forms for participants. Three commentaries accompany the case. Jeff Botkin from the University of Utah acknowledges that boilerplate language serves institutional functions, but claims that it is still necessary for IRBs to ensure this information is written in such a way that can actually help participants make decisions. He concludes that single IRBs or standard IRBs have the same obligation to ensure that information is understandable and accurate for participant groups. Sara Hull and Adam Shiffenbauer, from the National Human Genome Research Institute, National Institute for Environmental Health Sciences, and the National Institute of Health Clinical Center, agree with Botkin but discuss the specific complexities related to how implications of genetic research may be different for different populations, to support the importance of the single IRB working with the other relying IRBs collaboratively to ensure that the information is accurate. Melissa E. Abraham, Elizabeth Hohmann, and Megan Morash, from Massachusetts General Hospital, Partners HealthCare, and Harvard Medical School, also agree, but they further explore pragmatic approaches institutions can take to be responsive to the concerns raised by this case that also acknowledge the institutional challenges of that responsiveness.