Unpacking the NPRM: Informed Consent

Elisa Hurley

On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects , or “Common Rule.” If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.

In earlier posts, we explored a new category of activities that would be excluded from oversight under the Common Rule and proposed changes to the category of exempt research. We also reviewed the NPRM’s broad consent provisions for biospecimens research.

In this week’s post, we examine the NPRM proposals related to informed consent, including the waiver provisions.

Overview of Informed Consent in the NPRM

The NPRM outlines several new requirements about how information must be organized and presented to potential subjects to facilitate their understanding of the reasons to enroll in a research study or not. It emphasizes that potential subjects must be “provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate [in research]” [§__.116]. It also addresses the structure of an informed consent document.

Specifically, the NPRM proposes to reorient informed consent language to highlight the “essential information that a reasonable person would want to know” (DHHS 2015, 53970). An investigator who is obtaining informed consent would have to present the required information before any additional information is provided. This additional information must be placed in an appendix [§__.116]. The NPRM cites concern that, too often, subjects receive lengthy informed consent documents where important information is “buried” (DHHS 2015, 53970). The Secretary of DHHS will publish guidance on how consent forms should be written in order to comply with the new regulatory requirements.

The NPRM also proposes changes to the Common Rule’s provisions on waivers of informed consent [§§____.116 (e), (f) and ____.117]. DHHS cites concern that the current Common Rule criteria for waivers is not “flexible enough for dealing with a variety of circumstances, such as when federally sponsored research is conducted in an international setting where for cultural or historical reasons signing documents may be viewed as offensive and problematic” (DHHS 2015, 53975). Thus, under the proposed rules, the requirement for signed informed consent may be waived if the human subjects belong to “a distinct cultural group…for whom signing documents is not the norm” as long as the research is of minimal risk and that there is a mechanism to document that informed consent was given (DHHS 2015, 53977). It is important to note that the documentation requirement for informed consent may not be waived if the research is regulated by the FDA, “unless otherwise authorized by 21 CFR 56.109(c)(1)” (DHHS 2015, 54055). HHS received few comments on this area when the ANPRM was released in 2011.

Finally, the NPRM is requiring that a copy of the informed consent form for each federally supported trial be posted on a public federal web site. The form must be posted within 60 days after the trial closes recruitment by either the awardee or the federal department conducting the trial [§__.116(h)(1)(2)].

Analysis of Proposed Changes

Informed consent is an essential component of research with human subjects, as it operationalizes the principle of respect for persons and, when done successfully, provides potential subjects with an opportunity to make an informed decision about research participation, based on an understanding of the nature of the research, its risks, and its benefits. The NPRM, which, as discussed above, includes new requirements aimed at ensuring potential subjects are able to make thoughtful research participation decisions, clearly recognizes this fact. For those who have been lamenting the trend of longer and longer consent forms that seem more focused on protecting institutions from liability than providing potential research subjects with adequate information to support their autonomous decisionmaking, the informed consent proposals will be seen as a move in the right direction.

However, the NPRM does not create requirements or incentives to utilize techniques that have been demonstrated to enhance the consent process, such as tools aimed at assessing understanding. Furthermore, some of the NPRM proposals do not seem adequately informed by the wealth of empirical research on best practices in consent and the facilitation of subject understanding that has been generated since the regulations were first promulgated.

One notable example is the requirement to post consent forms on a public website. This requirement may reinforce the perception that a consent form is, if not the only acceptable way to obtain informed consent, the most important part of the consent process. However, when done properly, informed consent involves a robust and purposeful discussion that allows time for questions and that utilizes tools, such as visual aids, aimed at fostering subject comprehension.

The posting requirement also perpetuates the use of standard, written consent forms at a time when such a model is rapidly becoming outdated. Indeed, with the emergence of new technologies, many innovative ways of obtaining consent are being proposed and tested with the ultimate goal of enhancing subject understanding. A regulation that requires posting a standard form may in the end stifle such innovation, a result that contradicts DHHS’ stated goal of modernizing the regulations governing human subjects research.

In the absence of evidence to suggest otherwise, the requirement to post consent forms may well result in additional administrative burdens without corresponding gains for subject protections. However, DHHS may wish to consider the advantages of incentivizing sponsors and institutions to voluntarily share consent forms and investing in empirical evaluation of whether the availability of consent materials on a public website benefits the research enterprise or research subjects.

Members of the research ethics and oversight community are encouraged to share their thoughts on these topics, as well as other issues raised by the NPRM, by submitting formal comments to DHHS. Comments are being accepted on the proposed rule through January 6, 2016 at 5:00 PM ET.

Department of Health and Human Services (DHHS). 2015. Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects. Federal Register 80 (173): 53969-54055.