By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

The Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), proposes a new provision that would require a copy of the final version of the consent form (absent any signatures) for each clinical trial conducted or supported by a Common Rule department or agency to be posted (within 60 days after the trial is closed for recruitment) on a publically available federal website that would be established for such purpose.

In Part 3 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM, we address the rationale behind this proposal and its potential benefits, downsides, and missed opportunities.

Thanks to a 30-day extension of the public comment period for the NPRM, HHS extended the comment period to January 6, 2016 – and that has come! The ACRG has prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed changes.

ACRG Rapid Rundown: Three Things You Need to Know

1. Stated Rationale: Fear of Public Scrutiny Drives Quality. According to the executive summary of the NPRM, the posting of consent forms will ensure that other NPRM proposed rules regarding informed consent “do indeed change current practices … so that anyone drafting a consent form will do so knowing that it will eventually be subject to public scrutiny.” See 80 Fed. Reg. 53933, 53936 (Sep. 8, 2015). Dr. Jerry Menikoff, the Director of the Office for Human Research Protections (“OHRP”), reiterated this reasoning in the “Informed Consent Under the NPRM” webinar, which was developed by OHRP to help the public better understand the goals and impact of key aspects of the NPRM. Dr. Menikoff explained that the goal of the proposal is not to affect what happens during the clinical trial but rather for transparency to drive behavior and quality. As a result of the proposal, the individuals responsible for writing consent forms “will hopefully write better, more informative consent forms.” He added that since the federal government is funding or conducting these studies, it is reasonable that these consent forms be made public. The commentary to the NPRM notes that the website will be established as a searchable repository, which could provide a resource of examples as well as a research tool for individuals interested in studying consent forms. In summary, the public posting of consent forms is intended to increase transparency, enhance confidence in the research enterprise, increase accountability, and inform the development of future consent forms.

2. The Requirement Would Only Apply to Federally Conducted or Funded Clinical Trials. The commentary to the NPRM does not discuss why the proposed posting requirement would be limited to consent forms in federally conducted or supported clinical trials, or why it would be limited to clinical trials and not more broadly applicable to all research subject to the Common Rule. Presumably it is consent forms for clinical trials that have been of greatest concern in terms of content, length, and comprehensibility to potential participants. However, a consent form for an institutionally or industry funded clinical trial arguably poses the same concerns as a consent form for a federally funded one. For example, non-federally funded surgical clinical trials that are not subject to FDA oversight, although encapsulated by the Common Rule under the NPRM’s proposed expansion of scope, will not be required to comply with this public posting provision.

3. Only One Posting Is Required for Each Trial. The Common Rule agencies anticipate that the version of the consent form that would be posted would be the version most recently approved by the governing IRB at the time the posting is required to be made. Newer or amended consent forms developed and approved after the initial posting would not need to be posted. (It is not clear whether such forms could be posted if desired.) In addition, in a multi-site trial, only one posting would be required; each study site would not need to post its version of the consent form. (Again, it is not clear whether multiple such versions could be posted if a site so desired.)

A Few Comments on Comments

While the goal of improving consent forms by increasing transparency and accountability for content, length, understandability of forms is laudable, as drafted, this proposal could lead to unintended consequences that will avert achieving this goal. With the comment deadline upon us, institutions may wish to consider including comments on the following issues:

Could the Proposal Actually Undermine the NPRM’s Consent-Related Goals?

The possibility and fear of public scrutiny may encourage investigators to draft more informative and meaningful consent forms, but it may also drive investigators, institutions, and IRBs to defensively add more language that protects against investigator and institutional liability – producing unduly long documents that are difficult to understand. In other words, drafting for a larger audience (the public), as opposed to only prospective subjects, may actually, perversely, have the effect of making consent forms even more complex and less readable, and in essence result in exactly what the NPRM seeks to prevent.

Would the Proposal Cause Confusion for Trial Participants and the Public?

Sites in a multi-site clinical trial may for legitimate reasons use different versions of a consent form, but the NPRM does not clarify which version should be posted. Furthermore as noted above, the posted version is not required to be updated as new versions are approved. The posting of only one consent form at a moment in time may confuse subjects who have participated in the trial at a different site and signed a different form or those who signed a previous version. To those subjects, it may not be clear why/when there are legitimate reasons for such differences. Without the opportunity to include some context/framing remarks with the posted version, subjects may be puzzled as to why the posted consent form differs from the form they signed. Furthermore, the proposal also requires that the awardee or the Federal department or agency component conducting the clinical trial will be required to post the name of the protocol and contact information, but the proposal is unclear as to whose contact information must be posted (i.e., the investigator or the institution) and to what purpose, as it may differ from the contact information on an individual participant’s consent form.

Would IRBs Face Increased Liability?

The NPRM mentions that this proposal will increase accountability for those drafting consent forms, but does not address the increase in accountability and (more significantly) potential liability to Institutional Review Boards (“IRB”), which review and approve the consent forms. The purpose of IRB review is to assure protection of the rights and welfare of humans participating as subjects in research. The public’s negative reaction to certain consent forms may encourage subjects to sue the IRB that approved the form, spurring more litigation overall.

Would the proposal stifle meaningful innovation?

Other commentators have suggested that the posting requirement “perpetuates the use of standard, written consent forms at a time when such a model is rapidly becoming outdated”. (Amp&rsand: The PRIM&R Blog. (2015, Nov. 24). Unpacking the NPRM: Informed Consent. Retrieved from https://blog.primr.org/nprm-informed-consent/). As Elisa Hurley, Executive Director of PRIM&R, points out, “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 HHS’ stated goal of modernizing the regulations governing human subjects research.” For example, how will interactive Q&A modalities to assess subject understanding and electronic consents be dealt under this proposed requirement?

Repository of Consent Forms: A Valuable Asset But Also a Missed Opportunity

The creation of a searchable website/repository of consent forms, if set up correctly, could be a valuable tool to help institutions, investigators, and researchers studying informed consent establish patterns, identify common mistakes, and highlight examples of good provisions. However, as it is currently set up in the NPRM, this proposed requirement does not seem fully formed. The NPRM does not explain how the public will be able to distinguish a poorly written consent form from a well-written more informative one. Given that there is no additional level of review by OHRP before posting and without access to the corresponding protocol or accompanying documents, the public will be forced to review a consent form in isolation to determine whether it achieves its intended purpose. Alternatively, the proposal could more effectively be framed as an OHRP-run website where OHRP reviews and posts redacted examples of good and bad language from its perspective, or post evaluations of forms from the public/participants as learning exercises for what to do and not to do in a form. The repository may also be better structured as a controlled-access data base for researchers wanting to study informed consent forms.