United States: The Proposed Common Rule: The Tribe Has Spoken, And They Have Concerns (Part 2)

Last Updated: May 31 2016
Article by Gregory E. Fosheim

An overview of stakeholder comments on proposed revisions to informed consent forms and the posting of informed consent forms within 60 days after closure of enrollment

On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection of Human Subjects, more commonly known as the Common Rule. Earlier this month, we summarized stakeholder comments regarding the redefinition of "biospecimen" as a "human subject" and the consent requirements for secondary use of these biospecimens. This update focuses on proposed changes to informed consent forms (ICFs) and the requirement to post ICFs within 60 days after patient enrollment closes.

Proposed Changes to Informed Consent Forms

All comments we reviewed lauded the efforts of HHS to emphasize the importance of concise and conversational ICFs. Many also agreed with the suggestion to reorient ICFs to provide a clear description of the study and its associated risks at the beginning of any document. A number of stakeholders, however, expressed general reservations that adding four new consent elements, by definition, lengthens the ICFs and defeats the intent of the NPRM. To recap, these would include:

  • A statement that identifiers may be removed from patient data and that non-identifiable data may be used for future research studies, or shared with a different investigator, without obtaining the subject's informed consent for the additional use. § ____.116(a)(9). This would be applicable to all ICFs.
  • A statement that a subject's biospecimens may be used for commercial profit and to disclose to subjects whether they would share in this profit. §___.116(b)(7).
  • A statement regarding whether and under what conditions clinically relevant results would be disclosed to subjects. §___.116(b)(8).
  • The option for subjects to consent or refuse to consent to future contact seeking additional information or biospecimens or soliciting subjects' enrollment in future studies. §___.116(b)(9).

Of all the newly-proposed informed consent elements, this last one received the most stakeholder criticism. For example, one commenter recommended clarifying that contact refusal should only apply after completing the current study or researchers may be unable to continue all necessary follow-up assessments. Others contended that the option could limit the ability of researchers and institutional review boards (IRBs) to provide subjects with updated risk information, and could undermine their ability to contact subjects for a future study, or to provide subjects with study results impacting their care. One stakeholder hypothesized a scenario where subjects enrolled in two simultaneous studies could make contrary selections. Which selection controls? Would researchers risk an Office of Human Research Protections complaint if they contacted the patient for clarification?

HHS stated in its discussion of the new ICF elements that the §___.116 introductory text would instruct researchers to "reorient the language [in ICFs] to first provide essential information that a reasonable person would want to know in order to make an informed decision about whether to participate, and to provide an opportunity to discuss that information." 80 Fed. Reg. at 53970. As a result, revised §___.116 would limit the contents of the ICF only to the regulatory requirements with any other information relegated to an appendix.

Stakeholders generally encouraged better organization and separation of ICFs into required and non-required elements, even if the separation does not shorten the documents. A few commenters included suggestions for revising ICFs that would present information clearly without burying key facts in a long and overly complex document. Recommendations included front-loading the ICF with a summary explanation of the study, duration, risks, benefits, and alternate courses of treatment, followed by the full ICF. Some suggested HHS offer guidance on simplified risk language it considers sufficient and understandable so researchers would not feel the need to provide exhaustive lists. Likewise, others recommended that HHS clarify what the NPRM means by "reasonably foreseeable risks and discomforts" and when the elements found at §___.116(b) were truly required.

Voicing discomfort with a seemingly one-size-fits-all approach to ICFs, some commenters expressed concern that the NPRM focuses the informed consent process too heavily on document compliance rather than on ensuring meaningful understanding by research subjects. Others cautioned that researchers' flexibility to account for individual patients' needs could be undermined, as certain study populations may benefit from information presented in a different order. Some stakeholders objected to relegating non-required information to appendices, noting that it could impose a hardship on IRBs as the NPRM does not provide the IRBs with authority to control such content. As a result, IRBs would have no recourse against sponsors that overload appendices with extraneous liability-limiting language because they are not technically part of the ICF.

Posting ICFs within 60 Days after Enrollment Closes

The NPRM proposed a new §___.116(h) requiring a final version of the ICF for a trial conducted or sponsored by a federal department or agency to be posted on a publicly-available federal website within 60 days after the trial closes to further recruitment. Of all the proposed changes to the Common Rule, this offering may be the most universally disliked by stakeholders. Many argued that the requirement added a significant administrative burden (1) on researchers to upload ICFs, (2) on hospitals to implement compliance oversight procedures, (3) on IRBs to report investigator non-compliance, and (4) on agencies to develop this yet-to-be-established website. Stakeholders expressed concern that such burdens would not be offset by any real protection to patients.

Other commenters maintained that posted ICFs are likely to become even more lengthy and legalistic with sponsors and institutions attempting to protect themselves from post hoc scrutiny by federal regulators and plaintiffs' attorneys. Additionally, because informed consent is a process, the public posting of ICFs does not capture many of the interpersonal interactions between investigators and subjects when discussing the research. As such, these commenters contend that a posted ICF may provide an incomplete and potentially misleading snapshot into a subject's consent.

Stakeholders also queried how the public would use these ICFs as HHS provided no examples of proper versus improper documents. Again, without context, any potential scrutiny may be unfounded and likely too late to affect enrollees. Finally, commenters expressed worry that the industry may conduct studies in foreign markets to avoid this obligation. Because many ICFs contain confidential study designs, proprietary drug or device information, pre-market safety and efficacy information, or other commercialization strategies, commenters contend the risk of loss may not be worth the headache and drug and device manufacturers may seek friendlier regulatory pastures overseas.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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