United States: Welcome To The Future: HHS Releases Final Rule To Modernize Protections For Clinical Trial Participants

The Federal Policy for the Protection of Human Subjects, or the "Common Rule," governs the ethical conduct of research involving human subjects and is funded through various federal agencies. On January 19, the U.S. Department of Health and Human Services in collaboration with 15 other federal agencies (the Agencies) issued a Final Rule to update the Common Rule. This update represents the most substantive update to the Common Rule since 1991 and follows the 2015 Notice of Proposed Rulemaking (NPRM). A detailed overview of stakeholder comments and concerns in response to the NPRM is available here and here. The majority of the Final Rule goes into effect January 19, 2018.

The changes to the Common Rule reflect the evolving nature of research and research settings over the past few decades. The Agencies noted that the evolution in technology has changed the scale, nature and integration of information collected, allowing researchers to collect and analyze data in ways that were unimaginable when the Common Rule was first adopted. The most significant changes to the Common Rule are addressed below.

New informed consent requirements

The Final Rule establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process. Consent forms must include a concise explanation – at the beginning of the document – of the key information that would be most important to individuals contemplating participation in the named study. Key information includes the purpose of the research, the risks and benefits, and appropriate alternative treatments that might be beneficial to the prospective subject. If appropriate, the summary may indicate that these pieces are explained in greater detail later in the consent form. Although the Agencies declined to provide explicit requirements or a sample template, their expectation is that this initial presentation of the key pieces of information will be relatively short.

In addition, the Final Rule alters existing consent requirements by allowing institutional review boards (IRBs) to approve a research proposal for which investigators obtain information or biospecimens without individuals' informed consent for the purpose of screening, recruiting or determining the eligibility of prospective human subjects of research, provided certain conditions are met. Finally, the Final Rule contains a new requirement that entities must post to a federal website a copy of an IRB-approved version of the consent form that was used for enrollment purposes, for each clinical trial conducted or supported by a federal department or agency.

Use of broad consent

The Final Rule permits the use of a broad consent from a subject for the storage, maintenance and secondary research use of identifiable private information and identifiable biospecimens. Thus, investigators may seek prospective consent to unspecified future research.

Under the Final Rule, broad consent provides investigators with an alternative to seeking IRB waiver of the informed consent requirement or obtaining subject consent for certain types of study. The federal government is not obligated to develop a template for broad consent forms.

New categories of exempt research

The Final Rule establishes new categories of research exempt from IRB review based on their risk profile. Significant exemptions include:

  • Certain secondary research involving identifiable private information if the research is already subject to the HIPAA rules
  • Certain research involving benign interventions
  • Certain research involving educational tests, survey or interview procedures, or observation of public behavior where identifiable private information was recorded, so long as data protection standards are met
  • Secondary research use of identifiable private information originally collected for non-research purposes
  • Activities relating to storing and maintaining biospecimens and identifiable private information for secondary research use, if subjects provided broad consent
  • Secondary research studies that would use the biospecimens and identifiable private information stored or maintained under the above exemption

These new exempt categories are designed to allow IRBs to spend more time reviewing riskier studies. To further that goal, the Final Rule also removes the requirement to conduct a continual review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow-up in conjunction with standard clinical care.

Single IRB requirement

The Final Rule creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. It should be noted that nothing in the Final Rule prevents an institution from conducting its own additional (i.e., local) IRB review of a project; however, the commentary surrounding the Final Rule does make clear that the local IRB would have no regulatory authority and its review would have no regulatory standing in such instance. The single IRB requirement becomes effective January 20, 2020.

What the Final Rule did not do

Of perhaps greatest importance is what the Final Rule did not do. In the NPRM, one of the major proposed revisions was a requirement that research involving non-identified biospecimens be subject to the Common Rule, and that consent would need to be obtained to conduct such research. The Final Rule however, did not implement this requirement, citing concerns received from the scientific community about the complexity and lack of justification for such changes. In addition, the Final Rule did not expand the Common Rule to cover clinical trials that are not federally funded.

Furthermore, to the extent that some of the proposals in the NPRM relied on tools or standards that had not yet been proposed, the Final Rule either does not adopt those proposals or includes revisions to eliminate such reliance. Unfortunately, many of these items were tools that entities could use to ensure compliance with the Final Rule, such as a template to be used for broad consent forms, and a decision tool to be used for making exemption determinations.

Conclusion

While the publication of the Final Rule was much anticipated, the future of the Final Rule remains somewhat uncertain due to the possibility that the new Congress may overturn this and other new regulations passed by the prior administration in recent months.

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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