On January 17, 2018, sixteen federal departments and agencies (the “Agencies”)[1] delayed implementation of sweeping changes to the Federal Policy for the Protection of Human Subjects (the “Common Rule”) adopted a year ago that were largely to become effective January 19, 2018.[2] The Agencies’ interim final rule (“IFR”)[3] delays until July 19, 2018 compliance with the final rule published in January 2017 (the “2018 Requirements”).[4]

After publication of the 2018 Requirements, the research community generally expressed concerns about the ability to implement all of the 2018 Requirements by the January 19, 2018 compliance date, though most commentators favored proceeding with provisions designed to reduce administrative burdens on human subjects research. As set forth below, the Agencies agreed and believe the implementation delay affords additional time to research grantees for the preparations necessary to implement the revisions and additional time to consider a proposal for an even further delay in implementation. But the IFR also postpones the opportunity to rely on those provisions in the 2018 Requirements that would have reduced the administrative burden on research entities.

Background

The Common Rule is designed to protect human subjects in connection with research conducted or supported by one of the Agencies. The Common Rule requirements are codified at various places, including, for example, 45 C.F.R. Part 46. The Common Rule applies only to:

  • human subject research; and
  • research either conducted or supported by the federal government or otherwise covered by an HHS Office for Human Research Protection approved federal-wide assurance.

When they take effect, the 2018 Requirements will implement multiple sweeping changes to the Common Rule, including the addition of new categories of exempt research, alterations to patient consent requirements, a new provision for broad consent for future research, and multiple changes to Institutional Review Board (“IRB”) requirements. Specifically, some of the major changes to the Common Rule provided in the 2018 Requirements include:

  • Allowing the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on non-identified information and non-identified biospecimens, having an IRB waive the requirement for informed consent, or obtaining consent for a specific study.
  • Establishing new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
  • Creating 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. This requirement becomes effective 3 years after publication of the final rule.
  • Removing the requirement to conduct continuing 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.

2018 Common Rule Delay

The IFR delays the effective date and general compliance date for regulated entities to comply with the 2018 Requirements until July 19, 2018. The delay was interposed for several reasons:

  • Concerns from the regulated community, following publication of the 2018 Common Rule Update, about their ability to implement all of the 2018 Requirements by the scheduled general compliance date.
  • The HHS Secretary’s Advisory Committee on Human Research Protections (“SACHRP”) recommendation in August 2017 that implementation of the 2018 Requirements should be delayed.
  • The absence of guidance to grantee institutions on the four categories of activity deemed not to be research under the 2018 Requirements, which would have made it difficult for institutions to fully take advantage of the exclusion of these activities from the definition of research.
  • The need for guidance to grantee institutions on exemption categories, in light of the 2018 Requirement’s inclusion of five new exemption categories and modification of all but one of the exemptions allowed before the pre-2018 Common Rule Update requirements. Specifically, the SACHRP advised that significant guidance is needed in (i) applying the categories of the new exemptions themselves; (ii) conducting limited IRB review (as required in four exemptions); (iii) developing and using broad consent (as required in two exemptions); (iv) utilizing the exemption for certain HIPAA covered activities; and (v) understanding which federally supported or conducted non-research information collections qualify for exemption.

Of note, the IFR also delays until July 19, 2018 the ability of regulated entities to comply with the 2018 Requirements. As such, studies initiated prior to July 19, 2018 would, as a default, continue to be subject to the current Common Rule for their duration.

Finally, it is also significant that the Agencies indicate that they are developing a notice of proposed rulemaking contemplating a further delay in the implementation of the 2018 Requirements until January 21, 2019.

Delay does not affect NIH Policy on use of single IRB in NIH funded multi-site studies.

Meanwhile, significant changes to IRB review requirements for certain NIH-funded human subjects research studies will be implemented on schedule. For applications to NIH for extramural research funding with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites located in the United States that are participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board to conduct the ethical review required for the protection of human subjects.[5]