Another Delay: Revising US rules for Human Subject Research

Another Delay….

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies announced a Notice of Proposed Rulemaking (NPRM) proposing to delay until January 21, 2019 the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (the “Common Rule”).  This NPRM is intended to provide regulated entities additional time for the preparations necessary to implement the Requirements. If finalized, the NPRM would generally require regulated entities to continue to comply with the requirements of the current Common Rule (the “pre-2018 Requirements”) until January 21, 2019.

The NPRM has been put on public display by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/04/20/2018-08231/federal-policy-for-the-protection-of-human-subjects-proposed-six-month-delay-of-the-general

The ORI will continue to monitor these changes and provide information to the campus as new information comes available.

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On January 19th, 2017, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released their revisions to the “Common Rule” governing federally funded research involving human subjects. These changes are the first implemented since 1991, and have important implications for human subject research on UNCG’s campus. Some of these changes are listed below. The Office of Research Integrity is committed to assisting the campus community with all compliance efforts towards these new changes. Don’t hesitate to contact us if we can be of help in anyway.

Biospecimens and Private Information:

• The definition of “human subject” has been altered to include identifiable biospecimens such that identifiable biospecimens and identifiable private information are treated equally in the final rule. These definitions will be revisited by the various federal departments and agencies regularly.

IRB Operations:

• Continuing review is eliminated for all studies that undergo expedited review, as well as research that has progressed to the point of data analysis only.
  • Exceptions are provided for when a reviewer documents a rationale for conducting continuing review.
  • Investigators will no longer be required to provide annual confirmation to the IRB that research is ongoing and that no changes have been made.
• For multi-site/cooperative research, a single IRB will be required for most cases (change to be effective 1-19-2020).
• External IRBs – reliance arrangements with non-institutional IRBs are to be documented.

Informed Consent:

• Consent forms must be clear and focused, information must facilitate a potential subjects understanding of why they might participate or not.
• Electronic consent is ok, must provide written copy.
• Additional elements of informed consent:
  • Broad consent:obtaining consent to allow for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens,
  • language indicating that identifiers might be removed from identifiable private information or identifiable biospecimens,
  • whether such information or biospecimens might or will not be used for future research studies,
  • information on whether biospecimens will be used for commercial profit,
  • whether results will be disclosed to the subject, and
  • whether the research might include whole genome sequencing.

Exclusions & Exemptions:

• The Final Rule now names certain activities as “Not Research” including:
  • Some scholarly and journalistic (including oral history) activities,
  • Public health surveillance, and
  • Criminal justice and intelligence activities.
• The Final Rule adds to and modifies existing exemptions:
  • Modifying previous exemptions to allow use of identifiable information with limited IRB review;
  • Inclusion of benign behavioral interventions; and
  • Storage, maintenance and secondary use of identifiable private information and identifiable biospecimens where broad consent is obtained consistent with the final rule.

Cooperative Research:

• The Final Rule mandates the use of a single IRB for multisite studies. Agreements for oversight between the organization operating the IRB and the institution must document responsibilities of each party.
  This change will be effective January 19th, 2020.

Burden-Reducing Provisions:

The Office for Human Research Protections (OHRP) announced in the July 25, 2018 issue of the Federal Register the availability of three draft guidance documents that relate to three burden-reducing provisions in the revised Common Rule that institutions may choose to implement during the delay period (July 19, 2018 through January 20, 2019) for general compliance with the revised Common Rule. UNCG will be implementing two of the three burden-reducing provisions:

• “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements.” It explains how certain scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected are deemed not to be research under the 2018 Requirements of the regulations for the protection of human subjects (45 CFR Part 46, subpart A), and consequently do not have to satisfy the requirements of those regulations.  For the draft guidance “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements,” go here: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-scholarly-and-journalistic-activities-deemed-not-to-be-research/index.html, and https://www.regulations.gov/searchResults?rpp=25&po=0&s=HHS-OPHS-2018-0012&fp=true&ns=true, respectively.
• “Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements.” It provides guidance on the elimination of the requirement in the pre-2018 Requirements (45 CFR 46.103(f)) that each application or proposal for research undergo IRB review and approval as part of the certification process. For the draft guidance, “ Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements,” go here: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-elimination-of-irb-review-of-research-applications-and-proposals/index.html, and
  https://www.regulations.gov/searchResults?rpp=25&po=0&s=HHS-OPHS-2018-0014&fp=true&ns=true, respectively.

Additional Information:

Science Article (August 18th, 2017) What do revised U.S. rules mean for human research?

PRIM&R’s (Public Responsibility in Medicine and Research)

• Quick reference guide to the most significant changes in the revised Common Rule
• The official published version of the new Common Rule was made available on January 19, 2017.

COGR Council On Government Relations

• Summary of Changes
• Common Rule Summary Table
• Final revised common rule