New federal regulations recently took effect that make significant changes to the “Common Rule,” the uniform set of regulations governing human subject research adopted by 16 federal agencies (most notably the U.S. Department of Health and Human Services (HHS).

Among the changes:

• New requirements about the information that must be provided to prospective research subjects
• Allowing the use of broad consent by research subjects for storage, maintenance and secondary research to conduct future unspecified research using identifiable private information and identifiable biospecimens
• New exempt categories of research based on risk profile
• Requirement that U.S.-based institutions engaged in cooperative research use a single Institutional Review Board (IRB) effective January 21, 2022, for that portion of research that takes place in the United States
• Eliminating the requirement for continuing review for:
  • ongoing research for studies  approved under an expedited review
  • studies that merely analyze study data after completing study interventions
  • studies that involve only observational follow up incident to standard clinical care

In effect since January 21, 2019, the revised regulations were originally promulgated in January 2017 and were anticipated to go into effect in January 2018, but were held in abeyance by the current federal executive administration.

While all the aforementioned changes are important and significant, the revised regulations will have a particularly profound effect on non-federally funded human subject research. No longer will institutions be permitted to voluntarily subject non-federally funded research to the jurisdiction of the Office for Human Research Protections (OHRP) within HHS.

Institutions that conduct human subject research funded by any of the 16 federal agencies covered by the regulations must submit a Federal Wide Assurance (FWA), which is a written assurance of compliance with the Common Rule.

'Checking the Box' Eliminated

Prior to the changes in the regulations, the FWA allowed research institutions conducting non-federally funded human subject research to voluntarily comply with the Common Rule and submit to the oversight of the Office of Human Research Protections. This election was simple and effectuated by merely checking a box on the FWA form. Widely termed “checking the box,” this method efficiently enabled the choice to work under the rubric of the Common Rule.

Eliminating the inability to voluntarily check the box for non-federally funded research will have a significant effect in states like New York where the Public Health Law contains Article 24-A Protection of Human Subjects that governs human subject research within the state. The New York law was enacted some 34 years ago, and arguably has not been kept current with the times. Under a provision in Article 24-A, much of the research conducted within New York State was not governed by state law. Section 2445 of the statute states, “the provisions of this article shall not apply to the conduct of human subject research [sic] which is subject to, and which is in compliance with, policies and regulations promulgated by any agency of the federal government for the protection of human subjects.”

Now that non-federally funded research in New York is not subject to any federal agency, clinical studies that are funded solely by non-federal entities such as pharma will be governed by state law.

New York is currently considering a state legislative solution to prevent any impediments to conducting human subject research within the state. The New York State Bar Association, Committee on Medical Research of the Health Law Section, published a report in January 2018 (not yet officially adopted by NYSBA) that proposes two recommendations for the New York State Commissioner of Health on how to manage the effects of this recent development.

The change in the federal regulations also may affect medical research conducted in New Jersey upon persons with cognitive impairments, lack of capacity, or serious physical or behavioral conditions and life-threatening diseases. According to applicable state law such research must be ”approved and monitored by an institutional review board that hold an assurance with the United States Department of Health and Human Service…” (N.J.S.A. 26:14-3).

The good news is that OHRP, based on informal communications, intends to continue to allow research institutions to make the voluntary election of compliance with the Common Rule using the FWA for some unspecified limited period of time.

Key Takeaways

For affected institutions, there are two important action items to ensure continued compliance with the newly revised regulations.

• Review your institutional research policies to ensure conformance with the changes in the Common Rule.
• Check local state law requirements for non-federally funded human subject research.

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