PRIM&R Weighs in on Future Bioemergency Planning

PRIM&R Weighs in on Future Bioemergency Planning

February 1, 2023

BOSTON — PRIM&R submitted formal comments to the White House Office of Science and Technology Policy (OSTP) late last week, detailing how to create a better research infrastructure to react efficiently, effectively—and ethically—in the event of a future biomedical emergency.

Specifically, PRIM&R commented on the “Request for Information—Clinical Research Infrastructure and Emergency Clinical Trials,” published in the Federal Register last October. The federal government invited comments on “improving the US clinical trials infrastructure, and in particular, our ability to carry out emergency clinical trials” during a biological emergency, which is part of the National Biodefense Strategy and the American Pandemic Preparedness Plan.

The OSTP, in partnership with the National Security Council (NSC), “is leading efforts to ensure that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies.” The OSTP was created in 1976 to coordinate federal science and technology policy and provide the President with guidance on advances in science and technology.

PRIM&R recognizes and appreciates the importance of proactively addressing how the United States and the research community can be better prepared to respond during future public health emergencies. PRIM&R offered comments related to three specific areas for OSTP consideration:

Streamlining institutional review board (IRB) review of research
Utilization of public health surveillance during bioemergencies
Tension between clinical care and research during public health emergencies
Streamlining IRB Review

PRIM&R recommends OSTP gather evidence to determine if the sIRB model—which designates a single IRB of record (sIRB) for multisite studies—make the review process more efficient, particularly within the context of time-sensitive research conducted during public health emergencies.

“Initially, adopting a flexible approach that supports but does not mandate sIRB may provide the research community with an opportunity to learn about the most efficient pathways to follow in future emergencies,” said Elisa A. Hurley, PhD, executive director of PRIM&R “This method would enable informed choices about the IRB review structure that can best support multisite research during an emergency.”

PRIM&R also recommended funding the development of emergency preparedness simulation exercises to ensure research oversight systems are poised for rapid response during future public health emergencies.

Misusing Public Health Surveillance Exclusion

During the pandemic, loopholes emerged in the current regulations for protecting the rights and welfare of research subjects. The 2018 Common Rule deems public health surveillance activities as falling outside the regulatory definition of “research” and, consequently, as exempt from compliance with the regulatory requirements. However, the regulations do not clearly distinguish between public health activities that constitute surveillance and those that constitute research.

During the pandemic, IRBs, which formally review and monitor biomedical research involving human subjects in accordance with FDA regulations, saw a surge in proposals identified as “public health surveillance,” where traditional protections such as informed consent and data confidentiality safeguards were not triggered.

“While PRIM&R appreciates the importance of not impeding vital research during a public health emergency, the public health surveillance exclusion must be utilized mindfully and in a manner that does not take advantage of the ambiguity in the regulations to intentionally skirt requirements such as for informed consent,” Hurley said. “Doing so threatens to further erode public trust in science and medicine.”

People who are the subjects of public health surveillance and public health research, as well as the general public, should be given general information about the scope and purpose of any public health surveillance activities and potential future uses of data collected.

Therefore, PRIM&R recommended OSTP engage the public in exploring provisions that would support public health activities broadly (both surveillance and research) while also ensuring that the rights and welfare of individuals and the public at large are protected. Provisions could range from public service announcements and education campaigns to, where appropriate, informed consent. Such provisions will serve the dual purpose of sustaining public health and promoting public trust in science and medicine.

Tension Between Clinical Care and Research During Public Health Emergencies

The COVID-19 pandemic illuminated tensions between clinical care and research, specifically as related to the use of the expanded access pathway.

“During the pandemic, it is likely at least some of the resources, including access to patients, that were invested in an Expanded Access Program for convalescent plasma could have been directed toward a greater number of properly designed clinical trials, resulting in more robust clinical data regarding the effectiveness of the treatment for COVID-19,” Hurley said.

For its third recommendation, PRIM&R called upon OSTP to compel the federal government to invest in a better clinical infrastructure. This would help sites that recruited during the COVID pandemic only because of the ongoing public health emergency. With additional investments to these sites, they will be better equipped to run clinical trials under both emergency and non-emergency conditions in the future—promoting clinical trial diversity and equitable access to clinical trials.

Read PRIM&R’s official comments.

Press Release

PRIM&R Weighs in on Future Bioemergency Planning

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