How cessation of funding undermines initiatives to guarantee the safety of patients in medical research

The Trump administration’s suspension of over $2 billion in federal research grants to Harvard has interrupted work across various domains, including initiatives to safeguard the rights and welfare of patients involved in medical studies.

The administration issued a stop-work directive concerning the SMART IRB federal funding contract on April 14. This communication arrived mere hours after Harvard declined government requests that entailed amendments to governance and hiring procedures as well as “audits” of the opinions of students, faculty, and staff, among other actions.

SMART IRB is a nationwide initiative managed by a Harvard Catalyst team in conjunction with other partners. It serves hospitals, universities, and federal entities to enhance oversight for medical research occurring at multiple sites.

Barbara Bierer is the director of the Regulatory Foundations, Law and Ethics Program at the Harvard Catalyst, the Harvard Clinical and Translational Science Award, and director of regulatory policy for SMART IRB. In this revised dialogue, she explains how cuts in funding will affect patients participating in research.

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How do NIH funds contribute to patient protection?

Typically, research, particularly NIH-funded endeavors involving human participants, must undergo review, approval, and subsequent oversight by an institutional review board (IRB) to ensure adherence to relevant institutional, local, state, and federal regulations, policies, laws, and guidelines, as well as to ensure the rights and welfare of research subjects.

For the majority of universities and research facilities, IRB review and oversight are factored in as indirect costs in the research lifecycle. A NIH policy established in 2018 and more broadly implemented for federally funded research in 2020 has mandated that multisite, collaborative research be reviewed by a single IRB (an sIRB), which assumes the responsibility of reviewing and overseeing research for all involved sites.

In certain cases, the expenses may be classified as direct costs funded by federal resources.

What function do these IRBs serve in protecting patients?

IRBs, which are established within — or work independently with — hospitals, universities, and other institutions conducting research, play a crucial role in meticulously evaluating research proposals to ensure participants’ protection in various ways.

These considerations encompass the research question and study design, recruitment strategies, processes for gaining and maintaining informed consent, assessment and mitigation of potential risks, participant safety, evaluation of adverse events related to the research, data monitoring, and more.

“Every individual who has benefited from clinical research efforts — taking a new medication, utilizing a medical device, or undergoing a diagnostic examination — is affected by the manner in which we conduct and supervise research.”

IRBs and human research protection programs also focus on training and supporting investigators, managing interactions with sponsors, and collaborating with federal and state regulators, among additional responsibilities.

Consider IRBs as the “checks and balances” system that sustains the ethics and oversight essential for medical research studies. Without this dedicated group of professionals and community members, our studies could inadvertently cause harm to the individuals and communities involved. Our cherished federal laws and regulations were devised and continue to adapt in response to actual instances of such damages.

Across the nation, thousands dedicate their careers to the ethical oversight and execution of research, collaborating every day to protect those who volunteer for studies.

And indeed, every person who has gained from clinical research endeavors — taking a new medication, employing a medical device, or undergoing a diagnostic test — is influenced by the way we conduct and supervise research.

In what areas do we observe the most significant impact?

Commitment to the safety, welfare, and protection of study participants drives this community of professionals. We ensure that systems are in place for prospective study participants to comprehend the research plan, risks, benefits, and burdens, allowing them to freely decide whether or not to take part in the research.

The IRB also serves as a resource for participants should they have inquiries or concerns about their involvement in a study.

IRBs emerged from historical events that underscored the necessity to monitor ethical issues that arise in human research. Could you elaborate on that?

History has shown what is at risk: the atrocities of medical experimentation by German scientists during World War II; the unfortunate 1932-72 Tuskegee syphilis study that shattered the public’s perception of safety and consent in medical trials and paved the way for the oversight system in an act signed by Richard Nixon in 1974; the hepatitis studies at the Willowbrook State School for Children where children with developmental disabilities were deliberately infected with hepatitis; and the breach of trust and principle of informed consent in genetic research involving members of the Havasupai Tribe.

Moreover, our nation’s capability to advance scientific research is at stake. Imagine a dozen or more hospitals and universities nationwide collaborating on a novel therapy for Alzheimer’s disease. Prior to the existence of SMART IRB, these institutions would have spent significant amounts of time and encountered numerous obstacles and delays just to cooperate. The process now available has alleviated many of these barriers to innovation.

How will funding reductions affect this work?

In general, the sweeping cuts to research funding, the cancellation of numerous grants and contracts at exceptional research institutions across the nation, will negatively impact research participants, as well as IRBs and research professionals.

Studies abruptly halted pose significant risks to participants and communities and can reinforce public skepticism and distrust of the research endeavor, hampering the commitment of researchers and institutions to engage fully, transparently, and collaboratively with the communities they serve.

Since SMART IRB received a stop-work order on April 14, current studies are unable to incorporate new clinical sites, over 25 institutions have been barred from joining, and numerous research studies have faced delays.

Currently, support from Harvard Medical School enables our team to persist in the critical work of fostering collaborative research across the nation. It is our aim to continue these efforts: the stakes are too high, and the health and safety of the American populace depend on it.