Impact of Funding Interruptions on Patient Safety in Medical Research: A Q&A

The recent suspension of over $2 billion in federal research grants to Harvard has significantly disrupted vital efforts to protect the rights and safety of participants involved in medical studies. On April 14, the U.S. government issued a stop-work order concerning the SMART IRB federal funding, a crucial system managed by Harvard Catalyst and partners that streamlines oversight of multi-site clinical research. This action followed Harvard's refusal to implement certain government-mandated changes, such as revised governance and hiring practices, and audits of institutional viewpoints.

SMART IRB (Single Institutional Review Board) is a national platform designed to facilitate efficient oversight across various research sites, preventing duplication and delays in multi-institutional studies. The suspension of this funding poses serious threats to ongoing research operations and patient safety.

According to Barbara Bierer, principal investigator of SMART IRB, federal funding plays a central role in ensuring participants’ protection. In most university and research settings, Institutional Review Boards (IRBs) are responsible for reviewing and overseeing research involving human participants to ensure compliance with legal and ethical standards. These boards assess study design, recruitment processes, informed consent procedures, risk mitigation strategies, and safety monitoring protocols.

IRBs operate as a regulatory 'check and balance' system, supported by community members and research professionals, to prevent potential harm to participants. Their work is rooted in lessons learned from past research abuses, such as the Tuskegee Syphilis Study, unethical hepatitis experiments at Willowbrook, and genetic research violations involving Indigenous communities. These historical events underscore the importance of strict oversight.

The work of IRBs has a direct influence on the efficiency and safety of scientific advancement. When there are delays or cancellations—like the current halt of studies at Harvard—research progress stalls, collaborations are hindered, and public trust can deteriorate.

The broader impact of funding cuts extends beyond delayed research; it hampers the capacity to respond swiftly to health crises and innovations, particularly in complex, multisite studies. Since the stop-work order, more than 25 institutions have been unable to join ongoing research efforts, and dozens of studies face delays, risking participant safety and scientific progress.

Currently, Harvard Medical School has temporarily continued supporting essential collaborative efforts through internal resources, but the long-term implications of these funding disruptions threaten the integrity and safety of medical research. Maintaining consistent financial support is vital to uphold research standards and protect public health.