Over a year after the release of the Bethesda Declaration on June 9, 2025, current and recent NIH staff remain deeply concerned about harmful and unlawful policies at the agency. On June 9th 2026, they (in their personal capacities) documented those concerns in The Bethesda Declaration: One Year Later, a comprehensive overview of policies that continue to disrupt NIH science.
Today, we highlight the third of nine concerns: ignoring ethical standards has put research participants and the public at risk. In case you missed it, we already covered concern 1 and concern 2, and will be covering the remaining concerns in the coming weeks on our substack.
If you share these concerns, please add your voice to our action network (named or anonymous) so we can draw attention to these issues. Read the full report and learn more about the Bethesda Declaration Movement on the 27 UNIHTED website.
Concern 3: Ignoring ethical standards has put research participants and the public at risk
Why It Matters
The early history of science was fraught with ethical violations and abuses of research participants. For example, beginning in 1932, the U.S. Public Health Service launched an observational study of untreated syphilis in Black men in Tuskegee, Alabama, without providing informed consent or disclosing diagnoses. They continued the study through 1972, well after treatment was available, causing participants to needlessly suffer neurological consequences and death, their wives to become infected, and their children to be born with congenital syphilis. This history demands that scientists remain constantly vigilant for such violations.
Motivated by these atrocities, the U.S. National Research Act commissioned the Belmont Report in 1974, which provides the foundational ethical principles and guidelines for research with human participants still used today. Adherence to the principles of the Belmont Report is codified for HHS and NIH research under 45 C.F.R. 46, also known as the Common Rule. These principles include:
Respect for persons, which requires researchers to treat individuals as autonomous agents capable of self determination and to protect people with diminished autonomy,
Beneficence, the obligation to avoid harm while maximizing potential benefits and minimizing possible risks, and
Justice, to ensure fair distribution of the benefits and burdens of research.
Director Bhattacharya’s NIH has violated these fundamental ethical standards, undermining the credibility of science and breaching trust with research participants and the public. Repairing this trust could take decades.
Examples
Abrupt clinical study disruptions created ethical issues of unprecedented scope. Beginning in February 2025, the Trump administration began terminating NIH research studies without warning. While termination of clinical trials is sometimes necessary, ethically justifiable reasons are typically limited to situations when preliminary study data reveal unexpected risks to participant safety, efficacy of the intervention, or futility of the study. Such terminations are also typically planned in advance, based on predetermined analyses, with clear expectations for safely closing down the study. Rather than adhering to these ethical standards, NIH prioritized political ideology by terminating 383 trials affecting more than 74,000 participants in 2025. The initial spate of terminations are widely attributed to DOGE, but the terminations continued under the leadership of NIH Director Dr. Bhattacharya, often at the explicit direction of Deputy Director Dr. Memoli, despite objections from NIH scientific and clinical staff. While some trials were reinstated under court order, they experienced lengthy disruptions. Many were not covered by the court ruling and remain canceled. Beyond terminations, many clinical studies were delayed for months due to uncertainty regarding “alignment with agency priorities” such as the presence of censored words or studies being conducted internationally, creating study disruptions. These terminations and delays compromised the principles of the Belmont report and, therefore, violated federal research regulations. Terminated studies, including clinical trials, were initially allowed no time or funding to ethically close out, safely disenroll participants, or follow through on commitments to participants. After months of harm, NIH finally changed policy to allow terminated studies to request costs to support an orderly study closeout. However, the damage caused by abrupt trial discontinuation and disruption was entirely foreseen by NIH staff and should never have occurred. These thoughtless terminations and delays created significant ethical violations, including:
Research participants and the public were put at unnecessary risk. When studies were abruptly terminated or held for months, research teams were left without funding to provide continued care required by participants, such as tapering patients off medicines or monitoring implanted devices. Terminated or delayed studies were often based in countries that lacked the public health infrastructure to absorb the care of these study participants without NIH collaborations and funding. In at least one case, the indefinite delay of a study on multi-drug resistant tuberculosis (TB) put the study team’s ability to continue antibiotic treatment at risk, potentially triggering further antibiotic resistance.
Altered risk-benefit balance, as social value decreased and risk increased. A reasonable risk-benefit ratio is central to ethical and regulatory approval of research. This consideration may also be a primary factor for participants when they decide to join a study. Study disruptions cause incomplete data collection, making it impossible to fully answer the original research question(s) or fully realize the benefit of the research. Thus, the clinical trial disruptions decreased the social value of the study, while simultaneously placing participants at greater risk.
Informed consent undermined. Study disruptions also conflict with commitments made to participants during the informed consent process, violating the respect for persons central to the ethical paradigms of science. Informed consent documents explain to participants how they can expect to be treated in the study. The informed consent guides their decision making process for joining the study. These unnecessary study disruptions forced research teams to shirk the commitments made to participants in informed consent documents, breaching participant trust.
Forced destruction of patient samples. As a result of study terminations, institutions were left without funding to support the storage of human tissue samples. When a participant donates tissue for research, they expect their contribution will advance scientific knowledge and benefit fellow patients. Causing the premature destruction of tissue samples donated for research through study termination undermines the participant’s altruistic intent and stymies scientific progress.
Erosion of trust. Decisions to terminate studies were made without consulting study teams, undermining ethical principles of collaborative partnership and affecting the research community’s trust in NIH. Many NIH clinical studies are conducted in collaboration with members of the relevant patient community, who may serve on study advisory boards or act as members of the study team. In these cases, the erosion of trust in NIH may extend to community partners. Indeed, a group of community research partners described their reaction to a termination letter stating that research programs like theirs “are antithetical to scientific inquiry, do nothing to expand our knowledge of living systems, provide low returns on investment and do not enhance or lengthen life or reduce illness.” The community partners said: “The majority of the patients on our [community advisory] board interpreted this message to mean: ‘Your life does not matter to us.’”
Termination of clinical center staff continues to disrupt patient care and research. Known as “the House of Hope,” the NIH Clinical Center is the nation’s largest hospital devoted only to research, previously attracting top research talent from around the globe. The Clinical Center focuses on trailblazing clinical research, including developing treatments where none exist, and diagnosing and treating rare or previously unknown diseases and conditions. The Clinical Center requires top-tier clinicians to support such unique and complex care needs. As a result of research interference (see Concern 1) and demoralizing working conditions (see Concern 9), world-class clinical research investigators, enormously talented staff, and patient care leaders are fleeing in droves. Many other staff, including essential nursing staff, were lost to reductions in force (RIF), probationary terminations, and mandated 35% contract cuts across NIH. The losses have become critical and threaten the hospital’s ability to operate and provide high-quality care. Tests and results are delayed due to a lack of staff. These breaches in care represent significant ethical concerns, putting patients at risk of adverse outcomes.
Recommendations
Ensure all current and future NIH policy changes prioritize the health and safetyof research participants and the public over political considerations and/or speed of implementation. Prior to initiating policy changes that will affect the conduct of studies that include human participants, NIH should carry out and publish a thorough ethics review that considers the policy’s impact on respect for persons, beneficence, and justice.
Address Clinical Center staff shortages to ensure patient wellbeing and continuity of research. To appropriately staff the Clinical Center, the NIH must: 1) remove contract cost limits to enable the hiring of trained nursing staff, 2) boost staff morale by acknowledging the chaos of the past 18 months and taking steps to repair the resulting harm, 3) reverse RIFs and probationary terminations.
Rebuild trust with research and patient communities by acknowledging, taking ownership of, and apologizing for the harms to participants and patients caused by rapid implementation of policy changes without regard to participant safety and other central ethical considerations.
Ensure all research participants, regardless of demographic background, identity or location, receive the respect, safety, and dignity they deserve for generously donating their time and bodies to research, as also noted in Concerns 2 and 8.
What you can do
Stay informed!
Read the full report.
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Look out for the next post in our Bethesda Declaration: One Year Later series on how an unstable research environment is undermining scientific advances and public trust
In case you missed it, find our first and second post of the series.
Inform others! Share this post with your colleagues.
Call your members of Congress and urge them to enact protections for NIH, including stopping the discriminatory censorship of grants and applications at NIH and saying no to Russell Vought’s proposed rule on financial federal assistance.
Add your concerns in an official comment on Russell Vought’s proposed rule on financial federal assistance. Read our comment guide on how to comment and learn more about what’s in the rule.
Need more ideas? Be on the lookout for our upcoming Advocacy Menu.