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The U.S. Department of Health and Human Services issued new guidance to teaching hospitals and medical schools April 1, requiring that medical providers obtain written consent before performing intimate examinations, particularly on patients under anesthesia.

The national directive marks a major milestone in a yearslong effort driven by the research and advocacy of Lori Bruce, associate director of Yale’s Interdisciplinary Center for Bioethics, supported by the Institution for Social and Policy Studies.

“This landmark achievement for patient consent was attained because countless advocates — including patients, community members, medical students, ethicists, and some physicians — spoke up despite pressure to remain silent,” Bruce said. “Our work isn’t done. We still need to ensure the careful implementation of the updated guidelines. But HHS’s commitment to patient rights is profoundly redeeming.”

In a letter signed by HHS Secretary Xavier Becerra, the department acknowledged media reports and scientific literature demonstrating how hospitals often perform pelvic, breast, and rectal examinations on unconscious patients without their informed consent. Such examinations are often medically unnecessary, Bruce said, serving as an opportunity for trainees and new clinicians to gain practical experience. But unconsented procedures can be traumatic for patients, particularly those who have experienced previous sexual trauma.

“It is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent from patients before performing sensitive examinations in all circumstances,” the HHS letter said, linking to guidelines hospitals must follow to receive Medicare and Medicaid funds.  “Informed consent includes the right to refuse consent for sensitive examinations conducted for teaching purposes and the right to refuse to consent to any previously unagreed examinations to treatment while under anesthesia.”

In 2020, Connecticut elected officials invited Bruce to shine a light on the ethics of consent for intimate medical examinations. She gave public lectures explaining the ethical tensions, served on the state’s strategic task force, solicited community insights through Yale’s Community Bioethics Forum, and conducted a national survey — the first of its kind — that helped instigate the passage of Connecticut’s 2022 bill requiring explicit consent for these examinations.

Bruce and her co-authors uncovered how potentially 3.6 million American women and men are likely to have received unconsented pelvic or prostate exams and that Black patients are four times more likely than white patients to report having received such unconsented exams.

In September, the national NBC Nightly News ran a story citing Bruce’s report, drawing the attention of RAINN (Rape, Abuse & Incest National Network), who sought out federal legislators who might help end the practice, Bruce said. About six weeks ago, an aide for U.S. Rep. Nancy Mace (R-South Carolina) reached out to Bruce and collaborated with her on a letter to HHS.

“It’s a step in the right direction that HHS has finally mandated hospitals obtain written consent for these invasive examinations,” Mace said. “The fact that doctors were conducting these exams on women under anesthesia without their consent or medical need is simply unacceptable.”

Bruce said that while medical professionals do not intend any harm in conducting intimate examinations on unconscious patients, research has uncovered how these practices can have a negative impact on medical students as well.

“When medical students participate in these unconsented exams, they often experience moral distress for having done something they felt was ethically impermissible,” she said. “They felt they had no choice except to comply because of pressure from their institution. Over time, some students develop moral erosion. They may devalue the importance of informed consent, and this shift in belief extends across all patient care, not just pelvic and prostate exams.”

In addition, several research studies have shown that if asked for permission to conduct an extra training exam, about 90% of patients will agree, Bruce said.

“We have been risking the mental health of patients and putting students and everyone in the room watching through this moral angst for no reason,” Bruce said. “Recent studies demonstrate that obtaining explicit consent improves clinicians’ relationship with their patients.”

Connecticut State Rep. Josh Elliot (D-Hamden) recruited Bruce to help inform the Public Health Committee and overcome what he called inertia over the informed consent bill in the years before it eventually passed.

“The biggest problem is that doctors in the state were coming out and saying this was not a problem and this law would cause more problems than it would solve,” Elliot said. “Being able to undercut that argument with specific figures and surveys was necessary. This wouldn’t have happened without Lori’s help.”

Other states followed with similar laws, Bruce said, and she is unaware of any institution reporting significant harm in their ability to train the next generation of medical providers.

ISPS Director Alan Gerber, Sterling Professor of Political Science, praised Bruce for demonstrating how science can inform effective, ethical policy.

“Lori and Interdisciplinary Center for Bioethics Director Stephen Latham exemplify the ideals we strive to uphold at ISPS,” Gerber said. “The Connecticut law and new HHS guidance on consent for intimate medical exams show how expertise, tenacity, and collaboration can culminate in more sensitive and thoughtful practices for everyone.”

Bruce agreed and hopes that the lessons of this overdue correction will reverberate to other areas of medical research and practice.

“Ethical medicine is reliant on good data,” she said. “When we don’t know exactly what is happening, it is challenging to write an ethical law.”