New Federal Guidance Says Hospitals Must Have Written Patient Consent for Pelvic Exams

This regulation aims to “reiterate and provide clarity” of hospital requirements for educational purposes, regarding informed consent.
The Operating Room or OR is a large sterile room where surgeons operate on patients.
Boy_Anupong

According to a report from AP, hospitals must obtain written consent from patients before subjecting them to pelvic exams and exams of other intimate areas, such as prostate exams, particularly if an exam will be done while the patient is under anesthesia.

Guidance released this week from the U.S. Department of Health and Human Services now requires consent for exams including pelvic, breast, prostate, or rectal examinations for “educational and training purposes” performed by medical students, nurse practitioners or physician assistants.

The direction, a memo from the Centers for Medicare & Medicaid Services states, is “Based on increasing concerns about the absence of informed patient consent prior to allowing practitioners or supervised medical, advanced practice provider, or other applicable students to perform training- and education-related examinations outside the medically necessary procedure.”

This regulation, which the HHS released through CMS, aims to “reiterate and provide clarity” of hospital requirements for informed consent, and ensure that hospital patients’ informed consent policies, processes and forms, allow for a patient, or their representative, “to make fully informed decisions about their care.”

HHS Secretary Xavier Becerra and top officials from the CMS and Office for Civil Rights scrutinized exams happening without explicit consent in a letter sent to teaching hospitals and medical schools Monday. The letter said the HSS was aware of “media reports and scientific research highlighting instances where, as part of medical students’ courses of study and training, patients have been subjected to sensitive and intimate examinations, while under anesthesia without proper informed consent being obtained prior to the examination.”

“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 letter said. “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.”

Non-consensual pelvic and prostate exams on patients under anesthesia have been a little known but surprisingly common part of U.S. medical education for decades: research from the Journal of Surgical Education published in 2022 shows that 84% of the medical students surveyed performed at least one pelvic “EUA” (exam under anesthesia) during their clerkship. And according to this study, “Of the 42% (142) of students that observed patient informed consent processes most or every time, 67% reported they never or rarely witnessed an explicit explanation that a medical student may perform a pelvic EUA.”

The letter is a “critical leap forward in protecting patients and medical residents,” Scott Berkowitz, founder and president of the Rape, Abuse and Incest National Network, said in a release.

“It’s a shocking problem with a very simple solution — hospitals need to ask for consent clearly and explicitly,” the RAINN founder said.