Citing increasing concerns, the federal government advises teaching hospitals that they must obtain informed consent as part of their participation in Medicare and Medicaid.
The federal government is warning hospitals and medical schools about the need to obtain the informed consent of patients before performing sensitive examinations.
Citing growing concerns about questions of exams performed without consent, the U.S. Department of Health & Human Services issued guidance to the nation’s teaching hospitals and medical schools Monday.
Hospital and medical schools were reminded to get consent for sensitive examinations, such as breast, pelvic, rectal and prostate examinations. The department also stressed the importance of securing consent from patients who are going to be under anesthesia, as well as asking patients if they consent to exams for teaching purposes.
The guidance also reminds that obtaining such consent is essential in order to participate in Medicare and Medicaid programs and receive federal funds.
The health department sent a letter to teaching hospitals and medical schools.
“The Department is aware of media reports as well as medical and scientific literature highlighting instances where, as part of medical students’ courses of study and training, patients have been subjected to sensitive and intimate examinations – including pelvic, breast, prostate, or rectal examinations – while under anesthesia without proper informed consent being obtained prior to the examination,” the letter stated.
“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 New York Times published a 2020 report which revealed patients received pelvic examinations under anesthesia without being asked for their consent.
The health department also told hospitals that consent is required for patients under anesthesia, and to specify that patients must give consent to exams done by medical students.
“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,” the HHS letter stated.
Alison Whelan, MD, chief academic officer of the Association of American Medical Colleges, said the organization supports well-established guidelines that state that medical students may only participate in such exams with the consent of patients.
Such examinations should be related to the planned procedure, and patients should recognize the students as part of the care team, Whelan said. Students should only perform such exams under the direct supervision of a teaching physician, she said.
“Medical educators value the importance of communication between physicians and patients about all aspects of their care, and patients have the right to know and agree to all procedures and treatments they will undergo, as well as who will be performing them,” Whelan said in a statement. “Performing examinations on patients under anesthesia, without their knowledge and consent, is unethical and unacceptable.”
Whelan said the health department’s guidelines “further underscore the importance of ensuring an informed consent process is established and followed in all learning institutions.”
Some states have passed laws requiring doctors to obtain consent for pelvic examinations and other sensitive examinations when patients are under anesthesia, but many states lack such clear guidelines. At least 20 states have passed laws requiring such consent, the Associated Press reports.
Some states have passed such laws only in recent years, as noted by an analysis published by Annals of Surgery Open in March 2022. Most state laws cover consent for pelvic examinations and exams under anesthesia. Some state laws have been crafted to include male patients. Some states, including Delaware, Maryland and Maine cover pelvic, rectal and prostate exams, while Utah’s law requires consent for exams “requiring contact with the sexual organs.”
RAINN, the Rape, Abuse & Incest National Network, issued a statement of support for the health department’s guidance to hospitals and medical schools.
“HHS has taken an important step toward ending the practice of non-consensual pelvic exams on anesthetized patients as a teaching practice in hospitals,” RAINN said on X, formerly Twitter.
RAINN has worked with the federal government and other states to require hospitals to gain consent from patients before performing sensitive examinations, including those for teaching purposes.
“This protects both patients and medical students, and underscores consent in one of the most vulnerable of settings - hospitals,” RAINN said.
A 2005 survey of medical students at the University of Oklahoma found that most said they performed pelvic exams on patients under anesthesia for surgical procedures, but nearly three-quarters said they did not believe those patients had specifically given consent to exams by students during the procedures.
Healthcare professionals and students welcomed the guidance from the health department in posts on social media. Some expressed anger and bewilderment that hospitals and doctors would need to be reminded of the need to secure consent from patients for sensitive examinations.