By Stacey Kusterbeck
Earlier this year, the Department of Health and Human Services mandated written consent for pelvic exams under anesthesia.1 “This is something that ethicists have discussed for decades. But this was an important regulatory action, and one that gained national attention,” says Alexander Langerman, MD, SM, FACS, Professor of Otolaryngology and Faculty in the Vanderbilt Center for Biomedical Ethics and Society.
Langerman and colleagues previously had assembled a national database of informed consent documents to examine what disclosures major hospitals included in their standard procedure consent forms (https://consentinformed.org/).2 The researchers decided to conduct a study to look specifically at the issue of consent involving exams under anesthesia.3 Of informed consent documents from 110 hospitals, only four discussed exams under anesthesia. Only one form explicitly asked for patients to consent to allow medical students to perform such examinations.
“For such a hot-button issue, we were surprised that so few consent documents included the possibility of exam under anesthesia,” says Langerman. The lack of transparency about exams under anesthesia raises ethical concerns involving patient autonomy and trust, assert the authors.
The absence of a disclosure in an informed consent document does not mean this topic was not discussed with a patient. It is possible that hospitals used other forms for this specific purpose. Rather, the authors argue that including information on intimate exams on standard forms makes this topic more likely to be discussed.
“This is in part because, although the news stories tend to focus on pelvic exams, there are other parts of the body that patients consider intimate, which may be examined as part of routine care,” says Langerman. “Ethicists can work with their institution to examine their own informed consent documents and see where important disclosures may be missing.”
Daniel Habib, the study’s lead author and a student-researcher at Vanderbilt School of Medicine, says that clinicians typically discuss two types of topics during informed consent. Those are events with a high likelihood of occurring (such as a common complication or side effect) and events that are less likely but potentially serious (such as the need for a blood transfusion or the risk of stroke).
Exams under anesthesia are fairly common for some procedures and rare for others. “But from a patient perspective, these are potentially serious events that require proper disclosure anytime they might happen,” says Habib. Although patients pick surgeons whom they believe will perform the best operation, they also choose surgeons who make them feel safe and instill a sense of trust. “Indeed, patients are often more upset by a failure of trust than by technical errors. To have trainees perform intimate exams on patients without their permission is a breach of this trust,” says Habib.
Another group of researchers conducted a study to evaluate the frequency of pelvic examinations performed by osteopathic medical students on anesthetized patients without informed consent.4 “This study highlights an ethical issue of interest to a wide array of osteopathic medical students,” says David Manna, PhD, one of the study authors and assistant dean of research at Touro College of Osteopathic Medicine-Middletown.
Researchers surveyed 291 osteopathic medical students. More than 90% of respondents disagreed that performing pelvic examinations on anesthetized patients was ethical. However, roughly 40% of those students reported having performed such a pelvic exam during their OB/GYN clerkship. A minority of those students reported obtaining explicit consent.
Most students indicated that they had not been properly educated to obtain consent before performing pelvic examinations under anesthesia. “This highlights the importance of interpersonal dynamics in medical education. Clinical rotation students are placed in a high-pressure and hierarchical educational setting. Ethical issues can be difficult for students to address with their preceptors,” observes Manna.
References
1. Centers for Medicare and Medicaid Services. Revisions and clarifications to Hospital Interpretive Guidelines for Informed Consent. Pusblished April 1, 2024. https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/policy-memos-states-and-cms-locations/revisions-and-clarifications-hospital-interpretive-guidelines-informed-consent
2. Lin GT, Mitchell MB, Hammack-Aviran C, et al. Content and readability of US procedure consent forms. JAMA Intern Med. 2024;184(2):214-216.
3. Habib DRS, Lin G, Langerman A. Gaps in informed consent for intimate exams under anesthesia. Ann Surg. 2024; Oct 18. doi: 10.1097/SLA.0000000000006568. [Online ahead of print].
4. Cutting R, Reddy V, Polam S, et al. Prevalence of pelvic examinations on anesthetized patients without informed consent. J Osteopath Med. 2024; Oct 7. doi: 10.1515/jom-2024-0058. [Online ahead of print].
Earlier this year, the Department of Health and Human Services mandated written consent for pelvic exams under anesthesia. Researchers decided to conduct a study to look specifically at the issue of consent involving exams under anesthesia.
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