By Donna Gorby, MLD, BSN, RN
Informed consent, when done properly, encourages transparency and trust between all parties. Despite this, many U.S. states and medical institutions do not require explicit consent for exams when the patient is under anesthesia. Recent lawsuits and state reforms have exposed concerning practices where providers-in-training conduct sensitive examinations without obtaining informed consent prior to anesthesia.
Sounding the alarm
A startling 2023 survey revealed that nearly 20% of hospitals affiliated with medical schools performed intimate exams under anesthesia without obtaining explicit consent.[1] These exams, often carried out by doctors or medical trainees for educational purposes, are sometimes done without the patient’s knowledge – a troubling practice that has persisted for years. A 2005 survey at the University of Oklahoma exposed that most medical students had performed pelvic exams on unconscious patients, with nearly three-quarters believing the patients had not given consent.[2]
Since his medical student days in the 1990s, Dr. Ari Silver-Isenstadt wrestled with the unsettling ethical dilemma of being asked to perform intimate exams during gynecological procedures, and even during unrelated surgeries. His discomfort ignited a determination to spark change, ultimately leading to his landmark 2003 study, “Don’t Ask, Don’t Tell,” which paved the way for California to become the first state to regulate this controversial practice.[4]
The issue came into sharper focus when Dr. Phoebe Friesen became aware of unauthorized sensitive examinations during her bioethics work at Mount Sinai Hospital around 2014. Friesen’s research culminated in a study published in the journal Bioethics in 2018, which shed light on women who felt violated by unauthorized examinations while under anesthesia.[3] This research led to the #MeTooPelvic movement and prompted testimonies before state legislatures, demanding action.
As of 2019, 11 states, including Maryland, Utah, New York, and Delaware, had passed laws mandating informed consent for pelvic exams, addressing the ethical concerns that have long plagued this practice. States like Illinois, Virginia, Oregon, Hawaii, and Iowa have joined the ranks, marking a significant shift in the medical field’s approach to patient autonomy and consent.[4]
Some medical faculty defend the practice as essential for training; they raise concerns that requiring disclosure of educational examinations will impair student learning. However, recent studies suggest that patients are generally willing to participate in educational exams when asked.5 Being included in the plan of care fosters agreement and trust. Moreover, some in the medical community argue that the educational value of these exams under anesthesia is limited. The use of paid non-patient volunteers for teaching purposes is gaining popularity and could be a viable alternative.6
CMS weighs in
On April 1, 2024, HHS officials sent a letter to teaching hospitals and medical schools emphasizing the importance of setting clear guidelines to ensure providers and trainees obtain and document informed consent from patients before performing sensitive examinations in all circumstances.7
Increasing concerns led CMS to revise its Acute Care Hospital interpretive guidance in the State Operations Manual, Appendix A-Hospitals, effective April 19, 2024. The updated language in the Surgical Services CoP at 482.51(b)(2) instructs surveyors to review hospitals’ informed consent policies, processes, and forms to ensure consent is obtained for any provider and learner performing sensitive examinations.8
Next steps
Enhance the informed consent process, ensure compliance with CMS requirements, and promote patient safety by:
- Ensuring true understanding. Verify that patients genuinely understand their treatment plan and that consent forms reflect all procedures and exams.
- Achieve agreement. Discuss, document and agree upon all procedures and examinations prior to surgery, including those for educational purposes.
- Use accessible terminology. Avoid medical jargon and use layman’s terms.
- Simplify consent documents. Make documents straightforward and easy to understand.
- Avoid assumptions. Do not assume patients understand; encourage feedback and use decision aids, interactive media and graphic tools.
- Overcome language barriers. Use health literacy screening tools and medical interpreter services; provide forms in the patient’s preferred language.
- Promote informed consent as a process. Treat informed consent as an ongoing communication process, not just a formality.
- Conduct training. Educate staff and providers about informed consent and CMS requirements.
- Enforce accountability. Do not delegate consent tasks to other staff.
- Engage with patients. Ask open-ended questions to understand patients’ needs and preferences; encourage them to ask questions.
- Support the right to refuse. Clearly state that patients have the right to refuse consent for any examinations while under anesthesia.
Call to action
A patient’s right to self-determination is a cornerstone of medical ethics, especially for intimate exams involving the most sensitive areas of the body. Informed consent encompasses both clinical and legal dimensions. Clinically, it represents a crucial conversation between physician and patient. Legally, it is enshrined in jurisprudence, highlighting the necessity for proper communication and documentation to avoid legal repercussions. Violations of informed consent can lead to professional liability and significant costs, including compensation and court expenses.
As health care systems prioritize patient involvement and decision-making autonomy, informed consent becomes increasingly important. All activities, including educational examinations, must be disclosed and agreed upon by all parties. Transparent communication and shared decision-making improve the adequacy of the informed consent process, leading to a trusting partnership between patient and provider.
– Donna Gorby, MLD, BSN, RN, is a standards interpretation specialist for acute care and critical access hospitals at Accreditation Commission for Health Care (ACHC). She holds a master’s degree in leadership development, a bachelor’s degree in nursing, and a Lean Six Sigma Black Belt.
Kempf, A. M., Pelletier, A., Bartz, D., & Johnson, N. R. (2023). Consent policies for pelvic exams under anesthesia performed by Medical Students: A National Assessment. Journal of Women’s Health, 32(11), 1161–1165. doi:10.1089/jwh.2023.0369
Schniederjan, S., & Donovan, K. (2005). Ethics versus education: Pelvic exams on anesthetized women. Retrieved from https://pubmed.ncbi.nlm.nih.gov/16206868/
Friesen, P. (2018). Educational pelvic exams on anesthetized women: Why consent matters. Bioethics, 32(5), 298–307. doi:10.1111/bioe.12441
Greene, H. H. (2019). Medical students allowed to do pelvic exams on unconscious, non-consenting patients. Retrieved from https://www.vice.com/en/article/43j59n/medical-students-allowed-to-do-pelvic-exams-on-unconscious-patients-without-consent
Jushchyshyn, J. A., Mulugeta-Gordon, L., Curley, C., Polite, F. G., & Merz, J. F. (2023). Patient consent for medical student pelvic exams under Anesthesia: An exploratory retrospective chart review. Retrieved from https://www.medrxiv.org/content/10.1101/2023.04.17.23288694v2.full
Eli Y. Adashi, M. (2019). Teaching pelvic examination under Anesthesia Without Patient Consent. Retrieved from https://jamanetwork.com/journals/jama/fullarticle/2725671
Becerra, X., Rainer, M. F., & Brooks-LaSure, C. (2024). Letter to the nation’s teaching hospitals and medical schools. Retrieved from https://www.hhs.gov/about/news/2024/04/01/letter-to-the-nations-teaching-hospitals-and-medical-schools.html
Survey & Operations Group, & Directors, Quality, Safety &Oversight Group. (2024). Revisions and clarifications to Hospital Interpretive Guidelines for Informed Consent. Retrieved from https://www.cms.gov/files/document/qso-24-10-hospitals.pdf
