On April 1, 2024, the Department of Health and Human Services issued revisions and clarifications to Hospital Interpretive Guidelines for Informed Consent. Hospitals must take immediate steps to ensure that informed consent policy and process along with informed consent forms have the necessary elements and information to permit a patient or patient proxy to make fully informed decisions about their care. These changes are in response to an article published on Annals of Surgery Open website. That article discussed the increasing number of states that have enacted statutes to regulate the performance of sensitive examinations, particularly in patients who are anesthetized or unconscious. Sensitive examinations include breast, pelvic, prostate, and rectal examinations. The focus of these laws has been on obtaining patient consent to perform these exams.
Briefly, an informed medical decision presumes that the patient or patient’s proxy has been given sufficient information about the patient’s health status, diagnosis, and prognosis. The patient or patient proxy participates in the care plan that includes consent or refusal for medical treatment/interventions, and postdischarge care.
To that end, hospitals must utilize an informed consent process that ensures that patients or their proxies are given the information needed to make an informed decision as to whether to consent to or refuse a procedure, intervention or type of care that requires consent. The medical record must contain a document reflecting informed consent and that the document was properly executed.
In summary, the new interpretive guidelines now require a consent process to be in place to inform patients about services that may involve training or education, which may be performed in addition to services they expect to receive, especially when they are anesthetized at the time.
The policy is in keeping with ACOG Committee Opinion 500 that states explicitly
Pelvic examinations on an anesthetized woman that offer her no personal benefit and are performed solely for teaching purposes should be performed only with her specific informed consent obtained before her surgery
This policy is effective immediately.
Revisions and Clarifications to Hospital Interpretive Guidelines for Informed Consent
Pelvic Exam Laws in the United States: A Systematic Review – PubMed (nih.gov)
ACOG Committee Opinion 819: Informed Consent and Shared Decision Making in Obstetrics and Gynecology
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