Background Legal requirements and clinical practices of securing patient consent for medical student pelvic examinations under anesthesia (EUA) vary widely, while ethical arguments and patients’ preferences for being asked for consent are well known.

Objective This study was performed to examine patients’ choices to permit or refuse medical student pelvic EUAs during planned gynecologic procedures.

Study Design An exploratory retrospective chart review of electronic consent forms at a single academic medical center, using contingency table and logistic regression to explore relationships between patient and provider characteristics and consent.

Results Electronic consent forms were downloaded for a census of 4000 patients undergoing gynecologic surgery from September 2020 through calendar year 2022 and linked to anonymized medical record information, including patient age, race, religion, and insurance carrier, along with physician name. Physicians were coded by gender, departmental affiliation, and status (attending, resident, or fellow). Of the 4000 patients, 142 (3.6%) were informed but not presented with a choice, and these patients were removed from further analysis. Of the remainder, 308 (8.0%) were asked for EUA consent more than once. Overall, of 3858 patients, 3308 (85.7%) consented every time asked and 550 (14.2%) refused or limited EUA consent at least once. Nine patients limited their consent to female students, and 2 patients refused medical student participation at all. Of the 308 asked more than once, 46 were not consistent. Exploratory multiple logistic regression analysis showed that patients identifying as Black or African American (OR=0.492, p<0.001) or Asian (OR=0.292, p<0.001), or of Moslem/Muslim/Islamic faith (OR=0.579, p=0.006) were substantially less likely to grant EUA consent than other patients. Moreover, male physicians, most of whom were attendings, were much more likely to secure consent from patients than their female colleagues (OR=2.124, p<0.001).

Conclusions The finding that some patients are more likely than others to refuse a pelvic EUA magnifies the dignitary harm from a nonconsensual invasion of intimate bodily integrity and perpetuates the historic wrongs visited upon vulnerable people of color and religious minorities. Patient’s rights to control over their own bodies can only be respected if their physicians take seriously the ethical obligation to inform their patients and ask them for permission.

Precis Racial, ethnic, and religious minority patients are more likely than others to refuse to allow medical students to perform pelvic examinations under anesthesia.

Jon Merz: Since 1997, JFM has been a paid expert witness in 3 civil cases involving the adequacy of informed consent and IRB review in research, twice for defense and once for plaintiff, as well as a 4th case involving the definition of human subjects research. In the last 3 years, JFM has received financial compensation for service on several Data and Safety Monitoring Boards for the NIH and the American College of Radiology Imaging Network, and for service on a pharmacogenomics ethics advisory board for Merck. JFM received partial salary support as moderator of the IRBForum (https://community.primr.org/home) by a grant from Public Responsibility in Medicine & Research (PRIMR) from 2012 through 2020.

This study was not funded.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

University of Pennsylvania Institutional Review Board

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

↵* Communicating author.

Competing Interests: Jon Merz: Since 1997, JFM has been a paid expert witness in 3 civil cases involving the adequacy of informed consent and IRB review in research, twice for defense and once for plaintiff, as well as a 4th case involving the definition of human subjects research. In the last 3 years, JFM has received financial compensation for service on several Data and Safety Monitoring Boards for the NIH and the American College of Radiology Imaging Network, and for service on a pharmacogenomics ethics advisory board for Merck. JFM received partial salary support as moderator of the IRBForum (https://community.primr.org/home) by a grant from Public Responsibility in Medicine & Research (PRIMR) from 2012 through 2020.

Email: jjushchybidmc.harvard.edu

Email: lakeisha.mulugeta-gordonpennmedicine.upenn.edu

Email: cara.curleypennmedicine.upenn.edu

Email: florencia.politepennmedicine.upenn.edu

Email: merzpennmedicine.upenn.edu, Phone: 267-254-6470

Anonymized data analyzed for this study are available upon reasonable request to the authors.