Bioethics Forum Essay
When Bioethics is Like Surfing: Changing Federal Policy
I was honored (and honestly a bit surprised) to play a pivotal role in a recent federal milestone for patients’ rights. On April 1, the Department of Health and Human Services revised its guidelines to require explicit consent from patients for sensitive medical examinations, including examinations conducted for educational and training purposes. The guidelines apply to all hospitals in the United States as a condition for receiving funds from Medicare and Medicaid.
In the months since then, people have asked, how did you do it? This essay describes the path to winning this decades-long policy battle. It also discusses the entrenched beliefs and assumptions of resistant teaching hospitals which stand in tension with values expressed by many clinicians, professional associations, students, legislators, and the public.
When announcing the policy change, HHS Secretary Xavier Becerra stated his awareness “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 [prior] informed consent.” An article that I co-authored in the Hastings Center Report had come to Secretary Becerra’s attention. It described the first national survey on the nature and prevalence of these exams, which found that 3.6 million U.S. residents may have received an unconsented intimate medical exam within the previous five years. These numbers are believed to be a conservative estimate. Sensitive exams have always required consent, but because of noncompliant teaching hospitals, Becerra reinforced federal guidelines to require written documentation of patient consent.
Our Path to Success
The causal mechanisms of this hard-fought battle are well articulated within the theories of a scholar largely unknown within bioethics: John W. Kingdon. In my six years teaching ethical policymaking courses to medical and graduate students, physicians, and professionals from around the world, I frequently call on Kingdon’s theories of public policymaking. Kingdon’s work explains the cumulative effort and conditions required to make a policy idea become accepted by key stakeholders and then eventually adopted by lawmakers. His work also explains that experts may have policy solutions, but that the influence of experts is limited by their environment (i.e., political climate, public opinion, social media) and reliant on additional actors to capture lawmakers’ limited attention.
In short, Kingdon’s theories explain the necessary criteria to build policymaking momentum. We need a problem, a concern of the general public, and we need a policy, the solution originating with communities of experts and lobbying groups.
However, since experts are beholden to our environments, Kingdon says we are like surfers waiting for a big wave. That brings us to the final criterion. We need politics, or political will, which is often brought on by a powerful narrative or compelling evidence. Once all three criteria exist, Kingdon says we have the necessary momentum to influence the policy agenda.
For unconsented sensitive exams, the problem and policy were already well defined, thanks in no small part to the wisdom and work of patient-advocates like Ashley Weitz. However, the movement lacked political will, so we needed to generate it. Many of us had already written op-eds, given testimony, advised legislators, and debated in public forums about this “stain on the history of medical education.” This work helped pass many state laws, but they were a patchwork of inconsistencies and watered-down protections.
Lawmakers were skeptical of testimony by medical students about unconsented sensitive exams since the administration in some teaching hospitals denied medical students’ reports on the premise that they were confused and uninformed. Generating political will was one of my aims in designing the first national survey of members of the public about their experiences with unconsented sensitive exams. On reflection, I think the survey caught the attention of policymakers for a few reasons. In addition to finding that these exams affected millions of U.S. residents, it also demonstrated, for the first time, that this was not just a women’s issue; unconsented sensitive exams were reported slightly more frequently by male respondents than female respondents. The survey also found racial disparity. Unconsented exams were reported nearly four times as often by Black respondents than white respondents.
The survey findings were picked up by a number of media outlets including NBC Nightly News. We finally achieved momentum. Finding the narrative credible and compelling, federal legislators asked me to join them in writing a letter to Becerra calling on HHS to require explicit consent. Less than six weeks after submitting our letter, Becerra issued the revised guidance.
Reflections
While this policy change is a victory for patients’ rights–perhaps one of the most significant extensions to patient consent in decades–it also reflects the disconnect between some teaching hospitals’ entrenched beliefs and assumptions and the values of many clinicians, professional associations, students, legislators, and the public. I’m baffled as to why a federal change was needed to safeguard patient consent in 2024. Patient consent should already be central to the philosophy of all teaching hospitals, but some still prioritized efficiency of practice and tradition over patients’ rights.
Concerns about these exams, raised by several thousand individuals, had been disregarded by some teaching hospitals for 35 years. Voices of concern included many physicians and medical students along with bioethicists, legislators, legal scholars, and patients. Several medical associations (including American Medical Association, the American College of Obstetricians and Gynecologists, and the Association of American Medical Colleges) had released guidelines promoting explicit consent for pelvic exams as far back as 2003, yet they, too, failed to rein in the practice. Even state laws requiring explicit consent often failed to stop the practice, having so many exceptions that their passage seemed, in retrospect, like a hollow victory. Some states, for instance, limited their explicit consent policy to exams outside ob/gyn services. This curtailed further cases of women receiving unconsented pelvic training exams when they, for example, were receiving laparoscopic stomach surgery. But these laws had no impact on the training exams within the ob/gyn clerkship, where many of the unconsented exams were taking place. These laws also did not protect patients with male genitalia from receiving unconsented prostate exams.
Leadership at some teaching hospitals repeatedly denied the practice of unconsented sensitive exams to state legislators even while it was occurring at their institutions. Some legislators have confided in me that the experience has damaged what they previously considered to be a trusted relationship with medical leadership in their state.
Medical students have experienced moral distress from their participation in unconsented sensitive exams. A recent study found that while 94% of medical students found them to be unethical, only 5% refused to participate out of fear of retribution from their superiors. Other students experienced moral erosion; they stopped valuing patient consent across all procedures (not just sensitive ones). This damage to medical students (and other learners required to participate in unconsented sensitive exams, like physician assistant and nursing students) was avoidable.
The resistance to consent was based on a faulty assumption. Resistant teaching hospitals assumed that consent rates would be so low that education would be disrupted. This is false. At least three studies including a recent analysis of consent within a Chicago clinic all found that about 88% of patients consent to pelvic training exams when asked.
Some teaching hospitals still believe that patients cannot refuse medical student examinations. Yet Becerra emphasized that patients are not required to participate in trainee exams, stating, “Informed consent includes the right to refuse consent for sensitive examinations conducted for teaching purposes.”
What might it reveal about medicine today that some teaching hospitals dismiss the voices of medical students? That medical students’ moral distress isn’t always deemed important? That some teaching hospitals have ignored consent guidelines by prominent medical associations for well over 20 years? That training sometimes takes precedence over patients’ rights to bodily autonomy? That some teaching hospitals may not regard patients’ bodies as their own, at least while under anesthesia?
Policies Today
These errant entrenched beliefs and assumptions embedded within policies in some teaching hospitals are misaligned with the values of many clinicians, professional associations, students, legislators, and members of the public–and continue to influence the patient experience.
For example, partly in response to media attention about unconsented exams, many hospitals have created mandatory chaperone policies. While chaperones seem to be a patient-centered measure, most policies were not created with patient input. Some hospitals don’t offer an opt-out clause, even when a competent adult patient has a longstanding relationship with their physician and feels distressed by the presence of an additional person. Nonbinary patients and patients with a history of sexual assault have confided in me that the mandatory presence of chaperones can be so distressing that they are sometimes less likely to schedule necessary doctors’ appointments.
Chaperones may prevent some of the most egregious ethical violations. However, chaperones have also been present during some unconsented pelvic exams and not only failed to protect the patient but continued to assist the physician until the exam was completed, despite the repeated wishes of the patient. Ashley Weitz states, “Chaperones simply have less power than the physicians conducting the exams, and especially when a policy lacks an opt-out clause, the benefits seem skewed in favor of the institution.”
Additionally, unconsented sensitive exams take place under broader conditions than are covered within the revised guidelines. Some unconsented exams have been conducted by an attending physician seeking a diagnosis (not a medical student seeking a training opportunity). Other patients similarly reported receiving such exams while conscious (not sedated); one of them was an older male physician who felt too overwhelmed by the power dynamics in the clinical setting to avoid an unconsented prostate exam by a medical student. These cases highlight the broad nature and frequency of unconsented sensitive exams and the importance of institutions requiring explicit consent.
Recent news of the sale of poor (and disproportionately Black) deceased patient bodies by Texas hospitals is another example of hospital policies made in the interests of medical education (and profit) without community input. More transparency–and community input–within hospital policymaking could help, but hospitals are reticent to share policies, and models of community engagement are limited and time-intensive. Perhaps whistleblower protections for clinicians and medical students (as passed recently in Colorado) may reveal more about the nature and conditions of concerning medical practices. Some hospitals are stalwart advocates of patient rights and early adopters of explicit consent. Perhaps they can share their policies and assuage concerns of institutions less likely to embrace change. Chor’s study enacting explicit consent, for instance, found that explicit consent improves the physician-patient relationship.
In closing, I tell my students that good bioethics requires community. Kingdon’s theories back me up; stakeholders must coalesce to instigate change. And while advocacy sometimes feels a bit frenetic, and you don’t know what will move the needle, Kingdon encourages us to keep going. Through public communications, coalition-building, and a search to identify compelling voices within the public discourse, our work sometimes manifests in meaningful policy change. When it happens, it’s as rewarding as surfing the perfect wave.
Lori Bruce, D.Bioethics, MA, HEC-C, is the associate director of the Interdisciplinary Center for Bioethics at Yale University. Views expressed are her own. LinkedIn. @lori_bruce.
“What might it reveal about medicine today that some teaching hospitals dismiss the voices of medical students? That medical students’ moral distress isn’t always deemed important?” this hits close to home. Thank you for seeing students and trainees in your work, and helping us to use our voices to advocate for our patients and communities. ❤️
@Sophie I believe we can act from a position of abundance, not scarcity; yes, medical training is important, and so is patient consent, and so is a medical student’s values and morals. We can successfully navigate multiple priorities, and when we “lean into” valuing those with the least power, that’s when we can increase trust in medicine…
Yes, yes, and yes! Thank you for this writing and advocacy.
very useful analysis of an important political achievement