Potential Synergies Between Bioethics and Health Policy Research

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Introduction

This document presents a comprehensive overview of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. It outlines the center's shared vision to foster critical reflection on ethical challenges in healthcare and biomedical research among all stakeholders.

The presentation details the center's activities, which are structured around three pillars: education, clinical ethics, and research, along with two crosscutting programs in health policy and collaboration/outreach. In the area of education, the center is involved in ethics curricula for undergraduate and graduate medical education, including dedicated pathways in medical ethics and health policy.

Their activities also extend to clinical ethics through fellowships, continuing medical education, and ethics consultation services at major healthcare institutions.

About the Center

The center recently held its faculty retreat in August. Its core primary faculty comprises members with diverse disciplinary backgrounds: four in philosophy, four in law, four in medical humanities and/or bioethics, two in public health, two in anthropology, two in religious studies, one in sociology, and one in medicine. Some faculty members represent multiple disciplines.

In addition to the primary faculty, the center has joint faculty members who hold primary appointments elsewhere but work extensively with the center, co-leading courses and other activities.

The center also has a distinguished group of affiliated health policy and medical ethics scholars, including Drew Helmer and Laura Peterson. Furthermore, there is a larger group of members open to anyone in the Baylor family or the Texas Medical Center (TMC) with overlapping interests. Members have their names listed on the center's website, can include their membership on their CV, and receive invitations to intellectual events. Membership also serves as a route to discovering collaborations as the application asks for research interests. The center's website, though often under renovation, provides a link to apply for membership.

Center Vision and Pillars

About 10 years prior to the presentation, a strategic planning retreat led to the creation of a shared center vision that has remained relevant. The vision is to create a shared sustainable intellectual environment in which all stakeholders can critically reflect on and respond to ethical challenges in healthcare and biomedical research.

The center operates through three primary pillars: education, clinical ethics, and research. It also has two crosscutting programs: a health policy program and a collaboration and outreach program.

Education

The center is actively involved in education at various levels:

• Undergraduate Level: The center is responsible for the ethics thread in the revamped medical school curriculum and is currently in year two of its rollout. It oversees two pathways: medical ethics and health policy, which together involve approximately 180 students, about 30% of the medical school class. Some ambitious students pursue both pathways. The center also manages the ethics thread for the engineering and medicine program, a collaboration between Houston Methodist and Texas A&M in Houston.
• Graduate Medical Education: The center is responsible for the ethics professionalism and policy program, which is being made publicly accessible as a series of videos and associated educational material covering various topics, including policy.
• Clinical Ethics Fellowships: The center currently has three clinical ethics fellows and typically has an additional fellow focusing on research or health policy. Currently, a fellow is working on psychedelic research.
• Continuing Medical Education: The center supports a grand round series co-sponsored by Baylor St. Luke's and Houston Methodist. This virtual series occurs six times a year, and topics are chosen for their relevance to a clinical audience, often using panel discussions and debates, such as one recently held on the unilateral withdrawal of life-sustaining treatment. The center also conducts a bioethics intensive course in the spring for individuals wanting to enhance their skills, such as ethics committee members and those interested in clinical ethics consultation. This year's course is virtual. Special events include the Brody lecture, honoring the center's founding director. The center also runs a summer internship program primarily for undergraduates from across the country.

Clinical Ethics

The center oversees two large clinical ethics programs at Houston Methodist and Baylor St. Luke's. These programs involve multiple faculty members and have expanded beyond the Texas Medical Center to broader networks or systems. The Houston Methodist program is considered one of the largest in the country by volume. Individuals connected to the center also run clinical ethics programs at other institutions, such as Dr. Savitri Fedson at the VA's advanced heart failure and transplantation program, who also co-chairs their ethics committee.

The center has close ties with Joey Fisher, who leads the clinical ethics program at Harris Health, and Holland Kaplan, a primary faculty member who recently took over the consult service at Ben Taub. The center is also strengthening its connections with the consult service and clinical ethics program at Texas Children's.

Research

The center receives approximately $4 million in external funding annually, with the National Institutes of Health (NIH) being the primary funder. Faculty members have also secured funding from PCORI and AHRQ. The center also receives funding from private foundations, particularly for psychedelic research. This funding supports about 20 to 30 funded projects at any given time, making the center one of the largest bioethics research programs in the country. The areas of research continue to expand.

Key research areas include:

• Ethical, Legal, and Social Implications (ELSI) research, with a long-standing track record of funding from the National Human Genome Research Institute.
• Neuroethics, including work on neurotechnology like deep brain stimulation, funded by the Brain Initiative.
• Medical decision-making, a growing area that integrates machine learning and artificial intelligence in collaboration with the G Coast Center for Precision Environmental Health, offering opportunities in epigenetics and environmental health.
• Health and science policy.
• Social determinants of health, health equity, and public health.
• Clinical ethics research conducted by clinical ethicists.
• Astroethics, a program in collaboration with science researchers at Baylor. This area focuses on human research ethics questions related to commercial space flight, such as the ethical considerations of research involving risky commercial space travel.
• Global health ethics.
• Philosophical ethics.
• Psychedelic research, with strong ties to the VA.

The center is also developing a research ethics consultation service, which will be part of the Consortium for Translational and Precision Health Resources module, led by Laura Peterson. This initiative arose from the recognized value of clinical ethics consultation and aims to apply a similar model to bench and translational research. While initially driven by a requirement for CTSAs, a vibrant network of research ethics consultation professionals continues to meet.

This service will address complex ethical questions in research at any stage, from project conception to post-project concerns, offering advisory (non-binding) recommendations that complement the role of the IRB. The IRB sometimes seeks guidance from such services.

Health Policy Program

The health policy program is directed by Christy Guerrini, who has a background in law and public health. This program encompasses the health policy pathway for medical students and is responsible for Baylor's position statements on topics such as mental health, gun safety, and public trust in science. These short statements are developed through a collaborative process, reviewed by the board of directors, and posted on the president's office webpage.

The center aims to increase engagement with government affairs and legislative outreach. It also organizes a health policy symposium typically in late April or early May, a virtual event involving panel discussions. The program also manages the Policy-Wise blog, seeking contributions from those publishing academic articles who wish to reach a broader public audience with their key findings.

Networking and Engagement

The center focuses on networking and engagement through intellectual events. The grand rounds and the series Developing Issues in Bioethics and Society are key initiatives. The latter is a virtual or hybrid event held approximately six times a year.

Potential Synergies and Collaboration

Mary Majumder, J.D., Ph.D. transitioned to discussing potential collaborations, using a past example from their time in Louisville before joining Baylor. This example was the publication of a controlled trial in the New England Journal of Medicine on arthroscopic surgery for osteoarthritis of the knee.

The ethically significant aspect was the placebo-controlled simulated surgery. Researchers at the VA, including Nelda Wray (a leader in health services research) and Baruch Brody (the founding director of the center and a prominent bioethicist), were involved.

This study raised ethical questions about the nature of the simulated surgery (use of anesthesia) and informed consent (patients writing a statement acknowledging they might receive placebo surgery).

The study found that neither surgical intervention group reported less pain or better function than the placebo group, highlighting the placebo effect and raising ongoing ethical questions about disclosure in informed consent.

Dr. Majumder, introduced current colleagues at Baylor as potential collaborators:

• Jennifer Blumenthal-Barby (philosopher) has done significant work on shared decision-making and its intersection with artificial intelligence. Her work includes conceptual and normative analyses, as well as engagement in the development, implementation, and evaluation of decision aids. She has collaborated with decision scientists across the TMC, including Aden Nyak (formerly at the VA and believed to be in IQest), and has received funding from PCORI for research on decision aids for advanced heart failure patients considering LVADs. She is also involved in developing personalized risk estimates and integrating them into decision aids using AI tools.
• Stacy Pereira (anthropologist) has a strong background in military medicine and has worked on studies involving genomic sequencing in the US Air Force (Milsek). Her research also focuses on attitudes of military veterans toward epigenomic biomarker toxic exposure testing, demonstrating her IQest connections. Dr. Pereira is a national and international leader on issues related to the use of polygenic risk scores, possessing extensive knowledge and research interests in this area.
• Joanna Smolinsky (philosopher), a newer faculty member with a clinical ethics postdoctoral fellowship from UCLA, focuses on informed consent and surrogate decision-making. Her work bridges theoretical concepts with practical realities in the clinic, as illustrated by her article on a case involving a Jehovah's Witness. She is also involved in Jenny's decision aid work and explorations into artificial intelligence.
• Melanie Jeske (sociologist), another recent addition to the faculty with a postdoctoral fellowship from the University of Chicago, conducts qualitative research on chronic illness, reflecting her graduate work at UCSF.

The presenter encouraged the audience to reach out to these faculty members directly if there were potential intersections of interest, also offering to facilitate connections.

Dr. Majumder's Own Work

The presenter's own research interests include access to care, privacy, and data governance, with a long-standing focus on access stemming from their dissertation on managed care.

One significant example of their work in access to care involved the Caesar (Clinical Sequencing Evidence Generating Research) consortium, funded by the NIH. This consortium aimed to include historically underrepresented groups in genetic and genomic research, specifically individuals with non-European ancestry and the medically underserved. Each site aimed for at least 60% participation from these populations.

The consortium had three main domains: clinical genomics, innovation in sequencing analysis, and ethical, legal, and psychosocial implications (ELSI) research. The presenter was part of the LC and diversity working group and initiated a project on access to care within the consortium.

Recognizing a lack of robust definitions of access in bioethics literature, the presenter and colleagues turned to the health services literature, adopting Ronald Anderson and colleagues' definition of access as the actual use of personal health services and everything that facilitates or impedes their use.

They valued the definition's breadth beyond insurance coverage and its focus on the right services at the right time for improved health outcomes. They also utilized a typology of barriers to care, including beliefs and perceptions of need, organization, financial aspects, and social barriers.

Caesar conducted baseline and follow-up surveys with harmonized measures for access to care, adapted from the HRQ Medical Expenditure Panel Survey. Surprisingly, less than a fifth of respondents reported any barrier to care in the past year, even within the targeted medically underserved groups.

Among those who reported barriers, issues related to beliefs and perceptions of need were most common. To gain a richer understanding, the project involved case studies at each site, using a standard list of questions and the same barrier typology to analyze anticipated and encountered barriers to research participation and the integration of clinical sequencing into routine care.

A case study from the CHARM (Cancer Health Assessments Reaching Many) project at Kaiser Permanente Northwest in partnership with Denver Health (a network of federally qualified health centers serving a largely uninsured, low health literacy population) illustrated strategies to address access barriers. Denver Health faced challenges such as lack of insurance, disruptions in care, limited primary care relationships, incomplete family histories, and low clinical knowledge among their patient population.

The CHARM research team employed various strategies to enhance access:

• Initial Engagement: Email and text outreach, alongside in-clinic recruitment, replacing multiple in-person clinical touchpoints.
• Family History Collection: An online tool specifically designed for low literacy populations.
• Risk Assessment and Communication: Conducted online.
• Sample Collection: Remote kits sent to participants.
• Communication of Positive Results: Handled by genetic counselors via phone, using an ARIA (Accessible, Relational, Inclusive, Actionable) genetic counseling model tailored for low literacy and limited English proficiency populations. All materials were available in English and Spanish.

This work exemplified Caesar's efforts to improve access to genomic medicine for underserved populations. The survey results, while showing low reported barriers, contrasted with the more nuanced picture from the case studies, highlighting that general access to care is a prerequisite for accessing genomic medicine or participating in clinical sequencing trials. A key motivator for participation was the opportunity to access clinical genomic services otherwise unavailable or unaffordable.

The project also raised ethical questions about the obligation to provide more support for family follow-up and cascade testing after a participant received a positive result, especially within underserved communities. The presenter emphasized the importance of effective and efficient dimensions of access in achieving the right services at the right time for improved health outcomes.

The presenter's current work involves formularies and access issues related to gene therapies, particularly in the context of sickle cell disease. The recent approval of gene therapies for sickle cell disease, involving CRISPR technology and high price tags (e.g., $2.2 million and $3.1 million list prices), raises significant access and equity concerns, especially given the historical underfunding of sickle cell disease care.

The presenter contributed an essay to Ethics & Human Subjects Research on ethics and translational research, collaborating with Dr. Bashipe, co-director of the sickle cell disease clinic at Texas Children's. They used the National Academies' framework for equitable innovation, focusing on input equity (who has a voice in development and implementation) and deployment equity (accessibility and benefit to diverse populations, including the underserved).

The case study concluded that funders play a crucial role in both input and deployment equity. The democratizing education for sickle cell disease gene therapy project, sponsored by the National Human Genome Research Institute (NHGRI) and led by Ben Bonum, exemplified successful input equity by involving researchers, advocates, and affected individuals in creating educational materials through workshops called "dialogues".

However, a survey following these dialogues revealed differing perceptions of power dynamics, with researchers less likely than advocates and patients to acknowledge their influence.

The Cure Sickle Cell Initiative, supported by NHLBI, also has a community input panel. Regarding deployment equity, the initiative is notable for funding two cost-effectiveness analyses that integrate equity considerations, an area that is still evolving in terms of methodology.

Furthermore, they are partnering with the federal government and the Innovation Center at CMS to support outcomes-based agreements to improve the accessibility of these high-cost therapies. This initiative, with findings expected in 2025, involves negotiating agreements with state Medicaid programs.

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