������Ƶ

Philosophical Bioethics Consortium and Web Hub

Dr. Blumenthal-Barby developed a Philosophical Bioethics Hub with support from the Greenwall Foundation and Consortium partners at the , and . The Hub website includes: Greenwall Philosophical Bioethics Seminar Series, normative-empirical bioethics toolkit, events and web-based lecture series in philosophy and bioethics.

Houston Area Philosophical Bioethics Network

The Network is comprised of philosophers working at the intersection of philosophy and bioethics. The network is a collaborative between philosophy faculty and post-docs in The BCM Center for Medical Ethics and Health Policy, , and . The network meets monthly or quarterly for works-in-progress sessions. Contact Dr. Blumenthal-Barby if you are a philosopher (faculty or post-doc) in the Houston area interested in joining the group. Recent topics have included consciousness and value, addiction and blameworthiness, the moral authority of experience, fetal pain and personhood—among others.

Philosophy Book Reading Group

The group reads and discusses (through five-six meetings) one new book in philosophy with relevance to bioethics each semester (fall, spring). Books read so far include: Philosophy of Devotion: The Longing for Invulnerable Ideals (OUP, 2023) by Paul Katsafanas; Moral Feelings, Moral Reality and Moral Progress by Thomas Nagel (OUP, 2023); Health Problems: Philosophical Puzzles about the Nature of Health by Elizabeth Barnes (OUP, 2023); excerpts from Rights and Their Limits by Francis Kamm (OUP, 2022); Green Light Ethics: A Theory of Permissive Consent and Its Moral Metaphysics by Hallie Liberto (OUP, 2022); Epiphanies: An Ethics of Experience by Sophie Grace Chappell (OUP, 2022); Ways to be Blameworthy: Rightness, Wrongness, and Responsibility by Elinor Mason (OUP, 2019); Morality by Degrees: Reasons Without Demands by Alastair Norcross (OUP, 2020).

Semi-Annual Philosophical Bioethics Workshop

This workshop is sponsored by the Greenwall Foundation. View program agendas from the past workshops for details:

• 2019 Philosophical Bioethics Workshop
• 2022 Philosophical Bioethics Workshop

Choice architecture refers to how the presentation of choices may influence decision-making and is a technique that has been implemented in public and private policy domains. The way in which options are categorized and then presented to a decision-maker is an example of presenting options in a way that influences choice. Related to health care, for example, nations that require citizens to opt-out of organ transplant donation have a significantly higher organ-donor rate than nations where the citizens must affirmatively choose to take part (opt-in). Another technique suggested is laying out various outcomes of a decision in a way that is easy for the choice-maker to understand. The literature on choice architecture builds a framework to distinguish between two types of tools that choice architects can use: those that structure a choice in a certain way, and tools that make use of how options are presented to decision-makers. To illustrate, the use of a default, where the default option will lead to a more socially desirable outcome, is an example of structuring choices.

This project aims to develop empirically-informed comprehensive normative guidelines for the use of choice architecture in (1) prostate cancer treatment decision-making, and (2) decision-making about tracheostomy placement in critically ill children.

Supported by: The Greenwall Foundation, Making a Difference in Real-World Bioethics Dilemmas Grant Initiative

The development and efficacy-testing of a holistic, personalized, electronically integrated clinical decision support system for left-ventricular assist device candidates will help to ensure that heart failure patients receive tailored treatments that lead to optimal and values-based outcomes. Our study involves utilization of an AI/machine learning system that predicts personalized risks using big data. Specifically, it applies the most advanced personalized risk prediction technologies and decision support available to make sure that evidence about cardiac outcomes is used by both patients and clinicians in the service of shared decision making that leads to more informed and value-concordant health decisions. The impact of this personalized approach to clinical decision making addresses the urgent need to better identify and respond to the specific and dynamic nature of patient needs in seeking treatment for advanced HF.

We will do this by updating and integrating a validated online risk prediction and communication tool, the Heart Mate 3 Risk Score calculator developed by Dr. Mandeep Mehra and colleagues at Brigham and Women's Hospital, with our efficacy-tested decision aid (Deciding Together) for LVAD. 

This five-year project builds on six years of research on the development, implementation, and dissemination of LVAD decision support, as well as a decade of research into .

Supported by: R01 HS027784, Agency for ������Ƶ Research and Quality

Perceptual computing (PC), in combination with artificial intelligence and machine learning (AI/ML), is poised to revolutionize clinical approaches to diagnosis, personalized treatment (precision medicine), symptom and out- come monitoring, telemedicine/mobile health, and primary prevention across a wide range of disorders. PC tools are rapidly expanding but unresolved ethical and practical challenges stand in the way of responsible translation into clinical care. These challenges stem from the specific, novel features of PC metrics, which differ from traditional measures of emotional and social behavior in that they 1) represent objectively observed rather than subjectively elicited states and may involve collection of digital data that patients may not be aware of or wish to share with their clinicians; 2) collect data passively using digital devices that observe and register moment-to- moment emotional and behavioral information; 3) yield voluminous material (i.e. “big data”) that is difficult to scale into actionable information at the individual level; and 4) rest on data easy to collect and make inferences from, inviting engagement from commercial and other entities whose goals may be profit-driven rather than fiduciary, as in healthcare.

Triangulated results from these aims will contribute concrete insights into what diverse stakeholders need to know in order to understand and translate PC metrics into actionable clinical knowledge and will contribute to NCAT’s aims by ensuring the success and predictable impacts of translating PC metrics into clinical care.

Funded by: NCATS-Ethical Issues in Translational Science 

Role: Co-I 

This program will offer students a paid opportunity to explore the ethical dimensions of neuroscience research, including issues such as cognitive enhancement, brain-computer interfaces, and neuroimaging techniques. It will consist of two main components focused on experiential learning: (1) An embedded research experience for approximately 10 weeks, hosted by BCM’s Center for Medical Ethics and Health Policy. (2) A weekly Lunch and Learn session with faculty working at the intersection of neuroscience and ethics. Participation will involve virtual and in-person options (a hybrid approach) for undergraduate and graduate students.

Funded by: The Dana Foundation

Role: PI

This project examines the neuroethical issues around shared-decision making (SDM) associated with the use of deep brain stimulation (DBS) treatment for Parkinson’s disease (PD), with careful attention paid to early versus late disease stage. Interviews with patients, caregivers, and clinicians will inform the subsequent development and testing of a patient-centered decision aid (PtDA) for neurotechnology treatment.

Role: Co-Investigator (PI: Laura Cabrera)

Supported by NIH BRAIN-Initiative 1R01MH133659-01A1

As federal agencies increasingly invest in translational research on neural and brain-implantable devices, many studies now involve first-in-human (FIH) trials in which patients receive experimental neurodevices. These studies raise complex ethical questions, particularly around how patients decide whether to participate. This project examines the ethical and decision-making challenges associated with enrollment in early translational neurodevice research, focusing on patient vulnerabilities, informational needs, and the dynamics between patients, families, and clinician-researchers.

Through interviews with patients, caregivers, neurosurgeons, study coordinators, and other care team members involved in FIH neurodevice studies, particularly in areas such as closed-loop deep brain stimulation for chronic pain and treatment-resistant mood disorders, the research will identify key ethical concerns and decision-making needs. Findings will be used to develop and test a patient-centered communication and decision-support tool designed to help clinicians and patients navigate participation in translational neurodevice research while supporting informed, value-concordant decisions.

Supported by: R01 grant from the National Institute of Mental Health (NIMH), National Institutes of Health (NIH).

Choice architecture refers to how the presentation of choices may influence decision-making and is a technique that has been implemented in public and private policy domains. The way in which options are categorized and then presented to a decision-maker is an example of presenting options in a way that influences choice. Related to health care, for example, nations that require citizens to opt-out of organ transplant donation have a significantly higher organ-donor rate than nations where the citizens must affirmatively choose to take part (opt-in). Another technique suggested is laying out various outcomes of a decision in a way that is easy for the choice-maker to understand. The literature on choice architecture builds a framework to distinguish between two types of tools that choice architects can use: those that structure a choice in a certain way, and tools that make use of how options are presented to decision-makers. To illustrate, the use of a default, where the default option will lead to a more socially desirable outcome, is an example of structuring choices.

This project aims to develop empirically-informed comprehensive normative guidelines for the use of choice architecture in (1) prostate cancer treatment decision-making, and (2) decision-making about tracheostomy placement in critically ill children.

Supported by: The Greenwall Foundation, Making a Difference in Real-World Bioethics Dilemmas Grant Initiative

Dr. Blumenthal-Barby received two career development awards to carry out original research on the clinical and policy dilemmas arising at the intersection of ethics and decision science. The science of behavior change describes the power to influence individual and group health behaviors, which raises many ethical issues. The goal of this study is to clarify and address these ethical issues and categorize them into a set of recommendations for policymakers and researchers considering utilizing science of behavior change techniques. In addition, this research seeks to identify settings in which clinicians envision implementing science of behavior change techniques to influence their patients’ health decisions and behaviors. These results will lead to the development of ethically justified recommendations for clinicians to implement science of behavior change techniques.

Supported by: The Greenwall Foundation and The Pfizer Foundation

This is a research project studying disorders of consciousness (DOC) patients’ family members’ and clinical care team members’ views on consciousness and its moral significance. This research is investigating the following questions by interviewing family members and clinicians:

• What are the perceptions of consciousness regarding vegetative state (VS) and minimally conscious state (MCS) patients, as perceived by those patients' family members and clinicians. How do family members think about consciousness?
• How do VS/MCS patients' family members and clinicians perceive the significance of this consciousness. Is it better to be minimally conscious or not conscious at all? How does degree of consciousness factor into decision making about life support?

Supported by: TIRR Memorial Hermann, BCM2015-01

In this highly collaborative multi-disciplinary initiative, we propose to explore and compare the impact of using WGS in clinical conditions that model pure forms of each of these approaches. To model General Genomic Medicine, 10 primary care physicians and 100 of their healthy middle-aged patients will be enrolled. To model Disease-Specific Genomic Medicine, 10 cardiologists and 100 of their patients presenting with familial hypertrophic cardiomyopathy (HCM) will be enrolled. We will conduct an exploratory clinical trial randomizing physicians and their patients within each of these models to receive clinically meaningful information derived from WGS versus current standard of care. Project 1 will create standards for variant disclosure, enroll physicians and patients into the protocol and safely monitor the use of genomic information in clinical practice. Project 2 will sequence, analyze and interpret WGS for the physicians to use. And Project 3 will examine preferences and motivations of physicians and patients enrolled, evaluate the flow and utilization of genomic information within the clinical interactions, and assess understanding, behavior, medical consequences and healthcare costs associated with the use of WGS in these models of medical practice. This initiative will significantly accelerate the use of genomics into clinical medicine by creating and safely testing novel ways of integrating information from WGS into physician care of patients.

Role: Co-Investigator 

Funded by: NIH Project # 5U01HG006500  

In the context of decision making about management for clinically localized prostate cancer, normative behaviors are currently informed by conventional wisdom that a cancer diagnosis should be followed by immediate treatment and that delaying treatment puts the patient at greater risk of progression, need for more aggressive treatments, and perhaps death. We attempted to create messages that depict AS as a reasonable choice for men and to slow the decision-making process by communicating that patients have time to weigh their values and preferences and do not need to make a decision immediately. These messages took the form of quotations from men about the decision-making process. An example of a quotation about the non-acute nature of the decision follows: “Deciding about prostate cancer is a decision you make in weeks, not days.”

The goal of this study was to test the acceptability of normative messages about AS (in contrast to immediate treatment) as a management option for men with clinically localized prostate cancer from the perspectives of men who have made a treatment decision. This group of men was selected because they benefit from the experiences of going through the decision-making process, selecting a management option, and living with the consequences of their management decisions. We developed messages that might help men to consider AS as a reasonable option for managing prostate cancer and then tested these messages in a sample of men who had a previous diagnosis of early-stage prostate cancer.

Role: Consultant 

Funding: U48DP001949-01 AND NCCDPHP CDC HHS/United States

The program teaches students the tenets of professionalism through clinical case studies that involve issues of conflict-of-interest, discrimination in health care delivery, and unjust distribution of resources. Students also participate in a professionalism workshop and undertake writing exercises to reflect on instances when they have observed issues of professionalism in clinical practice.

Funded by: Institute of Medicine as a Profession and the Josiah Macy Jr. Foundation 

Role: Co-Investigator 

Pediatric dystonia is a debilitating movement disorder characterized by involuntary muscle contractions that cause unwanted movements and postures. This progressive disease often results in development of musculoskeletal deformities, which can lead to significant impairments in gait, standing, and hand function thereby severely impacting quality of life.

Since 1999, pediatric deep brain stimulation (pDBS) for refractory dystonia has become increasingly common around the world, but there has been little systematic research (e.g., clinical trials) regarding its safety and effectiveness in minors and limited examination of the ethical challenges and implications of this practice.

The long-term goal of this study is to promote the responsible use of neurotechnologies in children by empirically examining pressing neuroethics issues and decisional and informational needs of using DBS in this vulnerable population. The objectives of this study are 1) to examine which neuroethics issues, if any, actually pose a problem in this setting, determine how these issues manifest, what is the magnitude of the problem from the perspective of stakeholders, and develop ethically-justified guidelines to help manage these issues and 2) to develop a decision aid for families considering pDBS for dystonia. A decision aid for the most common pDBS indication (dystonia) will promote informed decision making, responsible use of DBS in children, and facilitate the development of decision aids for other pediatric neurotechnologies or DBS applications.

Supported by: RF1 MH121371, National Institute of Mental Health, NIH

Role: PI

This funding award by the Patient-Centered Outcomes Research Institute will enable investigators at ������Ƶ of Medicine, Houston Methodist, MD Anderson Cancer Center, and UT Houston Health Science Center to develop . The project stems from the center's collaborative work with the Houston Methodist Hospital System Biomedical Ethics Program, clinicians in the heart failure service at Houston Methodist Hospital, and the John M. Eisenberg Center for Clinical Decisions and Communication Services.

Under the direction of Jennifer Blumenthal-Barby, Ph.D., the study will focus on creating a patient-centered decision aid that presents outcomes, risks, experiences, and uncertainties about ventricular assist device placement in a clear, comprehensive, scientifically-valid, and unbiased manner to help patients make informed and value-based decisions.

The multi-disciplinary research team, with experts in ethics, decision science, qualitative and quantitative methods, and cardiology and cardiovascular surgery, will be working regularly with patient representatives from Houston Methodist Hospital to ensure that their research is truly reflective of patient needs and perspectives.

Our work on the LVAD decision aid is being continued through a , as well as a supplemental project about LVAD decisional needs during the COVID-19 pandemic.

Supported by: Patient-Centered Outcomes Research Institute

Role: PI