The Berman Institute at ASBH 2021

The Berman Institute will be well represented at the virtual 23nd annual meeting of the American Society for Bioethics and Humanities (ASBH), with a group of faculty, fellows, and students scheduled to present. The full program is available online. Follow the meeting on twitter using #ASBH21

 

Preview our diverse presentations below by:

Schedule | Presenter

All times listed are Eastern.

Tuesday, October 12

Affinity Group: ELSI with Kadija Ferryman (11:00 AM – Noon) - Zoom Room 1

ELSI Affinity Group

11:00 am – 12:00 pm EDT (10:00 am – 11:00 am CDT) Zoom Room 1

Presenters: Kadija Ferryman, Aaron Goldenberg, Gabriel Lazaro-Munoz 

Affinity Group: Jewish Bioethics with Marielle Gross (11:00 AM – Noon) - Zoom Room 11

Jewish Bioethics Affinity Group

11:00 am – 12:00 pm EDT (10:00 am – 11:00 am CDT) Zoom Room 11

Presenters: Jonathan Crane, Marielle Gross 

Patient-derived organoids represent the future of precision oncology. They provide a living, 3D recapitulation of an individual’s inherently unique cancer that can be screened for treatment response without exposing the individual to trial and error. Since these immortal disease models are time-consuming, technologically complicated and expensive to produce, they are not yet scalable for broad application but are instead used for the advancement of generalizable research, diagnostics and therapeutics. 

However, as current deidentification norms do not provide any mechanisms or promises to return relevant results or other benefits to the patient of origin, patients remain unaware of the existence of organoids created using their tissue, and they do not benefit from critical insights (e.g., BRCA mutation status) or other products of research and development directly relevant to their own care. 

In this session we consider a Talmudic debate between Beit Shammai and Beit Hillel (BT Gittin 55a) regarding appropriate recourse when a stolen beam was used in a building’s construction as a framework for thinking about what is owed to patients whose deidentified tissues are used to create organoids. 

Wednesday, October 13

Reifying respect for participants: Going beyond consent to attend to the broader research context with Stephanie Morain (11:00 AM – 12:15 PM) - Zoom Room 14

Reifying respect for participants: Going beyond consent to attend to the broader research context 

11:00 AM – 12:15 PM EDT (10:00 am – 11:15 am CDT) – ZOOM ROOM 14

Presenters: Devan Duenas, Stephanie Kraft, Stephanie Morain, Seema Shah 

Researchers and research ethicists have traditionally taken a narrow view of what it means to show respect for participants, often focusing on respect for autonomous decision-making via the informed consent process. Yet participant perspectives on respect indicate that aspects of research beyond consent, such as study design and post-trial engagement, are critically important to participants’ experiences of respect. This panel session will examine what it means to respect participants, drawing on an empirically based framework. The panel will begin with an overview of the standard approach to demonstrating respect for research participants by focusing on informed consent. The moderator will introduce mixed-methods data illustrating a range of activities — including but not limited to consent — that participants from diverse backgrounds identify as important for making them feel respected in research. Each panelist will then critically examine an aspect of research through the lens of respect: (1) considerations for demonstrating respect in pragmatic clinical trials where obtaining consent may be impracticable; (2) respectful methods for paying incentives and reimbursements to participants and the implications for equitable research practices; and (3) post-trial obligations and novel approaches to honoring participants for their contributions. The moderator will then briefly summarize the key issues raised by each presenter, followed by a panel discussion with the audience exploring issues such as how to navigate differing participant perspectives on respect, when and how respect should be balanced with other ethical obligations, and future research priorities for understanding how to demonstrate respect to participants. 

Thursday, October 14

When Studies Reach the End of the Road: Ethical Obligations for Early Stopping of Contemporary Clinical Trials with Stephanie Morain (11:00 AM – 12:15 PM)

When Studies Reach the End of the Road: Ethical Obligations for Early Stopping of Contemporary Clinical Trials  

11:00 am – 12:15 pm EDT (10:00 am – 11:15 am CDT), Zoom Room 7

Presenters: Emily Largent, Alex London, Stephanie Morain 

 The decision to stop clinical trials early—whether for futility, safety, or efficacy—requires, among other ethical considerations, weighing the harms and benefits to current research subjects and to current and future patients. While considerable scholarship has explored the ethics of early stopping, several features of the contemporary clinical trial landscape challenge the applicability of existing guidance, and obligations to participants have largely been overlooked. This panel will use normative and case-based lenses to map what happens when studies reach the end of the road sooner than expected. First, the moderator will provide a normative overview of early stopping. The first panelist will then examine the applicability of traditional guidance on early stopping in the context of pragmatic clinical trials. Traditional justifications for stopping often rely on distinguishing the duties researchers owe subjects from those physicians owe patients—a potentially tenuous distinction when research is deliberately integrated with care.The second panelist will discuss the requirements of clinical equipoise, including the importance of ensuring that studies generate evidence necessary to alter clinical practice, and the challenges posed when equipoise is disturbed for one aspect of an intervention (short-term efficacy) but not others (longer-term safety).Finally, the last panelist will look at the practical effects on participants of early stopping. The panelist will discuss legal barriers to notifying participants the trial has ended (which have contributed to participants finding out via the media), outline investigators’ ethical obligations to participants, and identify tools to improve communication and support participants when trials end early. 

Birth at the Crossroads: Revisiting Ethics of Home Birth with Marielle Gross & Rebecca Seltzer (12:30 PM – 1:45 PM)

Birth at the Crossroads: Revisiting Ethics of Home Birth 

12:30 pm – 1:45 pm EDT (11:30 am – 12:45 pm CDT)
Zoom Room 11
 

Speakers: Paige Anderson, Marielle Gross, Ryann Morales, Rebecca Seltzer

Despite COVID-era imperatives to avoid hospitals and stay home, the American College of Obstetricians and Gynecologists does not recommend home birth given relative risks of neonatal morbidity and mortality. We reflect on ethics surrounding home birth policy and current practices wherein childbirth remains the most common reason for hospitalization. A women’s health clinician-in-training with expertise in organizational psychology will moderate the discussion while introducing normative medical perspectives on home birth and comparing maternal-infant risks and benefits in the U.S. with other high-income settings. A child abuse pediatrician will share their experiences managing neonatal morbidity and mortality in the setting of home birth, highlighting fears motivating avoidance of hospital birth (e.g., mistreatment, maternal-infant separation related to substance use, COVID, or other hospital interventions) and describe challenges of inconsistent qualifications of home birth attendants. An attorney and home birth midwife will then provide a counter-narrative, describing home birth as a compelling alternative, and providing insight into etiology of adverse outcomes. They will discuss medicolegal considerations, financing, insurance, and policies impacting access to, and safety of, home birth. An obstetrician bioethicist will synthesize these perspectives vis-a-vis beneficence, autonomy, and justice, highlighting how: 1.Withholding support of home birth may not minimize harms. 2.The lack of moral, financial, and infrastructural support undermines informed decisions. 3.Disparities in access to home birth exacerbates reproductive injustice, especially for marginalized populations. We call for revisiting policies treating pregnancy as a one-way highway to the hospital, and will outline next steps to making home birth a viable path. 

Does a Child’s Right to an Open Future Include Access to Fertility Preservation? Barriers Among Children at Risk of Iatrogenic Infertility with Yoram Unguru (12:30 – 1:45 PM)

Does a Child’s Right to an Open Future Include Access to Fertility Preservation? Barriers Among Children at Risk of Iatrogenic Infertility 

12:30 pm – 1:45 pm EDT (11:30 am – 12:45 am CDT) – Zoom Room 2

Presenters: Kristin Canavera, Liza-Marie Johnson, Stefanie Thomas, Yoram Unguru 

Fertility preservation technologies are at a crossroads: moving rapidly from experimental procedures available only via clinical trials to clinically standard therapies for patients who have access to medical centers with reproductive endocrinology services. Individuals with serious medical conditions who require therapeutic medical treatments likely to result in partial or complete future infertility may benefit from these recent advances. Examples of such medical therapies include many cancer-directed therapies, sickle cell disease or other disorders offered gene therapy or bone marrow transplantation. The choice to preserve reproductive tissues may preserve a patient’s fertility options in the future. Adults with reproductive maturity can make informed decisions to pursue fertility preservation treatments, although many face systemic barriers that limit access such as referral bias and financial barriers due to lack of insurance coverage. In pediatrics, the issue is more complicated with oncologists and parents often serving as the gatekeepers of decision-making. Furthermore, preservation is technically more difficult in pre-pubertal children and the future benefits are less certain in this subgroup of patients. After providing a brief overview of the technologies available for fertility preservation in pediatrics we will present the ethical issues associated with offering fertility preservation to children at-risk of future infertility while highlighting how the current system often promotes bias in referral and limits access to fertility preservation counseling and decision-making. As we stand at the crossroads of experimental and clinically standard therapy, we will offer suggestions for improving the current process through both advocacy and standardization of practice. 

The Immortal Life of Us: Mapping Intersecting Obligations in Learning from Care with Amelia Hood (4:30 – 5:45 PM) - Zoom Room 11

The Immortal Life of Us: Mapping Intersecting Obligations in Learning from Care 

4:30 pm – 5:45 pm EDT (3:30 pm – 4:45 pm CDT) – Zoom Room 11 

Presenters: Amelia Hood
Panel: Addressing and Learning From Bias and Perspective Taking 

Learning Health Systems (LHS) work to ensure that lessons learned while caring for patients today make tomorrow’s health better. LHS are driven by continuous cycles of learning whereby patients’ data are captured, create databases which serve as platforms for generating new knowledge, then translated into healthcare improvements. We use the Henrietta Lacks case to diagram flow of data through this system, conceptualizing role-related fiduciary duties of patients and physicians, and considering structural elements of these relationships which may raise justice concerns. First, we trace removal of Ms. Lacks’ cells during her cancer treatment, their use in creating an immortal human cell line as a platform for countless subsequent studies, their empowerment of scientific breakthroughs, and ultimately, essential medical advances, including beneficial vaccines, medications and therapies for which there are disparities in access (e.g., IVF). This case illustrates the structural distribution of value and learning-related obligations that may have applied to both Ms. Lacks, her physicians and the system itself. Then, we advance patient-qua-subject and physician-qua-researcher as fiduciary roles which must be clearly articulated within LHS wherein these identities merge. We consider the scientific and moral significance of non-voluntary research participation in the context of patient vulnerabilities and existing inequities in access to healthcare. Similarly, physicians’ fiduciary duties must expand by virtue of their obligatory role as extractors, documenters and primary users of clinical data. Finally, we discuss the LHS as fiduciary for both patients-qua-subjects and physicians-qua-researchers, and consider whether current learning, trust and translational structures are distributively just. 

Friday, October 15

Conceptualizing an Ethical Framework of COVID-19 Vaccine Hesitancy among Healthcare Personnel with Rachel Gur-Arie (Noon – 1:15 PM) - Zoom Room 11

Conceptualizing an Ethical Framework of COVID-19 Vaccine Hesitancy among Healthcare Personnel 

Noon – 1:15 pm EDT (11:00 am – 12:15 pm CDT) – Zoom Room 11 

Presenters: Rachel Gur-Arie
Panel: Vaccine Allocation and Healthcare Providers 

Healthcare personnel (HCP) are key connectors of vaccine information among the general public, yet HCP hesitancy towards COVID-19 vaccines is significant. COVID-19 vaccine hesitancy among HCP, characterized by uncertainty and their lived experiences on the frontlines of the pandemic, can pose a significant challenge to increasing their COVID-19 vaccine uptake. Vaccine hesitancy among HCP does not arise in a vacuum of professionalism — it is molded at the intersection of personal, professional, and societal influences. The COVID-19 pandemic has sharpened the need for further defining the ethical dimensions of this underexplored intersectional space in regards to negotiating vaccine hesitancy and HCP responsibilities. In this project, we utilize conceptual and deliberative methods to inform the development of a draft ethics framework regarding vaccine hesitancy among HCP, including mapping and categorizing data; identifying and naming concepts; deconstructing, categorizing, and integrating concepts; synthesizing and resynthesizing materials to develop the framework; and active validation. This draft ethical framework is targeted towards policymakers and professional societies involved in articulating and enforcing vaccine norms among HCP across health systems. We address ethical tensions that the COVID-19 pandemic has exacerbated, like uncertainty, disagreement regarding HCP obligations to the public, and unclear institutional responsibilities towards public health. Though this draft ethical framework is based on COVID-19 vaccine hesitancy among HCP, we intend for it to apply to hesitancy towards other vaccines as well, and offer constructs relevant to considering the ethics of vaccine decision making broadly. 

Becoming a Physician in a Disaster: Moral Resilience and Physician Identity Formation via Reflective Writing with Vivian Altiery De Jesus (5:30 – 6:45 PM) - Zoom Room 16

Becoming a Physician in a Disaster: Moral Resilience and Physician Identity Formation via Reflective Writing 

5:30 pm – 6:45 pm EDT (4:30 pm – 5:45 pm CDT) – Zoom Room 16 

Presenters: Vivian Altery De Jesus
Panel: Ethical Considerations of COVID-19 Flash Presentations 

As medical students (MS) transition from the classroom to the clinic, they are exposed to challenging clinical scenarios that, without careful consideration, may lead to moral distress or injury, negatively affecting professional identity formation (PIF). Unfortunately, in most cases, MS are unaware of their PIF development. Therefore, MS need appropriate and effective tools to properly guide their PIF. Reflective writing, which prompts critical, facilitates and supports PIF. This is especially important during times of high moral distress, such as disasters, which increase the risk of internalizing negative values, such as moral injury, hopelessness, and a lack of empathy. In September 2017, as an M3, I fully transitioned to the wards at a large hospital in Puerto Rico. That same month, Hurricane María devastated the island. Three years later, and I find myself as an M4 in the middle of another disaster: the COVID-19 pandemic. MS across the country, myself included, are facing similar uncertainties, distress, scarce resources, and other difficult events I endured in 2017. Through reflective writing, I explored my expectations, my frustrations, and other bioethical and humanistic aspects of medical care (e.g., end of life care, shared decision making, informed consent).This exercise helped me navigate these difficulties scenarios, process the experiences, to overcome the stress they induced, and to gain confidence as a physician. Reflection helped me internalize desirable professional values such as cultural humility, teamwork, and moral resilience . Narrative medicine may help MS construct a positive PIF and develop moral resilience, especially during disasters. 

Moving Beyond Mistrust: Centering Institutional Change by Decentering the White Analytical Lens with Alyssa Newman (5:30 – 6:45 PM) - Zoom Room 8

Moving Beyond Mistrust: Centering Institutional Change by Decentering the White Analytical Lens 

5:30 pm – 6:45 pm EDT (4:30 pm – 5:45 pm CDT) – Zoom Room 8 

Speakers: Alyssa Newman
Panel: Institutional Responses to Racism 

The topic of Black mistrust of medical institutions has received a great deal of attention over the course of the Covid-19 pandemic, especially with the arrival of vaccines and the emergence of a gap in vaccination rates by race. This paper examines current discourses and debates over medical mistrust, and describes the limitations of the mistrust framework for identifying and addressing the institutional change necessary to remedy racial health inequities. As numerous observers have pointed out, the mistrust discourse largely places the burden of change on historically exploited and mistreated populations, rather than on the medical institutions that committed the violations and continue the mistreatment that are often identified as the source of mistrust. However, even the analytic shift to focus on the trustworthiness of institutions narrows the scope of the issue to the relationships of medical institutions to specific communities. While the mistrust literature has made important contributions to centering and valuing Black perspectives, this framework delimits the focus to Black perceptions rather than on medical institutions themselves, in particular their ability to maintain legitimacy in the face of mistrustful relationships and in light of their own stated values, principles, and purpose. Whereas the predominately white lens of bioethics scholarship has centered Black populations by making them the subject of analysis, this paper draws a distinction between simply analyzing, versus meaningfully centering and deriving an analysis from the perspective of marginalized populations within scholarship. This paper explores the applicability of the institutional legitimacy framework for addressing racial health inequities. 

Saturday, October 16

Ethical Considerations in Developing a Minimum Insurance Benefit Model for Gender Affirming Care with Theodore Schall (11:00 AM – 12:15 PM) - Zoom Room 15

Ethical Considerations in Developing a Minimum Insurance Benefit Model for Gender Affirming Care 

11:00 am – 12:15 pm EDT (10:00 am – 11:15 am CDT) – Zoom Room 15 

Presenters: Theodore Schall
Panel: Ethical Issues in Health Care Access 

A patchwork of state regulations variably mandate, prohibit, and omit coverage of gender affirming care for US transgender patients. Even in states with mandates, coverage varies by payer type and plan. While the World Professional Association for Transgender Health (WPATH) Standards of Care define some care as medically necessary, they do not specify which interventions are necessary in which circumstances, leaving payers to write heterogenous policies. Despite the proven benefits of gender affirming care, patients, clinicians, and legal advocates face ongoing difficulty obtaining coverage for it, which contributes to trans health disparities. Patients, clinicians, regulators, and payers stand to benefit from standardization of coverage for gender affirming care. Development of a minimum coverage model (for state or federal enactment) stands to provide a singular target for advocacy and likely make access more equitable. While some trans health advocates argue for coverage of all possible interventions as a remedy for social marginalization, this trans exceptionalism risks, among other issues, future reversals in political will. Instead, the rationale for coverage of gender affirming care should be consistent with that of other types of care, based on standard methods such as those used in health technology assessment. Ethically salient considerations for development of a minimum coverage model for gender affirming care include evidence of cost effectiveness, short and long-term outcomes (including measures of both euphoria and dysphoria), stakeholder ownership (relying on the double expertise of transgender health professionals and legal scholars), local and subpopulation needs, and procedural justice. 

Public Health Deference: Rethinking the Role of Courts During a Pandemic with Brian Hutler (12:30 – 1:45 PM) - Zoom Room 13

Public Health Deference: Rethinking the Role of Courts During a Pandemic 

12:30 pm – 1:45 pm EDT (11:30 am – 12:45 pm CDT) – Zoom Room 13 

Presenters: Brian Hutler
Panel: Public Health Policy 

Jacobson v. Massachusetts has long stood for the principle that courts should exercise deference toward the government during a public health emergency. But the COVID-19 pandemic has disrupted this traditional understanding, as federal courts have intervened to strike down or enjoin a number of pandemic-response policies on constitutional rights grounds. Most notably, in Roman Catholic Diocese of Brooklyn v. Cuomo, the Supreme Court blocked New York’s limits on in-person religious gatherings. At the same time, however, courts have continued to defer to the government’s pandemic response in other cases. For example, the Supreme Court upheld a Food and Drug Administration rule requiring patients to visit a clinic before obtaining a medicated abortion. These decisions reflect a troubling pattern of blocking pandemic-response policies when they conflict with religious freedom, while deferring to the government when its policies impact other, apparently less favored rights. This paper argues, first, that Jacobson must be reconsidered in light of COVID-19, but it should not be replaced by an ad hoc double standard. Instead, this article proposes a new theory of the “Public Health Deference” that courts should afford to the government during a public health emergency. Public Health Deference should be premised on the quality of the processes by which the government creates and implements pandemic-response policies. Courts should not blindly defer to the government’s pandemic response, but should instead evaluate the government’s decision-making processes to ensure that they meet standards of transparency, accountability, public justification, and community engagement. 

The Ethical Foundations of Harm Reduction (and Its Opposition) with Travis Rieder (2:15 – 3:30 PM) - Zoom Room 11

The Ethical Foundations of Harm Reduction (and Its Opposition) 

2:15 pm – 3:30 pm EDT (1:15 pm – 2:30 pm CDT) – Zoom Room 11 

Presenters: Travis Rieder
Panel: Making and Evaluating Ethical Policy 

Harm reduction is the name given to interventions that attempt to reduce the harm from some activity by ‘meeting people where they are’—without judgment or stigma—and without insisting that recipients of the intervention abstain from the activity in question. In the context of drug policy, harm reduction is about making drug use safer. Evidence-based interventions include widely accepted practices like the distribution of naloxone, which can reverse an opioid overdose; mildly controversial ones like syringe exchange, which can reduce needle-sharing and so reduce the incidence of blood-borne disease; all the way up through very controversial interventions like safe consumption sites (where drugs can be consumed in the presence of staffers trained to treat overdose) and prescription heroin or hydromorphone (in order to provide adulterant-free drugs).All of these interventions promise to reduce drug overdose deaths and drug-related harm in the midst of a terrible overdose crisis, and yet the US is deeply divided on the permissibility of many of them. While public health scientists advocate for harm reduction by repeatedly generating empirical evidence showing that such interventions work (that they do, in fact, reduce harm), in this paper I will argue that this strategy misses an important point: opposition to harm reduction isn’t always based on evidence; it’s often based on values and an implicit moral philosophy. I therefore propose to interrogate that moral philosophy, and to explore how understanding the ethical foundations of both harm reduction and its opposition may help to move the conversation forward. 

The Ethical Imperative for Diversity: Stakeholder Perspectives on Inclusion in Precision Medicine with Kadija Ferryman (3:45 – 5:00 PM) - Zoom Room 6

The Ethical Imperative for Diversity: Stakeholder Perspectives on Inclusion in Precision Medicine

3:45 pm – 5:00 pm EDT (2:45 pm – 4:00 pm CDT), Zoom Room 6 

Presenters: Johanna Crane, Kadija Ferryman, Sandra Lee, Alexis Walker 

Efforts to build precision medicine research (PMR) have increasingly included goals of “diversity and inclusion” of historically underrepresented populations, including people of color, sexual and gender minorities, individuals with disabilities, and people from socioeconomically disadvantaged groups. This multi-institutional panel presents empirical research of stakeholder perspectives on diversity from four studies of PMR in the US. The first panelist will draw on findings from a multi-sited study of three PMR consortia to discuss stakeholder perspectives on goals of inclusion as they relate to enrollment and participant engagement, and competing views on the promise of PMR for addressing health disparities. The second panelist will discuss a study of Federally Qualified Health Centers (FQHC) in the All of Us Research Program to describe how FQHCs serve as recruitment sites for diverse and underrepresented research participants and the ethical challenges raised by returning clinically actionable research results to un/under-insured FQHC patients. The third panelist will present findings from a study of researchers, software engineers, and patients involved in PMR projects on the ways that inclusion has been framed and understood in relation to ‘big data,’ and how this reveals and forecloses avenues for participant engagement in precision medicine. The fourth panelist will present results from a multi-methods study of perspectives from members of the private sector genomics industry in the US, regarding the ethical and scientific imperative of diversity of genetic datasets, and how stakeholders differ substantially in their understandings of “good science” and its roots, implications, and progress within commercial genomics. 

Disparity, Diversity, DNA & Drama: Equity in Ethics and Interprofessional Education with Karen Rothenberg (5:15 – 6:30 PM) - Zoom Room 8

Disparity, Diversity, DNA & Drama: Equity in Ethics and Interprofessional Education

5:15 pm – 6:30 pm EDT (4:15 pm – 5:30 pm CDT), Zoom Room 8 

Presenters: Lynn Bush, Cheryl Lew, Karen Rothenberg, Robert Truog

The premiere of amulti-vignette play will provide a dramatic narrative pedagogical approach at the intersection of genomics and ethics to explore deep concerns in interprofessional education and healthcare that are too often experienced as myopic and exclusionary. The two scenarios will each spotlight fictional voices of trainees, senior staff, and patients with disparate perspectives to actively engage the ASBH community in sensitive conversations in the context of ethical aspects across a broad spectrum related to genomics. The characters will bring to life challenging aspects in genetics, such as identity, inheritance, disability, databases, access to diagnosis and treatment, and professional education for diverse interdisciplinary providers.The play’s dialogue will illuminate the implications and current tensions arising from an historically narrow landscape paved with disparities to critically examine new paths that welcome and help individuals previously excluded, including due to structural racism and implicit bias in bioethics and genetics education, health services, and research. The twenty-minute drama will set the stage to enhance reflective ethical consideration of these thorny issues and foster lively interprofessional discourse that strives to create solutions for a more just, equitable, and diverse society. The nation-wide troupe of distinguished multidisciplinary bioethicists-educators-actors (to include PhD; MD; JD) will share insights based on their character’s role and own experiences. The audience is further engaged as well with active interaction elicited throughout the session on substantive issues raised by the vignettes and then, regarding the use of this narrative genomic pedagogy as methodology for interprofessional ethics education.

Presenter

Faculty and Staff | Hecht-Levi Fellows and Students

Kadija Ferryman, PhD
Assistant Professor
Affinity Group: ELSI

Tuesday, October 12

11:00 AM – Noon EDT (10:00 AM – 11:00 am CDT)

Zoom Room 1

Presenters: Kadija Ferryman, Aaron Goldenberg, Gabriel Lazaro-Munoz 

The Ethical Imperative for Diversity: Stakeholder Perspectives on Inclusion in Precision Medicine

The Ethical Imperative for Diversity: Stakeholder Perspectives on Inclusion in Precision Medicine

Saturday, October 16

3:45 pm – 5:00 pm EDT (2:45 pm – 4:00 pm CDT)

Zoom Room 6 

Presenters: Johanna Crane, Kadija Ferryman, Sandra Lee, Alexis Walker 

Efforts to build precision medicine research (PMR) have increasingly included goals of “diversity and inclusion” of historically underrepresented populations, including people of color, sexual and gender minorities, individuals with disabilities, and people from socioeconomically disadvantaged groups. This multi-institutional panel presents empirical research of stakeholder perspectives on diversity from four studies of PMR in the US. The first panelist will draw on findings from a multi-sited study of three PMR consortia to discuss stakeholder perspectives on goals of inclusion as they relate to enrollment and participant engagement, and competing views on the promise of PMR for addressing health disparities. The second panelist will discuss a study of Federally Qualified Health Centers (FQHC) in the All of Us Research Program to describe how FQHCs serve as recruitment sites for diverse and underrepresented research participants and the ethical challenges raised by returning clinically actionable research results to un/under-insured FQHC patients. The third panelist will present findings from a study of researchers, software engineers, and patients involved in PMR projects on the ways that inclusion has been framed and understood in relation to ‘big data,’ and how this reveals and forecloses avenues for participant engagement in precision medicine. The fourth panelist will present results from a multi-methods study of perspectives from members of the private sector genomics industry in the US, regarding the ethical and scientific imperative of diversity of genetic datasets, and how stakeholders differ substantially in their understandings of “good science” and its roots, implications, and progress within commercial genomics. 

Affinity Group: Jewish Bioethics

Tuesday, October 12

11:00 am – Noon EDT (10:00 am – 11:00 am CDT)

Zoom Room 11

Presenters: Jonathan Crane, Marielle Gross 

Patient-derived organoids represent the future of precision oncology. They provide a living, 3D recapitulation of an individual’s inherently unique cancer that can be screened for treatment response without exposing the individual to trial and error. Since these immortal disease models are time-consuming, technologically complicated and expensive to produce, they are not yet scalable for broad application but are instead used for the advancement of generalizable research, diagnostics and therapeutics. 

However, as current deidentification norms do not provide any mechanisms or promises to return relevant results or other benefits to the patient of origin, patients remain unaware of the existence of organoids created using their tissue, and they do not benefit from critical insights (e.g., BRCA mutation status) or other products of research and development directly relevant to their own care. 

In this session we consider a Talmudic debate between Beit Shammai and Beit Hillel (BT Gittin 55a) regarding appropriate recourse when a stolen beam was used in a building’s construction as a framework for thinking about what is owed to patients whose deidentified tissues are used to create organoids. 

Birth at the Crossroads: Revisiting Ethics of Home Birth

Birth at the Crossroads: Revisiting Ethics of Home Birth 

Thursday, October 14

12:30 pm – 1:45 pm EDT (11:30 am – 12:45 pm CDT)

Zoom Room 11 

Speakers: Paige Anderson, Jennie Green, Marielle Gross, Ryann Morales 

Despite COVID-era imperatives to avoid hospitals and stay home, the American College of Obstetricians and Gynecologists does not recommend home birth given relative risks of neonatal morbidity and mortality. We reflect on ethics surrounding home birth policy and current practices wherein childbirth remains the most common reason for hospitalization. A women’s health clinician-in-training with expertise in organizational psychology will moderate the discussion while introducing normative medical perspectives on home birth and comparing maternal-infant risks and benefits in the U.S. with other high-income settings. A child abuse pediatrician will share their experiences managing neonatal morbidity and mortality in the setting of home birth, highlighting fears motivating avoidance of hospital birth (e.g., mistreatment, maternal-infant separation related to substance use, COVID, or other hospital interventions) and describe challenges of inconsistent qualifications of home birth attendants. An attorney and home birth midwife will then provide a counter-narrative, describing home birth as a compelling alternative, and providing insight into etiology of adverse outcomes. They will discuss medicolegal considerations, financing, insurance, and policies impacting access to, and safety of, home birth. An obstetrician bioethicist will synthesize these perspectives vis-a-vis beneficence, autonomy, and justice, highlighting how: 1.Withholding support of home birth may not minimize harms. 2.The lack of moral, financial, and infrastructural support undermines informed decisions. 3.Disparities in access to home birth exacerbates reproductive injustice, especially for marginalized populations. We call for revisiting policies treating pregnancy as a one-way highway to the hospital, and will outline next steps to making home birth a viable path. 

Amelia Hood, MA
Research Associate
The Immortal Life of Us: Mapping Intersecting Obligations in Learning from Care

The Immortal Life of Us: Mapping Intersecting Obligations in Learning from Care 

Thursday October 14

4:30 pm – 5:45 pm EDT (3:30 pm – 4:45 pm CDT)

Zoom Room 11 

Presenters: Amelia Hood
Panel: Addressing and Learning From Bias and Perspective Taking 

Learning Health Systems (LHS) work to ensure that lessons learned while caring for patients today make tomorrow’s health better. LHS are driven by continuous cycles of learning whereby patients’ data are captured, create databases which serve as platforms for generating new knowledge, then translated into healthcare improvements. We use the Henrietta Lacks case to diagram flow of data through this system, conceptualizing role-related fiduciary duties of patients and physicians, and considering structural elements of these relationships which may raise justice concerns. First, we trace removal of Ms. Lacks’ cells during her cancer treatment, their use in creating an immortal human cell line as a platform for countless subsequent studies, their empowerment of scientific breakthroughs, and ultimately, essential medical advances, including beneficial vaccines, medications and therapies for which there are disparities in access (e.g., IVF). This case illustrates the structural distribution of value and learning-related obligations that may have applied to both Ms. Lacks, her physicians and the system itself. Then, we advance patient-qua-subject and physician-qua-researcher as fiduciary roles which must be clearly articulated within LHS wherein these identities merge. We consider the scientific and moral significance of non-voluntary research participation in the context of patient vulnerabilities and existing inequities in access to healthcare. Similarly, physicians’ fiduciary duties must expand by virtue of their obligatory role as extractors, documenters and primary users of clinical data. Finally, we discuss the LHS as fiduciary for both patients-qua-subjects and physicians-qua-researchers, and consider whether current learning, trust and translational structures are distributively just. 

Stephanie Morain, PhD, MPH
PhD Program Director; Associate Professor
Reifying respect for participants: Going beyond consent to attend to the broader research context

Reifying respect for participants: Going beyond consent to attend to the broader research context 

Wednesday October 13

11:00 AM – 12:15 PM EST

ZOOM ROOM 14

Presenters: Devan Duenas, Stephanie Kraft, Stephanie Morain, Seema Shah 

Researchers and research ethicists have traditionally taken a narrow view of what it means to show respect for participants, often focusing on respect for autonomous decision-making via the informed consent process. Yet participant perspectives on respect indicate that aspects of research beyond consent, such as study design and post-trial engagement, are critically important to participants’ experiences of respect. This panel session will examine what it means to respect participants, drawing on an empirically based framework. The panel will begin with an overview of the standard approach to demonstrating respect for research participants by focusing on informed consent. The moderator will introduce mixed-methods data illustrating a range of activities — including but not limited to consent — that participants from diverse backgrounds identify as important for making them feel respected in research. Each panelist will then critically examine an aspect of research through the lens of respect: (1) considerations for demonstrating respect in pragmatic clinical trials where obtaining consent may be impracticable; (2) respectful methods for paying incentives and reimbursements to participants and the implications for equitable research practices; and (3) post-trial obligations and novel approaches to honoring participants for their contributions. The moderator will then briefly summarize the key issues raised by each presenter, followed by a panel discussion with the audience exploring issues such as how to navigate differing participant perspectives on respect, when and how respect should be balanced with other ethical obligations, and future research priorities for understanding how to demonstrate respect to participants. 

When Studies Reach the End of the Road: Ethical Obligations for Early Stopping of Contemporary Clinical Trials

When Studies Reach the End of the Road: Ethical Obligations for Early Stopping of Contemporary Clinical Trials  

Thursday, October 14

11:00 am – 12:15 pm EDT (10:00 am – 11:15 am CDT)

Zoom Room 7

Presenters: Emily Largent, Alex London, Stephanie Morain 

 The decision to stop clinical trials early—whether for futility, safety, or efficacy—requires, among other ethical considerations, weighing the harms and benefits to current research subjects and to current and future patients. While considerable scholarship has explored the ethics of early stopping, several features of the contemporary clinical trial landscape challenge the applicability of existing guidance, and obligations to participants have largely been overlooked. This panel will use normative and case-based lenses to map what happens when studies reach the end of the road sooner than expected. First, the moderator will provide a normative overview of early stopping. The first panelist will then examine the applicability of traditional guidance on early stopping in the context of pragmatic clinical trials. Traditional justifications for stopping often rely on distinguishing the duties researchers owe subjects from those physicians owe patients—a potentially tenuous distinction when research is deliberately integrated with care.The second panelist will discuss the requirements of clinical equipoise, including the importance of ensuring that studies generate evidence necessary to alter clinical practice, and the challenges posed when equipoise is disturbed for one aspect of an intervention (short-term efficacy) but not others (longer-term safety).Finally, the last panelist will look at the practical effects on participants of early stopping. The panelist will discuss legal barriers to notifying participants the trial has ended (which have contributed to participants finding out via the media), outline investigators’ ethical obligations to participants, and identify tools to improve communication and support participants when trials end early. 

Travis N. Rieder, PhD
Director for Education Initiatives; Director of the MBE Program; Associate Research Professor
The Ethical Foundations of Harm Reduction (and Its Opposition)

The Ethical Foundations of Harm Reduction (and Its Opposition) 

Saturday, October 16

2:15 pm – 3:30 pm EDT (1:15 pm – 2:30 pm CDT)

Zoom Room 11 

Presenters: Travis Rieder
Panel: Making and Evaluating Ethical Policy 

Harm reduction is the name given to interventions that attempt to reduce the harm from some activity by ‘meeting people where they are’—without judgment or stigma—and without insisting that recipients of the intervention abstain from the activity in question. In the context of drug policy, harm reduction is about making drug use safer. Evidence-based interventions include widely accepted practices like the distribution of naloxone, which can reverse an opioid overdose; mildly controversial ones like syringe exchange, which can reduce needle-sharing and so reduce the incidence of blood-borne disease; all the way up through very controversial interventions like safe consumption sites (where drugs can be consumed in the presence of staffers trained to treat overdose) and prescription heroin or hydromorphone (in order to provide adulterant-free drugs).All of these interventions promise to reduce drug overdose deaths and drug-related harm in the midst of a terrible overdose crisis, and yet the US is deeply divided on the permissibility of many of them. While public health scientists advocate for harm reduction by repeatedly generating empirical evidence showing that such interventions work (that they do, in fact, reduce harm), in this paper I will argue that this strategy misses an important point: opposition to harm reduction isn’t always based on evidence; it’s often based on values and an implicit moral philosophy. I therefore propose to interrogate that moral philosophy, and to explore how understanding the ethical foundations of both harm reduction and its opposition may help to move the conversation forward. 

Disparity, Diversity, DNA & Drama: Equity in Ethics and Interprofessional Education

Disparity, Diversity, DNA & Drama: Equity in Ethics and Interprofessional Education

Saturday, October 16

5:15 pm – 6:30 pm EDT (4:15 pm – 5:30 pm CDT)

Zoom Room 8 

Presenters: Lynn Bush, Cheryl Lew, Karen Rothenberg, Robert Truog

The premiere of amulti-vignette play will provide a dramatic narrative pedagogical approach at the intersection of genomics and ethics to explore deep concerns in interprofessional education and healthcare that are too often experienced as myopic and exclusionary. The two scenarios will each spotlight fictional voices of trainees, senior staff, and patients with disparate perspectives to actively engage the ASBH community in sensitive conversations in the context of ethical aspects across a broad spectrum related to genomics. The characters will bring to life challenging aspects in genetics, such as identity, inheritance, disability, databases, access to diagnosis and treatment, and professional education for diverse interdisciplinary providers.The play’s dialogue will illuminate the implications and current tensions arising from an historically narrow landscape paved with disparities to critically examine new paths that welcome and help individuals previously excluded, including due to structural racism and implicit bias in bioethics and genetics education, health services, and research. The twenty-minute drama will set the stage to enhance reflective ethical consideration of these thorny issues and foster lively interprofessional discourse that strives to create solutions for a more just, equitable, and diverse society. The nation-wide troupe of distinguished multidisciplinary bioethicists-educators-actors (to include PhD; MD; JD) will share insights based on their character’s role and own experiences. The audience is further engaged as well with active interaction elicited throughout the session on substantive issues raised by the vignettes and then, regarding the use of this narrative genomic pedagogy as methodology for interprofessional ethics education.

Rebecca R. Seltzer, MD, MHS
Affiliate Professor
Birth at the Crossroads: Revisiting Ethics of Home Birth

Birth at the Crossroads: Revisiting Ethics of Home Birth 

Thursday, October 14

12:30 pm – 1:45 pm EDT (11:30 am – 12:45 pm CDT)

Zoom Room 11 

Speakers: Paige Anderson, Marielle Gross, Ryann Morales, Rebecca Seltzer

Despite COVID-era imperatives to avoid hospitals and stay home, the American College of Obstetricians and Gynecologists does not recommend home birth given relative risks of neonatal morbidity and mortality. We reflect on ethics surrounding home birth policy and current practices wherein childbirth remains the most common reason for hospitalization. A women’s health clinician-in-training with expertise in organizational psychology will moderate the discussion while introducing normative medical perspectives on home birth and comparing maternal-infant risks and benefits in the U.S. with other high-income settings. A child abuse pediatrician will share their experiences managing neonatal morbidity and mortality in the setting of home birth, highlighting fears motivating avoidance of hospital birth (e.g., mistreatment, maternal-infant separation related to substance use, COVID, or other hospital interventions) and describe challenges of inconsistent qualifications of home birth attendants. An attorney and home birth midwife will then provide a counter-narrative, describing home birth as a compelling alternative, and providing insight into etiology of adverse outcomes. They will discuss medicolegal considerations, financing, insurance, and policies impacting access to, and safety of, home birth. An obstetrician bioethicist will synthesize these perspectives vis-a-vis beneficence, autonomy, and justice, highlighting how: 1.Withholding support of home birth may not minimize harms. 2.The lack of moral, financial, and infrastructural support undermines informed decisions. 3.Disparities in access to home birth exacerbates reproductive injustice, especially for marginalized populations. We call for revisiting policies treating pregnancy as a one-way highway to the hospital, and will outline next steps to making home birth a viable path. 

Yoram Unguru, MD, MS, MA
Associate Professor
Does a Child’s Right to an Open Future Include Access to Fertility Preservation? Barriers Among Children at Risk of Iatrogenic Infertility

Does a Child’s Right to an Open Future Include Access to Fertility Preservation? Barriers Among Children at Risk of Iatrogenic Infertility 

Thursday, October 14

12:30 pm – 1:45 pm EDT (11:30 am – 12:45 am CDT)

Zoom Room 2

Presenters: Kristin Canavera, Liza-Marie Johnson, Stefanie Thomas, Yoram Unguru 

Fertility preservation technologies are at a crossroads: moving rapidly from experimental procedures available only via clinical trials to clinically standard therapies for patients who have access to medical centers with reproductive endocrinology services. Individuals with serious medical conditions who require therapeutic medical treatments likely to result in partial or complete future infertility may benefit from these recent advances. Examples of such medical therapies include many cancer-directed therapies, sickle cell disease or other disorders offered gene therapy or bone marrow transplantation. The choice to preserve reproductive tissues may preserve a patient’s fertility options in the future. Adults with reproductive maturity can make informed decisions to pursue fertility preservation treatments, although many face systemic barriers that limit access such as referral bias and financial barriers due to lack of insurance coverage. In pediatrics, the issue is more complicated with oncologists and parents often serving as the gatekeepers of decision-making. Furthermore, preservation is technically more difficult in pre-pubertal children and the future benefits are less certain in this subgroup of patients. After providing a brief overview of the technologies available for fertility preservation in pediatrics we will present the ethical issues associated with offering fertility preservation to children at-risk of future infertility while highlighting how the current system often promotes bias in referral and limits access to fertility preservation counseling and decision-making. As we stand at the crossroads of experimental and clinically standard therapy, we will offer suggestions for improving the current process through both advocacy and standardization of practice. 

Hecht-Levi Fellows and Students

Becoming a Physician in a Disaster: Moral Resilience and Physician Identity Formation via Reflective Writing

Becoming a Physician in a Disaster: Moral Resilience and Physician Identity Formation via Reflective Writing 

Friday, October 15

5:30 pm – 6:45 pm EDT (4:30 pm – 5:45 pm CDT)

Zoom Room 16 

Presenters: Vivian Altery De Jesus
Panel: Ethical Considerations of COVID-19 Flash Presentations 

As medical students (MS) transition from the classroom to the clinic, they are exposed to challenging clinical scenarios that, without careful consideration, may lead to moral distress or injury, negatively affecting professional identity formation (PIF). Unfortunately, in most cases, MS are unaware of their PIF development. Therefore, MS need appropriate and effective tools to properly guide their PIF. Reflective writing, which prompts critical, facilitates and supports PIF. This is especially important during times of high moral distress, such as disasters, which increase the risk of internalizing negative values, such as moral injury, hopelessness, and a lack of empathy. In September 2017, as an M3, I fully transitioned to the wards at a large hospital in Puerto Rico. That same month, Hurricane María devastated the island. Three years later, and I find myself as an M4 in the middle of another disaster: the COVID-19 pandemic. MS across the country, myself included, are facing similar uncertainties, distress, scarce resources, and other difficult events I endured in 2017. Through reflective writing, I explored my expectations, my frustrations, and other bioethical and humanistic aspects of medical care (e.g., end of life care, shared decision making, informed consent).This exercise helped me navigate these difficulties scenarios, process the experiences, to overcome the stress they induced, and to gain confidence as a physician. Reflection helped me internalize desirable professional values such as cultural humility, teamwork, and moral resilience . Narrative medicine may help MS construct a positive PIF and develop moral resilience, especially during disasters. 

Rachel Gur-Arie, PhD
Former Hecht-Levi Fellow
Conceptualizing an Ethical Framework of COVID-19 Vaccine Hesitancy among Healthcare Personnel

Conceptualizing an Ethical Framework of COVID-19 Vaccine Hesitancy among Healthcare Personnel 

Friday, October 15

Noon – 1:15 pm EDT (11:00 am – 12:15 pm CDT)

Zoom Room 11 

Presenters: Rachel Gur-Arie
Panel: Vaccine Allocation and Healthcare Providers 

Healthcare personnel (HCP) are key connectors of vaccine information among the general public, yet HCP hesitancy towards COVID-19 vaccines is significant. COVID-19 vaccine hesitancy among HCP, characterized by uncertainty and their lived experiences on the frontlines of the pandemic, can pose a significant challenge to increasing their COVID-19 vaccine uptake. Vaccine hesitancy among HCP does not arise in a vacuum of professionalism — it is molded at the intersection of personal, professional, and societal influences. The COVID-19 pandemic has sharpened the need for further defining the ethical dimensions of this underexplored intersectional space in regards to negotiating vaccine hesitancy and HCP responsibilities. In this project, we utilize conceptual and deliberative methods to inform the development of a draft ethics framework regarding vaccine hesitancy among HCP, including mapping and categorizing data; identifying and naming concepts; deconstructing, categorizing, and integrating concepts; synthesizing and resynthesizing materials to develop the framework; and active validation. This draft ethical framework is targeted towards policymakers and professional societies involved in articulating and enforcing vaccine norms among HCP across health systems. We address ethical tensions that the COVID-19 pandemic has exacerbated, like uncertainty, disagreement regarding HCP obligations to the public, and unclear institutional responsibilities towards public health. Though this draft ethical framework is based on COVID-19 vaccine hesitancy among HCP, we intend for it to apply to hesitancy towards other vaccines as well, and offer constructs relevant to considering the ethics of vaccine decision making broadly. 

Brian Hutler, JD, PhD
Hecht-Levi Fellow
Public Health Deference: Rethinking the Role of Courts During a Pandemic

Public Health Deference: Rethinking the Role of Courts During a Pandemic 

Saturday, October 16

12:30 pm – 1:45 pm EDT (11:30 am – 12:45 pm CDT)

Zoom Room 13 

Presenters: Brian Hutler
Panel: Public Health Policy 

Jacobson v. Massachusetts has long stood for the principle that courts should exercise deference toward the government during a public health emergency. But the COVID-19 pandemic has disrupted this traditional understanding, as federal courts have intervened to strike down or enjoin a number of pandemic-response policies on constitutional rights grounds. Most notably, in Roman Catholic Diocese of Brooklyn v. Cuomo, the Supreme Court blocked New York’s limits on in-person religious gatherings. At the same time, however, courts have continued to defer to the government’s pandemic response in other cases. For example, the Supreme Court upheld a Food and Drug Administration rule requiring patients to visit a clinic before obtaining a medicated abortion. These decisions reflect a troubling pattern of blocking pandemic-response policies when they conflict with religious freedom, while deferring to the government when its policies impact other, apparently less favored rights. This paper argues, first, that Jacobson must be reconsidered in light of COVID-19, but it should not be replaced by an ad hoc double standard. Instead, this article proposes a new theory of the “Public Health Deference” that courts should afford to the government during a public health emergency. Public Health Deference should be premised on the quality of the processes by which the government creates and implements pandemic-response policies. Courts should not blindly defer to the government’s pandemic response, but should instead evaluate the government’s decision-making processes to ensure that they meet standards of transparency, accountability, public justification, and community engagement. 

Alyssa Newman, PhD
Former Hecht-Levi Fellow
Moving Beyond Mistrust: Centering Institutional Change by Decentering the White Analytical Lens

Moving Beyond Mistrust: Centering Institutional Change by Decentering the White Analytical Lens 

Friday, October 15

5:30 pm – 6:45 pm EDT (4:30 pm – 5:45 pm CDT)

Zoom Room 8 

Speakers: Alyssa Newman
Panel: Institutional Responses to Racism 

The topic of Black mistrust of medical institutions has received a great deal of attention over the course of the Covid-19 pandemic, especially with the arrival of vaccines and the emergence of a gap in vaccination rates by race. This paper examines current discourses and debates over medical mistrust, and describes the limitations of the mistrust framework for identifying and addressing the institutional change necessary to remedy racial health inequities. As numerous observers have pointed out, the mistrust discourse largely places the burden of change on historically exploited and mistreated populations, rather than on the medical institutions that committed the violations and continue the mistreatment that are often identified as the source of mistrust. However, even the analytic shift to focus on the trustworthiness of institutions narrows the scope of the issue to the relationships of medical institutions to specific communities. While the mistrust literature has made important contributions to centering and valuing Black perspectives, this framework delimits the focus to Black perceptions rather than on medical institutions themselves, in particular their ability to maintain legitimacy in the face of mistrustful relationships and in light of their own stated values, principles, and purpose. Whereas the predominately white lens of bioethics scholarship has centered Black populations by making them the subject of analysis, this paper draws a distinction between simply analyzing, versus meaningfully centering and deriving an analysis from the perspective of marginalized populations within scholarship. This paper explores the applicability of the institutional legitimacy framework for addressing racial health inequities. 

Ethical Considerations in Developing a Minimum Insurance Benefit Model for Gender Affirming Care

Ethical Considerations in Developing a Minimum Insurance Benefit Model for Gender Affirming Care 

Saturday, October 16

11:00 am – 12:15 pm EDT (10:00 am – 11:15 am CDT)

Zoom Room 15 

Presenters: Theodore Schall
Panel: Ethical Issues in Health Care Access 

A patchwork of state regulations variably mandate, prohibit, and omit coverage of gender affirming care for US transgender patients. Even in states with mandates, coverage varies by payer type and plan. While the World Professional Association for Transgender Health (WPATH) Standards of Care define some care as medically necessary, they do not specify which interventions are necessary in which circumstances, leaving payers to write heterogenous policies. Despite the proven benefits of gender affirming care, patients, clinicians, and legal advocates face ongoing difficulty obtaining coverage for it, which contributes to trans health disparities. Patients, clinicians, regulators, and payers stand to benefit from standardization of coverage for gender affirming care. Development of a minimum coverage model (for state or federal enactment) stands to provide a singular target for advocacy and likely make access more equitable. While some trans health advocates argue for coverage of all possible interventions as a remedy for social marginalization, this trans exceptionalism risks, among other issues, future reversals in political will. Instead, the rationale for coverage of gender affirming care should be consistent with that of other types of care, based on standard methods such as those used in health technology assessment. Ethically salient considerations for development of a minimum coverage model for gender affirming care include evidence of cost effectiveness, short and long-term outcomes (including measures of both euphoria and dysphoria), stakeholder ownership (relying on the double expertise of transgender health professionals and legal scholars), local and subpopulation needs, and procedural justice.