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STEPPS

September 21, 2021

STEPPS integrates qualitative interviews with conceptual analysis to investigate occupational stress experienced by physicians working on the front lines of COVID-19 care in four American cities.

 

With funding from The Greenwall Foundation, STEPPS investigates moral stress among physicians providing frontline care for COVID-19 patients in New York City and New Orleans. Using interviews with 40 physicians in each city, we will: (1) describe physicians’ experiences of moral stress during the pandemic; (2) assemble a conceptual framework mapping sources of moral stress in crisis and non-crisis conditions; and (3) develop and disseminate evidence-based recommendations to guide systems-level change (e.g., state- and hospital-level policies) urgently needed to mitigate and respond to moral stress during and beyond this pandemic.

 

With funding from the National Institutes of Occupational Safety and Health, STEPPS investigates occupational health and wellbeing among physicians providing frontline care for COVID-19 patients in Los Angeles and Miami.

Drawing on interviews with 40 physicians in each city, our specific aims are to: (1) Describe the relationships among the systems-, professional-, and institutional-level factors shaping workplace conditions during the COVID-19 pandemic and physicians’ perceptions of occupational health and wellbeing; (2) Identify systems-, professional-, institutional-, and individual-level characteristics that protect physicians’ occupational health and wellbeing during the COVID-19 pandemic; and (3) develop and disseminate evidence-based recommendations to protect physicians’ occupational health and wellbeing during normal and crisis conditions, with expert panel input.

New Collaboration between UNC and Stellenbosch University, South Africa

September 16, 2021

The Research for Ethical Data Science in Southern Africa (REDSSA) project has the overall aims of producing new knowledge regarding the ethical, legal and social implications (ELSI) of conducting data science research to develop evidence-based, context specific guidance for the conduct and governance of data science initiatives such as DS-I Africa, and to strengthen the culture of responsible data science in Southern Africa. The project will be conducted in three phases. Phase 1 is research intensive and will obtain empirical data on key stakeholder views regarding the development of data science guidance to inform governance of DSI-Africa Research Hubs in Southern Africa. This phase will start with conceptual research and normative analysis of the ELSI issues related to data science.  In Phase 2, we will develop guidance documents informed by Phase 1 research and by best practices in international data science research guidance, the limited experience and existing literature to date concerning data science research and governance of data management in Southern Africa. In Phase 3, we aim to amplify the impact and enhance the sustainability of our research and governance activities by creating ELSI networks and communication channels focusing on data science in Southern Africa. This will involve establishing an ELSI Data Science Southern African Network (EDSSAN) to respond to evolving ELSI concerns in DS-I Africa Research Hubs beyond the funding period, hosting annual conferences, and leveraging existing local networks.

This is a U01 grant in response to the NIH funding opportunity RFA-RM-20-017: Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa): Ethical, Legal, and Social Implications Research. The purpose of the funding opportunity is to support research on the Ethical, Legal, and Social Implications (ELSI) associated with a new program entitled Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa). The goal of DS-I Africa is to spur new health discoveries and catalyze innovation in healthcare, public health, and health research on the continent through application of data science.

Co-PIs:

Stuart Rennie and Keymanthri Moodley.

Ethical Dimensions of Peanut Allergy Immunotherapy Research

August 19, 2021

With funding from the National Institute of Allergy & Infectious Diseases (NIAID), Dr. Jill Fisher is conducting a research study on pediatric clinical trials for food allergies, focusing primarily on peanut allergy. Using ethnographic research methods, the project investigates the on-the-ground ethical challenges that emerge in these clinical trials. In particular, the project explores how stakeholders—investigators, caregivers, adolescents, patient advocates, FDA officers, and pharmaceutical company representatives—define and understand acceptable risks and benefits from food allergy treatments, both in terms of research protocols and the eventual products to be used in clinical practice. The empirical findings from the project will be mobilized to develop a framework for the ethical conduct of peanut allergy clinical trials that attends to the myriad interests that drive biomedical research, including the search for therapies that meaningfully improve the lives of children with food allergies, the need to design and conduct clinical trials to meet the regulatory standards required by the FDA for the approval of products, and the commercial context in which investigators and companies have financial conflicts of interest that motivate the successful development of new therapies. Collaborating with Dr. Fisher on the project are Drs. Anne Drapkin Lyerly and Edwin H. Kim.

Incidental Enhancements: A Neglected Governance Challenge for Human Genome Editing Research

June 25, 2020

The increasing pace and international diffusion of developments in human genome editing research have prompted ongoing efforts to develop responsible governance for such research. One point of broad agreement across these efforts is that human genome editing research should prioritize medical applications over attempts to enhance human traits because of the moral concerns the latter would raise. What qualifies as human enhancement and how to address issues that may arise in this arena remain uncertain. Moreover, several influential reports expand their interpretation of medical applications beyond disease treatment to endorse disease prevention as a goal for genome editing research. Basic human genome research and animal studies aspiring to this goal are already underway. But preventing disease through human genome editing would incidentally facilitate human enhancement applications in a variety of ways. If these translational research efforts are penalized by policy concerns about those applications, then their preventive health benefits could be lost. Conversely, society could be caught off guard by the emergence of genome editing applications that evoke the very moral concerns that the policy line against enhancement is meant to forestall. To responsibly anticipate these challenges, science policymakers will need to know more about the salience of enhancement concerns in the context of preventive genome editing (PGE) research and how best to develop research governance to address them.

This project addresses these needs through the following research questions:

  1. How do the goals, incentives, and values driving cases of preclinical PGE research affect the ways that its incidental enhancement implications are interpreted and addressed for governance purposes?
  2. How well might different forms of research governance be expected to anticipate and address these different concerns?
  3. Given the potential human health benefits of preventive genome editing research, what ethical weight should science policy give to the various enhancement concerns? Answering these questions requires both empirical research and ethical analysis.

Specific Aims

  • Enlists scientists to examine the professional and social factors that shape the trajectory of basic research relevant to preventive genome editing. Their perspectives will inform a taxonomy of different ways of interpreting incidental enhancements for policy purposes, and a preview of the governance challenges they will raise.
  • Follow national and global genome editing policy groups to capture the lessons of their experiences, in order to assess the relative merits of different approaches to governance in dealing with incidental enhancement concerns.
  • To inform an empirically grounded ethical analysis of the policy choices facing those engaged in genome editing research governance in different cases. The product of this project will be a set of case studies designed to help science policy makers, the research community, and the public anticipates the incidental enhancement concerns that preventive genome editing research will pose.

Principal Investigators

Co-Investigators

  • Jean Cadigan, Ph.D., Associate Professor, Department of Social Medicine, University of North Carolina at Chapel Hill
  • Gail E. Henderson, Ph.D., Director, UNC Center for Genomics and Society, University of North Carolina at Chapel Hill
  • Douglas P. MacKay, Ph.D., Assistant Professor, Department of Public Policy, University of North Carolina at Chapel Hill
  • Rebecca L. Walker, Ph.D., Professor, Department of Social Medicine, University of North Carolina at Chapel Hill
  • Arlene M. Davis, J.D., Associate Professor, Department of Social Medicine, University of North Carolina at Chapel Hill
  • John M. Conley, Ph.D., Professor, School of Law, University of North Carolina at Chapel Hill

Funder

NIH – National Human Genome Research (1R01HG010661-01A1, 4/1/2020 – 3/31/2024)

Healthy Volunteers as Model Organisms

September 5, 2017

Comparative Research Ethics and Policy for Phase I Trials

Principal Investigators: Jill A. Fisher and Rebecca L. Walker

This project addresses the need for a novel evidence-based approach to the protection of Phase I healthy volunteers. Phase I clinical trials test the safety of investigational drugs that eventually may be used in affected patients. These trials have distinctive features that may undermine the validity of data gathered and lead to ethics and policy gaps in protecting healthy volunteers. One such feature is that healthy volunteers must stay in the clinic during the trial where they are given a prescribed diet and experience other restrictions. Another feature of Phase I trials is they rely on repeat volunteers who do not mirror the health or sociodemographic characteristics of typical patient populations. Given these unique features of Phase I trials, we contend that valuable insights may be gained through a comparison with non-human animal “model organism” research. We will investigate this comparison and generate new ethics and policy guidance that addresses the problems of risk, subject selection, validity, and translation that are particular to healthy volunteer trials.

To do so, this project has 3 primary aims:

  1. Describe and normatively evaluate the limitations of current research oversight in Phase I trials by analyzing data on healthy volunteers’ perceptions of clinical trials, including through a non-human animal research “model organism” lens;
  2. Compare the ways in which Phase I researchers, non-human animal researchers, bioethicists and policymakers, regulatory and research oversight staff, and healthy volunteers conceptualize: a.) similarities and differences between healthy volunteer and non-human animal research and b.) ethical, policy, and translational science problems particular to each arena; and
  3. Develop ethics and policy guidance for Phase I healthy volunteer research that a.) extrapolates from the model organism framework in Specific Aims 1 and 2, b.) is attentive to the structural features of Phase I research, and c.) is vetted by expert stakeholders.

This 4-year project is a renewal of our current longitudinal R01 study of 180 healthy volunteers (the HealthyVOICES Project). To address the new aims, we will analyze the current grant’s dataset to identify ethics and policy gaps and generate empirically-grounded points of comparison between Phase I trials and animal research (Aim 1). We will also conduct 60 interviews and 300 surveys with expert informants from Phase I healthy volunteer research, animal studies, and bioethics and regulatory perspectives about the key ethical, policy, and translational issues at stake (Aim 2). Finally, we will develop ethics and policy guidance to protect Phase I subjects and improve the translational science pipeline. Four stakeholder forums across the US will provide a vetting process for our draft guidance and initiate dissemination for our final recommendations (Aim 3). We expect the contribution of the proposed project to be significant because it will generate ethics and policy guidance that can provide advances in healthy volunteer welfare and the translational efficacy of Phase I trials.

Ethics of HIV-Related Research Involving Adolescents in Kenya

August 7, 2017

Despite the high social value of adolescent HIV prevention research in sub-Saharan Africa, investigators are reluctant to involve adolescents in studies with HIV testing and disclosure of results because of ethical concerns about the risks of their participation. This study examines four inter-related ethical issues essential to adolescent HIV research: the effects of disclosure of HIV test results on adolescent psychosocial well-being, health-seeking, or risk behavior; minimizing harms in the recruitment of adolescents; comprehension of informed consent among parents, children, and adolescents 18 years and older; and the appropriate use of compensatory payments for youth and parent participation. The study setting is Siaya County in western Kenya.

Specific Aims

  1. To examine the effects of HIV testing and disclosure on adolescent behavior and psychosocial well-being in the context of a research study.  About 4,200 adolescents aged 15-19 will participate in an empirical study of HIV testing and disclosure per the standard of care to inform ethical guidelines.
  2. To examine stakeholder perceptions about adolescent HIV research methods for recruitment, informed consent, HIV testing and disclosure of results, and compensation/inducements for study participation.
  3. To develop guidelines for the ethical conduct of adolescent HIV research and to refine them in consultation with key stakeholders. Findings from Aims 1 and 2 will be used to develop preliminary guidelines for conducting ethical adolescent HIV research. Perceptions about the guidelines from the Kenya advisory boards, and from comparable focus group participants and local ethicists from two additional sub-Saharan countries will be analyzed and used to refine the guidelines and assess their generalizability.

Principal Investigator

  • Winfred Luseno, PhD, Pacific Institute for Research and Evaluation (PIRE)

Co-Investigators

  • Stuart Rennie, PhD, University of North Carolina at Chapel Hill
  • Denise Hallfors, PhD, PIRE
  • Hyunsan Cho, PhD, PIRE
  • Daniel Kwaro, MBChB, MPH, Kenya Medical Research Institute (KEMRI)
  • Amek Nyaguara, PhD, KEMRI
  • David Ayuku, PhD, Moi University
  • Muhammed Afolabi, PhD, Gambia, Medical Research Council
  • Arthur Caplan, PhD, New York University

Funder

  • NIH-National Institute of Mental Health (R01 MH102125, 9/1/2014 – 8/31/2019)

 

Acute Infection: Lived Experiences and Ethical Challenges in HIV Research

February 6, 2017

A better understanding of acute HIV infection is essential to public health, impacting both HIV transmission and potential advances in HIV cure clinical research. Acute HIV infection refers to the earliest stages of HIV infection, the short window of time right after a person becomes infected when they are most infectious. Individuals diagnosed and treated during acute infection are an important population for HIV cure research.

Early phase HIV cure research protocols are both novel (and potentially riskier) to participants. Research done with this population presents a unique set of challenges as an acute diagnosis in itself may contribute to strong emotional and behavioral responses. Faced with new HIV-positive identities and increased transmission risk to their sex partners, acutely diagnosed patients may face greater stress and confusion as they navigate decisions related to medical care and research participation. This intersection of public health interest, HIV cure scientific value, and patients’ personal challenges indicates a compelling need to consider whether acute HIV experiences merit special ethical guidance for research.

The aims of this project are three-fold:

  1. Examine the experiences of acutely infected research participants involved in HIV treatment and cure-related studies using anthropological methods.
  2. Compare perceptions of risks and benefits of clinical HIV trial participation between acute and chronic HIV diagnosed research subjects.
  3. Develop a set of ethical recommendations that address specific challenges related to identifying, recruiting, and retaining AHI diagnosed individuals in HIV clinical (especially cure) research.

This project is conducted at three sites: the University of North Carolina at Chapel Hill, Duke University Medical Center, and Guy’s and St Thomas’ Hospital, London, UK.

Research team members:

  • Stuart Rennie (Principal Investigator), Assistant Professor, UNC Center for Bioethics, Department of Social Medicine, UNC-Chapel Hill
  • Adam Gilbertson (Co-Principal Investigator) Postdoctoral Research Fellow, UNC Center for Bioethics, Department of Social Medicine, UNC-Chapel Hill
  • Joe Tucker (Co-investigator) Assistant Professor of Medicine and Director of UNC Project-China, Department of Medicine, UNC-Chapel Hill
  • Julie Fox (Co-Investigator) HIV Consultant, King’s College London and Guy’s and St Thomas’ Hospital, London, United Kingdom
  • Audrey Pettifor (Co-investigator) Associate Professor, Dept. of Epidemiology, UNC-Chapel Hill
  • JoAnn Kuruc (Co-investigator) Clinical Program Director, UNC HIV Cure Center at the UNC-Chapel Hill
  • Kate MacQueen (Consultant) Senior Social Scientist, Global Health Research, FHI 360
  • Kara McGee (Consultant) Physician Assistant, Duke University Medical Center
  • Alice Sharp (Research Manager) Guy’s and St Thomas’s Hospital London, UK
  • Liz Kelly (Graduate Research Assistant) UNC-Chapel Hill

Funded by NIAID, the National Institute of Allergy and Infectious Diseases.
Grant number 1R21AI120549-01A1.

 

Re-Engaging Ethics: Ethical Issues in Engaged Research

January 30, 2017
Clockwise starting at top-left: Giselle Corbie-Smith, Al Richmond, Mysha Wynn, and Stuart Rennie

Project Description

Re-Engaging Ethics is a project that is funded by the Greenwall Foundation. The purpose of this project is to create and disseminate recommendations for the review and conduct of community-engaged research, by engaging a diverse set of stakeholders in dialogue about the unique ethical concerns that arise in this emerging scientific approach to public health and biomedical research. While there has been some conceptual work in the peer-reviewed literature on the ethical issues that arise in engaged scholarship, the field is so new that there hasn’t been a comprehensive examination of these issues, nor have there been clear recommendations for review. In addition, much of what has been written has been from the perspective of the investigator or ethicist; few include the perspectives of community members as authors, and even fewer bring all of these perspectives to bear in one set of recommendations. Our project seeks to remedy these issues by soliciting the varied perspectives of community, academic and ethics scholars through in depth interviews, questionnaires, workshops, and literature reviews, and developing a set of recommendations that address ethical issues in engaged scholarship.

Research Team

Real World Narratives Wanted!

The Re-Engaging Ethics team seeks narratives in the following topic areas: equitable and just research, relationship dynamics, community informed risk/benefit assessment, and accountability. Visit this page to learn more about submitting a narrative.

Strengthening Bioethics Capacity and Justice in Health

January 27, 2017
Kinshasa School of Public Health
Kinshasa School of Public Health

Francophone African countries are among the most resource-constrained in the world. Citizens in these regions commonly struggle with a wide variety of health problems related to poverty, political conflict and social upheaval. Those involved in local efforts to improve health, in clinical medicine, biomedical research or public health initiatives, often find themselves in difficult situations of moral conflict. Managing these conflicts is challenging, partly because local health professionals may come to them unprepared due to bioethics typically not forming an explicit part of the medical curriculum and having little presence in common culture.

This training project, entitled Strengthening Bioethics Capacity and Justice in Health, seeks to increase awareness of ethical issues in biomedicine in Francophone Africa, and contribute to locally relevant bioethics education and practice in this region. Our project conducts workshops, organizes conferences, provides training in bioethics for local collaborators and interested scholars, publishes peer-reviewed articles on bioethical issues in Francophone Africa, and integrates bioethics content into existing curricula in key educational institutions. The target countries for our initiatives are the Democratic Republic of Congo (DRC) and Madagascar. Strengthening Bioethics Capacity and Justice in Health is a collaborative project among leading health institutions in the United States, Belgium, Madagascar and the DRC.

Site leaders

Key investigators

Funding