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ABSTRACTNonhuman animal research and phase I healthy‐volunteer clinical trials are both critical components of testing the safety of investigational drugs as part of the development of new pharmaceuticals. In addition, these types of research share important structural features, as both take place in confinement and both use subjects that are dissimilar to the target population. By mobilizing a model‐organism framework for phase I trials, we employ concepts and mechanisms typical to animal research to query gaps in the human subjects ethics and policy framework. By bringing these two research worlds together, we aim to illustrate how the model‐organism framework can enhance healthy volunteers' welfare during trials, improve research oversight, and more critically assess the science value of current phase I trials.

Background: Since the National Institutes of Health (NIH) Revitalization Act of 1993, focus on the equitable inclusion of women in clinical research has been ongoing. NIH's 2015 sex as a biological variable (SABV) policy aims to transform research design, analysis, and reporting in the preclinical sphere by including male and female organisms in vertebrate animal research as well as human studies. However, questions remain regarding how researchers and members of research oversight committees perceive the value and need of the SABV policy. Materials and Methods: Based on 62 interviews with animal researchers and oversight personnel, we analyze what the animal research community knows about the policy and sees as the benefits and challenges of implementation. Results: We found that the 62 interviewees disagreed about the need for the policy, with some being supportive and others questioning whether the policy is based on science or is politically motivated. There were also tensions in how interviewees conceptualized the challenges to and resources needed for implementing the SABV policy. For instance, while some thought implementation would require a significant increase in numbers of animals used for each study, others explicitly rejected this claim. Conclusions: We conclude by discussing the practical and social implications of our findings about the views of members of the animal research community regarding the SABV policy.

ABSTRACTPhase I healthy volunteer trials test the safety and tolerability of investigational pharmaceuticals. In them, participants are exposed to study‐drug risks without the possibility of direct medical benefit and typically must spend days or weeks in a residential research facility. Monetary payments are used to incentivize enrollment and compensate participants for their time. Together, these features of phase I healthy volunteer trials create a research context that differs markedly from most other clinical research, including by enrolling disproportionate numbers of economically disadvantaged people of color as participants. Due to these unique trial features and participation patterns, traditional biomedical research oversight offers inadequate ethical and policy guidance for phase I healthy volunteer research. This article details five ethical criteria crafted to be responsive to the particularities of this type of research: translational science value, fair opportunity and burden sharing, fair compensation for service, experiential welfare, and enhanced voice and recourse.

Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement, including, but not limited to, the financial compensation, and we analyzed how these perceptions varied based on participants' sociodemographic characteristics and clinical trial history. We found that participants detailed economic, societal, and noneconomic personal benefits. We also found differences in participants' perceived benefits based on gender, age, ethnicity, educational attainment, employment status, and number of clinical trials completed. Our study indicates that many healthy volunteers believe they gain more than just the financial compensation when they accept the risks of Phase I participation.

For years, genomic medicine—medicine based on the growing understanding of the genetic contribution to many diseases and conditions—has been hailed as the future of medical treatment, but it has thus far had limited effect on day-to-day medical practice. The ultimate goal of genomic medicine has always been the ability not just to identify dangerous gene mutations, but to fix them. Now CRISPR and related genome-editing technologies may have the potential to provide a safe and effective way to repair dangerous mutations. In the wake of ethically dubious experiments with human embryos in China, the international governance of human genome editing is emerging as an urgent topic for scientists, regulators, and the public. Efforts to develop a governance model are underway at national and international levels. These efforts are the subject of multiple initiatives by national and international health and science organizations and are topics of discussion at scientific conferences, summits, and meetings. This Article reports on the Authors' multi-year, interdisciplinary project to identify and investigate the practical, ethical, and policy considerations that are emerging as the greatest concerns about human genome editing, and ultimately to develop policy options. The project involves monitoring the discussions of groups, both government-sponsored and private, that are considering how genome editing should be governed; observing conferences where the topic is discussed; analyzing emerging policy reports by national and international bodies; and interviewing a wide range of stakeholders, including scientists, ethicists, and those who make and comment on public policy. The Article identifies several stakeholder concerns that are especially prominent in the research to date and begins to explore the implications of these concerns for alternative models of governance. There are current indications that, for practical purposes, a focus on "soft," hybrid forms of governance based on networks of multiple public and private ...

The Social Medicine Reader, Volume I, Third Edition -- Frontmatter -- Contents -- Preface to the Third Edition -- Introduction -- Part I. Experiences of Illness and Clinician-Patient Relationships -- Silver Water -- "Is She Experiencing Any Pain?" -- The Cost of Appearances -- The Ship Pounding -- God at the Bedside -- The Use of Force -- Sunday Dialogue -- What the Doctor Said -- Part II. Professionalism and the Culture of Medicine -- The Learning Curve -- The Perfect Code -- Coeur d'Alene -- The "Worthy" Patient -- How Doctors Think -- Healing Skills for Medical Practice -- The Hair Stylist, the Corn Merchant, and the Doctor -- Necessary Accessories -- The Critical Vocation of the Essay -- The Art of Medicine -- Script -- Ordinary Medicine -- " Ethics and Clinical Research" -- Part III. Health Care Ethics and the Clinician's Role -- Glossary of Basic Ethical Concepts in Health Care and Research -- Ethics in Medicine -- Historical and Contemporary Codes of Ethics -- Enduring and Emerging Challenges of Informed Consent -- Teaching the Tyranny of the Form -- A Terrifying Truth -- The Lie -- Discharge Decisions and the Dignity of Risk -- No One Needs to Know -- Part IV. Death, Dying, and Lives at the Margins -- Forty Years of Work on End-of- Life Care -- Try to Remember Some Details -- Failing to Thrive? -- The Dead Donor Rule and Organ Transplantation -- The Darkening Veil of "Do Everything" -- Death and Dignity -- Active and Passive Euthanasia -- Clinician-Patient Interactions about Requests for Physician-Assisted Suicide -- My Father's Death -- Part V. Allocation and Justice -- Glossary -- Dead Man Walking -- Full Disclosure -- Seven Sins of Humanitarian Medicine -- About the Editors -- Index