The Ethical Review of Health Care Quality Improvement Initiatives: Findings From the Field

Based on surveys, examines the review mechanisms of quality improvement initiatives, including frequency; type, such as use of independent review boards; and consideration for ethical issues such as minimal risk and patient privacy and confidentiality

Clinical trials and pregnancy

Traditionally, there has been a reluctance to involve pregnant people in clinical trials due to complex ethical issues surrounding the risk to unborn babies. However it is crucial that new interventions are safe and effective for all patients and ensuring this can be difficult to achieve in the absence of clinical trials

Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response

Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely – and at times uniquely – affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks. This state of affairs is profoundly unjust to pregnant women and their offspring, and deeply problematic from the standpoint of public health. To ensure that the needs of pregnant women and their offspring are fairly addressed, new approaches to public health preparedness, vaccine research and development, and vaccine delivery are required. This Guidance offers 22 concrete recommendations that provide a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The Guidance was developed by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group – a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy – in consultation with a variety of external experts and stakeholders.Fil: Krubiner, Carleigh B.. University Johns Hopkins; Estados UnidosFil: Faden, Ruth R.. University Johns Hopkins; Estados UnidosFil: Karron, Ruth A.. University Johns Hopkins; Estados UnidosFil: Little, Margaret O.. University Of Georgetown; Estados UnidosFil: Lyerly, Anne D.. University of North Carolina; Estados UnidosFil: Abramson, Jon S.. University Wake Forest; Estados UnidosFil: Beigi, Richard H.. Magee-Womens Hospital of University of Pittsburgh Medical Center; Estados UnidosFil: Cravioto, Alejandro R.. Universidad Nacional Autónoma de México; MéxicoFil: Durbin, Anna P.. University Johns Hopkins; Estados UnidosFil: Gellin, Bruce G.. Sabin Vaccine Institute; Estados UnidosFil: Gupta, Swati B.. IAVI; Estados UnidosFil: Kaslow, David C.. PATH; Estados UnidosFil: Kochhar, Sonali. Global Healthcare Consulting; IndiaFil: Luna, Florencia. Facultad Latinoamericana de Ciencias Sociales; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Saenz, Carla. Pan American Health Organization; Estados UnidosFil: Sheffield, Jeanne S.. University Johns Hopkins; Estados UnidosFil: Tindana, Paulina O.. Navrongo Health Research Centre; GhanaFil: The Prevent Working Group. No especifíca

Advancing HIV research with pregnant women: navigating challenges and opportunities

Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research

An "ethical moment" in data sharing

This study draws on interviews with forty-nine members of a biomedical research community in the UK that is involved in negotiating data sharing and access. During an interview, an interviewee used the words “ethical moment” to describe a confrontation between collaborators in relation to data sharing. In this article, I use this as a lens for thinking about relations between “the conceptual and the empirical” in a way that allows both analyst and actor to challenge the status quo and consider other ethical possibilities. Drawing on actor network theory (ANT), I approach “the empirical” using the concepts of controversy and ontological uncertainty as methodological tools to tackle the problem of ethics. I suggest that these concepts also provide a bridge for understanding the ontological structure of the virtual and the actual, as described in Deleuze’s Difference and Repetition. While other science and technology studies scholars have sought to draw on Deleuze, this article addresses the integration of ethics and empirical research. It arises as a critical reaction to existing treatments of this problem as found in empirical ethics, especially in the sociology of bioethics, and indirectly in ANT texts

Oral History of Ruth R. Faden

This interview with Ruth R. Faden, PhD, MPH, was conducted by Suzanne Snider on December 12 and December 13, 2022 in Washington, DC as part of Moral Histories: Voices and Stories from the Founding Figures of Bioethics, an oral history project of the Johns Hopkins Berman Institute of Bioethics. Prof. Faden is the Philip Franklin Wagley Professor of Biomedical Ethics at Johns Hopkins University and was the founder of the Johns Hopkins Berman Institute of Bioethics, serving as its director from 1995 until 2016. Prof. Faden’s areas of expertise include ethics and public health, social justice, reproductive rights, women’s health, the rights of pregnant people, and informed consent.On Day 1, Prof. Faden recounts growing up in an insular Jewish community in Northeast Philadelphia and hearing family stories about surviving the Holocaust. Prof. Faden tells the story of her family’s trip to Texas for corrective back surgery and the impact of seeing racial segregation there that she had not seen in Philadelphia. While Prof. Faden describes herself as a poor student in high school, she was the first in her family to graduate from high school (at the age of 16) and to pursue higher education. She describes transferring from Temple University to the University of Pennsylvania to complete her undergraduate education. She outlines her subsequent educational path: earning a master’s degree in the General Studies in Humanities program at the University of Chicago and a Master of Public Health and PhD in attitudes and behavior at the University of California, Berkeley.Prof. Faden describes her consistent engagement with reproductive justice work and volunteering with law firms in the Bay Area around issues of forced sterilization for migrant women. She highlights her drive to understand consent as it relates to the law and to ethics. Prof. Faden speaks to the significance of The Hastings Center and the Kennedy Institute of Ethics. She reflects on her mentors––David Louisell at University of California Berkeley School of Law, Albert Jonsen at the University of California, San Francisco, Jay Katz at Yale Law School––and attributes their generosity to her involvement in the emerging field of bioethics. Prof. Faden describes her first teaching appointment in the School of Hygiene and Public Health (now Bloomberg School of Public Health) at Johns Hopkins and her introduction to André Hellegers at Georgetown University, who ultimately gave her the institutional support to do work on bioethics at Georgetown’s Kennedy Institute of Ethics.On Day 2, Prof. Faden spends significant time describing her work on a book about informed consent with her collaborator and husband, Tom Beauchamp. She argues that rigorous consent practices are not sufficient if they don’t account for structural contexts, sharing as an example the story of Henrietta Lacks, a poor Black woman whose cancerous cervical cells were used in scientific study for years without her or her family’s knowledge. Prof. Faden talks about her work on ethics and social justice within health, co-authoring two books with philosopher-lawyer Madison Powers and her commitment to making the world a little less unjust. Prof. Faden describes her early work related to pregnant women and HIV, exploring questions around policy-making within unjust background conditions.Prof. Faden describes her recruitment to be chair of the White House Advisory Committee on Human Radiation Experiments (ACHRE) in the Clinton Administration in 1994, noting a profound alignment of her parents’ history as Holocaust survivors and her professional life, as she led an effort to understand the history of radiation experiments performed on humans by the US government during the Cold War, and to make recommendations to ensure that the unethical research uncovered would never happen again. Prof. Faden speaks to the work and successes of ACHRE. After ACHRE, Prof. Faden was invited to found a bioethics program at Johns Hopkins, which ultimately became the Berman Institute of Bioethics. Prof. Faden describes the process of shaping the Institute around her core wishes for the Institute’s success and longevity. She tells the story of Phoebe Berman–a major donor, friend, and the Institute’s namesake–and speaks about other close relationships with board members and trustees.This interview may be of interest to those seeking to learn more about: the field of bioethics and history of bioethics in the US, reproductive rights and gender justice, social justice and health, ethics and public health, informed consent, the Holocaust and experiences of survivors and children of survivors, national commissions and advisory committees, experiences of founding bioethics programs, and the Berman Institute of Bioethics