Ruth R. Faden

Public Health Ethics: Mapping the Terrain

Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics.Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors — biological, behavioral, social, and environmental in developing effective interventions.

The limitations of "vulnerability" as a protection for human research participants.

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges.

Trust The Fragile Foundation of Contemporary Biomedical Research

It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient-subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient-subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.

Quality of life among women living with HIV: the importance violence, social support, and self care behaviors

This paper describes the relationship between psychosocial factors and health related quality of life among 287 HIV-positive women using items from the Medical Outcomes Study HIV Health Survey to measure physical functioning, mental health and overall quality of life. Multivariate models tested the relative importance of sociodemographic characteristics, HIV-related factors and psychosocial variables in explaining these quality of life outcomes. A history of child sexual abuse and adult abuse, social support and health promoting self-care behaviors were the psychosocial factors studied. Women in the sample were on average 33 years old and had known they were HIV-positive for 41 months; 39% had been hospitalized at least once due to their HIV; 83% had children; 19% had a main sex partner who was also HIV-positive. More than one-half of the women (55%) had a history of injection drug use and 63% reported having been physically or sexually assaulted at least once as an adult. A history of childhood sexual abuse. reported by 41% of the sample, was significantly related to mental health after controlling for sociodemographic and HIV-related characteristics. Women with larger social support networks reported better mental health and overall quality of life. Women who practiced more self-care behaviors (healthy diet and vitamins, adequate sleep and exercise, and stress management) reported better physical and mental health and overall quality of life. The high prevalence of physical abuse and child sexual abuse reported by this sample underscores the importance of screening for domestic violence when providing services to HIV-positive women. That such potentially modifiable factors as social support and self care behaviors are strongly associated with health-related quality of life suggests a new opportunity to improve the lives of women living with HIV.

An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion.

Interpersonal conflict and physical violence during the childbearing year

Reducing physical abuse directed at women by male partners is one of the nations Year 2000 health objectives. An important target group for achieving this health objective is pregnant women. The present study examines the frequency, severity, perpetrators and psychosocial correlates of violence during the childbearing year. A panel of 275 women were interviewed 3 times during pregnancy and at 6 months postpartum. Moderate or severe violence was somewhat more common during the postpartum period than during the prenatal period--19% of women reported experiencing moderate or severe violence prenatally, compared to 25% in the postpartum period. For partner-perpetrated violence, being better educated was associated with increased risk of violence as was having had a sex partner who ever shot drugs; being older, having a confidant and having social support from friends were significant protective factors. For violence perpetrated by someone other than a male partner, having a confidant was a significant protective factor. Obstetric care providers who routinely come in contact with pregnant women, as well as emergency department staff, need to be systematically screening for violence against women. Efforts to enhance womens social support networks should be included in primary and secondary prevention programs.

Disclosure of Information to Patients in Medical Care

It is generally agreed that patients have a right to be adequately informed. However, little is known about the extent to which doctors and patients agree about information that should be disclosed. We studied what patients want to know, as contrasted with what physicians report actually disclosing, in a population of physicians who treat seizures and patients or parents of patients who have this disorder. In general, it was found that patients prefer far more detailed disclosures than physicians routinely offer and that the two groups have widely different beliefs about the consequences of detailed disclosures. Patients and parents preferred extensive disclosures, particularly regarding risks and alternative therapy. Physicians were likely to disclose only risks with a relatively high probability of occurrence and they provided little information about alternative therapies. Patients and parents were also much more likely than physicians to believe that the final decision concerning therapy should rest with the patient. The data suggest that a better empirical understanding of the consequences of detailed disclosures may help resolve differences of opinion regarding how much information should be provided to patients.

Women living with HIV: Disclosure, violence, and social support

This paper describes the frequency of womens disclosure of their HIV status, examines the extent to which they experience adverse social and physical consequences when others learn they are infected, and analyzes correlates of these negative outcomes. There were 257 HIV-positive women between the ages of 18 and 44, recruited from HIV/AIDS primary care clinics and from community sites, who completed a face-to-face interview. Women in the sample were 33 years old on average; 92% were African-American; 54% had less than 12 yeas of education; 56% had used intravenous drugs; and 30% knew they were HIV positive for 5 or more years. There were 97% who disclosed their HIV status; 64% told more than 5 people. Negative consequences associated with others knowing they were HIV-positive were reported by 44%, most commonly the loss of friends (24%), being insulted or sworn at (23%), and being rejected by family (21%). There were 10 women (4%) who reported being physically or sexually assaulted as a result of their being HIV positive, and 16% reported having no one they could count on for money or a place to stay. Violence was widespread in this sample, with 62% having experienced physical or sexual violence, including sexual abuse or rape (27%), being beaten up (34%), and weapon-related violence (26%). Logistic regression analysis indicated that women with a history of physical and sexual violence were significantly more likely to experience negative social and physical consequences when their infection became known to others, adjusting for age and the number of people women had disclosed to, both of which were only marginally significant. Partner notification policies and support programs must be responsive to the potential negative consequences associated with others learning that a woman is HIV positive. The high rates of historical violence in the lives of women living with HIV underscore the need for routine screening and intervention for domestic violence in all settings that provide health care to HIV-positive women.

The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight

The rise of quality improvement research and comparative effectiveness research in health care settings constitutes progress toward the goal of what the Institute of Medicine has called a “learning healthcare system,” in which we are “drawing research closer to clinical practice by building knowledge development and application into each stage of the healthcare delivery process.” As clinical research and clinical practice move closer to a deliberately integrated system, the distinction between the two is increasingly blurred, although the sharp distinction in U.S. regulations and research ethics literature remains in place. In the 1970s and for two decades thereafter, this distinction was helpful: for some forms of research, it sheds light on which activities require ethical oversight. Research that is closely integrated with health care—notably, health delivery research—was then uncommon, however. That is no longer the case, and regulations and research ethics need to change to accommodate the new landscape. In this paper, we argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice. We start with the history of the research-practice distinction in the reports of a U.S. national commission and in U.S. federal regulations, and then offer a critical assessment of five characterizations of research that have been used in policy documents and the scholarly literature to try to make a sharp distinction between research and practice. We challenge the clarity and the tenability of these characterizations as a way of distinguishing research from practice. We argue that the received view of the research-practice distinction leads to overprotection of the rights and interests of patients in some cases and to underprotection in others. We contend that a new ethical foundation needs to be developed that facilitates both care and research likely to benefit patients, and that provides oversight that, rather than being based on a distinction between research and practice, is commensurate with risk and burden in both realms.

RESEARCH AND INFORMED CONSENT IN AFRICA : ANOTHER LOOK

The current practice of requiring the informed consent of research subjects is relatively new. The emphasis on a persons right to accept or refuse participation in biomedical research stems direct...