Anna C. Mastroianni

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.

Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research

Federal policies on human subjects research have performed a near-about face. In the 1970s, policies were motivated chiefly by a belief that subjects needed protection from the harms and risks of research. Now the driving concern is that patients, and the populations they represent, need access to the benefits of research.

The importance of expanding current training in the responsible conduct of research.

Despite the growing need to teach principles of the responsible conduct of research (RCR) to those training to be biomedical researchers, no descriptive, easily compared information about the nations RCR programs exists. To draw some preliminary conclusions about the state of RCR education and training and to gain insight into what kinds of future initiatives are needed, the authors reviewed materials describing U.S. training programs in RCR that had been collected by the Department of Health and Human Services in June-August 1996. In direct response to a 1990 federal policy, formal RCR training programs have been established at many institutions that carry out research. This policy requires that recipients of National Research Service Award Institutional Research Training Grants from the National Institutes of Health provide RCR training to the predoctoral and postdoctoral trainees supported by these grants. The authors found that two thirds of the 45 institutions represented in the materials provided RCR training only to those trainees whom they were required to train, although among the rest of the institutions, a few required that all trainees receive such training. The training programs studied were quite diverse regarding who was responsible for the program (the principal investigator, the ethics faculty, etc.), what kinds of instruction were given (lectures, seminars, small-group discussions, etc.), course content, and how discipline-specific the focus was. The authors review the obstacles to effective RCR training (e.g., the needs for culture change and for sizable faculty, financial, course time, and administrative resources; the need for proper evaluation of programs) and discuss ways to foster such programs (e.g., sharing of resources; identifying competencies; tailoring teaching to the individual institutions and departments characteristics; public-private partnerships). They conclude that the institutional efforts needed to establish widespread and effective RCR training are more than justified by the result that such training will help foster: the integrity of the research process and a solid future for the research enterprise.

Risk and responsibility: ethics, Grimes v Kennedy Krieger, and public health research involving children.

The legal case of Grimes v. Kennedy Krieger Institute, Inc, has raised concerns in the public health research community regarding the acceptable level of risk in research involving children, parental authority for informed consent, and exploitation of research subjects for the benefit of public health. We provide an overview of the case and discuss the impact of the courts decision and its possible effect on future research protection policies and practices.

Ethical Issues in Health Research with Novel Online Sources

Health-related research is increasingly drawing on novel sources of online data, such as crowdsourced information about disease outbreaks, consumer-supplied information provided to health or wellness Web sites, Internet search queries about personal health, and social network postings that identify health behaviors. We offer examples of online sources and their uses, identify ethical and policy issues they generate, and formulate key questions for future discussion and investigation. Further work in this area will require cross-disciplinary collaboration to develop ethics and policy guidance for the ethical use of these novel data sources in health-related research.

Caught in the Web: Informed Consent for Online Health Research

Context-specific informed consent for Web-based health research can promote a dynamic research enterprise and maintain the public trust. A context-specific approach to informed consent for Web-based health research can facilitate a dynamic research enterprise and maintain the public trust.

Encouraging Accountability in Research: A Pilot Assessment of Training Efforts

Purpose. This pilot assessment describes institutional approaches to satisfying the NIH training requirement in the responsible conduct of research. Descriptive information from this review will be valuable for institutions and researchers who are developing or improving training programs. Methods. The authors reviewed materials submitted by a sample of grantee institutions in response to a request by the U.S. Department of Health and Human Services. Institutional and programmatic characteristics were summarized and described. Results. Institutions in the sample employed a diversity of approaches to satisfying the training grant requirement. Approaches varied both among and within institutions. Further, the number of training grants held at the institution had some impact on how the training grant requirement was met. Conclusion. This assessment is a valuable first step in describing institutional responses to the NIH training grant requirement. It indicates the need for further research on institutional approaches to education and training in the responsible conduct of research, including research on characteristics of training programs, effectiveness of training initiatives, and on how to broaden current training efforts to ensure that all scientists in training are prepared to address ethical dilemmas in their professional careers, regardless of the source of funding for their training.

Opinion: Learning as we go: Lessons from the publication of Facebook's social-computing research

In the aftermath of the publication of the “emotional contagion” study conducted by Facebook researchers working with Cornell University scholars (1, 2), many observers weighed in about everything from the acceptability of undertaking the research at all, to how it was conducted, the rules and regulations that applied to it, and even the advisability of publishing the article. The views were disparate and conflicting (3⇓⇓–6). Our goal in this Opinion is not to try to settle these debates, but rather to attempt to draw some general lessons and offer recommendations from an ethics perspective as large-scale social-computing research moves forward. Our motivation is not to defend or chastise the research and technology communities or those responsible for ethics oversight of research. Instead, we wish to suggest that the development and application of an appropriate ethical framework and some form of ethics oversight is a moral imperative that is also in the interest of all. First, such oversight acts as a crucial signal of rules and accountability, which can increase overall trust and, in turn, the willingness to support and participate in research. Second, oversight leads to more credible research that others can build upon and funders and investors will support. Third, consistent approaches ease and encourage the trust and legitimacy needed for partnership and collaborations, which is the basis of 21st century science of all kinds.

Creating a Stem Cell Donor: A Case Study in Reproductive Genetics

During the nearly 10 years since its introduction, preimplantation genetic diagnosis (PGD) has been used predominantly to avoid giving birth to a child with identified genetic disease. Recently, PGD was used by a couple not only to test IVF-created embryos for genetic disease, but also to test for a nondisease trait related to immune compatibility with a child in the family in need of an hematopoetic stem cell transplant. This article describes the case, raises some ethical and policy issues, highlights gaps in U.S. policy, and finally makes some recommendations for addressing advancing genetic and reproductive technologies.

Women and Health Research: A Report from the Institute of Medicine

In recent years, claims have been made by segments of the research community and by womens health advocacy groups that clinical research practices and policies have not benefitted womens health to the same extent as mens health. Central to these claims has been an assertion that women have been inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women — e.g., menopause — nor womens manifestations of health problems affecting both sexes — e.g., heart disease — have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of womens participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Womens Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committees charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences. Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committees deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.