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The near-routine exclusion of pregnant women from clinical research has resulted in evidence gaps that endanger the health of pregnant women and their future offspring. Although existing literature documents numerous obstacles along the clinical trial pathway that can stymie research involving pregnant women, there is little guidance on how to facilitate such research. This qualitative study aims to fill that void by examining the experiences of individuals involved in conducting, approving, or overseeing research involving pregnant women at one academic institution. The study identifies factors throughout the clinical pathway-from protocol development, to IRB review, and ultimately trial execution-that likely contribute to the successful conduct of research with pregnant women. Attention to those factors, coupled with agreement among stakeholders that research with pregnant women should and can be done ethically and legally, is critical to shifting the narrative from "why we cannot" do such research to "how we can."

This chapter focuses on informed consent, which is a central concept and practice in the protection of the rights and interests of both patients receiving clinical care and individuals participating in research. It addresses the commitment to the ethical principles underlying informed consent that dates back to the early twentieth century, as reflected in many countries' laws governing the physician–patient relationship. It also recounts how informed consent was codified into national policies and international guidelines and standards for research on human subjects. The chapter explores the parallel origins of informed consent and its applications, which are based on distinctions between clinical practice and research and do not naturally apply to or readily translate to epidemiology. It outlines the requirements for consent that have been and are treated differently in epidemiology depending on the type of activity and sometimes the practicability of seeking consent from participants.

In the early days of a pandemic, repurposing biospecimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision‐making where the specific consent accompanying the identifiable biospecimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast‐moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so.

Drawing on the ethical principles of the Belmont Report, this chapter critically examines the legacy and current policies and practices in the United States related to the inclusion of women in clinical research. Historically, protectionist policies and practices excluded women from research participation, justified by, for example, reliance on the male norm, male bias, and fears of legal liability resulting from tragic cases of fetal harm. Recognition of the ensuing harms to women’s health from exclusion and underrepresentation in research led to significant policy changes in the 1990s encouraging women’s participation in research. Although the knowledge gap in women’s health is narrowing, significant challenges remain, including the need to develop robust approaches to defining sex and gender, identifying and analyzing sex and gender differences, and acknowledging and addressing intersectionality and women’s health needs across their life spans.

This chapter, which grew out of a Greenwall Foundation–funded working group of a dozen or so ethicists, lawyers, and public health practitioners, provides a rough conceptual map of the terrain of public health ethics. It examines the nature of public health and public health interventions, and it identifies a number of general moral considerations (principles) relevant to public health policy and practice and often, especially as articulated in basic human rights, promotive of public health. Because these moral considerations are general and broad, they require specification and weighting. In cases of conflict, five “justificatory conditions” need to be met: effectiveness, proportionality, necessity, least infringement, and public justification. These conditions help to determine whether protecting or promoting public health warrants overriding individual liberty in particular situations.

Congenital bilateral renal agenesis has been considered a uniformly fatal condition. However, the report of using serial amnioinfusions followed by the live birth in 2012 and ongoing survival of a child with bilateral renal agenesis has generated hope, but also considerable controversy over an array of complex clinical and ethical concerns. To assess the ethical concerns associated with using serial amnioinfusions for bilateral renal agenesis, we assembled a multidisciplinary group to map the ethical issues relevant to this novel intervention. The key ethical issues identified were related to 1) potential risks and benefits, 2) clinical care compared with innovation compared with research, 3) counseling of expectant parents, 4) consent, 5) outcome measures, 6) access and justice, 7) conflicts of interest, 8) effects on clinicians, 9) effects on institutions, and 10) long-term societal implications. These ethical issues should be addressed in conjunction with systematic efforts to examine whether this intervention is safe and effective. Future work should capture the experiences of expectant parents, women who undergo serial amnioinfusions, those born with bilateral renal agenesis and their families as well as clinicians confronted with making difficult choices related to it.

Public health is fundamentally concerned with promoting the health of populations through the prevention of disease and injury. It is, at its core, a moral endeavor, because the end it seeks is the advancement of human well-being. Vexing ethics issues are inherent in all aspects of public health practice and policy. This chapter provides a concise overview of the topics and issues examined in the Oxford Handbook of Public Health Ethics.

We evaluate Peter Adler’s challenge to the Centers for Disease Control and Prevention (cdc) draft recommendations on male circumcision (this issue, see pp. 237–262). Thecdcadvocates elective male circumcision (mc) to improve public health in theusabased on strong scientific evidence. In marked contrast to thecdc, Adler’s criticisms depend on speculative claims and obfuscation of the scientific data. Adler’s central argument that circumcision in infancy should be delayed to allow a boy to make up his own mind as an adult fails to appreciate that circumcision later in life is a more complex operation, entails higher risk, is more likely to involve general anaesthesia and presents financial, psychological and organisational barriers. These limitations are avoided by circumcision early in infancy, when it is convenient, safe, quick, low risk, usually involves local anaesthesia and provides benefits immediately. Benefits of male circumcision include: protection against: urinary tract infections that are ten times higher in uncircumcised infants; inflammatory skin conditions; other foreskin problems; sexually transmitted infections and genital cancers in the male and his female sexual partners. Circumcision during infancy is also associated with faster healing and improved cosmetic outcomes. Circumcision does not impair sexual function or pleasure. Some authorities regard the failure to offer circumcision as unethical, just as it would be unethical to fail to encourage paediatric vaccination. Since the benefits vastly outweigh the risks, each intervention is in the best interests of the child. In conclusion, Adler’s criticisms of thecdc’s evidence-based male circumcision policy are flawed scientifically, ethically and legally, and should be dismissed as endangering public health and individual well-being.

National Institutes of Health (NIH) Director Francis S. Collins and Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently coauthored a New England Journal of Medicine commentary s...

Although pregnant women rely on medical interventions to treat and prevent a wide variety of health conditions, they are frequently excluded or underrepresented in clinical research. The resulting dearth of pregnancy-specific evidence to guide clinical decisionmaking routinely exposes pregnant women, and their future offspring, to risk of uncertain harms for uncertain benefits. The two legal factors regularly cited as obstacles to such research are the federal regulatory scheme and fear of liability. This article reveals a far more nuanced and complex view of the legal context. First, legal professionals may—at any time from product conception to marketing—influence decisions about research with pregnant women. Second, factors not previously articulated in the literature may prompt legal professionals to slow or halt such research. They include: financial interests, regulatory ambiguity, obstacles to risk management, and site-specific laws unrelated to research. Any efforts to promote the ethical inclusion of pregnant women in research must acknowledge the role of legal decisionmakers and address their professional concerns.

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.

Objective 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. Methods We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. Results Experts discussed a breadth of needed research, including safety, efficacy, and appropriate dosing of: newer antiretrovirals for pregnant women, emerging preventive strategies, and treatment for coinfections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. Conclusion Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.

HIV/AIDS is among the most serious diseases confronting women who are pregnant. It is also one of the few areas of research involving humans where there is a long track record of research involving pregnant women. Yet the HIV/AIDS research community has struggled to expand the research agenda from research to prevent mother-to-child transmission of HIV to research encompassing issues pertaining to the pregnant woman’s own health. Research questions of interest include: which antiretrovirals are safest and most effective for pregnant women; how best to pursue preventive regimes for pregnant women who are not infected; or, how to treat HIV’s deadly co-infections, such as tuberculosis (TB), during pregnancy. In this chapter, we describe two key lessons about research in pregnancy from the context of HIV/AIDS: first, why addressing the health needs of pregnant women, not just the needs of their offspring, is so critical; and second, why doing so is immediately possible, even as we work to resolve certain ethical and regulatory debates, particularly about when it is appropriate to impose foetal risk without the prospect of foetal benefit. In particular, the HIV/AIDS context shows how treatment or prevention of maternal disease often entails not just risk – but the prospect of benefit – to the foetus; and creative trial designs can advance no-benefit studies without imposing foetal risk in the first place. For all the challenges that research with pregnant women entails, the HIV/AIDS context reveals that it is possible to conduct a wide range of important research during pregnancy that is both ethically responsible and consonant with US regulations.

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.

Purpose To identify best practices in education related to the responsible conduct of clinical research (RCCR). Method American Society for Bioethics and Humanities (ASBH) members involved with teaching RCCR were asked to complete an online survey, followed by an in-depth telephone interview. The online survey asked about respondents’ RCCR teaching, trainees, and institutional context. The phone interview involved discussions about teaching strategies, institutional context, and needs. The study was conducted between 2003 and 2005. Results Forty-eight respondents to the online survey indicated a breadth of topics being covered in RCCR curricula; 35 respondents indicated that their RCCR teaching applied toward institutional RCCR requirements. Among the 21 instructors interviewed, many described a wide variety of teaching responsibilities. Recommended teaching strategies included fostering interactive discussion, using skills-based exercises such as designing IRB applications, accommodating students’ individual interests in curriculum design, involving experienced researchers, involving trainees early in their careers as well as requiring continuing education, and designing a curriculum with a clear view of educational objectives. Interviewees described the institutional supports they needed, and they noted that insufficient support sometimes undermines RCCR teaching goals. Participants generally agreed that RCCR education should be required. Conclusions Strong agreement among participants concerning recommended strategies for teaching RCCR provides useful, if provisional, guidance to instructors and institutions charged with providing such training. The study suggests a need for substantial investments in RCCR training, studying outcomes, and developing mechanisms to ensure the quality of instruction.

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 court's decision and its possible effect on future research protection policies and practices. (Am J Public Health. 2002;92:1073–1076)

30 (2002): 170 –178.© 2002 by the American Society of Law, Medicine & Ethics.ublic health ethics, like the field of public health itaddresses, traditionally has focused more on practiceand particular cases than on theory, with the resultthat some concepts, methods, and boundaries remain largelyundefined. This paper attempts to provide a rough concep-tual map of the terrain of public health ethics. We begin bybriefly defining public health and identifying general fea-tures of the field that are particularly relevant for a discussionof public health ethics.Public health is primarily concerned with the health ofthe entire population, rather than the health of individuals.Its features include an emphasis on the promotion of healthand the prevention of disease and disability; the collectionand use of epidemiological data, population surveillance,and other forms of empirical quantitative assessment; a rec-ognition of the multidimensional nature of the determinantsof health; and a focus on the complex interactions of manyfactors — biological, behavioral, social, and environmental— in developing effective interventions.How can we distinguish public health from medicine?While medicine focuses on the treatment and cure of indi-vidual patients, public health aims to understand andameliorate the causes of disease and disability in a popula-tion. In addition, whereas the physician-patient relationshipis at the center of medicine, public health involves interac-tions and relationships among many professionals andmembers of the community as well as agencies of govern-ment in the development, implementation, and assessmentof interventions. From this starting point, we can suggestthat public health systems consist of all the people and ac-tions, including laws, policies, practices, and activities, thathave the primary purpose of protecting and improving thehealth of the public.

Mr Halabi and Dr Omer proposed the creation of a global vaccine injury compensation program.1 Although there is a need for a mechanism to address the liability concerns of vaccine manufacturers and ensure fair treatment of individuals with vaccine-related injuries, the authors failed to attend to legal complexities inherent in their proposal.

National, independent oversight is vital to resolve the problems and inconsistencies in oversight of human subjects research. Three key functions that must be considered in any proposal for such a mechanism are (1) issue spotting, (2) guidance on identified issues, and (3) sampling and follow‐up. The 1998 report and recommendations of the National Bioethics Advisory Commission concerning research involving persons with mental disorders that may affect decisionmaking capacity address these functions in part, but application is limited to a small segment of the research population. Incorporation of these three key functions in a formal, national, independent oversight process is necessary in order to ensure accountability and maintain public trust in 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 nation's 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 institution's and department's 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.

Personal health data supplied by users of mobile devices, health apps, and the social Web and data from tracking of consumers’ online behavior — coupled with advanced bioinformatics tools — offer opportunities for use in health research. A central ethical question is whether individuals who have provided personal information online in nonresearch contexts have consented to research uses. Here, we explore this issue of informed consent, discuss some limitations of current practices, and offer recommendations for improving consent practices through a more tailored, context-sensitive approach that makes use of the dynamism of the Web-based context. Our proposals are rooted in the ethical imperative of protecting individual rights and respecting autonomy while enabling a dynamic research environment for the advancement of clinical medicine and public health.

At a White House ceremony in October 1995, the Advisory Committee on Human Radiation Experiments presented its Final Report to President Bill Clinton. The 925-page report and the over 2,000 pages of supplemental volumes summarized eighteen months of investigative research, debate, and deliberation on historical and contemporary issues in human subjects research. The Advisory Committee's efforts were aided by unprecedented support from the highest levels of the executive branch, including the heads of eight cabinet-level agencies and their departments' resources. The presidentially appointed committee and its staff delved into long-forgotten Cold Warera government archives, listened to hours of public testimony, interviewed key players in the development of medical therapies and nuclear weapons, and studied ethical issues arising in today's research.In this article we focus on a critical, but narrowly defined, part of the Advisory Committee's Final Report: remedying harms or wrongs to subjects of human radiation experiments conducted or sponsored by the U.S. government between 1944 and 1974.

To force potential parents to tell their child of his/her genetic origin as a requirement for admission into an infertility programme is both wrong and discriminatory. In addition, comparing the practice of using donor gametes to conceive a child with adoption is incorrect for a number of reasons. In this article we make the argument that mandatory disclosure is both inappropriate and intrusive, and the presently available data do not justify a rigid position. Furthermore, no reasonable, practical system can be envisaged to guarantee compliance with mandatory disclosure. Although it is entirely reasonable at the time of consultation to encourage couples to consider their positions and obtain a mutual agreement on their future intent prior to treatment, the final decision on this should be a matter of free choice within the context of the couple's own value system.

Apologies are rare in the medical world, where health care providers fear that admissions of guilt or expressions of regret could be used by plaintiffs in malpractice lawsuits. Nevertheless, some states are moving toward giving health care providers legal protection so that they feel free to apologize to patients for a medical mistake. Advocates believe that these laws are beneficial for patients and providers. However, our analysis of "apology" and "disclosure" laws in thirty-four states and the District of Columbia finds that most of the laws have major shortcomings. These may actually discourage comprehensive disclosures and apologies and weaken the laws' impact on malpractice suits. Many could be resolved by improved statutory design and communication of new legal requirements and protections.

An aura of complacency surrounds the protection of human research participants in the United States. From investigators to policy-makers, many involved in research are exhibiting bureaucratic resignation, allowing paperwork compliance and checkboxes to protect the rights and interests of participants. The routinizing of ethics gives some tangible assurance that a system is in place, but it also undermines deliberate attention to ethical issues. Meanwhile, there is a disconnect between oversight practices and public perceptions. In a March 2008 survey conducted jointly by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health, 28 percent of respondents believed that most pharmaceutical companies acted unethically when testing new drugs on people. (1) Since the line between public and private sector research has blurred, this perception could readily affect attitudes toward public sector drug development as well. Maintaining public trust is absolutely crucial to the research enterprise. Without trust, volunteers will be impossible to recruit, and the public will be unwilling to fund research. Here I venture some preliminary thoughts on some of the central marks of public trust in the research enterprise: creating accountability in research, instilling confidence in the integrity of process, ensuring fairness and transparency in the research enterprise, and affirming a commitment to the protection of human participants by all involved in research. To create accountability, the public needs to be assured that processes are in place to protect research participants. We have those systems in the form of regulations and oversight bodies, such as institutional review boards, the Office of Human Research Protections, the Food and Drug Administration, and Congress. Although the system has been subject to legitimate criticism, some level of standardization (and bureaucracy) is required to ensure a common approach to research protections. In the USA Today survey, 44 percent said that government regulation was insufficient to ensure that prescription drugs are safe. (2) Perhaps the movement toward voluntary accreditation of human research protection programs through the Association for the Accreditation of Human Research Protection Programs offers a way to certify public accountability by establishing performance standards above federal and state requirements. Accreditation may become more desirable in an increasingly competitive research environment. Indeed, public, private, and international entities are paying attention, and nearly one hundred and twenty institutions have received accreditation to date. (3) The public also needs to be confident that the system is working as intended and is being maintained. Are we falling short in instilling public confidence in research? Although infrastructure deficiencies in research approval and oversight have been heavily scrutinized in the scholarly literature, they rarely attract public attention until something goes wrong. A surge in litigation for research injuries and declining confidence in the FDA show that the public is indeed paying attention--and that its confidence is shaken. Over the years, the volume of research has grown tremendously, and research has come to involve more complex and invasive technologies. Given the litigious climate in health care, it is no surprise that litigation for research injuries is on the rise. (4) Every death and injury (preventable or not) can have a negative impact on the public's perception of the research enterprise. Participants surely expect that if they are injured while providing benefit to society, they will receive prompt treatment and be reimbursed at least for the real costs imposed on them (such as medical expenses and loss of work), if not also for "pain and suffering." Yet the regulations require only that participants be informed about whether compensation and medical treatment for research injury is available, not that researchers or sponsors actually provide compensation or treatment. …

Purpose State laws concerning decision-making authority for voluntary inpatient substance abuse (SA) treatment of minors may be a potential barrier to appropriate treatment. We sought to identify and classify relevant laws related to the provision of voluntary inpatient SA treatment to adolescents 12 to 17 years (minors) as an exploratory assessment to improve understanding of how these laws might affect treatment decisions. Methods In summer 2006, we conducted a survey of statutes, regulations, and legal cases in the 50 states and the District of Columbia regarding the authority of parents (or guardians) and minors to make treatment decisions for voluntary inpatient SA treatment. Results All 50 states have laws applicable to voluntary inpatient SA treatment for adolescents, and the laws vary significantly throughout the nation. If a minor and parent disagree about SA treatment, some states defer to the decision-making authority of the minor, whereas other states defer to the parent. Most significantly, the majority of states fail to specify whether the minor's or the parent's decision will control in the event of a conflict. Conclusions The lack of clarity in state laws regarding decision-making authority for voluntary inpatient SA treatment of minors may create a potential barrier to treatment for adolescents, especially those with more serious SA problems. This lack of clarity could lead to confusion among parents, adolescents, healthcare professionals, and treatment facilities, and ultimately could result in a failure to treat adolescents in need of medical attention. Policymakers should ensure that state laws clearly specify procedures to enable treatment if a conflict arises between adolescents and parents, including procedures to ensure that the due process rights of adolescents are protected.

Posthumous reproduction refers to a deliberate decision to produce a child after one or both potential biological parents die (1). For purposes of this chapter, we are also using this term to refer to reproduction when one or both of the biological parents is in a permanent unconscious condition (2). Posthumous reproduction may involve several distinct levels of physician involvement: (1) in the procurement (“harvesting”) of the biological specimens; (2) in the preparation and/or storage of those specimens; and (3) in the use of the specimens for reproduction. Posthumous reproduction may include the use of “banked” specimens that were knowingly procured and stored by explicit consent of the individual. However, this chapter focuses on a more recent phenomenon of harvesting and use of specimens collected after death or a diagnosis of a permanent unconscious condition of the “donating” individual (3). The medical and legal communities have debated what physicians should or should not do in response to requests for posthumous reproduction for a number of years without achieving a complete consensus. In the United States, there are currently no uniform laws or regulations for governing assisted reproduction (4). Through a series of questions listed below, this chapter poses the common questions and examines the trends in posthumous reproduction.

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 reproduc- tive technologies.

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 ...

In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues.Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies.Leading experts present general principles for the ethical conduct of research on women--principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research.Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research.The book addresses present-day challenges to equity in four areas: Scientific--Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethical--The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legal--Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Risk--The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it is wise to do so, remains to be seen.

Ed Anna C Mastroianni, Ruth Faden, Daniel Federman National Academy Press, £28 (vol 1), £23 (vol 2), pp 271 (vol 1), 247 (vol 2) ISBN 0-309-04992-X (vol 1), 0-309-05040-5 (vol 2) Ed Michael A Grodin, Leonard H Glantz Oxford University Press, pounds sterling 30, pp 258 ISBN 0-19-507103 A profound change has occurred in societal attitudes towards participation in medical research, but it has gone almost unnoticed. Some sections of the community are actually queuing up and indeed demanding to be included as research subjects in clinical studies. The favourite fantasy of clinical researchers seems to be coming true. What powerful forces have brought about this dramatic change in public perception of human experimentation? One major factor is the improved protection provided to research subjects from the legislative …