Report and recommendations: Research involving prisoners -- Preface

This preface is the first of five files creating a single report entitled: Research involving prisoners.The Preface of this report contains introductory letters as well as a synopsis of the recommendations the Commission compiled with regard to prisoner research.Supported by the Department of Health, Education, and Welfare (DHEW)

Report and recommendations: research on the fetus appendix -- Part 16

This is the appendix to the 'Reports and recommendations: research on the fetus'. This appendix contains multiple parts. Each part equates to a file. Files include parts 1-16.Part 1 of this report discusses human fetal research. Part 2 explores the value of life. Part 3 considers an ethical appraisal. Part 4 discusses balancing the need for experimentation versus obligation to the fetus. Part 5 proposes fetal research policy. Part 6 discusses moral issues. Part 7 nonviable fetus research. Part 8 covers ethical and public policy. Part 9 explores ethical issues concerning the nonviable fetus. Part 10 discusses moral issues and institutional control. Part 11 discusses defining death in fetuses. Part 12 reports on distinguishing between viable and nonviable. Part 13 relates to the law on fetus experimentation. Part 14 reports on the legal issues involved in research on the fetus. Part 15 assesses the Batelle Report and the Cook Critique. Part 16 covers the stability of the decision to seek induced abortion

Report and recommendations: Research involving prisoners -- Part III

Part III is the fourth of five files creating a single report entitled: Research involving prisonersPart III of this report contains the activities of the Commission including site visits and public hearings.Supported by the Department of Health, Education, and Welfare (DHEW)

Report and recommendations: Research involving prisoners -- Part II

Part II is the third of five files creating a single report entitled: Research involving prisoners.General history, nature, and extent of research involving prisoners in the United States is discussed in Part II.Supported by the Department of Health, Education, and Welfare (DHEW)

How payment for research participation can be coercive

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent- undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment

Ethical and Legal Standards for Research in Prisons

Biobehavioral research, especially that which is conducted with prisoners, has become much more closely regulated in the last 30 years. State and federal law, as well as professional standards, regulate the conduct of many types of research; in the case of prisoners, this regulation is even more stringent. However, currently no mandatory, uniform, national regulatory or oversight process exists, and many privately funded research endeavors are operating in a regulatory void. In response to this, the National Bioethics Advisory Commission has argued for the creation of a single, national, independent regulatory body to oversee all human participant research, regardless of funding source. As ethicolegal research standards evolve alongside advances in science and technology, an appreciation of the history of prisoner research and an awareness of current standards is critical to conducting ethical prison research

The ethical contours of research in crisis settings: five practical considerations for academic institutional review boards and researchers.

The number of research studies in the humanitarian field is rising. It is imperative, therefore, that institutional review boards (IRBs) consider carefully the additional risks present in crisis contexts to ensure that the highest ethical standards are upheld. Ethical guidelines should represent better the specific issues inherent to research among populations grappling with armed conflict, disasters triggered by natural hazards, or health-related emergencies. This paper seeks to describe five issues particular to humanitarian settings that IRBs should deliberate and on which they should provide recommendations to overcome associated challenges: staged reviews of protocols in acute emergencies; flexible reviews of modification requests; addressing violence and the traumatic experiences of participants; difficulties in attaining meaningful informed consent among populations dependent on aid; and ensuring reviews are knowledgeable of populations' needs. Considering these matters when reviewing protocols will yield more ethically sound research in humanitarian settings and hold researchers accountable to appropriate ethical standards

Ethical Issues in Measuring Biomarkers in Children’s Environmental Health

Background: Studying the impact of environmental exposures is important in children because they are more vulnerable to adverse effects on growth, development, and health. Assessing exposure in children is difficult, and measuring biomarkers is potentially useful. Research measuring biomarkers in children raises a number of ethical issues, some of which relate to children as research subjects and some of which are specific to biomarker research. Objective: As an international group with experience in pediatric research, biomarkers, and the ethics of research in children, we highlight the ethical issues of undertaking biomarker research in children in these environments. Discussion: Significant issues include undertaking research in vulnerable communities, especially in developing countries; managing community expectations; obtaining appropriate consent to conduct the research; the potential conflicts of obtaining permission from an ethics review board in an economically developed country to perform research in a community that may have different cultural values; returning research results to participants and communities when the researchers are uncertain of how to interpret the results; and the conflicting ethical obligations of maintaining participant confidentiality when information about harm or illegal activities mandate reporting to authorities. Conclusion: None of these challenges are insurmountable and all deserve discussion. Pediatric biomarker research is necessary for advancing child health

Report and recommendations: Research involving prisoners -- Part I

Part I is the second file in a series of multiple parts constituting the report: Research involving prisoners.Part I of this report contains the recommendations as well as the deliberations and conclusions of the Commission and a summary of background materials.Supported by the Department of Health, Education, and Welfare (DHEW)