Ethics In Neurobiological Research With Human Subjects

The papers included in this book were presented at the Baltimore Conference on Ethics in 1995. The purpose of this conference was to bring together ethicists, psychiatrists, researchers, family members, consumers, and representatives of government, industry and academia to discuss the following issues: History and Ethics of Neurobiological Research with Human Subjects, Current Practices, Informed Consent, Government Oversight/Institutional Review Boards, and the Patient and Family Perspective. Over the past 40 years, there has been a significant increase in research on neurobiological disorders for basic scientific knowledge, and to develop new treatment therapies. This has led to significant advances in the treatment of schizophrenia, manic-depression and other disorders which have improved the lives of thousands. Public attention has been raised recently over the potential vulnerability of patients with neurobiological disorders who participate in such research since these patients often s

Behavioral neuroscience encompasses the disciplines of neurobiology and psychology to study mechanisms of behavior. This volume provides a contemporary overview of the current state of how ethics informs behavioral neuroscience research. There is dual emphasis on ethical challenges in experimental animal approaches and in clinical and nonclinical research involving human participants.

Media headlines about research misconduct in American Universities have focused public attention on the dramatic ethical problems that can arise during the conductof research. In the current atmosphere of accountability, scientific research on humans is now under increased scrutiny by the media, Congress and the public. Ethics of the Use of Human Subjects in Research fills the need for learning materials and strategies providing support for training programs related to the ethics of the use of human subjects in research. It presents a practical introduction to the ethical issues at stake in the conduct of research with human subjects. Beginning with a chapter on research ethics, a total of 10 chapters range in scope from the deveolopment of a protocol for ethical decision making to how to obtain IRB approval, with an emphasis on ethical factors underpinning the IRB process.

In this chapter, we use the special features of neuroimaging to illustrate research ethics issues for the clinical neurologic sciences, and focus on one particularly compelling case: studies involving first-episode schizophrenic treatment-naïve individuals (FESTNIs) (). FESTNIs are scanned prior to the administration of medication in order to control for the confounding effects of treatment. By concentrating on this program of research, we capture the distinctive ethical challenges associated with neuroimaging research overall, and foreground the issues particular to neuroimaging research involving FESTNIs that have yet to receive sufficient attention in the literature. We highlight assessment of risks and burdens, including risks associated with treatment delays and incidental findings; assessment of benefit, including direct benefit, social value, and scientific quality; subject selection; justice questions related to responsiveness and poststudy access; and, finally, issues related to consent and capacity.

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.

Research with human subjects has long been controversial because of the conflicts that often arise between promoting scientific knowledge and protecting the rights and welfare of subjects. Twenty-five years ago the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research addressed these conflicts. The result was the Belmont Report: Ethical Principles and Guidance for Research Involving Human Subjects, a report that identified foundational principles for ethical research with human subjects: respect for persons, beneficence, and justice. Since the publication of Belmont, these three principles have greatly influenced discussions of research with human subjects. While they are often regarded as the single-most influential set of guidelines for biomedical research and practice in the United States (and other parts of the world), not everyone agrees that they provide adequate guidance. Belmont Revisited brings together a stellar group of scholars in bioethics to revisit the findings of that original report. Their responses constitute a broad overview of the development of the Belmont Report and the extent of its influence, especially on governmental commissions, as well as an assessment of its virtues and shortcomings. Belmont Revisited looks back to reexamine the creation and influence of the Belmont Report, and also looks forward to the future of research—with a strong call to rethink how institutions and investigators can conduct research more ethically.

Is using children as research subjects ever justified? Are there limits to such use? Does the fact that children are medically and psychosocially different from adults have implications for research? What can we learn from the history of the use and abuse of children as research subjects? Do parents have the authority to volunteer their children for research projects? How should children participate in the decision to be involved in research? How should research risks be assessed and balanced? These perplexing questions and others are addressed by a distinguished group of experts in the field of biomedical and behavioral research with children. This book adopts an integrated multidisciplinary approach which uses science, ethics, and law as guides for exploring these most difficult issues. The tension between acquiring important new knowledge and fulfilling the obligation to protect children from exploitation and harm is a recurring theme. As the first book to be devoted solely to the science, ethics, and law of research with children, it is an indispensable resource to physicians, psychologists, educators, lawyers, ethicists, Institutional Review Board members, child advocates and others involved in performing or reviewing research with children.