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Human Subjects Research Regulation
Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect other...
Ethical Considerations When Preparing a Clinical Research Protocol
Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more.
Finding Your Seat at the Table
Service on Institutional Review Boards (IRB) and Institutional Animal Care and Use Committees (IACUC) is an uncommon activity for librarians. Even librarians who participate in institutional research activities in a supportive capacity or conduct their own original research as scholars themselves and are familiar with the IRB/IACUC research approval process, they may hesitate to participate more fully with these boards. There may be a perception that the work of the IRB and IACUC is too scientifically complex for librarians without an appropriate background. Library administrators may not advocate for librarian inclusion on the board for fear of additional burdens on the librarian’s time; ...
The Ethics of Research Biobanking
Biobanking, i.e. storage of biological samples or data emerging from such samples for diagnostic, therapeutic or research purposes, has been going on for decades. However, it is only since the mid 1990s that these activities have become the subject of considerable public attention, concern and debate. This shift in climate is due to several factors. The purpose of this book is to investigate some of the ethical, legal and social challenges raised by research biobanking in its different modern forms and formats. The issues raised by research biobanking in its modern form can be divided into four main clusters: how biological materials are entered into the bank; research biobanks as institutions; under what conditions researchers can access materials in the bank, and problems concerning ownership of biological materials and of intellectual property arising from such materials; and how the information is collected and stored, e.g. access-rights, disclosure, confidentiality, data security and data protection.
The Birth of Bioethics
This book is the first broad history of the growing field of bioethics. Covering the period 1947-1987, it examines the origin and evolution of the debates over human experimentation, genetic engineering, organ transplantation, termination of life-sustaining treatment, and new reproductive technologies. It assesses the contributions of philosophy, theology, law and the social sciences to the expanding discourse of bioethics. Written by one of the field's founders, it is based on extensive archival research into resources that are difficult to obtain and on interviews with many leading figures. A very readable account of the development of bioethics, the book stresses the history of ideas but does not neglect the social and cultural context and the people involved.
