Issues in Medical Research Ethics

by Boomgaarden, Jurgen; Louhiala, Pekka; Wiesing, Urban

• ISBN13: 9781571816016
• ISBN10: 1571816011
• Format: Hardcover
• Copyright: 2003-07-01
• Publisher: Berghahn Books

Summary

With the advances of medicine, questions of medical ethics have become more urgent and are now considered of great social and political significance. An innovatively designed, activity-based workbook, this text was prepared using papers and case studies collected from several countries in the European Union. It reflects the issues and concerns that confront clinical practitioners throughout Europe and elsewhere today and presents varying national responses in law and policy to these concerns, as identified by ethicists, lawyers, theologians and practitioners. The problems they examine include the relationship between medical research and medical practice, elementary regulations of medical research, the complexity of informed consent, and the role of the sponsor or scientific community.

Table of Contents

Introduction	1	(4)
On the nature of research	5	(10)
The case of recruiting patients	5	(4)
The conceptual foundations of scientific research and medical practice	9	(6)
Regulation of research	15	(26)
The Case of DNA samples	15	(2)
Commentary on the case	17	(4)
Consent, inducement and conflict of interest in medical research and development	21	(10)
Human dignity in medical research	31	(10)
Research versus consent	41	(28)
The Case of saliva samples	42	(3)
Commentary on the case	45	(3)
Paternalism versus informed consent: Issues in research ethics	48	(8)
Ethical issues surrounding the use of women as subjects in clinical research	56	(8)
Clinical research in emergency settings	64	(5)
Vulnerable groups	69	(18)
The Case of challenging behaviour	69	(2)
Commentary on the case	71	(10)
Philosophical reflections on research with cognitively impaired persons	81	(4)
An open trial of drug X for Alzheimer's disease	85	(2)
The extent of the researcher's duties	87	(12)
The case of the open label extension study	87	(2)
Commentaries on the case	89	(6)
Bad science---bad ethics?	95	(4)
Glossary	99	(5)
References	104	(4)
Appendices	108	(21)
(1) The Nuremberg Code	108	(2)
(2) Council of Europe Convention on Human Rights and Biomedicine	110	(13)
(3) World Medical Association Declaration of Helsinki	123	(6)
List of participants	129	(3)
List of critical readers	132	(1)
Index	133