The motivation and inspiration for this book come directly from expe- ences with clients during the years that I practiced HIV-related law at the Legal Aid Society of San Diego, Inc. The issues discussed in this work reflect issues that arose on a recurring basis with clients participating in HIV research studies, with investigators calling for guidance on the legal implications of particular aspects of their proposed studies, and with research institutions and health care facilities struggling to make sense of legal maneuvers aimed at obtaining the records of their HIV-infected patients. It is impossible to thank each of these persons individually for their provocative questions and their insights. The discussion of ethical and legal issues relating to the design of clinical trials reflects questions raised during discussions with Donald J. Slymen, Ph.D. Don was one of the first researchers, in my realm of experience, to pay close attention to ethical concerns, and I am greatly appreciative of his contribution to both my professional growth and the development of various scenarios discussed in this text. The portions of this text dealing with confidentiality are the result of many hours of thoughtful discussion and analysis with Penn Lerblance, J.D., now deceased and still missed. Penn and I often participated together as presenters of in-service training programs for health prof- sionals. Penn addressed discrimination, and I focused on confidentiality.

Prestudy Planning.- The Evolution of Protections for Research Participants.- Governing Principles.- Clinical Trials.- Recruitment.- Issues Arising during the Study.- Confidentiality.- Potential Conflicts.- Scientific Misconduct.- Following the Study.- Participants and Records.- Publication and Dissemination of Research Results.- New Roles for the HIV Researcher.- An Overview of the Legal System.- The HIV Researcher as an Expert Witness.- The HIV Researcher and Legislative Advocacy.- The HIV Researcher in the Regulatory Arena Conclusion.