Legal And Ethical Aspects Of Hiv-related Research (the Language Of Science)

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.

This unique volume summarizes the basic legal and ethical principles related to HIV research, striking a balance between theory and practice. The author offers practical suggestions for the implementation of these principles and integrate them with a discussion of relevant scientific research principles. The book's organization follows the sequence of a study: pre-study planning, issues that may arise during the course of the study, and issues that arise after the study's conclusion. Features include sample forms that can be adopted for use, explanatory tables and figures, and the citation of examples specific to HIV research.

Robert D. Boyer

This new book provides information concerning the legal and ethical aspects of conducting clinical HIV research. Its purpose is to instruct and advise researchers on the basic legal and ethical principles related to HIV research. It provides an in-depth analysis of the various issues that arise before, during, and after the course of a study. The author's attempt to strike a balance between theory and practice meets with much success. This book is intended primarily for individuals involved in HIV research. It is also an important reference tool for attorneys who are called on to advise HIV researchers but who are not familiar with the various scientific aspects of HIV research. The author practiced HIV-related law and is a credible authority on the subject matter. The illustrations in this book are adequate for the subject matter. The text provides detailed examples of the various forms required to conduct a research trial. The table of contents is well organized, and the structure of the book allows the reader to reference each chapter individually. This is a very useful book for everyone involved in HIV-related research. It is a practical guide that addresses the major issues that each researcher faces during the course of a study and provides guidance on how to apply the underlying legal and ethical concepts to specific situations. It is an easily readable reference tool that should be included in any HIV reference library.

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 The Evolution of Protections for Research Participants....Pages 5-12 Governing Principles....Pages 13-45 Clinical Trials....Pages 47-62 Recruitment....Pages 63-75 Confidentiality....Pages 79-117 Potential Conflicts....Pages 119-136 Scientific Misconduct....Pages 137-141 Participants and Records....Pages 145-148 Publication and Dissemination of Research Results....Pages 149-153 An Overview of the Legal System....Pages 157-159 The HIV Researcher as an Expert Witness....Pages 161-176 The HIV Researcher and Legislative Advocacy....Pages 177-186 The HIV Researcher in the Regulatory Arena Conclusion....Pages 187-194 Summarizes the basic legal and ethical principles related to HIV research. This title offers practical suggestions for the implementation of these principles and integrate them with a discussion of relevant scientific research principles.