Ethical Issues in the Design and Conduct of HIV Vaccine Trials
نویسنده
چکیده
lthough of crucial importance, human trials of HIV vaccines should not go forward without appropriate attention to ethical considerations. This chapter provides an overview of the ethical considerations that arise in the design and conduct of clinical trials of preventive HIV vaccines.1 The primary focus of this chapter is on Phase III (efficacy) trials; however, many ethical issues relevant to early stage (Phase I and II) clinical trials and to the marketing of HIV vaccines are also addressed. This chapter begins with a review of some basic ethical principles and background information about clinical trials. The chapter then discusses ethical issues in clinical trial design, sample selection, informed consent, trial termination, and compensation for adverse reactions. The chapter concludes with a discussion of ethical issues relevant to clinical trials in developing countries, and issues arising from the incorporation of HIV vaccines into clinical practice.
منابع مشابه
Commentary on UNAIDS 18 guidance points.
Beginning in 1997 and continuing for two years, UNAIDS held regional and international deliberations and consultations concerning the issue of HIV/AIDS and vaccine research in particular. According to the organisers the purpose of such international consultations was 1) to further define important ethical issues and 2) to formulate guidance that might facilitate ethical design and conduct of HI...
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