SPECIAL COMMUNICATION What Makes Clinical Research Ethical?

WHAT MAKES RESEARCH IN-volving human subjectsethical? Informed con-sent is the answer most US researchers, bioethicists, and insti-tutional review board (IRB) members would probably offer. This response re-flects the preponderance of existing guidance on the ethical conduct of research and the near obsession with autonomy in US bioethics.1-4 While informed consent is necessary in most but not all cases, in no case is it suffi-cient for ethical clinical research.5-8 In-deed, some of the most contentious con-temporary ethical controversies in clinical research, such as clinical research in developing countries,9-13 the use of placebos,14-16 phase 1 re-search,17-19 protection for communi-ties,20-24 and involvement of chil-dren,25-29 raise questions not of informed consent, but of the ethics of subject se-lection, appropriate risk-benefit ratios, and the value of research to society. Since obtaining informed consent does not en-sure ethical research, it is imperative to have a systematic and coherent frame-work for evaluating clinical studies that incorporates all relevant ethical consid-erations. In this article, we delineate 7 require-ments that provide such a framework by synthesizing traditional codes, declara-tions, and relevant literature on the eth-ics of research with human subjects. This framework should help guide the ethi-cal development and evaluation of clini-cal studies by investigators, IRB mem-bers, funders, and others