Clinical research with healthy volunteers: an ethical framework

Clinical research involving healthy volunteers is important for advancing medical knowledge but raises a variety of ethical issues, many of which stem from the fact that such studies pose risks to research participants without the prospect of medical benefits to them. Ethical issues in research with healthy volunteers are identified and analyzed with the help of an ethical framework consisting of seven ethical requirements for clinical research. These ethical requirements include (1) scientific or social value; (2) scientific validity; (3) fair subject selection; (4) favorable risk-to-benefit ratio; (5) independent review; (6) informed consent; and (7) respect for enrolled subjects.