Vaccines, human experimentation, and ethics in evolutionary perspective.

Abstract

Clinical testing of unlicensed biological products is woven into issues of ethics and technology that reflect the state of the art. Materials for human testing must be of best possible quality and content, and must be safe. Testing of vaccines demands fulfillment of three ethical principles established since World War II. Thus, autonomy (informed consent), beneficence (optimize benefit to risk, and do no harm), and justice (equitable distribution of benefits and burden among volunteer participants). Ethical and technical considerations are the driving force for regulation, by National Control Authorities, of both products and clinical testing. Regulation is facilitated by guidelines promulgated by the larger National Control Authorities, by the European Community, and by the World Health Organization. Sane and sensible regulation is best achieved by well-trained and informed regulatory staffs and is optimized by their continuing hands-on conduct of research. The difficulties of the past products have been diminished by increasing technical sophistication. The future bodies well for improved and new vaccines that will be based mainly on the established technologies of the past. New technologies will be approved slowly.