title: Participation of healthy volunteers in research projects.
abstract: Research that involves healthy normal volunteers frequently is performed. This article examines ethical guide-lines for the recruitment of healthy volunteers in research projects. Ethical decisions on projects that are based on patient-volunteers or healthy normal volunteers should balance the risk to the volunteer and the collective benefit to the community. For healthy normal volunteers that risk should be minimal or trivial. Investigators should follow recruitment practices that avoid approaches to persons who are dependent upon them in some way, and should carry the day-to-day ethical responsibility even after institutional ethical approval has been granted. Pilot studies and self-experimentation readily can transgress ethical guide-lines. Compensation for mishaps or injuries that occur during research in which there is no question of negligence (for example, an unforeseeable reaction in a phase-1 drug trial) is an unresolved issue which should be addressed by the research community. It is recommended that action be taken to ensure that healthy volunteers who participate in approved research have redress in the rare event of an accident, whether this is a result of negligence, chance or misadventure. Hospitals/institutions or other bodies that sponsor research should extend their insurance to cover specifically such unforeseeable events in which there may be liability, and to have the facility for a payment of beneficence in the case of accidents in which liability cannot be established.
authors.affiliation: Royal Melbourne Hospital, Parkville, VIC.
authors.forename: F A
authors.initials: FA
authors.lastname: Macrae
authors.forename: I R
authors.initials: IR
authors.lastname: Mackay
authors.forename: J R
authors.initials: JR
authors.lastname: Fraser
mesh_terms: D001315:Australia; D032762:Autoexperimentation; D035881:Compensation and Redress; D030881:Disclosure; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D007349:Insurance, Health, Reimbursement / Q000191:economics; D008318:Malpractice / Q000191:economics / Q000331:legislation & jurisprudence; D033281:Nontherapeutic Human Experimentation; D018579:Patient Selection; D012106:Research; D035842:Research Subjects; D018570:Risk Assessment; D012307:Risk Factors; D014838:Volunteers