Participation of healthy volunteers in research projects. 1989

F A Macrae, and I R Mackay, and J R Fraser
Royal Melbourne Hospital, Parkville, VIC.

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.

UI MeSH Term Description Entries
D007258 Informed Consent Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment. Consent, Informed
D007349 Insurance, Health, Reimbursement Payment by a third-party payer in a sum equal to the amount expended by a health care provider or facility for health services rendered to an insured or program beneficiary. (From Facts on File Dictionary of Health Care Management, 1988) Health Insurance Reimbursement,Reimbursement, Health Insurance,Third-Party Payments,Third-Party Payers,Health Insurance Reimbursements,Insurance Reimbursement, Health,Insurance Reimbursements, Health,Payer, Third-Party,Payers, Third-Party,Payment, Third-Party,Payments, Third-Party,Reimbursements, Health Insurance,Third Party Payers,Third Party Payments,Third-Party Payer,Third-Party Payment
D008318 Malpractice Failure of a professional person, a physician or lawyer, to render proper services through reprehensible ignorance or negligence or through criminal intent, especially when injury or loss follows. (Random House Unabridged Dictionary, 2d ed) Professional Negligence,Negligence,Negligence, Professional,Professional Negligences
D012106 Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. (Webster, 3d ed) Research Priorities,Laboratory Research,Research Activities,Research and Development,Activities, Research,Activity, Research,Development and Research,Priorities, Research,Priority, Research,Research Activity,Research Priority,Research, Laboratory
D004992 Ethics, Medical The principles of professional conduct concerning the rights and duties of the physician, relations with patients and fellow practitioners, as well as actions of the physician in patient care and interpersonal relations with patient families. Medical Ethics
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001315 Australia The smallest continent and an independent country, comprising six states and two territories. Its capital is Canberra. Canton and Enderbury Islands,Christmas Island,Christmas Island (Australia)
D012307 Risk Factors An aspect of personal behavior or lifestyle, environmental exposure, inborn or inherited characteristic, which, based on epidemiological evidence, is known to be associated with a health-related condition considered important to prevent. Health Correlates,Risk Factor Scores,Risk Scores,Social Risk Factors,Population at Risk,Populations at Risk,Correlates, Health,Factor, Risk,Factor, Social Risk,Factors, Social Risk,Risk Factor,Risk Factor Score,Risk Factor, Social,Risk Factors, Social,Risk Score,Score, Risk,Score, Risk Factor,Social Risk Factor
D014838 Volunteers Persons who donate their services. Voluntary Workers,Volunteer Personnel,Untrained Personnel,Volunteer Workers,Volunteerism,Personnel, Untrained,Personnel, Volunteer,Voluntary Worker,Volunteer,Volunteer Worker,Worker, Voluntary,Worker, Volunteer
D018570 Risk Assessment The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988) Assessment, Risk,Benefit-Risk Assessment,Risk Analysis,Risk-Benefit Assessment,Health Risk Assessment,Risks and Benefits,Analysis, Risk,Assessment, Benefit-Risk,Assessment, Health Risk,Assessment, Risk-Benefit,Benefit Risk Assessment,Benefit-Risk Assessments,Benefits and Risks,Health Risk Assessments,Risk Analyses,Risk Assessment, Health,Risk Assessments,Risk Benefit Assessment,Risk-Benefit Assessments

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