Safeguards for healthy volunteers in drug studies.
Safeguards for healthy volunteers in drug studies have not been as strict as those involving patients. The shortcomings include the lack of surveillance over the scientific validity of the protocol and its ethical review, and over the financial inducements to volunteers. Recruitment is open to abuse because the volunteers may have some allegiance to the investigators. There is an urgent need to institute checks on these aspects. Most important, however, is the lack of legal safeguards for volunteers taking part in research done outside the pharmaceutical industry. The suggested procedure for obtaining consent, for health checks, and for providing compensation can be equitable to all concerned, and yet not restrict initiative, nor curtail research aims.
D035843:Biomedical Research; D004341:Drug Evaluation; D026724:Ethical Review; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D064368:Healthy Volunteers / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent; D007880:Legislation, Drug; D007883:Legislation, Medical; D010380:Peer Review; D012106:Research; D035842:Research Subjects; D012449:Safety; D013333:Student Health Services; D013334:Students; D006113:United Kingdom