title: Healthy human volunteers and informed consent.
abstract: The use of healthy human volunteers poses major ethical and medical dilemmas. The ethical dilemma is "without some form of payment most volunteers will not volunteer." Furthermore, no clear distinction exists between legal consent and valid consent. The former involves signing a document of informed consent. Valid consent poses unique problems, since the animal experiments performed prior to clinical trial are not predictive with any degree of confidence for human beings. Participants in clinical trials (particularly early phase) must always receive written assurances that they, or their next-of-kin, will receive significant guaranteed (i.e., no fault) financial compensation (at least on a par with a reputable life insurance company), in the event of participant damage or death. In addition, ethical committees whose task it is to approve or oversee clinical trials should be comprised of at least 50% non-scientists (as in the Danish system of medical ethics).
authors.forename: A
authors.initials: A
authors.lastname: Menache
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D003718:Denmark; D004282:Documentation / Q000592:standards; D005190:Family; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D023421:Models, Animal; D006113:United Kingdom; D014481:United States