title: Balancing justice and autonomy in clinical research with healthy volunteers.
abstract: In clinical research, ethics review generally first examines whether study risks are reasonable in light of benefits provided. Through informed consent, then, prospective subjects consider whether the risk/benefit balance and procedures are reasonable for them. Unique ethics issues emerge in clinical research with healthy volunteers. Certain types of studies only recruit healthy volunteers as participants. Phase 1 studies, for example, including first time in human studies of investigational drugs and vaccines, generally are conducted in healthy volunteers. Although such research carries inherent and often unknown risks, healthy subjects provide the most efficient target population in which to conduct such research, as these volunteers generally are free of concurrent diseases or medications that could confound interpretation of toxicity. Other studies enrolling healthy volunteers often are simply looking for the most scientifically sound population for the study of normal human physiology.
authors.affiliation: Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Berman Institute of Bioethics, Baltimore, Maryland, USA. nkass@jhsph.edu
authors.forename: N E
authors.initials: NE
authors.lastname: Kass
authors.forename: R
authors.initials: R
authors.lastname: Myers
authors.forename: E J
authors.initials: EJ
authors.lastname: Fuchs
authors.forename: K A
authors.initials: KA
authors.lastname: Carson
authors.forename: C
authors.initials: C
authors.lastname: Flexner
mesh_terms: D000328:Adult; D000368:Aged; D001291:Attitude of Health Personnel; D001294:Attitude to Health; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence / Q000379:methods*; D003299:Cooperative Behavior; D034462:Dissent and Disputes; D005260:Female; D006266:Health Education; D064368:Healthy Volunteers / Q000331:legislation & jurisprudence*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010353:Patient Education as Topic; D018579:Patient Selection; D026684:Personal Autonomy; D011329:Prisoners / Q000331:legislation & jurisprudence; D012052:Reimbursement, Incentive; D035844:Researcher-Subject Relations; D012935:Social Justice