TY - JOUR
T1 - Balancing justice and autonomy in clinical research with healthy volunteers
AU - Kass, N. E.
AU - Myers, R.
AU - Fuchs, E. J.
AU - Carson, K. A.
AU - Flexner, C.
PY - 2007/8
Y1 - 2007/8
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=34447547668&partnerID=8YFLogxK
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U2 - 10.1038/sj.clpt.6100192
DO - 10.1038/sj.clpt.6100192
M3 - Article
C2 - 17410122
AN - SCOPUS:34447547668
SN - 0009-9236
VL - 82
SP - 219
EP - 227
JO - Clinical pharmacology and therapeutics
JF - Clinical pharmacology and therapeutics
IS - 2
ER -