Balancing justice and autonomy in clinical research with healthy volunteers.
Clin Pharmacol Ther
; 82(2): 219-27, 2007 Aug.
Article
in En
| MEDLINE
| ID: mdl-17410122
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.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Social Justice
/
Personal Autonomy
/
Biomedical Research
/
Healthy Volunteers
Type of study:
Prognostic_studies
Aspects:
Determinantes_sociais_saude
/
Equity_inequality
/
Ethics
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Clin Pharmacol Ther
Year:
2007
Document type:
Article
Affiliation country:
United States