Women in early phase trials: an IRB's deliberations.
Anderson
James R
JR
Department of Preventive and Societal Medicine, University of Nebraska Medical Center, USA.
Schonfeld
Toby L
TL
Kelso
Timothy K
TK
Prentice
Ernest D
ED
D000014:Abnormalities, Drug-Induced; D000328:Adult; D000367:Age Factors; D026686:Beneficence; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D003267:Contraception / Q000379:methods; D028744:Ethics Committees, Research; D005260:Female; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent; D016365:Liability, Legal; D018579:Patient Selection / Q000941:ethics*; D026684:Personal Autonomy; D011247:Pregnancy; D012107:Research Design / Q000592:standards; D018570:Risk Assessment; D012935:Social Justice; D014481:United States; D014486:United States Food and Drug Administration; D014930:Women