Consent documents, reproductive issues, and the inclusion of women in clinical trials.
OBJECTIVE
To describe language used in consent documents at one academic medical center to inform women participating in studies of potential reproductive and fetal risks.


METHODS
The authors reviewed consent document language describing reproductive and fetal risks in 114 approved protocols. Protocols were identified as being of high, low, or unknown risk based upon FDA drug-risk and radiation-risk categories.


RESULTS
Although most consent documents advised women against participating for one or more pregnancy-related reasons, specific information about reproductive or fetal risks was included in fewer consent documents: 8 (73%) of the high-risk studies, 12 (40%) of the low-to-moderate-risk studies, and 29 (40%) of the unknown-risk studies.


CONCLUSIONS
Investigators often omit fetal risk information from consent documents. Full disclosure of reproductive and fetal risks in consent documents and discussions can be taught and modeled during the research training period. The authors present a template with language that can be used in consent documents and recommend ongoing discussion of reproductive and fetal risks with women subjects throughout the study period.
Nolan
M T
MT
Johns Hopkins University, Baltimore, MD 21205, USA. mtnolan@welchlink.welch.jhu.edu
Pressman
E K
EK
Starklauf
B L
BL
Gregory
R E
RE
D000014:Abnormalities, Drug-Induced / Q000209:etiology / Q000517:prevention & control*; D000016:Abnormalities, Radiation-Induced / Q000209:etiology / Q000517:prevention & control*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D032962:Consent Forms; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D008297:Male; D010353:Patient Education as Topic / Q000331:legislation & jurisprudence; D011247:Pregnancy; D035842:Research Subjects; D012306:Risk; D012737:Sex Factors; D014481:United States; D014486:United States Food and Drug Administration