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Contraceptive requirements for clinical research
J Cain1, J Lowell, L Thorndyke
1Department of Obstetrics/Gynecology, College of Medicine, The Pennsylvania State University, Hershey, USA. jcain@psghs.edu
Objective:
To survey the type and frequency of use of contraceptive requirements for entry into clinical trials.
Methods:
We reviewed 410 protocols submitted between January 1994 and January 1997 to one Institutional Review Board.
Results:
Contraception or sterility for women was required in 171 (41.7%) protocols without explanation and 146 (35.6%) based on study drug. Eight and one half percent hd no exclusions. Signature certification of contraceptive use was required in 138 protocols; 230 required certification of understanding requirements; and 101 required two signatures. Signature certification documenting no pregnancy at enrollment was required in 234 protocols. There were no requirements for signatures from male subjects. Celibacy or sexual orientation were not recognized as reasons for waiver from signature requirements.
Conclusion:
The broad application of contraceptive requirements potentially creates disproportionate burdens and access by gender to participation in clinical research. Careful elucidation of methods, timing, and the consent process in order to avoid potential fetal risk and encourage inclusion of hormonally intact women will improve research and access.