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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
Obstetrics and Gynecology
|June 1, 2000
Summary
Many clinical trials require women to use contraception, potentially limiting research participation. These requirements, often lacking clear justification, need re-evaluation to ensure equitable access and improve study inclusivity.
Area of Science:
- Clinical research ethics
- Reproductive health policy
Background:
- Contraceptive requirements are common in clinical trials.
- The rationale for these requirements is often not clearly stated.
Purpose of the Study:
- To determine the types and frequency of contraceptive requirements in clinical trial protocols.
- To assess the implications of these requirements on research participation.
Main Methods:
- Review of 410 clinical trial protocols submitted to an Institutional Review Board between January 1994 and January 1997.
- Analysis of contraceptive and sterility mandates, and associated signature requirements.
Main Results:
- 41.7% of protocols required contraception/sterility for women without explanation; 35.6% based on study drug.
- Signature certification for contraceptive use, understanding, or pregnancy status was frequently mandated.
- No male subject signature requirements were noted; celibacy/sexual orientation were not accepted waivers.
Conclusions:
- Widespread contraceptive requirements may create gender-based disparities in clinical trial access.
- Clearer guidelines on contraceptive methods, timing, and consent are needed.
- Improving these processes can reduce fetal risk and enhance inclusion of women in research.