Ethical, Evidence-Based Guidelines for Contraceptive Use in Research (Report‪)‬

Research ethics review committees commonly approve protocols that require women of childbearing potential to use one or two means of birth control while enrolled in clinical drug trials, and sometimes the means of birth control are specified (e.g., oral contraceptives or an intrauterine device). The purpose of a contraception requirement is to protect a developing fetus from exposure to drugs that might harm it by preventing pregnancy for the duration of the trial. Some commentators contend that it is ethically unacceptable to require women of childbearing potential to use contraception as a condition of trial participation because such a requirement violates women's autonomy and is inconsistent with women's well-being, as some forms of contraception carry health risks for women. These risks are all the more significant when contraceptive use is unnecessary, as when there is no risk of pregnancy. For others, mandated contraception for women of childbearing potential is ethically defensible on the grounds that while women might benefit from participating in clinical drug trials, they should not expose a potential fetus to drugs that could be harmful. In an effort to balance the duty to respect women's autonomy and well-being and the (contested) duty to protect potential fetuses from possible research harms, many research ethics review committees have developed policies regarding contraceptive use for women who participate in clinical trials. One published policy is that of the IRB at the University of Nebraska Medical Center (UNMC). (1) This policy uses the U.S. Food and Drug Administration's (FDA) categories for prescription drug labeling for drugs used during pregnancy "as thresholds for levels of required contraception." (2) The underlying reasoning is that the current FDA labeling categories (A, B, C, D, X) (3)--in place to protect actual fetuses from potential harm in the context of therapeutic treatment--can reasonably be used to protect potential fetuses from potential harm in the context of clinical research.