Women and contraception in research: A pilot study

Background: There are no data on women's willingness to participate in clinical trials as a function of real or perceived reproductive risk. Further, it is unknown whether the requirement for contraception or the common practice of limiting women's contraceptive choices influences their willingness to participate in research. The uncertainty about women's preferences on these matters remains a barrier for recruiting women to and retaining women as subjects in clinical trials. Methods: We developed a pilot study to determine women's willingness to participate in research with contraceptive requirements by looking at the three most common types of reversible contraceptives: hormonal contraception, barrier contraception, and intrauterine contraception. This study tested the hypotheses that restrictions on contraceptive choice impact women's willingness to participate in research and that the impact of contraceptive choice differs depending on women's perception of risk. Results: Women's willingness to participate in the proposed study decreased overall as reproductive risk increased. In addition, requirements for specific contraceptive methods negatively impacted women's reported willingness to participate in the research studies in our survey. Conclusions: Results suggest that requirements for specific contraceptive methods negatively impacted women's reported willingness to participate in research. If confirmed in a larger sample, the negative effect of contraceptive limitations on women's willingness to participate in research would be of importance to clinical investigators and to institutional review boards (IRBs), as most adult biomedical research has as an explicit goal the equitable recruitment of women of childbearing potential.