Objective: We present a preventive ethics approach for including women of childbearing potential in clinical trials.
Study design: We explain the concept of preventive ethics and identify its implications for study design, the informed consent process, and study management.
Results: We identify and address ethically significant questions for investigators and institutional review boards to address, to responsibly enroll women of childbearing potential in clinical trials. These questions concern preventive ethics for study design, for the informed consent process, and for study management. Distinctive components of this preventive ethics approach include the distinction between directive and nondirective counseling, the recognition of the concept of moral risk for women as research subjects, and the distinction between professional and individual conscience. We identify ethical considerations for physicians considering referral of their patients to clinical trials.
Conclusion: A comprehensive, preventive ethics approach to the ethical challenges in clinical trials related to the prevention and occurrence of pregnancy is essential for responsibly enrolling women of childbearing potential.