The purpose of this study is to provide information on legal and ethical issues to the NIH and the scientists and others who undertake and monitor these studies. The centerpiece of the study will be the planning, coordination and conduct of a workshop which will examine issues including but not limited to the following: (1) recruitment and retention of women in trials; (2) types, clarity, and comprehensibility of informed consent; (3) use and reliability of various forms of contraception that may be used by women in studies; (4) behavior of women who participate in studies (including sociodemographics, reliability in contraceptive use and existing options for women in the course of a study; (5) relevant case law, including individual and class action suits; (6) potential and actual injuries to research subjects; (7) current research practices involving women of child bearing age; (8) what legal liabilities and protection are involved for the woman and/or her fetus; (9) what current legal circumstances, such as regulations and policies, deter undesirable risky practices of exposing fetuses to unwarranted risks or teratogenic compounds while not deterring desired research activities, and (10) whether women's and men's concerns for the well-being of existing or future children can be known and deemed sufficient to ensure fetal protection.
