Ethical And Policy Issues In International Research Commissioned Papers And Staff Analysis

The companion volume to a report by the Nat. Bioethics Advisory Commission that discusses the ethical issues that arise when research subject to U.S. regulations is sponsored or conducted in developing countries. Papers in this volume include: the challenge of equivalent protection; attitudes and experiences of U.S. and developing country investigators regarding U.S. human subjects regulations; the relevance of culture for informed consent in U.S.-funded international health research; comparative analysis of international documents addressing the protection of research participants; and international perspectives on protecting human research subjects.

There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies. Women and Health Research, Volume 2, addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation. The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal.