| Recently implemented federal mandates requiring adequate inclusion of women in federally-funded clinical trials have been offered in response to real and perceived gender gaps in medical research. However, mandates address only part of the problem. Investigators cite challenges to recruiting and retaining women as the primary reason for not including women.;The University of Michigan Women's Health Registry (Registry) is a practical response to investigator challenges in reaching women interested in research participation. The Registry is a database of volunteers who have consented to be contacted whenever they meet study criteria, as determined by their self-reported health profiles. This dissertation explores the conceptual underpinnings of the Registry, describes its implementation at one medical center, and explores its potential efficacy as a response to the problem of inadequate inclusion of women in research studies. Secondary analyses of the Registry participant profiles (N = 1480) was performed and demographic and health characteristics are explored. To assess Registry effectiveness compared to other strategies, determine variations in usefulness among projects or disciplines, and explore perceived value of the model, structured interviews were conducted with investigators who have used the Registry.;The Registry exceeded investigator expectations and was credited with reducing time, money, and energy dedicated to recruitment. For the thirteen projects represented in the interview sample, 914 total women subjects were enrolled, 333 (36.4%) of whom were Registry participants. Neither protocol invasiveness nor investigator departmental affiliation affected success using the Registry or expressed value of the Registry. Stringent inclusion criteria was the only reported barrier to Registry usefulness---the Registry proved only slightly more useful than other recruitment techniques.;Overall, the Registry is an effective tool to complement existing strategies for recruiting women subjects. Based on the experience of this one institution, this model is worthy of further exploration by those seeking creative and complementary strategies for increasing the participation of women in clinical research. |
