Ethical Considerations Related to the Inclusion of Women in Clinical Trials

Authors

  • Judith T. Fullerton CNM, PhD, FACNM,

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    • Judith T. Fullerton, CNM, PhD, FACNM, received the BSN from Wayne State University, an MS and certificate in nurse-midwifery from Columbia, and the PhD from Columbia University. She is a consultant in women's reproductive health.

  • Georgia Robins Sadler PhD, MBA

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    • Georgia Robins Sadler, BSN, MBA, PhD, received a BSN from the University of Pennsylvania School of Nursing, the MBA from the Wharton Graduate School at the University of Pennsylvania, and the PhD in Public Health and Resource Management from the Union Institute. She is a Clinical Professor of Surgery at the University of California San Diego (UCSD) School of Medicine and the Associate Director for Community Outreach at the Rebecca and John Moores UCSD Cancer Center.


7717 Canyon Point Lane, San Diego, CA 92126-2049. E-mail: jfullerton@san.rr.com

Abstract

Clinical trials are the primary way the most promising new preventive, diagnostic, therapeutic, and palliative measures move from the basic science laboratory to the bedside. Attracting participants to clinical trials occurs at a painstakingly slow pace, delaying the public's access to new care modalities. Additional ways are needed to increase the public's awareness and understanding of the important role of clinical trials. As key members of the health and social welfare promotion team, nurse-midwives/midwives are well positioned to help advance the public's access to clinical trials information. Generic ethical issues related to human subjects review processes, their specific application to clinical trials, and the impact of recent HIPAA legislation are discussed.

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