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Published on: November 26, 2015
Ethical considerations related to the inclusion of women in clinical trials
Judith T Fullerton1, Georgia Robins Sadler
1School of Medicine, University of California-San Diego, CA, USA. 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.
Insights
Clinical trials accelerate medical advancements but face slow participant enrollment. Midwives can improve public awareness and access to vital clinical trial information.
Area of Science:
- Medical research methodology
- Public health initiatives
- Healthcare professional roles
Background:
- Clinical trials are crucial for translating scientific discoveries into patient care.
- Slow participant recruitment in clinical trials delays public access to new treatments.
- Increased public awareness and understanding of clinical trials are necessary.
Purpose of the Study:
- To highlight the slow pace of participant recruitment in clinical trials.
- To emphasize the role of midwives in promoting clinical trial awareness and access.
- To discuss ethical considerations and recent legislation impacting clinical trials.
Main Methods:
- Literature review on clinical trial recruitment challenges.
- Analysis of the role of healthcare professionals in patient education.
- Discussion of ethical review processes and Health Insurance Portability and Accountability Act (HIPAA) implications.
Main Results:
- Participant recruitment is a significant bottleneck in clinical trial progression.
- Midwives are uniquely positioned to disseminate clinical trial information to the public.
- Ethical reviews and HIPAA compliance are critical components of clinical trial conduct.
Conclusions:
- Enhancing public understanding of clinical trials is essential for faster medical progress.
- Midwives can play a pivotal role in bridging the gap between research and patient access.
- Addressing ethical concerns and regulatory requirements is key to successful clinical trial implementation.
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