Research for Her , a Cedars-Sinai online medical research database aimed at increasing women's participation in clinical studies, received the 2013 Award for Excellence from the Health Improvement Institute for its user-friendly electronic consent form.
The Research for Her registry allows women to register for potential participation in clinical trials through an online, verified consent process that is just two pages long and written in nontechnical, easy-to-understand language. In comparison, a typical clinical trial consent form, even for low-risk clinical trials, is a printed document ranging from eight to 15 pages and includes complex medical and legal terminology.
"By listening to the new ideas and barriers of our target population, we were able to respond and adapt to better meet the needs of women in the community," said Beth Y. Karlan, MD, director of the Women's Cancer Program at the Samuel Oschin Comprehensive Cancer Institute, director in the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology, director of the Gilda Radner Hereditary Cancer Program and the Board of Governors Chair in Gynecologic Oncology. "Women have responded affirmatively and we have more than quadrupled the monthly enrollment average in our clinical trials. The hope is for this template to become standard practice for low-risk clinical trial enrollment across the nation and to bolster women's access to cutting-edge clinical studies."
Research for Her was awarded the 2013 Award for Excellence in Human Research Protection for Best Practice from the Health Improvement Institute because of Cedars-Sinai's commitment to developing practices that safeguard the safety and welfare of research participants while keeping up with modern technology and lifestyles.
"Online consenting is not only sustainable, it is vital to the growth of research programs, such as Research for Her," said Eifaang Li, director of the Office of Research Compliance and Quality Improvement at Cedars-Sinai. "Utilizing technology allows the program to not only reduce the time patients spend in the clinic, but also increase operational efficiency. Online consenting also allows the Research for Her program to stay up to date in an increasingly technological society."
Historically, relatively few women have participated in clinical research, and as a result, the medical science community has often ignored biological differences between men and women. Research for Her, a partnership with the Samuel Oschin Comprehensive Cancer Institute, the S. Mark Taper Foundation Imaging Center and the Cardio-Oncology Program, aims to improve the involvement of women in clinical trials and register women with or without a history of breast or gynecologic cancers.
As the Research for Her program continues to advance, approved investigators will review the collected information and identify opportunities to improve care for women with cancer risk factors and those who are at high risk for other diseases. The registry will also help identify subjects who may be eligible for research studies, including large-scale epidemiological studies, cancer screening studies, focus groups and clinical therapeutic trials. Research for Her study participants will then be contacted by Cedars-Sinai investigators to gauge enrollment interest and eligibility.
Co-principal investigator BJ Rimel, MD, a gynecologic oncologist in the Department of Obstetrics and Gynecology at Cedars-Sinai, said nearly 300 of the more-than 535 women who have consented in the lifetime of the registry did so online. Many of these participants have been linked to several studies. To participate in Research for Her, please visit http://www.researchforher.org.
"This award piggybacks on Cedars-Sinai's institutional commitment to providing excellent clinical and service quality, offering compassionate care and supporting research and medical education, while also responding to patient needs," said Karlan.
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