The ICL database is a comprehensive resource to assist researchers and clinical operations personnel with writing and amending informed consents for study participants. Currently, the database contains more than 1,500 standardized lay language descriptions of risks and events associated with clinical research.
The ICL content was developed through collaboration with two NCCN Member Institutions: Dana-Farber/Brigham and Women's Cancer Center and The University of Texas MD Anderson Cancer Center, whose Institutional Review Board (IRB) committees routinely review, approve, and update the standardized language to ensure consistency and accuracy.
"NCCN is pleased to announce the public availability of the ICL database for investigators and industry professionals," said Diane Paul, MS, RN, Vice President, ORP at NCCN. "The ICL database is a superb example of collaboration between NCCN Member Institutions for the improvement of patient care and information, as well as process improvements for investigators. The initial phase, which covers risk language for side effects of treatment, marks the first of several planned phases of the database."
The ICL database is an initiative proposed by members of the NCCN IRB Directors Forum and ultimately an outcome of the Informed Consent Risk Language Task Force. The Forum is comprised of IRB administrators representing the 21 NCCN Member Institutions who convene regularly to discuss relevant issues in the field.
"Informed consents are frequently not approved during the initial IRB review of protocols, and investigators are asked to incorporate language that lay people will understand and comprehend," said Michele Russell-Einhorn, JD, Senior Director, Office for Human Research Studies, Dana-Farber/Brigham and Women's Cancer Center and co-leader of the NCCN IRB Directors Forum. "Standardized lay language for informed consents will have a significant impact on improving the efficiency of the research approval process."
Users can access the ICL database through NCCN.org. All terms are easily searchable by alphabetical order, as well as through keyword search.
The NCCN ORP invites institutions and organizations involved in human subject research to visit the ICL database, as well as link to the database from their own websites, where appropriate. The NCCN ORP is committed to supporting initiatives to improve clinical research processes and plans to expand the database to include language for drugs and medical procedures.
The NCCN Oncology Research Program (ORP) is organized to obtain funding to support scientifically meritorious research projects at NCCN Member Institutions. Policies and standards for the program were set by the NCCN Investigator Steering Committee, a group comprised of senior research physicians appointed by each NCCN Member Institution. The NCCN ORP has received more than $36 million in research grants from major pharmaceutical companies to support investigator-initiated trials. These trials explore new venues of clinical investigation that answer important scientific questions. Studies evaluate innovative combinations and sequencing regimens of drugs, drug resistance, or mechanisms of action of specific agents or explore extended uses for specific agents.
About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 21 of the world's leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.
The NCCN Member Institutions are: City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Memorial Sloan-Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/University of Tennessee Cancer Institute, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; UNMC Eppley Cancer Center at The Nebraska Medical Center, Omaha, NE; The University of Texas MD Anderson Cancer Center, Houston, TX; and Vanderbilt-Ingram Cancer Center, Nashville, TN.
Clinicians, visit NCCN.org. Patients and caregivers, visit NCCN.com.