New Additions Published to the NCCN Informed Consent Language Database
Michael Mehler, MA, Research Study Associate, NCCN
The National Comprehensive Cancer Network® (NCCN®) has published updates to the NCCN Informed Consent Language (ICL) Database. Part of the NCCN Oncology Research Program (ORP) commitment to supporting initiatives to improve clinical research processes, the latest updates to the NCCN ICL Database include definitions of General Risk Language, Procedures, and Procedure Risk Language.
Containing more than 2,200 standardized lay language descriptions of risks and events associated with clinical research, the NCCN ICL Database is a comprehensive resource to assist researchers and operations personnel with writing and amending informed consents for study participants.
The Database content is 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. The University of Texas MD Anderson Cancer Center maintains a database and glossary that describe and define the potential side effects relating to oncology drugs and procedures. The Adverse Events (AE) Database contains a list of more than 1,000 U.S. Food and Drug Administration (FDA) approved and investigational, drugs and procedures. The AE Glossary contains a list of more than 2,200 side effect definitions used to develop the verbiage for each drug and procedural risk profile housed in the AE Database. Both the glossary and database are updated on a regular basis based on a combination of external and internal adverse event reporting from both pharmaceutical companies and participating sites.
Both institutions' IRB groups routinely review, approve, and update the standardized language to ensure consistency and accuracy.
The NCCN ICL Database is available free-of-charge at NCCN.org. Registration is required.