December 2, 2020
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The purpose of this Guide Notice is to notify the extramural community of NICHD's guidelines and procedures related to the monitoring and oversight of data and safety monitoring.
NICHD expects all clinical research to be conducted with a high standard of quality that assures the research question is answered in a reliable, valid, and unbiased manner, and that the rights and welfare of human subjects are protected. Starting with competing applications or newly started protocols for January FY21, the NICHD expects investigators to utilize the newly released NICHD Data and Safety Monitoring guidelines.
Consistent with NIH policy, NICHD guidance for data and safety monitoring plans must describe procedures for the following:
All NIH-sponsored multi-site clinical trials and all NIH-defined Phase III clinical trials that pose potential risk and some single site clinical trials require DSMB oversight. A DSMB is an independent group of experts charged with reviewing study data for integrity, participant safety, study conduct and progress, and providing directives regarding study continuation, modification, and termination. Applicants will be expected to establish an independent, external DSMB (i.e., appointed by the institution) that is approved by the IRB if one is required either by NIH policy or NICHD (as required by Networks).
The purpose of these enhancements to monitoring and oversight of trials is to ensure that trials funded by the NICHD are successful in achieving their objectives and that the NICHD remains responsible stewards of public funds. For more information on NICHD and NIH guidelines and procedures related to clinical trials, please visit our webpage: https://www.nichd.nih.gov/grants-contracts/process-strategies/policies/clinical-research.
NICHD Clinical Trials