Multisite Clinical Research: Leveraging Network Infrastructure to Advance Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (U01 Clinical Trial Optional) (PAR-23-037)
- The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has issued a Funding Opportunity Announcement to invite applicants for multisite clinical trials and observational studies developed in conjunction with NICHD Networks that will be conducted using NICHD-supported Network infrastructure. The goal of this FOA is to operationalize the previously reported NICHD guiding principles for multisite clinical trials delineated in Notice NOT-HD-19-034.
- Consequently, multisite clinical trials and observational studies conducted by and within the participating NICHD-supported Clinical Research Networks will be submitted as investigator-initiated, multi-Principal Investigator (PI) grant applications by any qualified investigator in the extramural community (including NICHD Network investigators) in conjunction with the respective NICHD Network Data Coordinating Center (DCC).
- Prior to application submission, all proposals must first undergo a rigorous pre-application process. For additional information about this pre-application process, refer either to the FOA (PAR-23-037) or the following NICHD website: Pre-Application Process for NICHD Network Multisite Clinical Research | NICHD - Eunice Kennedy Shriver National Institute of Child Health and Human Development (nih.gov)
- The first full protocol submission due date June 5, 2023, after which submissions will follow NIH Standard Submission Dates. The PAR expires May 8, 2026.
- For specific questions not addressed in the FOA or website, please email the Scientific Contact for the FOA, Dr. Robert Tamburro, at NICHD-Network-ClinicalResearch@nih.gov
For questions regarding any of these issues, please feel free to contact Tessie October, MD, MPH at tessie.october@nih.gov or Tammara Jenkins, MSN, RN at tjenkins@mail.nih.gov