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Notice of Special Interest (NOSI): Administrative Supplements to Leverage Network Infrastructure to Advance Multisite Research for Women, Children, Pregnant and Lactating Individuals and/or Persons with Disabilities

National Institutes of Health

In order to enhance clinical trial stewardship and transparency, and thereby, further assure the success of its clinical trial enterprise, the NICHD proposed four principles that would guide its plan for continued commitment to infrastructure support for rigorous multisite clinical trials in Notice ( NOT-HD-19-034 ) and at the Webinar ( Strategic Plan 2020 Implementation: NICHD’s vision for multisite clinical trials infrastructure ). The four guiding principles expressed in those forums included:

Enhancing the rigor and reproducibility of clinical trial protocols
Promoting greater availability of multisite clinical trial infrastructure to support trials from a wider range of investigators
Facilitating data sharing and access to biospecimens to efficiently expand research capacity for all investigators
Facilitating greater involvement of diverse populations in multisite clinical trials.

To operationalize these guiding principles, a funding opportunity announcement ( PAR-23-037 ) was published to solicit applications for multisite clinical trials and observational studies to be conducted by and within the participating NICHD-supported Clinical Research Networks. Applications in response to PAR-23-037 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). These applications will undergo the formal evaluation of NIH peer review. It is the intent that research projects conducted by these NICHD-supported Networks will be supported via this funding mechanism. However, it is recognized that there will be situations in which this process may not afford the nimbleness to respond to emerging health care crises and/or other time-sensitive opportunities and/or issues. Consequently, the purpose of this Notice is to affirm that NICHD will consider administrative supplement requests from Network awardees to address such situations and opportunities.

These administrative supplement requests to existing NICHD-supported Network grants will be intended to leverage participating NICHD Networks (listed below) to address emerging health care crises and/or other time-sensitive opportunities and/or issues . All other proposals should be submitted via funding opportunity announcement PAR-23-037 .

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.