NICHD Policy on Receipt of Investigator-Initiated Clinical Trials

Notice Number: NOT-HD-17-019

Key Dates
Release Date: August 4, 2017

Related Announcements
NOT-OD-16-147
NOT-OD-17-043
NOT-OD-17-062

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

This notice is to inform potential applicants to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of a new policy for the acceptance of investigator-initiated clinical trials.

Effective, January 25, 2018, the NIH will no longer accept clinical trials on parent Funding Opportunity Announcements (FOAs) and will require that all clinical trials be submitted through an FOA specifically designed to accept clinical trials (for more details see this policy announcement, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-147.html).

As a result of this new NIH policy, NICHD is preparing to issue or join FOAs that will support investigator-initiated clinical trials using the following grant activity codes: R01, R03, R15, R21, R41, R42, R43, R44, K01, K08, K23, K25, K99/R00. Applicants for fellowships (F-series activity codes) will also be allowed to gain clinical trial research experience led by another investigator (e.g., sponsor), through standard Fellowship FOAs.

This policy announcement does not impact receipt of clinical trials to NICHD network programs or other programs announced through specific Funding Opportunity Announcements (FOA). Detailed information may be found at the NICHD Clinical Trials website (https://www.nichd.nih.gov/grants-funding/policies-strategies/policies/Pages/default.aspx) as well as in each related FOA that will be released in the coming months.

Questions about NICHD's support for research projects involving clinical trials should be directed to the staff contacts listed on the relevant Funding Opportunity Announcements or to the appropriate program staff listed on the NICHD webpage at: https://www.nichd.nih.gov/grants-funding/grants-process/NICHDContactsbyPhase/Pages/default.aspx.

Inquiries

Please direct all inquiries to

NICHD Senior Policy Advisor for Clinical Research
Division of Extramural Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: NICHDTrials@mail.nih.gov