NICHD Guidance for Investigator-initiated Basic Experimental Studies Involving Humans (BESH) That Meet NIH's Definition of a Clinical Trial

Notice Number: NOT-HD-19-012

Key Dates
Release Date: April 05, 2019

Related Announcements
NOT-OD-19-092
PA-18-480
PA-18-481
PA-18-482
PA-19-090
PAR-19-133
PAR-19-135

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

Purpose

The purpose of this Notice is to provide guidance for potential applicants proposing basic experimental studies involving humans (BESH) projects for consideration by the National Institute of Child Health and Human Development (NICHD).

NICHD will accept BESH applications that meet NIH’s definition of a clinical trial in response to the following broad topic Funding Opportunity Announcements (FOAs):

  • PA-18-480 NICHD Research Project Grant (R01 – Clinical Trial Required)
  • PA-18-481 NICHD Small Grant Program (R03 – Clinical Trial Optional)
  • PA-18-482 NICHD Exploratory/Developmental Research Grant (R21 – Clinical Trial Optional)
  • PAR-19-133 Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 – Clinical Trial Required)
  • PAR-19-135 Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 – Clinical Trial Required)

When scientifically appropriate, BESH applications may also be submitted to one of the topic-specific Clinical Trials FOAs in which NICHD participates, as listed on the NICHD website at: https://www.nichd.nih.gov/grants-contracts/FOAs-notices/active-FOAs.

Regarding “Parent” FOAs, NICHD participates in the K99/R00 BESH Parent FOA, PA-19-090 NIH Pathway to Independence Award (Parent K99/R00 Independent Basic Experimental Studies with Humans Required), and will accept applications for appropriate BESH projects submitted to that FOA. But NICHD does not participate in the R01 BESH Parent FOA, PA-19-091, or the R21 BESH Parent FOA, PA-19-092, and therefore cannot accept applications submitted to those FOAs.

Research projects considered for funding by NICHD must fall within the scientific missions of the twelve Scientific Branches of the NICHD Division of Extramural Research (DER) or the National Center for Medical Rehabilitation Research (NCMRR).Information about those scientific missions and program staff contacts may be found on the web pages for the DER scientific branches at: http://www.nichd.nih.gov/about/org/der/branches/Pages/index.aspx and the NCMRR at: http://www.nichd.nih.gov/about/org/ncmrr/Pages/overview.aspx. Potential applicants are strongly encouraged to read these webpages for any updates in response to recent scientific advances or emerging public health topics.

NICHD encourages applications that address its extramural program priorities and will consider how well research projects align with one or more of those priorities when making award decisions. A detailed list of NICHD high priority research areas may be found at: https://www.nichd.nih.gov/grants-funding/opportunities-mechanisms/areas-research/Pages/priorities.aspx.

Potential applicants proposing BESH projects are reminded that the National Institutes of Health (NIH) has released a clinical trial protocol template with instructional and example text for NIH funded investigators to use in writing protocols for behavioral and social sciences clinical trials, as described in NOT-OD-19-092. Additional guidance regarding BESH projects may also be found on the NIH website at: https://nexus.od.nih.gov/all/2019/01/08/new-resources-available-for-basic-experimental-studies-with-humans-besh-funding-opportunities/ and https://osp.od.nih.gov/2019/03/28/protocol-template-behavioral-social-sciences-research-involving-humans-new-community-resource/.

Inquiries

Please direct all inquiries to:

James A. Griffin, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: James.Griffin@nih.gov