Notice Number: NOT-OD-19-024

Key Dates
Release Date: October 26, 2018

NOT-OD-24-118 - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies with Human Participants.

NOT-OD-22-205 - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health intends to publish a series of new parent Funding Opportunity Announcement (FOAs) for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research.

Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

These new parent FOAs are expected to be published in late November 2018 for due dates beginning on January 25, 2019.

Parent FOAs will be published for the following activity codes: R01, R21, K99/R00, K01, K02, K08, K23, K24, K25.

Research Initiative Details

All applications submitted to these new parent Funding Opportunity Announcements must propose basic science experimental studies involving humans, otherwise referred to in NOT-OD-18-212 as prospective basic science studies involving human participants, that fall within the NIH definition of a clinical trial and also meet the definition of basic research.

NIH defines basic research consistent with the definition of basic research in federal code, the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. (32 CFR 272.3).

Types of studies that should submit under these new parent FOAs include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

For the purposes of these FOAs, specific application towards processes or products refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.

Basic experimental studies in which participants are prospectively assigned to conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena should submit under these new parent FOAs.

Prospective studies with humans conducted with specific applications towards processes or products in mind, including FDA Phase 0 or 1 studies, mechanistic clinical trials (e.g., those that examine the mechanisms by which an intervention works or the processes that account for an intervention's effects on clinical outcome), and safety and efficacy studies should submit under the parent Clinical Trials Required FOAs, or other 'Clinical Trials Required' or Clinical Trial Optional FOAs, but not under these new parent FOAs.

Observational studies involving humans should submit under a Clinical Trials Not Allowed FOA.

For additional information, see our FAQs and table comparing Funding Opportunity Types by Clinical Trial Allowability.

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

NIH Grants Information
Email: [email protected]