Notice Number: NOT-AT-15-004

Key Dates
Release Date: March 6, 2015

Issued by
National Center for Complementary and Integrative Health (NCCIH)

Purpose

The purpose of this Notice is to define the types of clinical studies which may be submitted to NCCIH in response to the NIH parent R21 Funding Opportunity Announcement (FOA) PA-13-303 and subsequent reissuances to this FOA. After May 8, 2015, NCCIH will not accept R21 applications which include clinical trials to PA-13-303.

NIH Clinical Trial Definition:
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html).

This policy does not apply to other NCCIH-specific announcements that specifically solicit clinical trials

Applicants submitting investigator initiated applications to NCCIH which contain a preliminary clinical trial must submit to one of the following NCCIH (formerly NCCAM) FOAs specifically designed for clinical trials:

• Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) PAR-14-182
• Phased Innovation Award for Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R21/R33) RFA-AT-16-001
• Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R33) RFA-AT-16-002

Inquiries

Please direct all inquiries to:

Wendy Weber, ND, PhD, MPH
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov