Notice to Clarify the Types of Clinical Trials NIBIB Will Support Under PA-18-048 Zika Virus (ZIKV) Complications (R21 Clinical Trial Optional)

Notice Number: NOT-EB-18-007

Key Dates
Release Date:  March 19, 2018

Related Announcements
PA-18-048

Issued by
National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Purpose

The purpose of this Notice is to clarify the types of clinical trials that NIBIB will support under the Funding Opportunity Announcement (FOA) PA-18-048, Zika Virus (ZIKV) Complications (R21 Clinical Trial Optional). The following text is added at the end of Section I.

For NIBIB assigned applications submitted to this FOA that propose clinical trials, NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Applicants are strongly encouraged to contact NIBIB Program staff (https://www.nibib.nih.gov/research-funding) or the Scientific/Research contact for this FOA for guidance in advance of submitting an application to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial projects that NIBIB supports

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Šeila Selimovic, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4577
Email: Seila.Selimovic@nih.gov