Notice to Clarify the Types of Clinical Trials NIBIB Will Supported Under PAR-18-208 Bioengineering Research Partnerships (U01 Clinical Trial Optional)

Notice Number: NOT-EB-18-004

Key Dates
Release Date:   December 18, 2017

Related Announcements
PAR-18-208  

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) PAR-18-208 , Bioengineering Research Partnerships (U01 Clinical Trial Optional).
 
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.

Inquiries

Please direct all inquiries to:

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