Key Dates

Related Announcements

• PA-20-184, Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required (BESH))
• PA-20-196, NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required (BESH))
• PA-20-183, Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-194, NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

Issued by

National Eye Institute (NEI)

Purpose

The purpose of this Notice is to inform potential applicants that NEI acceptance of NIH-defined clinical trials in response to the following announcements, as well as all reissuances, is limited to basic experimental studies involving humans (BESH) and minimal participant risk trials.

• PA-20-184, Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required (BESH))
• PA-20-196, NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required (BESH))
• PA-20-183, Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-194, NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

NIH defines a clinical trial as “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” (NOT-OD-15-015).

Basic experimental studies involving humans (BESH) are studies that meet both the NIH definition of a clinical trial and the federal definition of basic research (i.e., a systematic study directed toward understanding the fundamental aspects of phenomena). More information regarding the definition and key characteristics of BESH and the associated policy flexibilities for BESH funding opportunities can be found here: https://grants.nih.gov/policy/clinical-trials/besh.htm

Minimal participant risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46). As part of the review process, the application must include a clear, detailed plan for monitoring safety that is commensurate with the risks to study participants. In addition to the minimal risk designation from the Institutional Review Board, other reporting to the NEI may be required and will be outlined in the Notice of Award Terms and Conditions.

NEI supports clinical trials according to the following guidance:

• NEI will accept applications proposing basic experimental studies with human subjects that are submitted under the BESH funding opportunities listed above.
• NEI will accept applications proposing minimal risk trials that are submitted under the Parent R01 and Parent R21 clinical trials listed above.
• NEI will accept applications proposing human gene-transfer and stem cell therapy or complex, large-scale, high resource- or safety-risk clinical trials that aim to test efficacy, effectiveness, or safety that are submitted to one of the Clinical Research cooperative agreement FOAs, including PAR-21-041, PAR-21-042, PAR-21-043 and any subsequent reissuances of these FOAs.
• NEI will accept applications proposing early-stage clinical trials with greater than minimal risk that are submitted to PAR-22-149 and any subsequent reissuances of this FOA providing they do not involve gene-transfer or stem cell therapy interventions. Gene-transfer and stem cell therapy trials must use the NEI UG1 FOAs.

NEI does not accept any type of clinical trial applications submitted under FOAs that are “Clinical Trials Not Allowed,” including parent FOAs PA-20-185 (R01), PA-20-195 (R21), and their re-issuances. Clinical trial applications that are submitted to these FOAs will be withdrawn prior to review.

NEI strongly encourages applicants to consult with NEI Program Officials prior to submitting an application with human subjects to determine which available FOA would best support the proposed research.

Applicants are encouraged to refer to the NEI Clinical Trial Funding Opportunities webpage.

Inquiries

Please direct all inquiries to:

Cheri Wiggs, Ph.D
National Eye Institute (NEI)
Phone: (301) 402-0276
E-mail: [email protected]