NIH/NEI – Human Subjects Mechanistic and Minimal Risk Studies (R21 Clinical Trial Optional)

January 2, 2018 by School of Medicine Webmaster

The evolution and vitality of the biomedical, behavioral, and clinical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. Through the Exploratory/Developmental Research Grant Program, the NEI seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical, behavioral, and clinical research.

This program is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for Exploratory/Developmental Research Grant awards should include projects distinct from those supported through the traditional R01 activity code. For example, long-term projects, or projects designed to increase knowledge in a well-established area, are not appropriate for this FOA. Applications submitted to this FOA should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields are better suited for the NIH Small Research Grant Program.

Applicants should note that under this FOA, NEI will support two types applications that involve human subjects studies that are: 1) not NIH-defined clinical trials, and/or 2) NIH-defined clinical trials proposing mechanistic and/or minimal risk studies.

A mechanistic study is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. A minimal risk study is one in which 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.

A proposed research project that includes a clinical trial that is not a mechanistic study and/or involves a level of risk beyond that defined as minimal, will not be supported for this FOA. Large-scale clinical trials (even if minimal risk), human gene-transfer and stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials are not appropriate for this FOA.

Applicants are advised to contact the NEI Scientific/Research staff person listed below to discuss alternative mechanisms of support of these studies.

Definition of Mechanistic and Minimal Risk studies

Applications supported by this FOA that meet the NIH definition of a clinical trial and must also fulfill either of two NIH Definitions:

  • As defined by NIH, a mechanistic trial is “A study designed to understand a biological of behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.”
  • As defined in 45 CFR § 46.102, “Minimal 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.

Deadlines:  standard dates and standard AIDS dates apply

URL:  https://grants.nih.gov/grants/guide/pa-files/PA-18-500.html

Filed Under: Funding Opportunities