The Pharmacological and Physiological Sciences Branch in the NIGMS Division of Pharmacology, Physiology, and Biological Chemistry accepts investigator-initiated R01 applications for clinical studies and trials directly related to the Institute’s research areas, subject to the following requirements.
Investigators are strongly encouraged to consult with NIGMS staff at the earliest stages to establish the appropriateness of their proposal and to review Institute requirements. Staff will determine whether the goal of a trial fits the Institute’s scientific mission, and if in staff’s judgment NIGMS would want to support the full trial if properly planned. The planning process must be complete (with or without NIH funding regardless of whether a planning grant application has been funded), before NIGMS will accept a multi-site trial application that exceeds $500,000 in direct costs in any year. See NIH Guide
for more information on the NIGMS policy for the acceptance of clinical trial applications.
NIGMS now offers a planning grant mechanism for clinical trials, per discussion and concept approval at the September 2010 National Advisory General Medical Sciences Council
meeting, and details can be found in PAR-11-087
. Funding will enable limited time and support to assemble all necessary documentation prior to making an R01 application to NIH requesting full support for a clinical trial. Additionally, this will allow early review of the scientific rationale for the proposed clinical trial.
NIGMS Guidelines for Data and Safety Monitoring in Clinical Trials