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Message from the NIDCD Director
NIDCD director James F. Battey, Jr., M.D., Ph.D., now retired, sent this letter to current grantees and known potential funding applicants to explain 2017 policy and process changes regarding the evaluation, funding, and oversight for proposed and current NIH clinical research and clinical trials.
September 18, 2017
I am contacting you, as an NIDCD-funded researcher, to make certain you are aware of important policy and process changes regarding how the NIH will evaluate, fund, and provide oversight for clinical research and clinical trials. It is critical, if your NIDCD-funded research involves human participants, that you determine if your studies meet the NIH clinical trial definition. If the answers to all the questions below are "yes," your current/planned study meets the definition of a clinical trial (CT Decision Tree Tool):
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
For currently funded NIDCD researchers: The upcoming changes most likely do not affect your currently funded projects, but may impact your competing continuation. Many projects not previously identified or designated as "clinical trial" may be reclassified as a clinical trial on renewal. Please note that the NIH policies for Good Clinical Practice (GCP) training and ClinicalTrials.gov registration have already been in effect since January 2017.
If you are planning to submit an NIDCD intervention study/clinical trial in late January 2018 and beyond: You will need to select the correct funding opportunity announcement (FOA) to be sure you comply with all relevant regulations and policies and include the required information for peer review. Some of the new requirements include new forms, implementation of the NIH single IRB policy, training in Good Clinical Practice, and registration on ClinicalTrials.gov. (Clinical Trial Requirements for NIH Grantees and Contractors webpage.)
The NIDCD will be publishing several FOAs: some will be clinical trial-specific FOAs, and others will be reissued FOAs that will allow clinical trials. The NIH Guide will be regularly updated for FOA publications and announcements related to clinical trials. We anticipate that most NIDCD low-risk applications previously reviewed by the Center for Scientific Review (CSR) will continue to be reviewed in that venue; NIDCD Phase III, high-risk interventions, and/or more costly applications will be reviewed by NIDCD Scientific Review Branch.
NIDCD staff are available to help you through this transition. The NIDCD Clinical Trials Program Medical Officers can provide further clarity to your questions as well as work with you to determine whether your proposed study is a clinical trial, the appropriate funding mechanism for your application, and preparation of the appropriate clinical trial required documents. Written questions or requests for telephone consultation may be submitted to either Trinh Ly, M.D. or Steven Hirschfeld, M.D., Ph.D..
The NIDCD believes our clinical research and even some of our basic research will benefit from the soon-to-be required elements in the grant application and award process. We are all working together to be certain our important clinical research continues and thrives.
James F. Battey, Jr., M.D., Ph.D.
Director, NIDCD, NIH
NIH Building 31, Room 3C02
9000 Rockville Pike
Bethesda, Maryland 20892-2320