Below are links to essential information for particular aspects of the application process.
Several elements of essential information are enhanced by Decision Trees developed by other Institutes and Centers at NIH to help investigators learn how reviewers determine an applications compliance with human subject protection requirements, data and safety monitoring plans/boards and gender/minority/children inclusion requirements. These decision trees are generally applicable to research supported by any NIH Institute.
Note: Some files listed here are Word Documents, requiring Microsoft Word viewer to view them. Microsoft Word viewer can be downloaded here.
Policy on Reporting Race and Ethnicity Data
- Gender and the Inclusion of Women, Minorities and Children
- Decision Tree for Inclusion of Women Plan
- Decision Tree for Inclusion of Minorities Plan
- Decision Tree for Inclusion of Children Plan
- Assurance of Compliance With DHHS Regulations for the Protection of Human Subjects
- Decision Tree for Human Subjects
- Decision Tree for Protection of Human Subjects from Research Risk
- Decision Tree for IRB Waiver
- At least two online courses are available to provide this training. One is Learning About Clinical Trials and the other is PRIM&R Investigator 101 CD-ROM for Training in Human Subjects Protection
- Generic Data And Safety Monitoring Plan For Clinical Trials Not Requiring a Data And Safety Monitoring Board
- Decision Tree for Data and Safety Monitoring Plan
Procedures for Applications Requesting Direct Costs of $500,000 or More in Any Year
- Revised Policy on the Acceptance for Review of Uncolicited Applications that Request $500,000 or More in Direct Costs
NINR Policy for Data and Safety Monitoring of Clinical Trials
This policy is incorporated as part of the terms and conditions for all awards involving clinical trials. Funding for clinical trial research activities is contingent upon compliance with this DSM policy.
Click to download: NINR Policy for Data and Safety Monitoring (DSM) of Clinical Trials -- updated September 2014