Research grants are subject to a variety of policy requirements. Below are highlights of policy resources and announcements specific to NIH and NCCIH. The NIH Grants Policy Statement and the NIH Guide to Grants and Contracts contain the comprehensive grants administration policies, laws, and regulations for NIH research.
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- Notices of NIH Policy Changes Notices published in the NIH Guide for Grants and Contracts can supercede information in the NIH Grants Policy Statement and/or provide reminders to applicants and grantees. NIH incorporates these notices into the annual update of the NIH Grants Policy Statement.
- NIH Grants Policy Statement
Grant Policies
NCCIH Policies
- Natural Product Integrity Policy — Researchers must submit specific product information to NCCIH
- Study Accrual and Retention for Human Subject Research
Progress Reports
- NIH Form for Progress Reports (Revised 06/2009)
- Revised PHS 2590 (DHHS Public Health Service Noncompeting Continuation Progress Report) Now Available-Policy Changes Implemented
- New Requirement for eRA Commons User IDs for Individuals in a Postdoctoral Project Role with Measurable Effort on an NIH Annual Progress Report (PHS2590)
Clinical Research and Human Subjects
Human subjects research is research involving a living individual, or about whom an investigator conducting research obtains: data through intervention or interaction with the individual; or identifiable private information.*
- NCCIH Clinical Terms of Award for Human Subjects Research
- NCCIH Study Accrual and Retention for Human Subject Research
- Guidance for Compliance
- NIH Single IRB (sIRB) Policy
- Office for Human Research Protections (HHS)
- Research Involving Human Subjects (NIH)
- Required Education in the Protection of Human Research Participants (NIH)
- Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval (NIH)
- FAQ on Required Education in the Protection of Human Research Participants (NIH)
- What NIH Grantees Need to Know About FDAAA
- Why Should I Register and Submit Results?
Data and Safety Monitoring
- Data and Safety Monitoring of NCCIH-Funded Clinical Research
- NIH Policy on Data and Safety Monitoring Boards (NIH)
- Data and Safety Monitoring for Phase I and Phase II Trials (NIH)
- Data and Safety Monitoring: Frequently Asked Questions (NIH)
Resources for Clinical Investigators
- Resources for Researchers Includes the NCCIH Clinical Research Toolbox; Recruitment Resources; and Rigor and Reproducibility
- Share Your Research: Tips for Working With the Media
- Communicating and Acknowledging Federal Funding
- NIH Data Sharing Policy
- NIH Public Access Policy
- Certificates of Confidentiality (NIH)
- Application for NCCIH Certificate of Confidentiality (NIH)
Animal Studies, Care, and Protection Policies
International Studies
*https://humansubjects.nih.gov/walkthrough-investigator#tabpanel11