An official website of the United States government
Scope Note
This page provides links to important NIH policies and guide notices related human subjects research applications and funded studies. Resources for federal regulations and other agency information are also provided.
NIH Policies, Guidance, and Policy Resources
- NIH Grants Policy Statement- contains all policy requirements that serve as the terms and conditions of NIH grant awards, including those related to human subjects research
- NIH Guide Notice 07/30/2015 - Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval: Updated Notice (NOT-OD-15-128)
- NIH Guide Notice 07/30/2015 - Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards): Updated Notice (NOT-OD-15-129)
- Required Education in the Protection of Human Research Participants Policy
- ClinicalTrials.gov and FDAAA - This page seeks to help NIH awardees understand their roles and responsibilities in relation to FDAAA, and how to certify compliance.
- Inclusion Across the Lifespan policy (NOT-OD-18-116) and policy implementation page
- Inclusion of Women and Members of Racial and/or Ethnic Minority Groups in Clinical Research
- NIH Policy and IC Guidance for Data and Safety Monitoring of Clinical Trials
- NIH Certificates of Confidentiality Policy and CoCs for NIH-Funded Research page
- Final NIH Policy on the Use of a Single IRB for Multi-Site Research and Single IRB for Multi-Site or Cooperative Research page
Federal Regulations and Other Policy Resources
- Office for Human Research Protections (OHRP) website
- OHRP Frequently Asked Questions
- OHRP Revised Common Rule Resources
- 45 CFR part 46 HHS Regulations for the Protection of Human Subjects
- 45 CFR part 160 and 45 CFR part 164 Health Insurance Portability and Accountability Act (HIPAA) Regulations for Standards for Privacy of Individually Identifiable Health Information
- 42 CFR part 50, Subpart F HHS Regulations for Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought
- OHRP guidance on Engagement of Institutions in Humans Subjects Research
- OHRP guidance on Coded Private Information or Specimens Use in Research
- 21 CFR part 50 FDA Regulations for the Protection of Human Subjects
- 21 CFR part 56 FDA Regulations for Institutional Review Boards