Human Subjects Research Policies and Policy Notices

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 08/2/2012 - Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval (NOT-OD-12-129)

• NIH Guide Notice 08/02/2012 - Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (NOT-OD-12-130)

• Required Education in the Protection of Human Research Participants Policy

• ClinicalTrials.gov and FDAAA - This Web site seeks to help NIH awardees understand their roles and responsibilities in relation to FDAAA, and how to certify compliance.

• Inclusion Across the Lifespan policy and Policy Implementation Website

• Inclusion of Women and Minorities as Participants in Research Involving Human Subjects Policy Implementation Website

• NIH Policies and IC Guidance for Data and Safety Monitoring of Clinical Trials

• NIH Certificates of Confidentiality website

• Single IRB policy website

• Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding 

Federal Regulations and Other Policy Resources

• The Office for Human Research Protections (OHRP) website

• OHRP Frequently Asked Questions

• ​OHRP Revised Common Rule Q&As

• 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