The Office of Extramural Research (OER) has developed a quick decision tool that should assist you with determining if your research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research. This tool should not be used as the sole determination of exemption.
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- Decision Tool: Am I Doing Human Subjects Research?
Main navigation (Sidebar Template)
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Policy & Compliance
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Changes Coming for 2025
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Simplified Review Framework for Most Research Project Grants (RPGs)
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Revisions to the NIH Fellowship Application and Review Process
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Updates to NIH Institutional Training Grant Applications
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Updated Application Forms and Instructions (FORMS-I)
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Common Forms for Biographical Sketch and Current and Pending (Other) Support
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Simplified Review Framework for Most Research Project Grants (RPGs)
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Grants Policy Statement
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Notices of Policy Changes
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Compliance & Oversight
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Policy Topics
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Animal Welfare
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Animals in NIH Research
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Why Animals are Used in Research
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How Animals Have Helped Improve Public Health
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Adoption of Laboratory Animals after Research
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Why Properly Designed Experiments are Critical to Animal Research and Advancing Public Health
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Ensuring the Care of Research Animals
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When Are Alternatives to Animals Used in Research
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Why Animals are Used in Research
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Clinical Trial Requirements for Grants and Contracts
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NIH's Definition of a Clinical Trial
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Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?
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Basic Experimental Studies Involving Humans (BESH)
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Clinical Trial-Specific Funding Opportunities
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Clinical Trial-Specific Review Criteria
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Good Clinical Practice Training
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Human Subjects System
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Human Subjects and Clinical Trials Information Form
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Posting Clinical Trial Informed Consent Forms
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Protocol Templates for Clinical Trials
- Requirements for Registering & Reporting NIH-Funded Clinical Trials
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Information about NIH Clinical Trial Stewardship
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Training & Resources for NIH Clinical Trial Policies
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NIH's Definition of a Clinical Trial
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Communicating, and Acknowledging Federal Funding
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Early Stage Investigator Policies
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NIH Early Stage Investigators Policy
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Determining Early Stage Investigator (ESI) Status
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Early Stage Investigator Extensions
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Early Stage Investigator Related Data
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History of NIH Support for Early Career Investigators
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Related Notices, Laws, Statements and Reports
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List of smaller grants & awards that maintain ESI status
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NIH Early Stage Investigators Policy
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Family-Friendly Initiatives
- Financial Conflict of Interest
- Foreign Interference
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Human Subjects Research
- Definition of Human Subjects Research
- Pre-Award and Post-Award Processes for Projects Involving Human Subjects Research
- Certificates of Confidentiality
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Clinical Trial Requirements for Grants and Contracts
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Inclusion Policies for Human Subjects Research
- Single IRB for Multi-Site or Cooperative Research
- Policies & Regulations for Human Subjects
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Training & Resources for Human Subjects
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Inclusion Policies for Human Subjects Research
- Intellectual Property Policy
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Lobbying Guidance for Recipient Activities
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Natural Disasters
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Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding
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Applicant/Recipient COVID-19 Update History
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Funding Opportunities Specific to COVID-19
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NIH Implementation of OMB Memorandum M-20-26 “Extension of Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations” dated June 18, 2020
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Review Process during COVID-19 Pandemic
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The Impact of COVID-19 on the Research Community
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Applicant/Recipient COVID-19 Update History
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Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding
- NIH Fiscal Policies
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Peer Review Policies and Practices
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Public Access
- Research Integrity
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Research Misconduct
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What Is Research Misconduct
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Reporting a Concern About Research Misconduct
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Process for Handling Allegations of Research Misconduct
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NIH Expectations, Policies, and Requirements
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NIH Actions and Oversight after Findings of Research Misconduct
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Notices, Statements and Reports
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Responsible Conduct of Research (RCR)
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What Is Research Misconduct
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Rigor and Reproducibility
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Principles and Guidelines for Publishing Preclinical Research
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Guidance: Rigor and Reproducibility in Grant Applications
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Resources for Preparing Your Application
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Training and Other Resources for Rigor and Reproducibility
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Meetings and Workshops for Rigor and Reproducibility
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Notices, Blog Posts, and References for Rigor and Reproducibility
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Principles and Guidelines for Publishing Preclinical Research
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Select Agent Information
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Sharing Policies
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Subawards
- Submission Policies
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Supporting a Safe and Respectful Workplace
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Animal Welfare
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Changes Coming for 2025
Decision Tool: Am I Doing Human Subjects Research?
Scope Note
Tip
This tool uses the 2018 Revised
Common Rule requirements. For more information, please visit OHRP’s page
This page last updated on: September 10, 2024
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