In this section
Guidance for Researchers
Guidance Topics
General Information about Human Subject Research
Guidance on PI status for IRB Applications
Guidance on Protocol Issues
Data Issues
Research Involving Students
Research with Community Partners
Recruitment Resources
General Information about Human Subject Research
- Decision Tree 1 - When do the Regulations apply?
- Decision Tree 2 - Is this Human Subject Research?
- Decision Tree 3 - Do I need a Protocol for Existing Data or Specimens?
- General Guidance: Categories of Human Subject Research and IRB Review
- CHECKLIST: Exemption (Does My Project Qualify for an Exempt Determination from the IRB?)
- CHECKLIST: Is this a Quality Assessment (QA), Quality Improvement (QI) or Process Evaluation (PE) Study and “Not Human Research”?
- CHECKLIST: Engagement (Is This Institution Engaged in a Particular Human Subjects Research Project?)
Guidance on PI status for IRB Applications
- Requirements for Principal Investigator Status
- Guidance for Part-time or Volunteer Faculty Interested in Conducting Human Subjects Research
- Guidance for Students Interested in Conducting Research
Guidance on Protocol Issues
- Submitting a Protocol Application to the IRB
- Guidance on Modifications to an Approved IRB Protocol
- Guidance on Continuing Review for IRB protocols
- Guidance on Deciding Whether Expedited or Exempt Status Applies to the Project
- Guidance on Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform (SMART IRB)
- Guidelines: Benign Behavior Interventions
- Guidelines on Research with Vulnerable Populations
- Guidance for Requesting Informed Consent Waivers
- Guidance on 'Not Human Research' Determinations and Application Form
- Guidelines on Clinical Trials and NIH Requirements
- Guidelines and Definitions - Expiration, Noncompliance, Suspension, Termination, Voluntary Closure
- Guidance on Voluntary Closure of a Protocol
Data Issues
- Guidelines and Definitions: HIPAA, PHI and List of Identifiers
- Guidance on Preregistration and Sharing De-identified Data for Human Subject Research
- Guidelines: Using Coded or De-identified Private Data
- Guidelines: Secondary Use of Existing Data
- Guidelines: Data Use Agreements for IRB Submissions
- Requirements for Retaining Research Records
Research Involving Students
- Guidelines: Educational Activities and Human Subjects Research
- Guidelines on Research with K-12 Students
- Guidelines on Research with Students in Higher Education Settings