Guidance for Researchers
In this section
Guidance for Researchers
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