Templates, Check Lists & Decision Trees
Templates
Informed Consent
Social, Behavioral, and Educational Informed Consent Template
Biomedical Informed Consent and Authorization Template
Exempt Informed Consent Script Template
Syllabus Insert for Unknown Future Research Project Template
Subject Re-Consenting Guidance
Local Protocol
Biomedical Local Protocol Template
Social, Behavioral, and Educational (SBE) Local Protocol Template
Secondary Data/Biospecimen Local Protocol Template
Medical Record Review Local Protocol Template
Repository/Registry SOP Template
Humanitarian Use Device (HUD) Treatment Protocol Template
COVID-19 Safety Plan Template (Full)
Other
Translator Declaration Form
WSU Research Accounting of Disclosures Form (HIPAA)
Premier Health EPIC Data Request Form for Research
Check Lists
Informed Consent
Local Protocol
Biomedical Local Protocol Check List
Social, Behavioral, and Educational (SBE) Local Protocol Check List
Secondary Data/Biospecimen Local Protocol Check List
Medical Record Review Local Protocol Check List
Repository/Registry Local Protocol Check List
Humanitarian Use Device (HUD) Treatment Protocol Check List
Other
- Exemption Determination Checklist
- Subpart B Checklist - Pregnant Women
- Subpart C Checklist - Prisoner Research
Decision Trees & Charts
IRB Application Needed?
Reliance Agreement (IAA or IIA) Needed?
Reportable Event Form Needed?
IRB Review Process Flowchart
Office for Human Research Protections (OHRP)
- Chart 01: Is an Activity Human Subjects Research Covered by 45 CFR Part 46?
- Chart 02: Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.104(d)?
- Chart 03: Does Exemption 45 CFR 46.104(d)(1) for Educational Practices Apply?
- Chart 04: Does Exemption 45 CFR 46.104(d)(2) for Educational Tests, Surveys, Interviews, or Observation of Public Behavior Apply?
- Chart 05: Does Exemption 45 CFR 46.104(d)(3) for Benign Behavioral Interventions Apply?
- Chart 06: Does Exemption 45 CFR 46.104(d)(4) for Secondary Research that Does Not Require Consent Apply?
- Chart 07: Does Exemption 45 CFR 46.104(d)(5) for Public Benefit or Service Programs Apply?
- Chart 08: Does Exemption 45 CFR 46.104(d)(6) for Food Taste and Acceptance Studies Apply?
- Chart 09: Does Exemption 45 CFR 46.104(d)(7), Storage for Secondary Research for Which Broad Consent Is Required, Apply?
- Chart 10: Does Exemption 45 CFR 46.104(d)(8) for Secondary Research for Which Broad Consent Is Required Apply?
- Chart 11: Is Continuing Review Required Under 45 CFR 46.109(f)?
- Chart 12: Waiver or Alteration of Informed Consent in Research Involving Public Benefit and Service Programs Conducted by or Subject to the Approval of State or Local Government Officials (45 CFR 46.116(e))
- Chart 13: When Can Informed Consent Be Waived or Altered Under 45 CFR 46.116(f)?
- Chart 14: Can Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?