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)?
