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Templates, Check Lists & Decision Trees

Templates

Informed Consent

Local Protocol

 

Check Lists

Informed Consent

Local Protocol

Other

Decision Trees & Charts

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)?