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Last update
03.10.08
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A research investigator may access many tools to facilitate their understanding of the Campus IRB process. The Campus IRB offers its investigators access to many tools that aid in the decision-making process, with hopes that a clearer understanding of the review process may be learned.
DHHS Human Subject Regulations Decision Charts
Chart 1: Is an Activity Research Involving Human Subjects?
Chart 2: Is the Human Subjects Research Eligible for Exemption?
Chart 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) Apply?
Chart 4: Does exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply?
Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply?
Chart 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) Apply?
Chart 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) Apply?
Chart 8: May the IRB Review Be Done by Expedited Procedures?
Chart 9: May the IRB Continuing Review Be Done by Expedited Procedures?
Chart 10: May Informed Consent Be Waived or Consent Elements Be Altered under 45 CFR 46.116(d)?
Chart 11: May Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?
Human Subject Training Decision Charts (Word, 752K)
AAHRPP Decision Charts
FDA Definition Human Subject and Research (PDF, 64K)
DHHS Definition of Human Subject and Research (PDF, 80K)
Is Activity Research Involving Human Subjects according to DHHS and FDA (PDF, 48K)
CIRB Checklists
Determining When an Activity is Human Subject Research (PDF, 48K)
Determining When Human Subject Research Activities are FDA Regulated (PDF, 48K)
Determining When Human Subject Research Activities are VA Regulated (PDF, 32K)
Appropriate IRB Forum (PDF, 32K)
Does the research activity qualify for EXEMPT review? (Word, 224K)
Does the research activity qualify for EXPEDITED review? (PDF, 32K)
Does the research activity qualify for FULL BOARD review? (PDF, 16K) |
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