Human
Subject Regulations Decision Chart |
Link |
Is
an Activity Research Involving Human Subjects? |
(chart1) |
Is
the Human Subjects Research Eligible for Exemption? |
(chart2) |
Does
Exemption 45 CFR46.101(b)(1) (for Educational Settings) Apply? |
(chart3) |
Does
Exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys,
Interviews, Public Behavior Observation) Apply? |
(chart4) |
Does
Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents,
Records and Specimens) Apply? |
(chart5) |
Does
Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service
Programs) Apply? |
(chart6) |
Does
Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance
Studies) Apply? |
(chart7) |
May
the IRB Review Be Done by Expedited Procedures? |
(chart8) |
May
the IRB Continuing Review Be Done by Expedited Procedures |
(chart9) |
May
Informed Consent Be Waived or Consent Elements Be Altered Under
45 CFR 46.116(d)? |
(chart10) |
May
Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c) |
(chart11) |
