Human Subject Regulations Decision Charts

September 24, 2004

The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comment on these decision charts. The charts address decisions on the following:

  • whether an activity is research that must be reviewed by an IRB
  • whether the review may be performed by expedited procedures, and
  • whether informed consent or its documentation may be waived.

Considerations

The charts are intended to assist IRBs, institutions, and investigators in their decision-making process and should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.

These charts are necessarily generalizations and may not be specific enough for particular situations. Other guidance documents are available related to specific topics, at OHRP Policy Guidance by Topic. OHRP invites inquiries for additional information.

The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, or state or local governments.

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)?

 

 

1_G 1_E 1_I 1_H 1_F 1_D 1_C 1_B
2_BB 2_Q 2_P 2_O 2_N 2_M #c7 2_K 2_I 2_G 2_J 2_H 2_F 2_D 2_R 2_E 2_C 2_b 2_A
3_B 3_A
4_C 4_B 4_A
5_E 5_D 5_C 5_B 5_A
6_C 6_B 6_A
7_B 7_A
8_F 8_G 8_E 8_O 8_H 8_C 8_D 8_B 8_I 8_N 8_M 8_L 8_K 8_J 8_A
9_D 9_C 9_B 9_E 9_G 9_F 9_A
10_B 10_H 10_J 10_I 10_F 10_E 10_D 10_G 10_C 10_L 10_A
11_F 11_E 11_D 11_C 11_B 11_A