FSU Human Subjects Decision Trees

The FSU IRB provides the following graphic aids as a guide for investigators and others in determining 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. 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 investigators in their decision-making process and should not be used as substitutes for consulting the regulations. FSU 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 http://www.hhs.gov/ohrp/policy/index.html#topics OHRP Policy Guidance by Topic.

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.

OHRP also provides decision charts for IRBs and investigators to determine whether an activity is research and whether activities are exempt, expedited, and other related areas. Note that FSU interprets and applies the regulations in a specific manner, and distinctions should be taken into consideration when using the decision charts as a guide.

• Chart 1: Is an Activity Research Involving Human Subjects?
• Chart 2: Is the Research Involving Human Subjects Research Eligible for Exempt Review?
• Chart 3: Does Exemption for Educational Settings Apply?
• Chart 4: Does exemption for Tests, Surveys, Interviews, Public Behavior Observation Apply?
• Chart 5: Does Exemption for Existing Data, Documents, Records and Specimens Apply?
• Chart 6: Does Exemption for Public Benefit or Service Programs Apply?
• Chart 7: Does Exemption 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?
• Chart 11: May Documentation of Informed Consent Be Waived?
• Chart 12: Does the Activity Require Full Committee Review?
• Chart 13: Decision Tree for Existing Data, Documents, Records, or Specimens