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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.