Skip to main content

Decision Trees

SPECIFIC TO FLORIDA STATE UNIVERSITY:     

  • Not all research and creative activities may require IRB/OHSP review. Federal law and FSU policy dictate when review is required; how FSU faculty, staff, students and other agents may be involved in these activities is dispositive. Click on this Engagement algorithm and the related IRB worksheet to see how answers to specific questions will determine when IRB/OHSP review is required.
  • Quality Improvement: To see how quality improvement (QI) activities may be distinguished from research, and therefore not require IRB/OHSP review, click on this Quality Improvement or Research? algorithm. QI activities must be very carefully explicitly circumscribed so as to be excluded from IRB review. See also our 
    General FAQ#6.
  • Review Process: To obtain a high-level overview of select key decision points during the pathway of human research regulatory review at FSU, click on this Review Pathway for Human Research algorithm or RAMP IRB algorithm link. The algorithm spans the pathway beginning with a researcher’s submission of their study for IRB review through to FSU human research regulatory approval for the study to begin.

APPLICABLE TO RESEARCH GENERALLY: Provided below are other charts and graphic aids published by the U.S. government with regard to more specific human research protection requirements; these address 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.   

  • 2018 Requirements (link here)—Studies that are initially approved or determined to be exempt on or after 21 January 2019 are governed by the 2018 Requirements (i.e., the Revised Common Rule).
  • Pre-2018 Requirements (link here)Studies with an initial approval or exemption determination before 21 January 2019 are by default subject to the pre-2018 Requirements (i.e., the Common Rule as published in the 2016 edition of the CFR).

The federal charts are intended only as guidance and are not intended substitutes for consulting the regulations or obtaining official FSU regulatory determinations. Note that these charts are necessarily generalizations and may not be specific enough for or applicable to particular situations. Other guidance documents are available related to specific topics, at http://www.hhs.gov/ohrp/policy/index.html#topics. These 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, state or local governments or FSU policy.