SPECIFIC TO FSU: To obtain a high-level view of select key decision points during the pathway of human research regulatory review at FSU, click on this 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.
Three (3) swim lanes are depicted, for Principal Investigators (researchers), for the IRB/OHSP and for research that involve multisite studies. While not all decision points are depicted, those that involve strategic judgements that serve to pivot the review pathway forward or to the left are illustrated. Key terms and concepts are described in the endnotes. A unique feature of the algorithm is the temporary inclusion of a pathway that takes into account FSU COVID-19-related restrictions on research.
APPLICABLE TO RESEARCH GENERALLY: Additionally, links are provided below to other charts and graphic aids published by the U.S. Department of Health and Human Services (DHHS) 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.
Two sets of decision charts are included: one set is for studies subject to the pre-2018 Requirements and the other set is for studies subject to the 2018 Requirements. Please read the below instructions closely to ensure you reference the correct set of decision charts for your study.
- 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 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 DHHS charts are intended only to provide investigators with guidance about how applicable regulations may determine outcomes in the human research regulatory review process; the guidance are not substitutes for consulting the regulations or 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. Also note that 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.