Our decision trees (algorithms) provide snapshots of key decision points and outcomes about certain federal regulatory requirements for human research review, approval and oversight that must be made by the FSU IRB. Not every decision point is depicted; footnotes provide more detailed information, instructions and links to additional resources.
Scroll down to access a decision tree; brief annotations are provided. Also below are some more general (not specific to FSU) algorithms provided by federal agencies.
Decision Trees
SPECIFIC TO FLORIDA STATE UNIVERSITY:
- Student-led Activities. Student-led activities may be subject to requirements that are in addition to those for non-student studies. Check out these (1) Does Your Student-led Activity Require FSU IRB Review? and (2) Does Your COM Medical Student-led Activity Require FSU IRB Review? decision trees to see these requirements.
- What activities require IRB review? Click on our Engagement algorithm to find out.
- Review Process: Follow our Review Pathway for Human Research for a high-level overview of key IRB decision points.
- HIPAA Privacy Rule and Research: Click on our HIPAA Privacy Rule & Research Requirements algorithm to see what requirements apply to use or disclosure of health information.
- Clinical Trials: Specific legal requirements apply to clinical trials (evaluating effects of interventions on biomedical or behavioral health-related outcomes); refer to our draft Clinical Trials/Human Research Workflows algorithm to learn more.
- FDA-regulated Products and Test Articles: See our FDA Drug, Device and Dietary Supplement algorithms for special requirements for research using drugs, devices, including software considered a "device", biological products or dietary supplements.
- Quality Improvement (QI): To see how QI may be distinguished from research, use our Quality Improvement or Research? algorithm. See also our General FAQ#6.
- Parental Permission. Some exceptions to the general requirement for parental permission may apply for research involving children; refer to this Waiver of Parental Permission algorithm.
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.
