Skip to main content

All human research studies must undergo a specified review pathway; these are dictated by federal law based upon well-established criteria, such as risks to human subjects, type of research activities, use of certain regulated products, federal agency funding, and involvement of vulnerable persons as research participants. Researchers do not determine the review pathway for their studies; only the OHSP and IRB may make this decision. Upon receipt of a new or initial study submission, a review pathway will be selected.

The categories of review are as follows (click on the categories to learn more):

  1. Exempt Review
  2. Expedited Review (also referred to as Non-Committee Review)
  3. Full Committee Review (also referred to as a convened IRB meeting review, held at a scheduled monthly meeting; see meeting schedule)
  4. Other Reviews (e.g., follow-on submissions such as modifications or continuing review, Single IRB)  

To obtain a high-level overview of select key decision points that may determine the pathway of regulatory review of human research 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. 

1. Exempt review: To qualify for this category, the research must fall into one of eight exemptions at 45 CFR 46.104(d) (refer to page 7 of the pdf of this U.S. Department of Health and Human Services regulation; other signatory agencies have the same exemptions). See also the federally-provided exemption decision charts (beginning with Chart 2). These categories presumptively present low risk to potential subjects because they generally involve either collection of anonymous or publicly available data, or represent research for which the additional scrutiny required by federal regulations may have no added value for the protection of subjects; some exceptions apply. Examples of research that qualify as exempt are:

  • Surveys for which subjects' identities cannot be readily ascertained, or if so then with limited IRB review
  • Research involving normal educational practices not likely to adversely impact students or educators
  • Analyses of discarded pathological specimens without personal identifiers
  • Benign behavioral interventions in conjunction with collection of information from adult subjects

Important Distinction: It is the policy of FSU to review and determine whether research proposals meet the definition of “exempt.” Only the IRB and the Office for Human Subjects Protection (OHSP) staff have the authority to determine whether a proposal meets the exempt requirements. Utilize the informational sheet template on our Templates & Required Forms page under "Other Forms" instead of the consent template if it appears that your study may receive an exempt determination; you will after review be advised if otherwise. Check out our Metrics page to see the anticipated review turnaround information for studies handled through the exemption review pathway. Research that may be exempt are reviewed on a rolling (as-received) basis, and generally do not require full IRB committee review at a regularly scheduled monthly meeting.

Return to Top

2. Expedited review: To qualify for this category, research must fall into one of the nine federally-defined categories of research that may be reviewed through an expedited review process or that may require limited IRB review of certain exempt research. These categories involve research that involves no more than minimal risks to subjects. Some examples qualifying for expedited review are:

  • Studies involving collection of hair, saliva, or dental plaque samples
  • Studies of blood samples from healthy volunteers (limits apply)
  • Collection of data through noninvasive procedures routinely employed in clinical practice (excluding, however, procedures involving ionizing radiation, such as x-rays, DXA scans and CT; other exceptions apply)
  • Analysis of voice recordings
  • Studies of existing pathological specimens with personal identifiers
  • Exempt activities involving recording of subjects' identifiable information or secondary research involving identifiable private information or identifiable biospecimens.

This type of review process involves a subset of the full committee membership, delegated this authority by the Chair, to independently evaluate the protocol. At FSU, expedited review is performed by at least one IRB member. Research that may qualify for expedited review are reviewed on a rolling (as-received) basis, and generally (provided that the research is deemed to pose minimal risk as indicated above and an expedited approval can be made) do not require full IRB committee review at a regularly scheduled monthly meeting.

NOTE: Check out our Metrics page to see the anticipated IRB review turnaround information for studies handled through expedited review. Review time is optimized when applications are COMPLETE at the time of submission and researchers have answered ALL questions to the IRB's satisfaction; plan accordingly. To ensure the completeness of your application, please review our training requirements and templates/required forms.

Return to Top

3. Full Committee Review: This category of review is reserved for research proposals that are not eligible for expedited review; involve greater than minimal risk or a particular vulnerable population (e.g., children or at-risk or unhealthy individuals) as defined in the regulations, or that may require limited IRB review of certain exempt research. Examples include:

  • Invasive physiological or medical research or non-invasive research involving procedures that involve ionizing radiation, such as x-rays or DXA scans
  • Use of FDA-regulated products such as drugs (including supplements deemed as drugs) and devices that require FDA review
  • Research where a breach of confidentiality could reasonably place subjects at risk of criminal or civil liability, or be damaging to a subject’s financial standing, employability, educational advancement or reputation
  • Exempt activities involving recording of subjects' identifiable information or secondary research involving identifiable private information or identifiable biospecimens.

Important Distinction: Note that protocols involving the deception of research subjects, or other potentially vulnerable populations such as students or economically disadvantaged persons may be reviewed by the full committee.

Full committee meetings are generally held monthly. Protocols that require review at a convened full committee meeting must be received by the FSU OHSP prior to the posted times on each submission deadline day to provide sufficient time for triage, pre-review and IRB review. Meeting and deadline information may be obtained by checking Meeting Dates & Deadlines posted on this website.

Principal Investigators and faculty advisors may attend the full committee meeting if requested by the primary reviewer for a protocol, and may provide information to the members; however, they may not be present during the final discussion and vote. IRB members may not participate in the review and approval process of their own protocols.

NOTE: Check out our Metrics page to see the anticipated IRB review turnaround information for studies handled through the full committee review pathway. Review time is optimized when applications are COMPLETE at the time of submission and researchers have answered ALL questions to the OHSP and/or IRB's satisfaction; plan accordingly. More complex studies, such as those involving multiple sites, Single IRB review and reliance arrangements, clinical trials and use of FDA-regulated products will require more extensive review.

Return to Top