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Human Research Review at FSU

While review of human research can be a complicated and mystifying process owing to the many and sometimes overlapping and competing legal mandates imposed by different federal, state, local and even international agencies or organizations, the FSU Office for Human Subjects Protection (OHSP) and FSU Institutional Review Board (IRB) work to assist the FSU human research community and their external partners on the application and review processes associated with human subjects research.

As a first step, a study through which FSU employees (faculty or staff), students* or agents plan to obtain information or biospecimens from or about individuals (study participants or "human subjects") are required to undergo human research regulatory review (OHSP "pre-review"). Once a study is determined to involve human subjects, then as a second step the research may be assigned to one of three Institutional Review Board (IRB) review pathways depending upon the nature, scope and risks of the research. As a quick guidance, refer to this IRB risk-based review pathway guidance. These review pathways are determined by federal law; once within those pathways, then as a third step, other review criteria are applied before the research may be approved or cleared.

For all studies through which FSU employees, students* or agents may plan to obtain information or biospecimens from or about individuals, an application for human research regulatory review must, before study activities may begin, be prepared and submitted in RAMP IRB. Applicable law does not permit retroactive reviews, so plan accordingly. Study submissions are generally handled in order of receipt.

*Students that plan to lead or conduct activities that involve individuals as described above should refer to our Student-led Activities and Research page for specific instructions, resources and guidance tailored to student activities.

As a quick reference, refer to the Decision Trees link on the left and click on the Engagement algorithm to see how research may be deemed to require human research review. 

To learn more about the human research review process, including a description of the different IRB review pathways for new or initial study submissions, other types of reviews and IRB performance and productivity metrics, click on one of the panels below.

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.

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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 (see our risk-related guidance). 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.

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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 (see our risk-related guidance) 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.

Other Human Subjects Reviews ("Follow On" and other submissions)

Aside from new or initial study submissions, other submissions will require OHSP and/or FSU IRB review, including for example study modifications, annual continuing or more frequent review, closing out a study, reporting an incident or use of a Single IRB for a multisite study. Click on one or more of the following submissions to learn more.

Modifications or Changes to the Protocol (Revisions): When an Investigator desires to amend or change a protocol, even a very small change, he or she must submit to the FSU IRB for review and approval, prior to making any change, a request for an amendment or modification. A protocol change may affect the risks involved with a study, in addition to adverse events, unanticipated problems, or complaints about the research—all of which should be reported to the IRB. A written description of proposed changes to the protocol, informed consent process and/or research instruments must be submitted to the IRB for review and approval.

Minor changes proposed to previously approved protocols (i.e. number of participants, consent language) must be reviewed by the IRB Chair. All other proposed modifications (major changes) will be reviewed using the same process used for the review of the original protocol. Only when it is necessary to eliminate apparent immediate hazards to research participants may, according to the federal regulations, an Investigator be permitted to modify an approved protocol without the prior review and approval of the IRB; even then, the IRB must be promptly informed of the change upon implementation.

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Continuing Review (Renewals): With the general exception for studies under expedited review, all protocols approved by the FSU IRB are subject to continuing review at intervals appropriate to the degree of risk, but not less than once in the 12 months following approval. At FSU, this is called the "Renewal" process. If the Principal Investigator does not receive a form for request for continuing review (renewal) within one month prior to the expiration date of the current FSU IRB approval, a request for the form should be made by contacting the OHSP.

If the IRB approval of a protocol expires before it has been re-reviewed and renewal approved, the protocol shall be suspended. While in a suspended status, all study activities, to include for example new subject recruitment or consenting, interactions or interventions with study subjects, and data analyses, must immediately cease. The only exception to this requirement is when there are concerns for the safety or well-being of the research subjects. In such a case, the Investigator must contact the IRB promptly. The suspension will be removed when and if the protocol is re-approved by the IRB.

The IRB, as a courtesy, sends out a written reminder to the Principal Investigator that the approval date is approaching expiration, and a renewal form is attached to the notice. However, it is the responsibility of the Principal Investigator to timely track and schedule their renewal submissions and to apply for renewal prior to the expiration date of the IRB approval. The Principal Investigator will receive a written notification of the IRB's review and decision for continuing a research protocol when the review process is complete. If the protocol has been re-approved, the notice will be labeled as "Re-Approval."

NOTE: All renewals should be submitted at least two full months (60 days) prior to the study's expiration date to account for review time and any possible revisions that may be requested.

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Reportable New Information: When there are incidents involving unanticipated problems involving risks to subjects or others (see, e.g., serious adverse events below), non-compliance with applicable law and policy, suspension or termination of research, protocol deviations, agency audits, subjects' complaints and other events related to research, prompt reporting to the IRB may be required. Pursuant to IRB review and depending upon the substance of the report and risks to study subjects, further investigation may be necessary and corrective or mediating actions imposed. 

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Serious Adverse Events: A serious adverse event (SAE) is a serious, undesirable, and unintended result involving risks to research participants or others. These must be promptly reported in writing to the IRB Chair. The Investigator must provide a description of the event and state whether or not changes are needed in the protocol and the informed consent process. These revisions must be reviewed by the full committee. If the events are determined to place participants at increased risks, the Chair may request re-submission of the protocol for full committee review. If the IRB Committee determines that the research participant may be placed at an immediate risk, the Committee has the authority to suspend or terminate approval of a protocol, requiring the immediate cessation of data collection from research participants. The Investigator will be notified of the Committee action, and the Chair shall contact the appropriate University officials, sponsors, and/or OHRP as required.

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Study Closure (Closing a Study at FSU):

To close a study on or before the approval expiration date, Investigators must prepare in RAMP IRB a continuing review/study closure submission for IRB review. Likewise, if a study is terminated by the IRB due to an Investigator's failure to submit a study for a required continuing review, the IRB will notify the study's PI and, as applicable, a student's major advisor to request submission of a study closure.

To close your study already housed in RAMP IRB, follow these steps: under Next Steps create and submit a study continuing review, complete the Continuing Review/Study Closure Information items as applicable (the first 4 research milestones must be checked), acknowledge that the study will be closed, discard any open follow-on submissions related to the study, complete the remaining items, attach any supporting documents as may be needed, then select Save, Finish and under Next Steps select Submit. Your Study Closure submission will move into the queue for review and further handling.

To close your study that was never submitted within RAMP IRB but is instead housed in the legacy HSRS IRB system, complete and submit to OHSP the closure form located here on the OHSP web site.

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Single IRB (sIRB) and Other non-FSU IRB Review:

For FSU research that also involves collaboration with a non-FSU institution located in the U.S. (referred to as cooperative research), an FSU Investigator or their non-FSU research collaborators may request that FSU rely upon or be relied upon by an external (non-FSU) institution for IRB for review of the research. With some exceptions, such reliance (sometimes referred to as single IRB or sIRB review) may be required under applicable federal law and policy (e.g., U.S. Department of Health and Human Services regulation, 45 CFR 46, section 46.114; U.S. National Institutes of Health Policy NOT-OD-16-094). This arrangement is permitted when the external non-FSU institution has, like FSU, its own Federalwide Assurance agreement with the U.S. government to conduct research involving human subjects (if otherwise, see below about collaborators at external institutions that lack a Federalwide Assurance). For federally funded research this arrangement should have been considered in the funding application, but such an arrangement may also, subject to federal sponsor and FSU OHSP approval, subsequently be made. In order to implement such an IRB review arrangement, an IRB Authorization Agreement or IAA (referred to at FSU as a Reliance Agreement) must be executed between FSU and the non-FSU institution(s). Review the IRB section (pages 7-8) in the FSU Policy 7-IRB-0 (University Human Subjects Policy) to see the requirements for IRB reliance arrangements.

When preparing to submit a study in RAMP IRB, be sure to indicate either that the FSU IRB will act as the single IRB of record for the non-FSU collaborating institution(s), or that an external IRB will act as the IRB of record for your study. Upon review of your RAMP IRB submission, you will be instructed to prepare to submit a Reliance Agreement in RAMP Agreements (which is separate system from RAMP IRB and used for many different types of agreements). To assist you with a RAMP Agreements submission, you will be provided with the RAMP Agreements How-to-Guide as well as an agreement template to use for editing and uploading; when selecting an agreement type in RAMP Agreements, you will choose "Reliance Agreement". FSU may accept the standard OHRP template, the Smart IRB Acknowledgement letter or other comparable arrangement.

Whether or not sIRB is required or studies undergo required FSU IRB review, some external (non-FSU) institutions may depending upon study activities (e.g., collaboration involving non-FSU employees; use of non-FSU institutions or personnel to recruit study subjects, obtain subjects' biospecimens/information, or conduct other study-related activities) require their own IRB review. Furthermore, the cost of such reviews may be imposed upon the FSU study team. Before submitting your studies for FSU IRB review, during the life-cycle of their studies and at any time a study may involve a non-FSU institution, researchers are strongly advised to contact such sites to ascertain their review requirements (including payment of their IRB review fees as may be applicable, such as for TMH) and comply accordingly. Click here for more information. The FSU IRB may require documentation of such site contact.

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Independent Collaborators or Collaborators at External Institutions that lack a Federalwide Assurance:

For FSU research that involves an independent collaborator (a non-FSU researcher who is not affiliated with any institution) or a collaborator at an external institution that does NOT have a Federalwide Assurance agreement with the U.S. government to conduct research involving human subjects, an FSU Investigator or their non-FSU research collaborators may request that the FSU Federalwide Assurance (which applies to all FSU faculty, staff and students that may conduct human research) be extended to cover the collaborator. Federal law requires that ALL individuals regardless of their affiliation must be covered by a Federalwide Assurance in order to conduct human research. By extending the FSU Federalwide Assurance to a non-FSU collaborator, this federal requirement is satisfied.

In order to have the FSU Federalwide Assurance extended to cover such a collaborator, an Individual Investigator Agreement or IIA (also referred to as a Reliance Agreement, but different in form) must be executed between FSU and the non-FSU collaborator. When preparing to submit a study in RAMP IRB, be sure to list all external study team members, including study team members that are independent collaborators or collaborators at external institutions that do not have a Federalwide Assurance. Upon review of your submission, you will be provided with a template IIA and instructed to complete and submit the IIA (designating the type of agreement as a Reliance Agreement in FSU’s RAMP Agreements module) for separate review and approval among the parties to the agreement.

Note that this IIA arrangement would generally not apply to circumstances where one or more non-FSU collaborators are affiliated with a non-FSU institution that has its own Federalwide Assurance; in those circumstances the IRB reliance arrangement described above would be applicable. In some circumstances however, an FSU research study may require both an IRB Authorization Agreement and an Individual Investigator Agreement.

Learn more about the FSU Federalwide Assurance

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Completion of Review: When the IRB review process for any submission above is complete, you will receive notification of the Committee’s action. Please read all correspondence carefully because it may request additional information or describe conditions associated with the Committee’s decision. The approval period for a protocol can be for no longer than 12 months (365 days) from the date of the review, but may be less than 12 months, depending on the perceived risks to the research subjects and the timeliness of submission of any requested revisions. Please note that OTHER NON-IRB REVIEWS MAY BE REQUIRED, SUCH AS RESEARCH COMPLIANCE AND/OR LEGAL REVIEWS FOR RESEARCH-RELATED AGREEMENTS, SUCH AS DATA USE AGREEMENTS, BUSINESS ASSOCIATE AGREEMENTS, AND AGREEMENTS FOR USE OR DISCLOSURE OF FERPA-PROTECTED INFORMATION. Contact us with questions or referral.

For questions about your study, check out the Staff Listing tab to the left, or contact your assigned IRB Coordinator

Other Reviews or Requirements

*Note that other non-OHSP or IRB review (e.g., Sponsored Research, legal counsel) may be required before a research project may commence; plan accordingly.

IRB Metrics

FSU's electronic protocol management system for IRB review ("RAMP IRB") allows the OHSP to provide the FSU leadership and the human research community with meaningful and key metrics to help establish internal goals, benchmarks and expectations for human research regulatory review productivity and turnaround. To date, FSU IRB review turnaround times are consistently lower than established FSU performance goals as well as those reported by peer institutions.

Select metrics are depicted below

Notes:

(1) IRB Review Turn-around Times include metrics for 3 categories of review pathways: exempt, expedited and convened IRB review, for FSU human research studies that have ever been approved or cleared as of the end of the prior month for the months depicted. Counts by month are depicted to illustrate turn-around trends. The garnet bar captures actual FSU IRB turn-around in calendar days. The gold bar represents the FSU goal while the grey bar (AAHRPP*) refers to the median turn-around reported among accredited academic institutions/IRBs across the U.S. (*Association for the Accreditation of Human Research Protection Programs (2022).

(2) IRB Submission Status is reported for all studies that have ever been logged into the IRB electronic protocol management system. Counts by month are depicted to illustrate volume trends. "ALL" (garnet) submissions account for any submission (e.g., new or transferred studies, modifications, continuations) ever entered into the IRB system (since July 2019). "Active" submission volume (gold) accounts for currently IRB-approved or cleared studies. "In Review" submission volume (grey) accounts for studies currently in a queue awaiting disposition (e.g., pre-submission by PIs, faculty advisor review or Pre-Review by OHSP); approximately 2/3s of these are in pre-submission (i.e., not yet been submitted by PIs for regulatory review).

Review turnaround for any study begins when a submission is submitted by a PI, and ends when a final regulatory determination is rendered. The review process includes, for example, all of the following:

  • Verification of personnel training (CITI Human Subjects and/or Good Clinical Practice training) and conflicts of interest (via CAMS)
  • Faculty advisor review and approval (for student-led activities and research)
  • Pre-review and clarification requests (and review of PI response) by OHSP to ensure a submission is IRB review ready
  • Regulatory review and clarification requests (and review of PI response) by the IRB, an IRB member and/or OHSP staff
  • Ancillary (non-OHSP or IRB, e.g., other FSU offices or external partners or sponsors) reviews
  • PI response to required revisions (as applicable), resubmission and review by the IRB and/or OHSP team
  • Finalization of IRB-approved study materials
  • Drafting, processing and issuance of final regulatory determination letter