Generally, no. Under federal law for the protection of human subjects, applicant institutions such as FSU are not required (as they were before 2019) to provide federal agencies with certification of IRB approval when applicants submit their funding application; instead, certification is required before funds are awarded. Non-federal sponsors may have different requirements, so check with your funding sponsor or the funding opportunity announcement to be certain.

Refer to the Certification of IRB Approval at Time of Application section on our Guidance on Pre-Award (Applications for Funding) page for more information.

No. Applicable federal law does not permit any IRB to approve of human subjects research activities (whether proposed for funding or for which an award is received) for which activities the applicable regulatory criteria for IRB approval have not been satisfied; human subjects research activities that are not yet finalized cannot be appropriately reviewed by the IRB for the acceptability of risks to subjects, since such risks may yet be known. 

However, for funding applications or awards that involve delayed onset or delayed start to human subjects research activities, the IRB may provide the study team with a contingency letter that provides a statement to the effect that no human subjects research activities, even if planned, may begin until IRB approval has been granted. For more about this topic, refer to the Delayed Onset Studies section on our Guidance on Pre-Award (Applications for Funding) page.

Yes, the FSU IRB may serve as the single IRB (sIRB*) in the following circumstances:

1. FSU is the grantee institution with an FSU PI as the overall PI over the study and award, and the FSU IRB has the requisite experience and expertise to review the study; and,
2. OHSP agrees to have the FSU IRB serve as the sIRB, based upon certain factors, including that the FSU IRB has the requisite experience and expertise to review and provide continuing regulatory oversight of the study; the number of relying study sites; study scope and risks; qualifications of the FSU study team to adequately serve as the lead study site; and adequacy of the communication plan.

Any request that the FSU IRB serve as the sIRB may be declined based upon these and other considerations. All sIRB arrangements will be evaluated on a case-by-case basis and documented with an IRB Authorization Agreement (aka reliance agreement).

If sIRB is not mandated by sponsor's policies or federal regulations (e.g., the study is not funded by an applicable federal agency; the subawardee is not engaged in cooperative research; a subawardee institution is not located in the U.S.), the FSU IRB may still serve as the sIRB provided the circumstances 1 or 2 above apply.

Subawardee institutions may, if not subject to the sIRB mandate, elect to require their own separate IRB review of subawardee institution's human subjects research activities. However, the subawardee institution must provide their FSU grants contact with documentation of the subawardee institution's IRB approval as a condition of receiving subaward funds.

*sIRB review is generally required for research that is conducted in the U.S., involves collaboration among multiple institutions, and is funded by a federal agency; some exceptions may apply. For more about this topic, visit our Single IRB (sIRB) Reviews page, including instructions about how to request sIRB review for a study.

Yes. Receipt of any funding for a study is a modification that requires IRB review. Funding implicates a wide range of issues for which the IRB must have visibility, including for example, changes in study sites, study personnel and/or study objectives, aims or methods; whether funding requires disclosure during the informed consent process; public posting of the IRB-approved consent form; registration of clinical trial results; single IRB ("sIRB") review for multi-site studies or cooperative research; management and sharing of study data in accordance with sponsor requirements; and review of payments to study participants.

To submit a funding modification to the FSU IRB for review, start by logging into the University’s system for such submissions: RAMP IRB (or https://myramp.research.fsu.edu/). All modifications that will be submitted for IRB review must use the University’s RAMP IRB system. Before or while preparing an IRB modification submission, refer to the IRB Researcher's "how-to" RAMP IRB guide, and visit OHSP's RAMP IRB video tutorials and review our RAMP IRB-related FAQs at the links below:

Tutorials (or https://www.research.fsu.edu/research-offices/ohsp/investigator-resources/tutorials-for-using-ramp-irb/ramp-videos/). Tutorials are provided for each section of the IRB submission workspaces and generally last 2-3 minutes.

RAMP IRB-related FAQs (or https://www.research.fsu.edu/research-offices/ohsp/faqs/#RAMPIRBrelated).

Generally, no. Multiple studies covered by award (which may not be uncommon) for which the studies may have different PIs, study teams, specific aims and study samples should be separately submitted for IRB review. Also, given differences in study scope, parameters, and/or risks, different IRB regulatory review pathways (convened, expedited, exempt or limited IRB review) may be required for different studies covered by an award. Even where the same individual serves as the PI and the same study team members conduct multiple studies covered by an award, when multiple studies involving different aims and samples are combined in a single IRB application, the most stringent review pathway (convened IRB review) that must by law be applied will necessarily subject all studies in a single IRB application to more stringent review pathway.

It greatly depends. IRB review turnaround depends upon several key factors, including for example (1) if the study is complete and accompanied by required documents using FSU approved templates; (2) satisfactory responses have been timely provided to any requested clarifications; (3) whether in accordance with regulatory requirements IRB review will require a convened IRB committee (at a scheduled monthly meeting) or non-committee (subcommittee, also referred to expedited, for which review may be done at any time) review; and (4) whether any other outside or ancillary review (e.g., another institution's IRB reviews such as sIRB or local review; safety reviews for use of hazardous materials or radiation-emitting devices by other institutional committees or office; ethics or conflicts of interest reviews). With the above caveats:

• • Exempt studies may receive clearance within 2 weeks or 10 business days, often less;
  • Non-committee reviews may be completed within 4 weeks;
  • Committee reviews may be completed within 6 weeks;

Review turn-around is also subject to other factors, such as IRB reviewer availability or workload, complex studies (e.g., studies involving use of drugs, medical devices and other products subject to additional federal laws; studies involving vulnerable populations such as children, cognitively impaired, unhealthy persons or patients; agreements or arrangements with other outside agencies, institutions or sponsors, and clinical trials).

For more details about human research review and the IRB review turnaround, visit our Human Research Review page, where the information, including information about IRB meeting dates and submission deadlines, may be used for your IRB review planning purposes.

Yes. DoD policy requires that for any human subjects research activity funded or otherwise supported by a DoD component (e.g., Army, Navy, Air Force, Defense Health Agency etc.) that a non-DoD IRB approved study must be submitted to the applicable DoD Human Research Protection Office (HRPO) for the HRPO's administrative review. The HRPO may require changes to the research in order to satisfy DoD policy requirements (which are generally distinct from the usual IRB requirements and include special protections for human subjects research activities that involve military service members as prospective study participants); any changes required by the HRPO must be followed up with a modification submission to the IRB. The funded study may not begin before this DoD component HRPO review is completed and the study team so notified. The applicable DoD component HRPO should have been identified in the DoD award notice; if not, contact the DoD component office that awarded the funds to obtain their HRPO's contact information. All IRB-approved materials (e.g., protocol, consent-related materials, study instruments etc.) should be provided to the HRPO for their review.

Visit the DoD's Directorate of Human Research Protections to obtain additional information about the DoD HRPO policy, or search this DoD site for the policy, Department of Defense Instruction (DoDI 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and -Supported Research). Note that each DoD component will have their own component policy that implements DoDI 3216.02, so requesting the component policy from the HRPO may provide additional information specific to the DoD component.

Guidance about how to describe the way in which researchers will protect human subjects' data are provided at our NIH Data Management and Sharing (DMS) page.

Funding applications that are subject to the NIH Data Management & Sharing DMS Policy will require, for studies involving human subjects research activities, that any human subjects data that are collected will be adequately protected and, if whether or not sharing the data are anticipated, that both the IRB be notified in the IRB application and that prospective human study participants be so informed during the consent process.

Note that when funded, the study team's DMS plan accepted by the NIH sponsor must be followed and periodic updates or changes provided to the sponsor for subsequent review and acceptance. Any changes to the DMS plan must also be submitted as a modification to the IRB.

Our NIH Data Management and Sharing (DMS) page provides information about the DMS policy and how it applies to FSU research generally (not just human research), how to inform prospective study participants about how their data will be protected and shared, and a long list of DMS-related resources, both at FSU and beyond.