Certification of IRB Approval at Time of Application

Under federal law for the protection of human subjects, applicant institutions such as FSU are no longer (as of January 19, 2019) required to provide federal agencies with certification of IRB approval when submitting funding applications [link; see section --.118]; instead, certification is required when funding is anticipated or before funds are awarded. See our guidance on Post-Award (Funded Projects). Therefore, there is generally no need to obtain and provide documentation of FSU IRB approval in order to submit a funding application (but see exceptions below). 

Exceptions to the requirement or need to provide documentation of FSU IRB approval WITH a funding application may arise in some circumstances. For example:

1. The requirement to provide documentation of IRB approval with a funding application may be indicated in a funding opportunity announcement; therefore, review the announcement carefully to see if this requirement applies.
2. Some sponsors, such as the National Science Foundation (NSF), may instruct funding applicants to separately submit their study plans to the applicant institution's IRB for review at the SAME TIME that researchers submit their funding application to NSF. Always check with your funding sponsor to see if they instruct similarly.
3. Some sponsors may have a very abbreviated period of time between the sponsor's approval of funding and their requirement that prospective funding recipients provide the sponsor with documentation of IRB approval. Funding applicants are strongly advised to contact the funding opportunity program officer to see if the sponsor imposes a tight turn-around between an award notice or plan to approve of funding, and the need to provide the sponsor with documentation of IRB approval.

For any study that may meet the exceptions above, researchers should file their IRB applications at the SAME TIME that as their funding application. See the Important Note in Submitting a Study to the FSU IRB section below about IRB review turn-around timelines. ^

Submitting a Study to the FSU IRB

Important Note: for applications that require documentation of IRB approval with the application or very shortly after an award notice, be advised that FSU IRB review of a complete IRB application may take on average 40 days. This review turnaround is for IRB applications for which (a) there are no complex matters or confounding issues (e.g., clinical trials, FDA-regulated products, multi-site studies, unhealthy or patient populations, international research) and (b) there is no need for the study team to respond to the IRB's request for clarification (the study team has provided all required study documents; key study documents such as the protocol and consent-related materials conform to FSU templates; and all members of the study team have completed the required human subjects training and conflicts of interest disclosure). Otherwise, IRB review turnaround will be considerably longer. Visit our Human Research Review page to learn more, including IRB review pathways, meeting dates and submission deadlines.

To submit a study 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 studies that will be submitted for IRB review must use the University’s RAMP IRB system. Before or while preparing an IRB 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)

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Delayed Onset Studies

A delayed onset study is a study where human subjects research activities are anticipated within an application's project period, but definite plans for the involvement of human study participants cannot be described in the application (see bulleted reasons below). Before preparing a funding application, carefully review the funding opportunity announcement and confer with the funding opportunity program officer to see whether delayed onset study will be allowed, required or prohibited. When allowed or required, applicants should be prepared to explain and justify in their applications that upon a sponsor's request, the study team will apply to the FSU IRB for a "delayed onset", contingent or similar determination to the effect that no human subjects research activities will begin until IRB approval has been granted.

Sponsors may permit applications involving delayed onset of human subjects research activities in the following circumstances:

• The study team will need to complete pre-human subjects research activities before plans for human subjects involvement may be fully developed;
• The application seeks support to build out a consortium under which specific protocols involving human subjects research activities will be developed and added throughout an award period; or,
• The application seeks support to fund discrete protocols involving human subjects research activities that will only later be solicited and selected by the awardee institution.

Note that delayed onset is distinguished from and should not be confused with "delayed start", whereby human subjects research activities can be fully described and related supporting documents provided in a funding application (or provided before issuance of an award during the just-in-time process), but human subjects research activities will begin later in a funding period [see, e.g., NIH Glossary link]. For applications using the SF424 forms, follow the Delayed Onset Study instructions.

IF the IRB's delayed onset or contingent determination must be submitted with the funding application, refer to the Important Note under the Certification of IRB Approval at Time of Application section, and follow the instructions for Submitting a Study to the FSU IRB. For IRB submissions involving a delayed onset, RAMP IRB submission will still be required but abbreviated IRB criteria for approval will apply. ^

Preparing a Funding Application's Human Subjects Sections

Most sponsors' funding applications will require that applicants indicate whether a planned project will involve research activities involving human subjects at any time during the funding period. The term "human subject" is defined under federal law as:

• A living individual about whom an investigator conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, OR (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens (in (2), no intervention or interaction is necessary; the mere use of identifiable information or identifiable biospecimens is sufficient for the information or biospecimen to be considered a human subject).

General Guidance

1. In response to a funding application question about whether human subjects are involved, whether definitively or if human subjects research activities will during a proposed funding period be planned, possible or anticipated even if not definitive, check or answer "Yes" if research activities will or may involve human subjects as that term is defined above. If human subjects research activities are not nor will be planned, possible or anticipated, check or answer "No"; it is likely that the remaining human subjects sections in a funding application (and the remaining OHSP guidance below) may be skipped. However, since application forms and instructions may differ substantially among sponsors, carefully read instructions about responding to any questions or completing any section pertaining to human subjects. 
2. Some funding applications may include a follow-up question about whether, if "Yes" in response to the question about whether human subjects are involved, the applicant believes that all proposed human subjects research activities meet exemption criteria (i.e., IRB review may not be required), and if "Yes", into what exemption category any proposed human subjects research activities will fall. If asked to identify exemption categories but it is not clear into what category each human subjects research activity will fall, refer to these federal exemption charts (use charts 2-10) before selecting a category. The FSU IRB follows federal exemption criteria.
3. If an applicant believes that the proposed project is not exempt, then the applicant should provide a "No" response, upon which another follow up question may be prompted: Is IRB review pending. If IRB review is pending, whether or not the applicant has submitted an IRB application, an applicant should check or answer "Yes" and leave any approval date blank. However, if IRB approval has been extended, check or answer "No" and provide the most recent date of IRB approval. Note that if the funding application requires the FSU Assurance number, that number is FWA00000168 or 00000168 depending upon the required format for this field. 
4. For projects that will involve human subjects research activities, most sponsors will require that a thorough description of the activities be included in a funding application. This may include:
   • Basic information for each human subjects research study planned in a project
   • Information about the study population (e.g., condition of interest; eligibility; age; recruitment; study timeline)
   • Plans to protect and monitor study participants' safety
   • Synopsis of the study such as design, outcomes, and plan for dissemination
   • Clinical trial-related information, if applicable (see our Clinical Trials page)
   • Plans for managing and sharing study data (see our NIH Data Management and Sharing page; other sponsors may have similar requirements)
5. Always refer first to the funding application instructions to see what and how human subjects research activities must be described and what related documentation must be submitted in the application. Such instructions are generally very detailed. Also, confer with the funding opportunity's program officer if there are any questions, as well as refer to sponsors' human subjects-related policy requirements and guidance.

Note the human subjects research-related information required in a funding application is similar to the information required in FSU IRB applications, and congruence between a funding (or award) and FSU IRB application will be evaluated by the FSU IRB before IRB approval is granted. Refer to the FSU IRB protocol templates, available in RAMP IRB, under the IRB, Library and Templates tabs (see our HRP-503 series template protocols). ^

Single Institutional Review Board (IRB) ("sIRB") Review

A single IRB ("sIRB") is an IRB that provides human research ethical and regulatory review, on-going oversight, and related central IRB administrative coordination for a multi-site study or cooperative research. Under federal regulations, 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 sponsor [link; see section --.114]. Some exceptions apply; these include:

• research for which more than sIRB review is required by law;
• research for which a federal sponsor determines that sIRB review is not appropriate; or,
• research that is determined to be exempt or not involve human subjects (these determinations are made by the OHSP/IRB).

So as to avoid duplication here describing the sIRB review mandate, refer to our Single IRB (or sIRB) Review page where we provide extensive related information.

Before preparing a funding application, carefully review the funding opportunity announcement and confer with the funding opportunity program officer to see whether sIRB review will be required and, if so, how the study team must in the funding application describe or document sIRB review. Generally, and unless otherwise required in the applicable funding opportunity announcement pertaining to a central IRB, funding applicants are not required to submit a detailed plan describing their planned use of a single IRB at the time of application submission. However, applicants that are subject to the sIRB mandate are likely to be required to at least provide the name of the sIRB before an award will be issued; some sponsors may differ or require such information at the time of application. Again, carefully review the funding opportunity announcement or confer with its program officer for authoritative information and instructions.

OHSP provides a template of model language that applicants may consider for use in their applications, including sIRB-related information (beginning on page 2) if such information is required. ^