Certification of IRB Approval 

Federal law requires that FSU provide sponsors with certification of IRB approval of funded research involving human subjects before human subjects research activities are permitted to begin [link; see section --.103(d). 18]. The specific legal language is as follows:

"[I]nstitutions shall certify that each proposed research study . . . has been reviewed and approved by the IRB. . . . [u]nder no condition shall research . . . be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB."

When federal and other sponsors indicate that proposed research may be funded (awarded), the sponsors will notify FSU to provide official documentation ("certification") of IRB approval as a condition of receiving an award or spending awarded funds. Sponsors' notices will generally be sent to the FSU grants contact(s). Note that sponsors generally do not routinely send such notices to the FSU IRB.

When a study team is notified by a sponsor or the FSU grants contact about the need for official documentation of FSU IRB approval, researchers should promptly take one or more of the following steps:

1. If the study covered by an award has already been approved by the FSU IRB, provide the sponsor or FSU grants contact with copy of the most current FSU IRB approval letter. Approval letters are accessible in the RAMP IRB submission workspace for the covered study.
2. If the study covered by an award was approved by the sponsor for a "delayed onset" (i.e., human subjects research activities are planned in the funded project period, but definite plans for the involvement of human study participants were not described in the funded application) (refer to the Delayed Onset section below), submit the study for IRB review. Refer to the instructions in the Submitting a Study to the FSU IRB section. For IRB submissions involving a delayed onset, a RAMP IRB submission is required but abbreviated IRB criteria for approval may apply and an IRB approval contingency letter prepared accordingly.
3. If the study covered by an award was approved by the sponsor for a "delayed start" (i.e., human subjects research activities were fully described and related supporting documents provided in the funding application, but human subjects research activities will begin later in the funded project period), submit the study for IRB review. Refer to the instructions in the Submitting a Study to the FSU IRB section. For IRB submissions involving a delayed start, a RAMP IRB submission is required but abbreviated IRB criteria for approval may apply and an IRB approval contingency letter prepared accordingly.
4. If the study covered by an award has not been reviewed by the IRB and items 1-3 above do not apply, submit the study for IRB review; refer to the instructions in the Submitting a Study to the FSU IRB section.
5. For any multi-site study or cooperative research covered by an award, the sponsor may also request the name of the single IRB ("sIRB") and the sIRB plan. Refer to the Single Institutional Review Board (IRB) ("sIRB") Review section below for information and guidance.

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 any request about the need for official documentation of FSU IRB approval, 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).

If the study covered by an award involves a multi-site study or cooperative research and may require a single IRB to provide review, approval and oversight, see also our Single Institutional Review Board (IRB) ("sIRB") Review section below. ^

Delayed Onset Studies

A delayed onset study is a study where human subjects research activities are anticipated within the funded project period, but definite plans for the involvement of human study participants were not described in the funded application. Some reasons for a delayed onset study include the following:

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

Funded applications involving delayed onset are generally conditioned upon the study team's submission of an IRB application for a "delayed onset", contingent or similar IRB determination to the effect that no human subjects research activities will begin until IRB approval has been granted for a subsequent IRB submission that includes well-defined plans for the involvement of human study participants. A RAMP IRB submission is required for a delayed onset or contingent IRB determination, but abbreviated IRB criteria for approval may apply. ^

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).

For any multi-site study or cooperative research covered by an award and for which study the sIRB review mandate applies, the sponsor is likely as a condition of funding the award or permitting award funds to be used, to request that the awarded institution or study team provide the sponsor with name of the sIRB and documentation of the sIRB plan (laying out how the sites will coordinate and document sIRB review and approval), as well as certification of IRB approval, described above.

Upon the sponsor's request, promptly take one or more of the following steps:

1. If not already accomplished, FSU researchers should work with the lead study site (if other than FSU) and other participating study sites to agree to and coordinate the designation of the sIRB and develop/finalize the sIRB review plan.
2. If the study covered by an award has already been approved by the FSU IRB as the sIRB, provide the sponsor or FSU grants contact (and the study's participating sites if not already done so) with copy of the most current FSU IRB approval letter. Approval letters are accessible in the RAMP IRB submission workspace for the covered study.
3. If the study covered by an award was approved by the sponsor for a "delayed onset" (refer to the Delayed Onset section below), submit the study for sIRB review. If the FSU IRB serves as the sIRB, refer to the instructions in the Submitting a Study to the FSU IRB section. For IRB submissions involving a delayed onset, a RAMP IRB submission is required but abbreviated IRB criteria for approval may apply, and an IRB approval contingency letter prepared accordingly. If the FSU IRB does not serve as the sIRB, also communicate the sponsor's requirement to the lead study site team.
4. If the study covered by an award was approved by the sponsor for a "delayed start" (i.e., human subjects research activities were fully described and related supporting documents provided in the funding application, but human subjects research activities will begin later in the funded project period), submit the study for sIRB review. If the FSU IRB serves as the sIRB, refer to the instructions in the Submitting a Study to the FSU IRB section. For IRB submissions involving a delayed start, a RAMP IRB submission is required but abbreviated IRB criteria for approval may apply, and an IRB approval contingency letter prepared accordingly. If the FSU IRB does not serve as the sIRB, also communicate the sponsor's requirement to the lead study site team.
5. If the study covered by an award has not been reviewed by the sIRB and items 2-4 above do not apply, submit the study for IRB review; if the FSU IRB serves as the sIRB, refer to the instructions in the Submitting a Study to the FSU IRB section. If the FSU IRB does not serve as the sIRB, also communicate the sponsor's requirement to the lead study site team.
6. Provide to the sponsor upon the sponsor's request the name of the designated sIRB, the sIRB plan and/or certification of sIRB approval.

For model language about an sIRB plan, the OHSP provides a template of language about FSU's human research protections and related regulatory compliance that may be shared with other institutions (as well as study sponsors); sIRB language begins on page 2.

Aside from our Submitting a Study to the FSU IRB instructions above, for more detailed sIRB-related information and instructions, visit our Single IRB (or sIRB) Review page, and click on the "Requesting sIRB Review for Your Study" panel. ^