Some notes about Administrative or pre-IRB review:

• Certain study materials must be submitted to both the FSU and TMH IRB offices. 
  • First visit the TMH IRB website and look over the TMH IRB scope of review; then, contact the TMH IRB office to ask about their review requirements, including the study materials that must be provided. Use of the TMH electronic research administration system (which is separate and not the same as FSU's) may be required, so be sure to ask; sometimes, FSU studies that may only involve posting of fliers at TMH will not require use of the TMH system.
  • For studies that may require review by the TMH IRB, be certain that, when required by TMH, that TMH forms and templates are used. IF both TMH and FSU IRB are required (see third panel below ("When Duplicate IRB Review May be Necessary"), FSU will generally accept some key study materials (e.g., protocols or research plans; consent forms) based upon TMH templates or forms. However, some unique FSU requirements, such as conflicts of interest reporting, cannot be waived.
  • For all FSU administrative or pre-IRB submissions, use of RAMP IRB is required. To see what study materials (e.g., protocol or research plan; measures/instruments; consent forms) must be provided for review, check out our General FAQ #7. Once in RAMP IRB, you can see which study materials are required and how the materials must be uploaded by clicking the Help? buttons. Again, when TMH requires use of their forms and templates, FSU will generally accept those forms in lieu of using FSU templates, although some exceptions may apply.
• To see how long review may take, visit our Human Research Review page.
• Administrative review is not the same as IRB review. Pre-review is generally performed to determine whether (a) a study does not involve human subjects; (b) may qualify for exemption (from IRB review); or (c) is sufficiently complete and therefore ready for IRB review. Pre-review may also be used to see if duplicate IRB review may be avoided. In contrast, IRB review (via Committee or expedited or non-committee) is performed to determine whether ALL applicable federal and other regulatory conditions have been satisfied such that a study may be approved.
• Keep in mind that administrative reviews are not redundant, but serve as a federal regulatory basis to for both FSU and TMH to see whether single IRB review is appropriate and if so, which IRB is the most suitable for review.

For studies submitted to the FSU IRB office, the most appropriate place to describe TMH involvement is in the study protocol (see link to protocol templates below), particularly sections 13 (Recruitment) and 24 (Setting).

• The protocol section 13 instructions state in part that if recruitment will involve a non-FSU site, then a description of the non-FSU site's approval is required, and documentation of such approval attached (i.e., uploaded with the study submission). Also:
  • Carefully describe the involvement of any TMH clinician or provider in any recruitment activity (e.g., contact of patients, use of health information, posting or distribution of fliers).
  • Copies of recruitment materials must be provided with the IRB submission. Save time and effort by following any TMH requirements (about which you should have inquired as a first step before a RAMP IRB submission) about recruitment flier content and format. 
• The protocol section 24 instructions provide in part the following (the below have been tailored to research involving TMH):
  • Describe the TMH sites or locations where your research team will conduct the research.
    • Identify where in or at TMH prospective study participants will be identified or recruited.
    • Identify what specific TMH health information will be used or obtained and how the information will be disclosed by TMH to the study team.
    • Identify where in or at TMH any research procedures (e.g., screening, consenting, interviews, interactions) will be performed.
    • For research conducted in or at TMH, describe:
      • TMH-specific requirements pertaining to the research.
      • TMH scientific, ethics and/or IRB review requirements and procedures.
      • Describe TMH approval to conduct research at any TMH site or location; be certain to attach a copy of all approval documentation. If no such approval was required, so state and be prepared to provide documentation. Before submitting your studies for FSU IRB review, you must contact TMH to ascertain their review requirements (including as may be applicable payment of TMH IRB review fees) and comply accordingly. The FSU IRB will require documentation of such TMH contact.
  • The instructions also note that collaborations (e.g., clinical research) involving TMH are subject to specific requirements; click here for more information.
• Check out our protocol templates, available in RAMP IRB under the IRB, Library and Templates tabs.

Subsequent to completion of admistrative or pre-IRB review, both FSU and TMH will try to avoid duplicate IRB review; doing so reduces regulatory burden for study teams and our IRB offices! Additionally, certain studies that are funded by some federal sponsors (e.g., the National Institutes of Health) require that cooperative research undergo review by only one IRB ("Single IRB" or "sIRB") (check out our Single IRB Review web page to learn more).

For studies that involve both TMH and FSU and that are not subject to the federal sIRB requirement (i.e., studies that are not federally funded), review by a single IRB is at TMH and FSU's discretion. In the exercise of this discretion, the TMH and FSU IRB offices have in place a process to maximize the use of single IRB:

1. Generally, any study involving the use or disclosure of TMH health information, participation by TMH clinicians or staff in any study activity for a research purpose (regardless of location), or interventions involving study participants for which the interventions are located only in a TMH location, will require TMH IRB review. In these cases, FSU may after conducting its administrative (or pre-IRB) review, rely upon the TMH IRB for review.
   • • For any study for which FSU will rely upon the TMH IRB for review, the FSU RAMP IRB pre-review submission must indicate such an arrangement, and a reliance agreement is required by federal law to document such arrangement. Carefully review our Single IRB Review web page for detailed information and instruction.
2. Studies involving only the posting or distribution at TMH of recruitment fliers, and studies in which ALL interventions or interactions with study participants are located only at FSU or a non-TMH location, will require FSU IRB review. Keep in mind that TMH administrative review is first required, and that the procedures for posting or distributing recruitment materials, and the content and format of these materials, are subject to TMH review and requirements.
3. For studies that do not fall into 1 or 2 above, duplicate IRB review may be required. This may be the case if, e.g., (a) the FSU study is federally funded, subject to the sIRB requirement, and the FSU IRB was designated as the sIRB in the funding award but some condition in item 1 above also applies (e.g., use or disclosure of TMH health information); (b) all study activities are located at FSU but TMH employees are engaged in study activities (e.g., TMH employees will be interacting with study participants or analyzing identifiable private information); or (c) the study interventions or interactions with study participants are located at both TMH and FSU.
4. Exceptions to 1-3 may apply, so it is important to first contact the TMH IRB office, and to carefully prepare your studies to avoid ambiguity about study procedures, locations, and recruitment activities.