Definition
External Researchers are Principal Investigators (PIs) that are not TCC faculty, staff, or students. TCC faculty, staff, or students conducting research for graduate degree requirements at other institutions are considered external researchers for the purpose of their research request.
Review Process
All external research requests will be reviewed by an OIE Sub-Committee to ensure compliance with the federal assurances for human research protections covered under 45 CFR 46.101. Please note that the response time from the Sub-Committee is dependent on reviewers’ availability and varies per semester. Although the OIE attempts to ensure that all response times comply with timelines at comparable institutions, the process is iterative and reviews may not be finalized with the first submission. As a general guideline, all external PIs will be contacted by the OIE with respective updates within two-week timeframes.
Types of Research requests
All external research requests will be required against the federal assurances for human research protections covered under 45 CFR 46.101. Review procedures are dependent on the initial request’s incorporation of human subjects, the nature of the request, and the type of data being requested. To learn more about these procedures, please review the below information.
External Research Involving Human Subjects
Step 1
When a research request is classified as external involving human subjects, TCC procedures require the following for initial review:
(1) The original Institutional Review Board (IRB) application for the research request submitted to the PI’s home institution’s IRB.
Please note that should the information submitted for this item not cover all required sections associated with general Human Subjects Research reviews, the OIE Sub-Committee has the right to ask external PIs to complete the TCC Human Subjects Research application.
(2) Certification that indicates the PI and all co-PIs have completed the ethical training required to conduct human subjects research (e.g. CITI training).
TCC accepts four types of evidence to fulfill this requirement including ethical training from: The Office of Human Research Protections, The National Institute of Health, the Collaborative Institutional Training Initiative, and the University of Montana.
(3) A letter or document from the PI’s home institution’s IRB granting approval to conduct research with human subjects.
This document is different from item 1 and typically indicates approval for the type of research to be conducted. Official signatures of IRB representatives are integrated.
(4) The name of a faculty supervisor or point of contact at TCC.
This is generally in the form of a Gatekeeper or Permission letter and must indicate the PI’s name, name of the study, and nature of the data to be collected. This must match the information indicated in item 1 (above) and should be filed as part of the original IRB application with the home-institution indicating a collaborative agreement is already in place.
For the initial review, please submit all four of the above documents to the OIE at oie@tcc.fl.edu. Please note that initial review times vary depending on the availability of Sub-Committee reviewers.
Step 2
As part of the initial review process, the following items will also be discussed. Note that to conduct human subjects research at TCC as an external PI, an External Research Authorization Agreement form (item 5) must be on file. If applicable, all internal permissions for use of institutional and student related data will also need to be procured (item 6).
(5) Completion of the External Research Authorization Agreement form.
Please note that this needs to be signed by an IRB official at the PI’s home institution as well as any faculty advisors if the study is being conducted by a graduate or undergraduate student.
(6) Completion and approval of all required internal request forms from TCC (if applicable).
These forms are typically required if the research request is for data that is protected under FERPA or HIPAA. A permission letter from an Executive Team member may also be required, dependent on the type of data requested.
Please note that access to these forms will be shared upon submission of the above four items to the OIE for initial review.
All Other Requests
Other general data requests or non-research related requests may fall under categories that require different procedures than the ones described above.
For all other data or research requests stemming from external researchers, please contact the OIE at oie@tcc.fl.edu for more guidance.
Internal Research Requests
Internal Researchers are PIs that are TCC faculty, staff, or students conducting research as representatives of the College. This includes research efforts leading to publications, internal reports, or for class projects.
For all internal research requests, please review the information provided in the Internal PI Portal. Please note that you will need TCC Credentials to enter this portal. Should you have any questions or cannot access the portal, please contact the OIE at oie@tcc.fl.edu for more assistance.