Tufts Medical Center and the Floating Hospital for Children participate in the independent model of the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) Initiative. Under this model, the Adult and Pediatric CIRBs are the IRBs of record for certain adult and pediatric national multi-center cooperative oncology group cancer treatment trials.
Refer to the CIRB website for more information, including a list of CIRB studies.
Refer to the NCI IRB Manager website to open and manage CIRB studies.
Submit the following to the Tufts Health Sciences IRB electronically (via flash drive; e-mail is acceptable as long as you call the IRB office staff person to let them know you are sending this via e-mail):
*The PI/research team are responsible for ensuring all comments have been addressed and resolved prior to starting the study.
The Tufts MC/TUHS IRB Office will notify the PI and study coordinator via e-mail when the review of these documents is complete and will provide a signed Form 9. Once you receive a signed Form 9, you may submit the Study-Specific Worksheet about Local Context to the CIRB using IRB Manager. Once CIRB approves this worksheet, the CIRB is the IRB of record for the study, responsible for study review and local context considerations for the Tufts Medical Center site.
When to correspond with the Tufts MC/TUHS IRB once a study is active at Tufts MC:
The Tufts Medical Center Site-Specific Appendix is not needed, because the information in this document is included in the CIRB Study-Specific Worksheet about Local Context.
Any local recruitment tools and locally-developed materials should be submitted to CIRB for review and approval via the Locally-Developed Material Submission Form.
Submit a completed CIRB form to add or remove Signatory and or Component Institution Personnel to the Tufts MC/TUHS IRB via e-mail, and the Tufts MC/TUHS IRB will submit the request to the CIRB.
Unanticipated problems and potential serious and/or continuing non-compliance are to be reported to the CIRB with a copy to the Tufts MC/TUHS IRB. The CIRB reviews these reports, makes a determination, and reports to OHRP and FDA, as applicable.
Per Tufts’ Annual Signatory Institution Worksheet about Local Context, Tufts MC/TUHS IRB approved short forms may be used per the Tufts MC/TUHS IRB short form policy.
The CIRB is not constituted to review studies enrolling prisoners.
Please note: If the enrollment of prisoners is proposed, the research must fall within the categories of research permissible under 45 CFR 46.306(a)(2).