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Tufts Medical Center/Tufts University Health Sciences IRB
CIRB Process (Independent Model)

NCI CIRB Background

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.

Opening a New CIRB Study

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):

  1. Form 9 (CIRB)
  2. Pharmacy Review, if applicable*
  3. Form 4 for research related radiation, if applicable*
  4. Tufts Biosafety Committee Review, if applicable*
  5. Financial conflict of interest (COI) form(s)
  6. For studies that utilize an informed consent form (ICF), please also submit the following:
    1. Clinicaltrials.gov Form – Submitting this form is required.
    2. Tufts MC Clinical Research Recruitment Website form – Submitting this form is required for Tufts Medical Center studies. For Tufts University studies, submitting this form for posting studies on this recruitment website is optional.

*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:

  • Requests for CIRB website access for new study personnel (as well as requests to remove study personnel) should be e-mailed to the Tufts MC/TUHS IRB. Submit a completed CIRB form to add or remove Signatory and or Component Institution Personnel.
  • Provide a copy of:
    • Audit reports, and notifications to CIRB of regulatory deficiencies
    • Unanticipated Problems & Serious and/or Continuing Non-Compliance
  • If/when a study subject becomes a prisoner, because the CIRB is not constituted to review studies enrolling prisoners (refer to Prisoners section below.)

Site-Specific Appendix

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.

Locally-Developed Material

Any local recruitment tools and locally-developed materials should be submitted to CIRB for review and approval via the Locally-Developed Material Submission Form.

Requests for CIRB Website Access for New Study Personnel (and requests to remove institution personnel)

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.

Serious Adverse Events and Non-Compliance

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.

Short Forms

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.

Prisoners

The CIRB is not constituted to review studies enrolling prisoners.

  • Studies enrolling prisoners must be reviewed by the convened Tufts MC/TUHS IRB.
  • If a study participant becomes a prisoner while participating in a research study, the study must be reviewed by the convened Tufts MC/TUHS IRB for the participant to remain in the study. (Check with the sponsor before submitting a CIRB study to the Tufts MC/TUHS IRB for convened IRB review to make sure the sponsor allows local IRB review).  

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).


PI Responsiblities

Division of Responsibilities (as described in the IRB Authorization Agreement)