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IRBchoice is a joint IRB review model for multisite studies that provides a mechanism for IRB review through the sharing of and reliance on IRB-approved documents among IRBs. IRBchoice is a tool for IRBs that allows IRBs to utilize the reviews of another IRB while still allowing the local institution to maintain oversight of the research.

In IRBchoice, a participating site may be either:

  • The Lead Site IRB (reviewing IRB – Tufts IRB will post their review for other sites to choice), or
  • A Local Oversight IRB (relying IRB – Tufts IRB will consider sharing the Lead Site’s IRB review)

Tufts Health Sciences IRB will decide whether IRBchoice may be used for your study.

To request the Tufts Health Sciences IRB to serve as the Lead Site IRB (reviewing IRB) for a new study, please submit the following:

  1. Cover letter requesting Tufts Health Sciences IRB serve as the Lead Site IRB (reviewing IRB) for the study through IRBchoice.
  2. Submit a complete new study submission, including the following, as applicable:
    1. Form 1
    2. Protocol
    3. Site-Specific Appendix
    4. Form 2 for any study drugs & supporting drug information
    5. Form 3 for any devices & supporting device information
    6. Form 4 for any research related radiation
    7. Form 6 for any tissue banking , i.e., unspecified future use of specimens
    8. A copy of the informed consent forms (ICFs) for the study. For studies that utilize and ICF, please submit the following:
    9. Questionnaires & handouts to be given to research subjects
    10. Recruitment material
    11. Grant documentation (the grant narrative for this research study)
    12. Research Conflict of Interest (COI) form for the Principal Investigator plus any research team member COI forms with a “YES” response.

o request that Tufts Health Sciences IRB be a Local Oversight IRB (relying IRB) and utilize a Lead Site’s IRB review for a study, please submit the following:

  1. A cover letter which requests the Tufts Health Sciences IRB act as a Local Oversight IRB (relying IRB) through IRBchoice, specifying the Lead Site IRB that has posted its review to IRBchoice.
  2. Tufts Health Sciences IRB forms, including the following, as applicable:
    1. Form 1
    2. Protocol
    3. Site-Specific Appendix
    4. Form 2 for any study drugs & supporting drug information
    5. Form 3 for any devices & supporting device information
    6. Form 4 for any research related radiation
    7. Form 6 for any tissue banking , i.e., unspecified future use of specimens
    8. A copy of the informed consent forms (ICFs) for the study. For studies that utilize and ICF, please submit the following:
    9. Questionnaires & handouts to be given to research subjects
    10. Recruitment material
    11. Grant documentation (the grant narrative for this research study)
    12. Research Conflict of Interest (COI) form for the Principal Investigator plus any research team member COI forms with a “YES” response.
  3. Informed consent forms (ICFs) for the study, modified based on the following template: IRBchoice ICF Template. Edit this template to include the Lead Site’s IRB ICF language in the noted fields.
  4. Submit 1 original paper copy plus the electronic documents on a flash drive or CD to the IRB office, Tupper 1 (or IRB Box 817). The paper copy can be double-sided.

Links to Tufts Health Sciences IRB Forms and Templates

Links to IRBchoice Resources