eIRB Submission Forms

• SBER IRB Study Submission Checklist 
  This tool can be used as a study document checklist when preparing new studies or making changes to existing studies. You are NOT required to submit this to the IRB.
   
• Not Research/Not Human Subjects Research (NR/NHSR) Determination Request Form 
  If you believe that your project does not meet the regulatory definition of “research” or does not involve “human subjects”, use this form to request a formal Not Research or Not Human Subjects Research Determination from the IRB. 
   
• SBER IRB Protocol Template
  Required for all new human subjects research applications, regardless of the required level of review (Exempt, Expedited, or Full IRB review)
   
• SBER IRB Reliance Agreement Request Form
  Required when requesting that Tufts serve as the reviewing IRB for another site (multi-site/collaborative study) or to request that Tufts cede review to another IRB (external IRB study). For expedited and full review studies only.
  - Submit whether Smart IRB or an IRB Authorization Agreement will be used to document reliance

• SBER IRB Individual Investigators Agreement (IIA)
  A signed IIA is required for all investigators who are not Tufts faculty, staff or students, unless an IRB reliance agreement is in place.

• SBER IRB Research Financial Interest Disclosure Form (RFID)
  All research team members must complete the RFID form, and the PI must retain these in their research records. Any RFID form with a "Yes" response to any item in Section B must be submitted to the IRB.
   
• SBER IRB Certificate of Translation
  The Principal Investigator is responsible for the accurate translation of all study documents and use of IRB-approved translated documents only, as noted below.

  Exempt studies: This form is not required for Exempt studies, as translated study documents do not require IRB review or approval when the study is determined to be Exempt.

  Expedited or Full Board studies: Translated study documents must be reviewed and approved by the IRB prior to use.

  • Submit this certificate along with translated study documents for approval and stamping prior to use.
  • The person certifying the translations cannot be on the research team.
  • Research team members can translate the study documents, however, someone outside of the study team must verify and attest to their accuracy by signing the Certificate of Translation.
• Tufts University GDPR Research Questionnaire

eIRB System Request Forms

• Institutional Profile and pSite PI Request Form
  These forms can be used to add an Institutional Profile and/or a pSite PI to the eIRB system, if they are not already listed. These are required when submitting “external IRB” or pSite submission for multi-site studies.
• New or Edit Sponsor Request Form
  This form can be used to add or edit a funding source in the eIRB system.

Other IRB Forms

These forms must be submitted to sber@tufts.edu, not eIRB.

Consent Templates

Modification & Continuing Review Forms - Pre-2019 Studies Only

The following five forms should only be used for continuing reviews and modifications of studies first submitted on an IRB Protocol Application form. Do not use these for new studies.