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New Simplified Continuing Review Process

The Tufts Medical Center/Tufts University Health Sciences Institutional Review Board (Tufts MC/TUHS IRB) approves all human subject research studies conducted by faculty and students based on the Boston and Grafton campuses. All studies that have been approved through expedited or full review are required to undergo a Continuing Review by the IRB at least once per year. IRB office staff are available to assist researchers in preparing for their Continuing Review so that research involving human subjects can continue without gaps. Please see the hyperlink at the end of this article for IRB office drop-in hours and staff contact information.

What materials must be submitted to the Tufts MC/TUHS IRB for Continuing Review?

  1. Form V: Continuing Review

    • If your study will continue human subject enrollment and/or research during the new approval period, please complete all sections.

    • If your study has completed human subject enrollment and/or research with no problems to report, and only data analysis continues, please complete sections A. Demographics, B. Current Funding Sources, C. Conflict of Interest (COI), and D. Study Current Status. Please also submit a research COI form for the PI. No other IRB forms or study documents are required.

  2. IRB forms and study documents that had been submitted during the initial review

    • In general, all IRB forms that had been submitted for your initial review (except for Form I, which is only required for new studies) should be submitted during the Continuing Review.

    • In general, all documents that had been submitted for your initial review, such as consent forms, surveys, advertising materials, recruitment materials, and letters, should be submitted during the Continuing Review. If subject enrollment in your study has closed, informed consent forms and recruitment materials that are no longer being used do not need to be submitted.

    • It is OK to submit revised documents during your Continuing Review. Please track all changes.

    • Please submit the most recently approved version of each required document.

    • Please use the same file name and title on the document that was used when it was submitted initially and include version dates on all documents. Please note: Version dates should not be revised unless you are submitting a revision to the document.

    • The PI needs to sign the cover letter and all Tufts MC/TUHS IRB forms. If the PI will not be available to sign completed forms, he or she should submit a letter to the Tufts MC/TUHS IRB formally designating a co-investigator to sign in his or her absence.

    • Please submit one hardcopy of the original Continuing Review Application; double-sided printing is fine.

When must materials be submitted to the Tufts MC/TUHS IRB for Continuing Review?

The Continuing Review submission due date is the last business day of the month that is two months before the anniversary of the initial IRB approval date. For example, if your approval anniversary date is any day in November, your Continuing Review submission due date is the last business day of September. Please submit your Continuing Review forms and documents before the due date to ensure prompt review of your study. The Tufts MC/TUHS IRB will send a reminder to the PI on the first business day of the month the Continuing Review submission is due. The PI should forward the reminder to the study coordinator and any other people involved in the Continuing Review submission. The Tufts MC/TUHS IRB office strongly suggests that people involved in the Continuing Review submission create a reminder in their own calendars.

IRB Approval
Anniversary Date
(any day in)

Continuing Review
Submission Due Date

(last business day of)
January November (previous year)
February December (previous year)
March January
April February
May March
June April
July May
August June
September July
October August
November September
December October

Please note: If you don’t submit all Continuing Review materials by the submission due date, the Tufts MC/TUHS IRB cannot guarantee that your IRB approval will be completed by the anniversary date. Without IRB approval, all human subject research must stop. The federal government mandates that research cannot continue without current IRB approval.

Tips for a Timely Continuing Review

  • Submit your Continuing Review application by the due date.

  • Refer to the most recently approved protocol when filling out the Continuing Review Form. Ensure that the number of participants approved for each site that you included on the Continuing Review Form agrees with the number previously approved.

  • Do not enroll more subjects than have been approved by the Tufts MC/TUHS IRB. You may request an increase in enrollment at any time during the study or at Continuing Review.

  • When enrolling subjects, use a copy of the IRB-approved Informed Consent Form (ICF) that contains the IRB validation dates. You may request approval of a revised ICF at any time during the study or at Continuing Review. All changes to the ICF must be reviewed and approved by the IRB prior to use.

  • Ensure that all research team members are up-to-date on mandatory human subject research education requirements.

  • Follow the Tufts MC/TUHS IRB serious adverse event and unanticipated problem reporting policy throughout the year. Provide a summary of all serious adverse events and clinically significant adverse events with your Continuing Review submission. You should also submit any Data and Safety Monitoring Board (DSMB) reports or study status summary reports you have available.

  • Respond as quickly as you can to Tufts MC/TUHS IRB requests for information.

How can I get help with preparing my Continuing Review submission?

The staff of the Tufts MC/TUHS IRB office welcome calls and emails from researchers requesting assistance with all aspects of the IRB process.

  • IRB Drop-In Hours:
    Stop by during the new drop-in hours every Tuesday from 2 to 4 PM. The Tufts MC/TUHS IRB office is located on the first floor of 15 Kneeland Street (Tupper Building) in Boston. If you do not have a pass card to open the door, call the Tufts MC/TUHS IRB office at (617) 636-7512 and staff will buzz you in.
  • Contact us:
    Call the office at (617) 636-7512 and make an appointment to speak with a continuing review coordinator.
    Email or call one of the continuing review coordinators:
    • Christine Choy, cchoy1@tuftsmedicalcenter.org, (617) 636-3310
    • Andrew Simon, asimon1@tuftsmedicalcenter.org, (617) 636-3261

For more information, please see the Tufts MC/TUHS IRB website at http://viceprovost.tufts.edu/HSCIRB.

 

 

Tufts University, Office of the Vice Provost for Research
Health Sciences Campus: (617) 636-6550
Medford/Somerville Campus: (617) 627-3417
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