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Social, Behavioral & Educational Research (SBER) Institutional Review Board (IRB)

Continuing Review of Human Subject Research Studies

The Tufts University Social, Behavioral & Educational Research Institutional Review Board (SBER IRB) approves all human subject research studies conducted by faculty and students based on the Medford/Somerville campus. All studies that have been approved through expedited or full review are required to undergo a Continuing Review by the SBER 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 a gap. Please see the IRB office contact hyperlink at the end of this article.

What materials must be submitted to the SBER IRB for the Continuing Review?

  1. Continuing Review Form

    • Complete all sections.

    • Please note:

      • Section II. Current Status of Human Participant Use

        • If you check either of the first two boxes indicating that participant use is ongoing, please also respond to the question concerning consent forms marked by an asterisk (*).

        • If you check the last category indicating that participant use is completed, please provide the date the intervention was completed. This does not close the study but signifies that all human subject enrollment and research have been completed and only data analysis continues.

      • Section V. Participant Numbers and Site Summary

        • A) For each site, please provide the number of participants run since the date of the initial approval or the date of the last Continuing Review (whichever is most recent) and the total number run since the study began.

        • B) For each site, please provide the number of participants approved for that site. Also provide the number of additional participants requested (zero if no increase is requested), the site totals, the study total, and a rationale for any requested increase. If the only protocol modification requested is a change in the number of participants, you do not need to submit a Request for Protocol Modification Form.

        • If you aren’t sure about any of these numbers, please contact the IRB office before you submit.

      • Section VI. Protocol Modification

        • If you plan to request a protocol modification in conjunction with the Continuing Review (other than a change in the number of participants), please check “Yes” and include the Request for Protocol Modification Form with your Continuing Review submission documents.

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

    • Please submit an unstamped “clean” copy of the most recently approved version of all study documents submitted for your initial review, such as consent forms, surveys, advertising materials, recruitment materials, and letters. 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.

    • Please use the same file name and title as used on the initially submitted document. It may be helpful to include version dates.

    • The PI needs to sign all SBER IRB forms. Electronic signatures provided through the PI’s Tufts email account are acceptable. If the PI will not be available to sign completed forms, he or she should contact the SBER IRB office for advice on providing a signature in his or her absence.

    • Please submit one hardcopy of the original Continuing Review application; double-sided printing is fine but please do not staple your application.

    • It is OK to submit revised documents during your Continuing Review. Please track all changes and include the Request for Protocol Modification Form.

When must materials be submitted to the SBER IRB for Continuing Review?

The Continuing Review submission due date is six weeks before expiration of the initial IRB approval (noted on the IRB approval letter). Please submit your Continuing Review documents before the due date to ensure prompt review of your study. The SBER IRB office will send a reminder notice to the PI and study coordinator two months before the expiration date. The PI should forward the reminder to all members of the research team. The SBER IRB office strongly suggests that people involved in the Continuing Review submission create a reminder in their own calendars.

Please note: If you don’t submit all Continuing Review materials by the submission due date, the SBER IRB cannot guarantee that your IRB approval will be completed by the expiration 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 include on the Continuing Review Form agrees with the number previously approved.

  • Do not enroll more subjects than have been approved by the SBER 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.

  • Include copies of all translated materials for review and stamping as well.

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

  • Follow the SBER IRB adverse event and unanticipated problem reporting policy throughout the year.

  • Respond as quickly as you can to SBER IRB requests for information.

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

The staff of the SBER IRB office welcomes calls and emails from researchers requesting assistance with all aspects of the IRB process. Please call the office at (617) 627-3417 or email sber@tufts.edu and request an appointment to speak with an SBER IRB staff member.

For more information, please see the Tufts SBER IRB website at http://www.tufts.edu/central/research/IRB.

 

 

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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