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Per federal regulations, an IRB must conduct continuing review of previously approved research at intervals appropriate to the degree of risk, but not less than once per year [21 CFR 56.108(a)(1) and 56.109(f)].

Depending on the type of research, continuing review may be performed by expedited review or by convened IRB review. Continuing Review is not required for studies that have been granted an exemption from IRB review.

Both the Office for Human Research Protection (OHRP) agency’s  10 November 2010 Guidance on IRB Continuing Review of Research and the Food and Drug Administration’s (FDA) February 2012 Guidance for IRB’s Clinical Investigators and Sponsors IRB Continuing Review after Clinical Investigation Approval have reiterated that the key issues to focus on at continuing review are:

  • Risk assessment and monitoring;
  • Adequacy of the process for obtaining informed consent;
  • Local issues/Investigator and institutional issues; and
  • Research progress.

Submission Requirements

If you are submitting a continuing review (for studies previously determined to be expedited or required review by the convened IRB)* please submit the following documents to the IRB office (Box 817; Tupper 1), as a hard copy (paper copy)** with original ink signatures:

Open to Enrollment

  1. Form 5 (Continuing Review): Submit for all continuing reviews.
  2. Form 2 (Drug): Submit when the research includes testing the safety and/or efficacy of a drug. Submit a copy of the Investigator’s Brochure and/or study drug information as applicable.
  3. Form 3 (Device): Submit when the research includes testing the safety and/or efficacy of a medical device. Submit a copy of the Operator’s Manual and/or Device Manual as applicable.
  4. Form 4 (Radiation): Submit when the research includes research-related radiation. Submit the most recent version reviewed and signed by the Radiation Safety Officer (This can be a previously submitted signed Form 4 if no changes have been made to research-related radiation).
  5. Form 6 (Tissue Banking): Submit when the research includes tissue banking, which is defined as storage of any specimens for unspecified future use. Submit a copy of the tissue bank’s policies or answer questions 14a –14d.
  6. Form 7 (Chart Review): Required for retrospective medical record/chart/electronic database/specimen review and databases created for research purposes.  When submitting a Form 7, there is no need to submit a separate protocol.
  7. Site-Specific Appendix: Submit if the protocol does not already contain site-specific details such as recruitment and consent (typically multi-center protocols are not tailored to this site).
  8. Protocol: Required at every continuing review except for studies that are closed to enrollment and conducting data analysis only.
  9. Informed Consent Forms:

Submit a copy of the last (most recent) lCF that has been signed by a subject. All identifiers should be blacked out on this ICF prior to submission.
Submit a clean, unvalidated copy of the ICF currently in use for new validation.  If any revisions are being made to the ICF with this continuing review, submit a tracked copy highlighting the changes and a clean/updated copy for validation.

If a DSMB exists for the study, submit a copy of sponsor’s, DSMB/DMC, and/or coordinating statistical center, progress report, or annual report, or DSMB/DMC report if available.  This report should include the following:

A statement indicating what information (for example, study-wide adverse events, interim findings, and any recent literature that may be relevant to the research) was reviewed;
The date of the review; and
An assessment of the information reviewed.

  1. Subject Materials: Submit any materials that will be provided to, seen or heard by subjects (e.g. questionnaires, scripts, instruction sheet, etc.)
  2. Recruitment Materials: Submit all advertisements and recruitment material, such as flyers, recruitment e-mails or letters, newspaper advertisements, radio advertisements, social media postings, etc.
  3. Tufts MC Clinical Research Recruitment Website form: Submit for all Tufts MC studies that utilize an Informed Consent Form. This is a Tufts MC institutional requirement and must be submitted in order to receive IRB approval.  The form for posting studies on this recruitment website is optional for Tufts University studies.
  4. Research COI form: Submit the completed PI’s research COI form as well as COI forms from research team members who have indicated a “YES” response in any field on the form. 

Closed to Enrollment

  1. Form 5 (Continuing Review)
  2. Protocol
  3. Site-Specific Appendix
  4. Research COI form

Submit applicable additional documents if subjects are still participating in active study intervention:

  1. Form 2 (Drug)
  2. Form 3 (Device)
  3. Form 4 (Radiation)
  4. Form 6 (Tissue Banking)
  5. Subject Materials

Closed to Enrollment and in Data Analysis Only

Where Tufts Health Sciences IRB is the IRB of Record

IRB Authorization Agreement (IAA)

  1. If a continuing review for a study with a previously executed IAA is being submitted, a Form 5 should be completed for each site and submitted with this continuing review.
  2. If an IAA request is being submitted with this continuing review, submit a completed Form 10 with this continuing review.