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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 as of 19 July 2018; rather Administrative Annual Review is conducted if the following criteria apply (in chronological order): 

  1. Studies that are NOT regulated by the FDA
    NOTE: The US Food and Drug Administration (FDA) regulates clinical studies conducted on drugs, biologics, devices, diagnostics, and in some cases dietary supplements and food additives. If you are unsure if the study is FDA-regulated, contact the study sponsor or the IRB Office.NOTE: Studies subject to FDA regulations require a Continuing Review.
  2. Studies that are NOT receiving / have never received federal funding
  3. Studies that have received federal funding, and were initially approved as a new study after 21 January 2019
    NOTE: If a study received federal funding and was initially approved as a new study before 21 January 2019, a Continuing Review is required.
  4. The study is eligible for expedited review under categories 1 through 7 of the OHRP Expedited Review Categories
    NOTE: It may be that the study was reviewed under one or more of these categories, in which case, it will still be eligible for Administrative Annual Review as long as those categories are 1 through 7.
  5. Research that has advanced to involve one or both of the following:
    1. Data analysis, including analysis of identifiable private information or identifiable biospecimen, and/or
    2. Accessing follow-up clinical data from procedures that subject would undergo as part of clinical care; not specifically for research

 If your study meets the above criteria, you will complete an Administrative Annual Review submission by using the Form 5 at the time of Continuing Review. If your study is FDA-regulated, federally funded and was initially approved as a new study before 21 January 2019, or does not meet the above Administrative Annual Review criteria, a Continuing Review submission is required.

Reportable New Information and Amendments or Modifications to the approved research must be submitted to the IRB for review and approval regardless of whether Continuing Review applies.

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 or Administrative Annual Review, please submit the following documents electronically to the IRB Office and via hard copy with original ink signatures from the Principal Investigator to the IRB Office (Box 817; Tupper 1), by the Continuing Review deadline :

Open to Enrollment

  1. Form 5 (Continuing Review): Submit for all Continuing Reviews / Administrative Annual Reviews.
    NOTE:While completing Form 5, if you are notified your study is eligible for Administrative Annual Review, no additional documents are needed. Please sign the Administrative Annual Review Investigator Acknowledgment and submit it to the IRB Office.
  2. Form 2(Drug): Submit when the research includes testing the safety and/or efficacy of a drug or supplement. 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 copy of the previously submitted and 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): Serves as the study’s protocol for retrospective medical record/chart/electronic database/specimen review and databases created for research purposes.  When submitting a Form 7, there is no need for 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 (ICFs):
    1. Submit a copy of the last (most recent) lCF that has been signed by a subject. All identifiers should be redacted (i.e. blacked out) on this ICF prior to submission.
    2. If revisions are being made to the ICF with this Continuing Review, submit:
      • A tracked copy highlighting the changes, and
      • A clean, electronic Microsoft Word document version for validation upon study approval.
    3. Data Safety Monitoring Board (DSMB): If a DSMB exists for the study, submit a copy of the most recent DSMB/DMC and/or coordinating statistical center progress or annual report. 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.
      • If the DSMB/DMC has not met yet, submit the DSMB/DMC Charter.
    4. Subject Materials: Submit any materials that will be provided to, seen or heard by subjects (e.g. questionnaires, scripts, instruction sheet, etc.)
    5. Recruitment Materials: Submit all advertisements and recruitment material, such as flyers, recruitment e-mails or letters, newspaper advertisements, radio advertisements, social media postings, etc.

Research COI Form: Submit only if there have been changes in any research team member’s COI form(s) over the past year for existing research team members, or if you are adding a new research team member their COI form 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 only if there have been changes in any research team member’s COI form(s) over the past year or if you are adding a new research team member their COI form indicated a “YES” response in any field on the form.
  5. Form 2(Drug)
  6. Form 3(Device)
  7. Form 4 (Radiation)
  8. Form 6 (Tissue Banking)
  9. Subject Materials

Closed to Enrollment and in Data Analysis Only

  1. Form 5 (Continuing Review)
  2. Research COI FormSubmit only if there have been changes in any research team member’s COI form(s) over the past year or if you are adding a new research team member their COI form indicated a “YES” response in any field on the form.

Where Tufts Health Sciences IRB is the IRB of Record

  1. If Tufts Health Sciences IRB is the IRB of record for an external site(s) under a previously executed IRB Authorization Agreement (IAA), complete and submit a Form 5 for each external site. For guidance on how to complete a Form 5 for external sites, refer to How to Complete Form 5 for External Sites Under an IAA .
  2. If a new IAA request is being submitted, submit a completed Form 10,Amendment Cover Letter, as well as tracked and clean versions of any study documents that require revisions as a result of this request (i.e. Protocol).

For more information about Multisite Research, refer to the Single IRB Review for Multisite Research page on our website.

Additional Information

Where Tufts Health Sciences IRB is the IRB of Record

  1. If Tufts Health Sciences IRB is the IRB of record for an external site(s) under a previously executed IRB Authorization Agreement (IAA), complete and submit a Form 5 for each external site. For guidance on how to complete a Form 5 for external sites, refer to How to Complete Form 5 for External Sites Under an IAA .
  2. If a new IAA request is being submitted, submit a completed Form 10, Amendment Cover Letter, as well as tracked and clean versions of any study documents that require revisions as a result of this request (i.e. Protocol).

For more information about Multisite Research, refer to the Single IRB Review for Multisite Research page on our website.

Additional Information

Common Questions About Continuing Review (CR)/Administrative Annual Review (AAR)

1) How do I submit a continuing review (CR)/administrative annual review (AAR) submission?

All documents must be submitted in electronic form (via email at irboffice@tuftsmedicalcenter.org or flash drive) as well as a signed paper original to the IRB Office (15 Kneeland Street, Tupper 1) or by interoffice mail to Box #817. Be sure to submit the Informed Consent Form(s) in Microsoft Word document format.

In order to gain entrance to the IRB office, please press the buzzer on the left side of the doorway in front of 15 Kneeland St. For security reasons, it is required that you show your Tufts-issued ID.

2) When is the CR/AAR submission due for my study?

To find out when your study’s annual CR/AARs are due, please refer to our Continuing Review/Administrative Annual Review Submission Deadlines page.

If the IRB office does not receive a CR/AAR submission by the deadline, you might not receive IRB approval before the study’s expiration date. In the event that your study expires, all research activity must stop until IRB approval is granted.

3) Can the IRB send the CR/AAR notices to my study coordinator as well?

No. Unfortunately, the IRB can only send CR/AAR notices to the Principal Investigator (PI). The IRB is unable to send these notices to any other research team member(s) at this time.

The PI is encouraged to forward the notices to their study coordinator(s)/research team member(s) upon receipt to allow ample time to prepare the submission before the study’s deadline. It is also recommended that coordinators log the CR/AAR Submission Deadlines in your calendars and set reminders for each of the studies you work on to ensure timely submissions.

4) I want to amend my study, but the CR/AAR for my study is due. Can I submit an amendment along with my CR/AAR?

Yes, you can submit amendments with your CR/AAR submission. Please note that amendments will be reviewed at the time of CR/AAR (which can be as long as one month later than the time of submission). Therefore, if an amendment is urgent please communicate this to the IRB over the phone and include this in your Amendment Cover Letter. This way the amendment may be separated from the CR/AAR submission and processed independently.

5) I forgot to submit my CR/AAR and the IRB approval of my study has expired. Can I still conduct research activity on my study?

No, if IRB approval for your study has lapsed, you are no longer approved to conduct any research activity for this study. Research activities may not occur until IRB approval is granted. If you do have to conduct research (i.e. due to a subject safety issue), please let the IRB know as soon as possible.