Subject: Continuing Review

Procedure:

1. Principal Investigator (PI) Responsibilities.
   1. The PI shall submit all information required for continuing review.
      1. Submission to the IRB indicates the PI is in agreement with all the information being presented for continuing review as the most current and accurate information regarding the status of the study.
   2. The PI shall submit the Continuing Review Report and all continuing review documents a minimum of 14 days prior to the expiration date to allow adequate time for IRB review and to avoid any unnecessary delays.
   3. The PI Continuing Review Report shall include, as applicable:
      1. The number of subjects accrued;
      2. A narrative summary of any problems (UPIRTSO and Non-UPIRTSOs). In many cases, such a summary could be a simple brief statement that there have been no UPIRTSO’s and that non-UPIRTSO’s have occurred at the expected frequency and level of severity as documented in the research protocol, the consent form, and any investigator brochure;
      3. A summary of any withdrawal of subjects from the research since the last IRB review;
      4. A summary of any complaints about the research since the last IRB review;
      5. A summary of any recent literature that may be relevant to the research and any modifications to the research since the last IRB review;
      6. Any relevant multi-center trial reports;
      7. Any other relevant information, especially information about risks associated with the research; and
      8. A copy of the current consent form and any newly proposed consent form.
   4. If IRB approval expires, the PI shall cease all research activities and proceed in accordance with IRB Procedure III.I.2.^[1]
2. IRB Committee Responsibilities.
   1. The IRB will review and determine whether each research study meets the criteria for approval of research as set forth in IRB Policy III.F ^[2]. These criteria apply to all research studies that require continuing IRB approval, including those requiring full committee review and those eligible for expedited review.
   2. The IRB will conduct continuing review at the full committee if the research activity was originally approved by a full committee unless:
      1. The study has been modified and is now eligible for expedited review as defined in the regulations (e.g., change in risk to minimal); or
      2. The study meets one of the following expedited review criteria:
         1. The research is permanently closed to the enrollment of new subjects; and All subjects have completed all research-related interventions; and The research remains active only for long-term follow-up of subjects; or
         2. No subjects have ever been enrolled at any site and no additional risks have been identified; or
         3. The remaining research activities are limited to data analysis.
   3. The IRB will conduct continuing review at the full committee if the research activity was originally reviewed or had previously met criteria for expedited review, if the research activity no longer meets the criteria for Expedited Review.
   4. The IRB will review the currently approved consent form to assure that the information is still accurate and complete. Any significant new findings that may relate to the subject’s willingness to continue participation will be provided to the subject in an updated consent form.
   5. The IRB may determine that it needs verification from sources other than the PI that no material changes have occurred since the previous IRB review, and may request an independent assessment of information or data provided in the renewal application. The IRB may determine that material changes have occurred if the information indicates that the risk/benefit ratio of the study has changed.
   6. The IRB will determine the appropriate interval for continuing review each time it reviews the research activity, by taking into consideration the following factors:
      1. Involvement of vulnerable populations;
      2. Research conducted internationally;
      3. Involvement of recombinant DNA or other types of gene transfer protocols;
      4. Use of waiver of informed consent procedures, (e.g. surrogate consent);
      5. Research for which subjects would be exposed to additional risks, e.g. breach of confidentiality, phase I studies, disproportionate number or severity of adverse events;
      6. Previous administrative holds or suspensions of the research and/or PI due to compliance, record-keeping or other concerns; and/or
      7. Recommendations from other Institutional Committees (e.g., Radiation Safety Committee; Conflict of Interest Committee).
   7. If IRB approval expires, the PI shall cease all research activities and proceed in accordance with IRB Procedure III.I.2. ¹
3. IRB Specialist Responsibilities.
   1. Upon receipt, the Specialist will determine the type of review for which the research is eligible as set forth in IRB Policies III.D^[3] and III.E ^[4] within two working days and will assign it to the next available agenda.
   2. The Specialist will record the discussions, determinations and motions of the IRB meetings and will provide written notification to the Investigator of the IRB’s determinations.
   3. The Specialist will ensure that all relevant information has been entered into the IRB database in an accurate and timely manner.
   4. The Specialist will ensure that all IRB approved documents are provided to the Investigator in an accurate and timely manner.

^[1] IRB Procedure III.I.2

^[2] IRB Policy III.F

^[3] IRB Policy III.D

^[4] IRB Policy III.E