CONTINUING REVIEW CRITERIA FOR RENEWAL

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1 1. POLICY Steering Committee approved / Effective Date: 9/2/19/19/11 The IRB conducts continuing review of research taking place within its jurisdiction at intervals appropriate to the degree of risk, but not less than once per year. HHS and FDA regulations set forth the criteria for IRB approval of research (See SOP 402). These criteria apply to both initial review and continuing review of research and provide the framework for the IRB s evaluation of research. In order to re-approve research at the time of continuing review, the IRB must determine that all requirements are satisfied, as outlined by this policy. When conducting continuing review, the IRB starts with the presumption that the research, as previously approved, continues to satisfy all of the criteria for approval. At the point of continuing review, the IRB focuses on whether there is any new information provided by the investigator, or otherwise available to the IRB, that alters the IRB s prior determinations relative to the approval criteria, particularly with respect to the evaluation of the potential benefits or risks to the subjects. The IRB assesses whether there is any new information that would necessitate revision of the protocol and/or the informed consent document. The Aurora IRB has the authority to disapprove or require modifications in (to secure re-approval of) a research activity that they determine no longer meets the regulatory criteria for approval. If research does not satisfy all of the regulatory criteria for approval, the IRB must require changes that would result in research satisfying these criteria, defer taking action, or disapprove the research. Specific Policies Terms used in this policy, but not defined herein shall have the meanings set forth in the Glossary Interval for Review for Purposes of Renewal The IRB must conduct continuing review of protocols for purposes of renewal of the IRB approval period, at intervals appropriate to the degree of risk. The IRB determines the interval for review, which may not be less than once per year., at the time of initial and continuing review. This period is communicated to the Investigator in the approval letter or the approved continuing review form. Investigators are required to submit a periodic reportcontinuing review application (see form RR 404-A) prior to the expiration of the study or as requested by the IRB, but at least annually Expiration of Approval Period Page 1 of 7

2 There is no grace period extending the conduct of the research beyond the expiration date of IRB approval. Aurora IRB Policy RR 402 (section 1.) explains how the approval period is determined. Extensions beyond the expiration date will not be granted. If Continuing Review Report forms and/or other requested progress reports are not received as scheduled, or, for other reasonsand the IRB s review completed prior to study approval expiration date, the IRB review process is not completed by the expiration date, the Investigator must stop all research activities including recruitment, advertisement, enrollment, consent, interventions, interactions, data collection, and data analysis until reports are reviewed and approved. If the iinvestigator is actively pursuing renewal with the IRB at the time of approval lapse, and the IRB believes that it is in the best interest of individual subjects to continue participating in the research interventions or interactions, the IRB may permit the study to continue for the brief time required to complete the review process. The IRB s decision will be communicated to the investigator and appropriate institutional officials via letter (RR 404-E). However, no new subjects may be enrolled. Prospective research data cannot be collected, and no procedures that are being conducted solely for the purposes of the protocol with no benefit to the subjects may be performed until a Continuing Review Report or other progress report is reviewed and approved Criteria for Renewal See section 1.2. of PolicySOP RR 402 for the criteria for approval. Each protocol due for continuing review will receive an initial review by a Research Compliance Analyst (a voting member of the IRB) acting as the Primary Reviewer. The Research Compliance Analyst will perform an initial assessment of the continuing review. If, in the opinion of the Research Compliance Analyst, the risk associated with the study has changed since the previous IRB review and approval or there is new information that could affect subject safety, the continuing review form and any other pertinent materials are sent to an IRB Reviewer member with specific expertise the initial study Primary Reviewer if available Continuing IRB review is required as long as the study is open to enrollment, subjects are receiving research interventions, and/or individually identifiable follow-up data from subjects are collected or analyzed on subjects enrolled in all protocols. This remains the case even after a protocol has been closed to enrollment at all sites and protocol-related treatment research intervention has been completed for all subjects. In these circumstances, these renewal requests may qualify for expedited review Continuing review of DSMB-monitored clinical trials being monitoringed by Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC): When a clinical trial is subject to monitoring oversight by a DSMB whose responsibilities include review of adverse events, interim findings and relevant literature (e.g., DSMBs operating in accordance Page 2 of 7

3 with the National Cancer Institute Policy for Data and Safety Monitoring of Clinical TrialsFDA s Guidance for Clinical Trial Sponsors Establishment and Operation of Clinical Trial Data Monitoring Committees), the IRB conducting continuing review may rely on a current statement from the DSMB indicating what information was reviewed by the DSMB (e.g., study-wide adverse events, interim findings and any recent literature that may be relevant to the research), the date of review, and the DSMB s assessment of the information reviewed, in lieu of requiring that information about external adverse events be submitted directly to the IRB. However, the IRB must still receive and review reports of local Unanticipated Problems Involving Risks to Subjects or Others and any other information needed to ensure that its continuing review is substantive and meaningful Continuing Review report: For studies receiving full committeerequiring convened IRB continuing review, all IRB members shall receive a copy of the Continuing Review Report form and any additional documentation (including the current informed consent document if applicable) submitted by the Investigator. Additional information (for example, the complete protocol, relevant significant new findings, minutes of the initial review) is available to any IRB member who requests it before or during the IRB meeting., and tthe complete protocol (including previously approved modifications) is reviewed by at least one IRB member Primary Reviewer Criteria for review more often than annually: Studies undergoing continuing review may be reviewed by the IRB more frequently than annually if determined by the IRB. The criteria established for more frequent review are the same as those indicated for initial review (see SOP 402). In addition, the IRB may request more frequent reviewthe study is high risk, if the IRB feels that the study population is especially vulnerable, if the continuing review application indicates previous similar studies indicate a high incidence of adverse eventsunanticipated problems, violations or instances of noncompliance, or if the IRB feels that close monitoring is indicated. The IRB may request interim reports at intervals deemed appropriate by the IRB in addition to the required more frequent continuing review. The determinations will be made at the fully by the convened IRB meeting and documented in the minutes Possible Outcomes of Continuing Review As an outcome of continuing review, the IRB may require that the research be modified or halted altogether. The IRB may impose special precautions or relax special requirements it had previously imposed on the research protocol. At the discretion of the IRB, failure to notify the IRB (within time frames established in Aurora IRB SOP RR 403these policies) of: Page 3 of 7

4 changes in approved research prior to implementation of such changes, except where necessary to eliminate apparent immediate hazards to human subjects; reportable local adverse events and unanticipated problems; reportable significant protocol deviations/violations; and/or other actions deemed to be in violation of federal regulations or the Aurora policies and procedures; may result in action to suspend research activities (see Aurora policy SOP RR 407). and review in accordance with the Noncompliance policy (Policy SOP CO 601). 1.. Expedited Review for Renewal A protocol that was originally reviewed using the expedited review procedure (see Policy SOP RR 401) may receive expedited its continuing review on an expedited basis. Additionally, an expedited review procedure may be used for the continuing review of research previously approved by the IRB at a convened meeting provided it meets established criteria under Expedited Review Category (8) a protocol that received initial full committee review and approval and: 1) is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, and sis active only for long-term follow-up of subjects; 2) where no subjects have been enrolled and no additional risks have been identified; or 3) where the remaining research activities are limited to data analysis may be reviewed using an expedited review. In addition, continuing review may be expedited when the research is neither conducted under an IND or an IDE and no other expedited review category applies but the IRB has determined and documented at a convened IRB meeting that the research involves no more than minimal risk and no additional risks have been identified (Expedited Review Category 9). When conducting research under an expedited review procedure, the IRB Chair or designated IRB member conducts the review on behalf of the convened full IRB using the same regulatory criteria for approvalrenewal as stated in section 1.3 of this policy. If the reviewer feels that there has been a change to the risks or benefits, he or she may refer the study to the full convened IRB for review Verification by Third Party At the time of continuing review, the IRB has the authority to determine that a particular study needs verification from sources other than the investigator that no material changes in the research have occurred since the previous IRB review [21 CFR 6.108(a)(2)]. may require verification from sources other than the investigator that no material changes have occurred since previous IRB review. The need to verify any information will be determined by the Page 4 of 7

5 convened IRB and be documented in the meeting minutes. The purpose of the verification will be to provide necessary additional protections to subjects when deemed appropriate by the IRB. See SOP 402 for the types of studies that may require third party verification and who may review this material. Results of the verification will be reported to the IRB as necessary. Third-party verification may be required for studies such as the following: Studies that involve a potential high risk to subjects, Studies that involve vulnerable populations, Studies that involve large numbers of subjects, or Studies conducted by an investigator who has had incidences of Serious or Continuing noncompliance. The information provided by the investigator is inconsistent with other information known to the IRB and the inconsistency cannot be resolved through communication with the investigator. The IRB has concerns about the accuracy or integrity of the information submitted or has reason to believe the investigator/study staff has submitted inaccurate information The IRB has concerns about the manner in which the study will be or is being conducted. Any other reason where the IRB believes verification should be required. Projects that have been determined to need third -party verification will have such verification performed by the RSPP staff or Research Quality Assurance Specialist. Results of the verification will be reported to the IRB as necessary. The IRB has the authority to determine that a particular study needs verification from sources other than the investigator that no material changes in the research have occurred since the previous IRB review [21 CFR 6.108(a)(2)]. The IRB may consult sponsors, consultants, regulatory agencies, etc. regarding a study in order to determine whether the IRB should approve, modify, halt or place conditions or requirements on the study or investigator in order to ensure the safety of human subjects Notification of approval expiration due to nonsubmittal of continuing review application or lack of IRB continuing reviewnotification of IRB Action Page of 7

6 Per OHRP guidance, when continuing review of a research study does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. OHRP does not consider such an expiration of IRB approval to be a suspension or termination of IRB approval. Therefor not external reporting (per SOP 408) on the part of the Aurora IRB is necessary. However, Iinvestigators will be notified in writing as soon as possible as to action taken by the Aurora IRB with regard to the expiration of research approval. for any continuing reviews, including, but not limited to any suspensions or terminations of approved studies (see SOP RR 407), or special conditions placed on the study or enrollment. If the research has been suspended or terminated by the Aurora IRB, the external reporting policy (SOP RR 408) will be followed for notifying other entities. 2. SCOPE These policies and procedures apply to all research submitted for continuing review. 3. APPLICABLE REGULATIONS, GUIDELINES AND STANDARDS 21 CFR 6.108, CFR , CFR 6.108(a)(2) 4 CFR (b)(4)] OHRP Guidance on IRB Continuing Review of Research (January 1, 2007November 10, 2010) FDA Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval (February 2012) 63 Fed. Reg (Nov. 9, 1998) AAHRPP Elements II.2.D.2. and II.2.E REFERENCES TO OTHER APPLICABLE SOPS SOP 401 Page 6 of 7

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