Research studies initially reviewed and approved by the convened IRB must be reviewed and approved at intervals appropriate to the degree of risk, but not less than once per year. The determination of the period of approval is made at the time of initial review or previous continuing review. Continuing review is required as long as the research remains active.
For studies initially reviewed by a convened IRB, continuing review will no longer be required when the activities that remain for the study are eligible for review by expedited procedure in accordance with CPHS policy on expedited review; or research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
- Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
For research studies initially reviewed and approved by expedited review, continuing review is not required, unless the IRB reviewer determines that continuing review would enhance protection of research subjects.
Reminders for Continuing Review Submission: IRB outcome letters state the expiration date at initial review and subsequent continuing reviews. Automatic email reminders are sent by iRIS to the Principal Investigator 120, 90, 60 and 30 days prior to the expiration date. For studies that do not require continuing review, outcome letters will not have an expiration date. However, a letter will be sent before the one year anniversary date to remind Principal Investigators to request an update on the study status and remind them to submit to the IRB any protocol amendments, adverse events, protocol deviations, personnel changes, conflicts of interest, and any other type of reporting.
Submission – The Principal Investigator must complete and submit a Continuing Review Application via iRIS. The Continuing Review Application should include:
The status report on the progress of the research includes:
- Number of participants accrued.
- A summary since the last IRB review of:
- Adverse events, untoward events, and adverse outcomes experienced by participants.
- Unanticipated problems involving risks to participants or others.
- Participant withdrawals.
- The reasons for withdrawals.
- Complaints about the research.
- Amendments or modifications.
- Any relevant recent literature.
- Any interim findings.
- Any relevant multi-center trial reports.
- The researcher’s current risk-potential benefit assessment based on study results.
- Relevant study related documents, including but not limited to, reprints of articles, deviation log, etc.
- Any other documentation that CPHS may request.
Assigning for Review –IRB staff will screen the submission to assess if the information is adequate. If the information is not adequate, IRB staff will request additional information from the Principal Investigator. Once adequate information is obtained, IRB staff will determine if the continuing review may be reviewed by expedited review or Full Board review.
Research studies reviewed by expedited procedure do not require continuing review. The expedited reviewer may require continuing review if it would enhance protection of research subjects. If continuing review is required for these studies, the expedited reviewer must explicitly justify and document why continuing review would enhance protection of research subjects. IRB staff will assign the continuing review to the same reviewer that initially reviewed the proposal, if possible. If the reviewer determines that the continuing review does not qualify for expedited review, the IRB staff will assign the submission for Full Board review.
For research initially reviewed and approved at a convened IRB, IRB staff will schedule the continuing review for the next available Full Board meeting of the same IRB panel that initially reviewed the research project. IRB staff shall assign the submission to the chair of the subcommittee that initially reviewed the research. If the chair is not available, IRB staff will assign it to one of the other subcommittee members or another IRB member.
Review Process - IRB members, including the assigned reviewer, have access to the continuing review submission and all study documents previously submitted and approved. All members are expected to review at least the continuing review submission.
When conducting continuing review, the IRB starts with the working presumption that the research, as previously approved, satisfies all of the criteria for approval. The IRB review focuses on whether there is any new information provided by the investigator, or otherwise available to the IRB, that would alter the IRB’s prior determinations, particularly with respect to the IRB’s prior evaluation of the potential benefits or risks to the subjects. The IRB also assesses whether there is any new information that would necessitate revision of the protocol and/or the informed consent document. When conducting continuing review and evaluating whether research continues to satisfy the criteria for IRB approval of research, the IRB review will pay particular attention to the following four aspects of the research:
- Risk assessment and monitoring;
- Adequacy of the process for obtaining informed consent;
- Investigator and institutional issues; and
- Research progress.
When the study is part of a multi-center trial or when a study subject to oversight by a DSMB, the CPHS may rely on a current statement from the DSMB or sponsor indicating that it has reviewed study-wide adverse events, interim findings, and any recent literature that may be relevant to the research.
Verification from Other Sources: CPHS may determine that the study needs verification from sources other than the investigators that no material changes had occurred since previous CPHS review. CPHS may seek verification from sponsor, study coordinator, monitoring by Clinical Research Monitor, external audit etc. Some of the situations where verification could be considered appropriate are:
- Investigators who do not have a proven track record,
- Investigators who have had problems in the past,
- Studies that have complex designs,
- Phase I studies,
- Investigator initiated clinical trials,
- Research involving high risks to subjects;
- Particularly complicated procedures or interventions;
- Potentially vulnerable populations;
- Study staff with minimal experience in administering consent to potential subjects; or
- Other situations where CPHS has concerns.
Possible Outcome of Review – CPHS may decide to approve, approve pending, defer, disapprove or table the continuing review as per policy and procedure Initial Review. For continuing reviews approved by the Full Board, the approval date is the date of the meeting. For continuing reviews approved by expedited review, the date of approval is the date of the review. CPHS may approve the research for a period of one year or less as described in the policy and procedure Initial Review.
Communication of Outcome: IRB staff will notify the Principal Investigator of the outcome of review via iRIS in a timely manner. IRB staff will include a list of continuing reviews approved by expedited review in the agenda for the next Full Board meeting.
Expired Study - When continuing review of a research protocol does not occur prior to the end of the approval period specified by the CPHS, CPHS approval expires automatically. There is no grace period extending the conduct of the research beyond the expiration date of CPHS approval. Expiration of CPHS approval for the research will not be reported to OHRP as a suspension of CPHS approval.
After the date of expiration, the IRB staff will send a formal notice of termination of the study approval to the Principal Investigator, with the instructions that enrollment of subjects and all research related procedures must be stopped.
If the safety and wellbeing of the patients already enrolled in the study would be compromised by stopping study procedures, the Principal Investigator must contact executive chair or designee. The executive chair or designee may give permission for continuation and instruct the Principal Investigator to submit continuing review documents. IRB staff will place the research study for CPHS review at the next available meeting.
Study Completion: When a study is completed, the PI should submit study completion reports within 30 days after completion of the study. Completion reports should be submitted using the Study Closure Report.
IRB staff will review the Study Completion report and obtain any outstanding information or documentation from the Principal Investigator. If there are inconsistencies or if clarification is needed, IRB staff will request for additional information.
IRB staff will review the records to ensure all documentation is complete and indicate that the study has been completed on the Study File in iRIS.
- 45 CFR 46 Protection of Human Subjects
- 21 CFR 50 Protection of Human Subjects
- OHRP Guidance on Continuing Review
- FDA Information Sheet: Continuing Review After Study Approval
REFERENCES TO POLICIES AND PROCEDURES
- Initial Review
- Expedited Review
- Continuing Review Form
- Continuing Review – Approval Letter
- Continuing Review – Approval Pending Letter
- Continuing Review – Expired Letter
- Study Closure Report
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Executive Director, Research Compliance
1 Aug 2008
1 Jan 2009, 1 Aug 2011, 1 Jun 2016, 19 July 2018, 1 Jun 2021, 1 Sept 2021
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