POLICY
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. Continuing review allows the IRB to evaluate whether risks continue to be minimized and reasonable in relation to anticipated benefits, confirm that the study is being conducted as approved, review any new information that may affect the risk–benefit assessment or participants’ willingness to continue, and determine whether any changes or additional safeguards are needed.
Continuing Review is Required: Continuing review is required as long as the study is active or continues to meet the requirements for expedited review, which the convened IRB confirms at continuing review.
For FDA regulated research, continuing review is required until the study is closed.
Status Report is Required: Continuing review is no longer required when the only remaining activities qualify for expedited review under CPHS policy, or when the study has reached a point where it only involves: 1) Data analysis, including analysis of identifiable private information or identifiable biospecimens; or 2) Accessing follow up clinical data from procedures that subjects undergo as part of their regular clinical care.
When either of these conditions are met, continuing review will not be required, however, a status report will be required, which must be submitted every two years until study closure.
Continuing reivew is also not required for studies initially reviewed and approved by expedited review procedure do not require continuing review; however, a status report is required every two years to maintain appropriate oversight. Additionally, at the time of initial review, the expedited reviewer may require annual continuing review if it would enhance protection of research subjects.
In addition to continuing review requirements by the reviewing IRB, studies reviewed by an external IRB are required to submit a status report to the UTHealth Houston IRB via iRIS every two years until the study is closed.
PROCEDURE
Reminders for Continuing Review/Status Report Submission: IRB outcome letters state the expiration date at initial review and subsequent continuing reviews/status reports. Automatic email reminders are sent by iRIS to the Principal Investigator 90, 60 and 30 days prior to the IRB approval expiration date. Studies that were reviewed by expedited procedure and for studies that are under an external IRB oversight do not require continuing review, however a status report is required before the IRB approval expiration date.
Submission: The Principal Investigator must complete and submit a Continuing Review/Status Report from via iRIS. The submission should address the following:
- Number of participants accrued (if multi-site study, break down enrollment by site).
- 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 DSMB or Medical Monitor meetings/reports
- Confirmation of current personnel
- Confirmation of current CITI training for study personnel
- If CPHS serves as the IRB of record for external sites, a Relying Site Continuing Review/Status Report form is required for each relying site.
- 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. IRB staff will review the status of the required CITI Program human subjects training for study personnel. If any study personnel do not have current training, IRB staff will request the training completion certificate or ask that the study personnel be removed from the study until they have completed their training.
When Continuing Review is Required: Once adequate information is obtained, IRB staff will determine if the continuing review may be reviewed by expedited review (as stated in Category 9 of the Expedited Review policy) or Full Board review.
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 a member of the subcommittee that initially reviewed the research, if possible.
When Status Report is Required: For research initially reviewed by the expedited procedure or by an external IRB, the status report will be assigned for review by the IRB staff.
Review Process:
When Continuing Review is Required: 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.
When Status Report is Required: For research initially reviewed by expedited procedure or by an external IRB, if there are any areas of concern as listed above, IRB staff will assign the report for review by an IRB member.
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:
When Continuing Review is Required: 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 Review/Status Reports 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.
When Status Report is Required: IRB staff may accept the Status Report as informational or request clarification if any responses are unclear or contradictory. If there are areas of concern as described earlier in this policy, IRB staff will assign the report for expedited review by an IRB member. The IRB member may escalate the review to the convened IRB. For research initially reviewed by the expedited procedure or by an external IRB, IRB staff will issue an outcome letter and reset the date for the next status report.
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 review and approval of a Continuing Review/Status Report 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 IRB approval to the Principal Investigator, with the instructions that enrollment of subjects and all research related procedures must be stopped.
If currently enrolled participants may be at risk of harm if research procedures are stopped, the Principal Investigator must submit a written request specifying which research procedures need to continue, how many participants are impacted, and the reasons those procedures are necessary to prevent harm. This information must be provided via an IRB Change Request and Amendment form. The IRB Chair or designee may give permission for conditional continuation to ensure the safety and well-being of participants.
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.
REFERENCES
- 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
- Initial Review
- Expedited Review
- Continuing Review – Outcome Letter
- Form - Continuing Review/Status Report
- Form - Study Closure Report
If you find errors in this document, contact [email protected]
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Document Number: |
101-C04 |
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Document Name: |
Continuing Review |
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Reviewed by: |
Executive Director, Research Compliance |
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Effective: |
1 Aug 2008 |
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Revision History: |
1 Jan 2009, 1 Aug 2011, 1 Jun 2016, 19 July 2018, 1 Jun 2021, 1 Sept 2021, 1 Jun 2026 |
Please contact the IRB office for answers to questions, express concerns, and convey suggestions regarding human subjects protections.
IRB HELPLINE: 713-500-7943
iRIS HELPLINE: 713-500-7960
Email: [email protected]
IRB Review Feedback: IRB Survey
IRB OFFICE HOURS: Thursdays, 1–4pm via Teams Room
Committee for the Protection of Human Subjects
7000 Fannin St, Suite 1840Houston, Texas 77030
Phone: 713-500-7943
Fax: 713-500-7951
Email: [email protected]
Committee for the Protection of Human Subjects
IRIS Support: 713-500-7960
