Non exempt human subjects research that has been reviewed and approved by the CPHS 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 including recruitment, enrollment, participant follow-up, and analysis of identifiable data.
Reminders for Continuing Review Submission: The ORSC Staff informs the Principal Investigator of the expiration date within the approval letter for 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.
Submission – The Principal Investigator must complete and submit a Continuing Review Form via iRIS. In addition, the Principal Investigator must also submit:
· Revised copy of "Authorization for the Use of PHI" form in iRIS, if applicable, so that the Office of Research Support Committees can re-stamp the form with the new expiration date.
· Relevant study related documents, including but not limited to, multi-center trial reports, NIH and/or other sponsored research reports, reprints of articles, deviation log, etc.
· Any other documentation that CPHS may specifically request.
Assigning for Review – The ORSC Staff will screen the submission to assess if the information is adequate. If the information is not adequate, ORSC staff will request additional information from the Principal Investigator. Once adequate information is obtained, ORSC Staff will determine if the continuing review may be reviewed by expedited review or Full Board review.
For proposals that were initially reviewed by expedited review, the ORSC 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 ORSC Staff will assign the submission for Full Board review. The Reviewer must declare any conflict of interest. If there is a conflict of interest, the ORSC staff will re-assign the review to another Reviewer.
Research projects that were initially reviewed by Full Board may qualify for expedited continuing review if they meet the criteria listed in Item 8 and 9 of policy and procedure, Expedited Review.
If the criteria for expedited review are not met, the research will undergo Full Board review. The ORSC Staff will schedule the continuing review for the next available Full Board meeting of the same IRB that initially reviewed the research project. The ORSC Staff shall assign the submission to the Chairperson of the subcommittee that initially reviewed the research. If the Chairperson is not available, ORSC Staff will assign it to one of the other subcommittee members or another CPHS member. The Reviewer must declare any conflict of interest. If there is a conflict of interest, the ORSC staff will re-assign the review to another Reviewer.
Review Process - All CPHS members, including the assigned Reviewer, have access to the continuing review submission and all study documents previously submitted and approved. All members have access to complete documentation for the research and are expected to review at least the protocol summary, consent documents and status report on the progress of the research. CPHS will determine if the criteria for approval as listed in Item 4 on Page 1 of policy and procedure on Initial Review continue to be met:
a. A current risk-benefit assessment is made based on study results, including a review of all reported unanticipated problems and serious adverse events. CPHS shall determine whether the level of risk has changed from the last review.
b. Selection of subjects continues to be reasonable and impartial.
c. When reviewing the current informed consent document(s) the CPHS shall ensure the following:
i. Whether the currently approved informed consent document is still accurate and complete;
ii. Any significant new findings that may relate to the participant’s willingness to continue participation are provided to the participant.
d. Adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data are provided, when appropriate.
e. There continues to be adequate provision for monitoring the data collected to ensure the continued safety of the participants, when appropriate.
f. Appropriate safeguards for vulnerable populations are provided.
g. Key study personnel listed on the continuing review submission form will be checked that they have been previously added to the study via a change request form. Personnel that have not been previously added to the study will be required to submit a change request with an attendant RCOI form to determine any potential conflicts of interest, which will be assessed as indicated in the Change Request and Protocol Amendments Policy.
When the study is part of a multi-center trial and is 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:
a. Investigators who do not have a proven track record,
b. Investigators who have had problems in the past,
c. Studies that have complex designs,
d. Phase I studies,
e. Investigator initiated clinical trials,
f. Research involving high risks to subjects;
g. Particularly complicated procedures or interventions;
h. Potentially vulnerable populations;
i. Study staff with minimal experience in administering consent to potential subjects; or
j. 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, Item 9.
Communication of Outcome: The ORSC Staff will notify the Principal Investigator of the outcome of review via iRIS in a timely manner. The ORSC 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 ORSC 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 Chairperson/Designee. The Executive Chairperson/Designee give permission for continuation and instruct the Principal Investigator to submit continuing review documents. ORSC Staff will place the research study for CPHS review at the next available meeting.
Study Completion: Continuing review must occur until the research is permanently closed i.e. all participants have completed all research-related activities, and collection and analysis of private identifiable information has been completed. 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.
ORSC 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, ORSC Staff will request for additional information.
ORSC 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.
1. 45 CFR 46.109(f)
2. 21 CFR 56.109(f)
3. OHRP Guidance on Continuing Review
4. FDA Information Sheets: Continuing Review After Study Approval
REFERENCES TO POLICIES AND PROCEDURES
1. Initial Review
2. Expedited Review
1. Continuing Review Form
2. Continuing Review – Approval Letter
3. Continuing Review – Approval Pending Letter
4. Continuing Review – Expired Letter
5. Study Closure Report
1 Aug 2008
1 Jan 2009
1 Aug 2011