XII. CONTINUING REVIEW
12.1 Updates and Adverse Events
The Principal Investigator shall advice the IRB of any adverse events, deviations from the protocol, or other information that may become available to the Principal Investigator that a reasonable person may judge relevant to determining the acceptability of the research project as safe for human participation or that may affect a subject's willingness to participate in the research. The Principal Investigator shall also advice the IRB when research is terminated. Relevant information would include all audit reports, whether positive or negative, by sponsors, co-operative research groups and/or data monitoring groups.
12.1.1 Serious Adverse Events
The Principal Investigator shall advise the IRB of any serious adverse events (as defined in attached definitions) within 24 hours of local event or within 24 hours of the receipt of information by the Principal Investigator of a non-local event. The Principal Investigator must simultaneously forward local serious adverse events reports to the sponsor and/or regulators. Because the exact causes of a serious adverse event and its relationship to the research protocol may not immediately be known, the Principal Investigator shall continue to update the IRB about the subsequent evaluation of the event on a timely basis.
12.1.2. Unanticipated Adverse Events
The Principal Investigator shall advise the IRB o f all unanticipated non-serious adverse events (i.e. any undesirable experience associated with the subject's participation in the research not disclosed in the consent form) on a monthly basis.
12.1.3 FDA or Other Regulator Changes
It is the responsibility of the Principal Investigator to notify the IRB in writing within thirty (30) days, if the FDA status of an investigational drug and/or device is changed in any way or if any government regulator having authority over the research has issued a ruling affecting the research.
12.1.4 Other Information
The Principal Investigator shall advise the IRB of all other relevant information such as deviations form the protocol which may become available on a timely basis. Externally created reports should be forwarded to the IRB within five (5) days of receipt.
12.1.5 Board Action
The foregoing information will be considered at the next regularly scheduled meeting of the IRB. Based on the foregoing information, the IRB may suspend the research and require a full review by the IRB to consider whether to allow the research to continue and/or what changes may be required in the protocol to address these circumstances. In the event that information gained in this way indicates a change in risk for participants, the Principal Investigator will prepare an informational notice to be approved by the IRB that notifies all subjects of this change. The Principal Investigator will also prepare amendments to the protocol, consent forms and authorization forms to reflect this change and submit them for IRB approval.
12.2 Amendments
The Principal Investigator must advise the IRB of any proposed changes to the protocol or consent form and submit the changes to the IRB for review and approval prior to initiating the changes. The Chair of the IRB will determine whether or not those proposed changes are to be subject to expedited or full review.
12.3 Continuing Review (Annual Re-Approval)
The IRB shall review all approved research not less than once per year" on or before the 1-year anniversary date of the previous IRB review required by 45 CFR 46, even though the research activity may not begin until some time after the IRB has given approval. The IRB has a legal obligation to, and reserves the right to review the progress of all continuing research approved by it, for the purpose of safeguarding the rights of human subjects.
12.3.1. Standards for Continuing review
Continuing Review must be substantive and meaningful. Review by the convened IRB, with recorded vote, is required unless the research is otherwise appropriate for expedited review. Ordinarily, if research did not qualify for expedited review at the time of initial review, it does not qualify for expedited review at the time of continuing review. It is also possible that research activities that were previously judged as exempt in accordance with Federal guidelines, or were qualified for expedited review , have changed or will change, such that other than expedited IRB review is now required.
Investigators must also report to the IRB planned changes in the conduct of the study, since these may affect the protection of human subjects. Minor changes proposed for previously approved research may be reviewed in an expedited manner prior to the scheduled continuing review date in accordance with federal guidelines. When a proposed change in a research study is not minor, then the IRB must review and approve changes at a convened meeting before changes can be implemented. The only exception is the rare circumstance in which a change is necessary to eliminate apparent immediate hazards to the research subjects. In this case, the IRB should be promptly informed of the change following its implementation and should review the change to determine that it is consistent with protection of human subjects. Unanticipated risks to subjects or new information that may affect the risk/benefit assessment must be promptly reported to, and reviewed by, the IRB to ensure adequate protection of human subjects.
12.3.2. Submission Requirements
The Principal Investigator must submit the protocol and any amendments as well as a status report on the progress of the research, including (a) the number of subjects accrued; (b) a description of any: adverse events or unanticipated problems involving risks to subjects or others, withdrawal of subjects from the research, or complaints about the research; (c) additional information including a summary of any recent literature, findings, or other relevant information, especially information about risks associated with the research; and (d) a copy of the current informed consent document.
12.3.3 Additional Required Documents
The "Request for Project Review Form", the original protocol (including any IRB approved amendments), and supporting materials will be submitted to a principal reviewer. Discussions regarding continuing review of protocols and the vote will be recorded in the Board's meeting minutes. The Principal Investigator must submit a current copy of the consent form which incorporates current information obtained during the course of the study. The IRB will notify Principal Investigators of their decision by mail.
The continuation of research after expiration of an IRB approval is in violation fo federal regulations (21CFR 56.103 (a)) Principal Investigators must cease conducting research if the study has not received IRB approval by the expiration date. New patients may not be enrolled in the study.
12.4 Publications
All publications, including abstracts, related to research, bearing the name of SHS must be submitted by the author to his or her Department Chair and reviewed by the IRB. Examples for reasons for reviews include:
- that the protocol was reviewed by the IRB and that, as far as can be determined, the ethics in use of human subjects and the original approved protocol were adhered to;
- that the manuscript does not include information that might compromise confidentiality (e.g. patient names);
- that inappropriate information is not included (e.g. product names.)
Department Chair The Chair of each department must deliver a copy of the manuscript to the IRB when it is ready for submission. He or she will also provide the IRB with an annual bibliography of publications of members of his or her Department.
12.5 Bibliography
The IRB will maintain a file of publications and publish an annual bibliography of publications submitted by each Department.
