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Human Subjects Research (IRB) - Processes and Reporting
Application Review Process
The OSU IRB Office, located in the Office of University Research Compliance (URC) coordinates the receipt and review of all IRB applications. The URC staff will pre-review the application to ensure that all of the necessary materials are provided for IRB review. If additional information is needed before review can begin, you will be contacted by phone or email. Once complete, the application is entered in the IRB database and assigned a unique number that is used to track it through the review process and beyond.
Ensuring responsible conduct of research must be an on-going process. DHHS regulations at [45 CFR 46.109(e)] require the continuing review of human subjects research by the IRB at intervals appropriate to the degree of risk, but not less than one year.
The goals of this process are to re-evaluate the acceptability of the risk/benefit ratio and subject safeguards, and to confirm that the approved protocol has been followed.
Any research activity initially reviewed and approved by the OSU IRB is subject to continuing review.
A first notice for continuation is sent to the principal investigator 60 days prior to the first of the month of the protocol expiration date. This notice requests either written confirmation from the PI that the protocol has been completed, or directs the PI to the IRB website to access the required continuation/renewal form.
A second notice will be sent 30 days prior to the first of the month of the protocol expiration date. It is important that the continuation/renewal form be received at least two weeks before the expiration date to allow for review and processing.
If the PI does not request closure or submit a continuation/renewal form prior to the expiration date of the protocol, the PI will be notified that IRB approval of the protocol has expired and that the protocol has been closed. If the protocol is closed, no human subject data collection may continue without submission and approval of a new application form.
The required Continuation/Renewal form is available for download under the Forms link on this page. The form requests information in the following areas:
- Status of research activity;
- Subject enrollment numbers for the approval period and total;
- Research purpose and progress to date;
- Past and/or proposed modifications to the protocol;
- Adverse events;
- Subject withdrawals;
The Continuation/Renewal form should be accompanied by the current informed consent document, recruitment script, and any new materials or instruments to be added to the protocol .
Forms are to be submitted to the IRB office, 223 Scott Hall a minimum of two weeks prior to the expiration date of the protocol.
Protocol Continuation Review
The IRB Manager makes the determination if a continuing protocol requires more extensive review than by the Manager at the exempt and expedited levels of review. Full board continuations will again be reviewed by the full board. For continuing protocols requiring full board review, the PI will need to be aware of the IRB meeting dates and deadlines to assure that review will occur before the expiration date.
The IRB reserves the right to change the review level of a continuing protocol based on changes to the protocol or in regulations governing human subject research. Review of full board continuations is conducted in a similar manner to the initial review. All members of the IRB receive the complete protocol file, including any modifications, consent documents and testing instruments, and the completed continuation/renewal form. One member of the IRB is designated to lead discussion of the continuation application. Any member also has access to any relevant minutes or communications regarding the protocol.
The IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less frequently than once per year . When determining the interval for continuing review, the IRB will consider, among other issues, the vulnerability of the subjects and the risks of the protocol procedures. The standard approval period for most protocols is one year. However, the risks associated with certain protocols may necessitate that reviews take place more frequently than annually. In these cases, the IRB may request that the PI report to the IRB on a shorter time interval, or after a specific number of subjects is enrolled. This information will be communicated to the PI in the official approval letter.
All protocols are subject to post-approval review by the IRB. The criteria for protocol selection include:
- characteristics of the subject population;
- level of board discussion during the protocol approval process;
- level of risk to the subject population; and
- occurrence of any official adverse events.
The review will consist of, at minimum, visible confirmation that the following items are consistent with those approved by the IRB:
- Total subjects enrolled verses total approved;
- Recruitment procedures/script;
- Informed consent form;
- Confidentiality/security procedures.
The exact documents or procedures to be reviewed will depend upon the protocol.
A study may also be closed by the investigator via email when ALL of the following criteria are met:
- All subject recruitment and enrollment is complete;
- All subject specimens, records or data have been obtained;
- No further contact with subjects is necessary;
- Analysis of subject identifiable data, records or specimens are complete, and;
- identifiers and any code lists have been destroyed.
The IRB Office will administratively close a protocol if a continuation has not been received by the IRB staff prior to the end date. The investigators may not continue to recruit new subjects, and activity with previously enrolled subjects must cease. A new application must be submitted in order to continue the study once it has been administratively closed. It is the investigator’s responsibility to keep track of the end dates of their protocols.