Continuation of Approved Research
Request for Continuation of Approved Research
SUNY Cortland is obligated to conduct continuing review of approved research at intervals appropriate to the degree of risk, but not less than once per year, and has the authority to observe or ask a third party observe the consent process and the research [§46.109(e)]. The investigator must plan ahead to meet required continuing review dates. As recommended by OHRP, SUNY Cortland requires that investigators include the date of IRB approval and the continuing review date at the bottom of the consent forms. This provision helps to remind investigators of their expiration date.
When continuing review of a research protocol does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. Information requested for a continuation must be received by the IRB with sufficient time to review the request. If data collection is completed and investigators are only analyzing unidentifiable data, a continuation request is not required. However, investigators must be certain to maintain the data as specified in the informed consent and application protocol, allowing only those individuals listed in the informed consent access to the data.
Exempt research only requires email notification (to email@example.com) indicating that the research continues to remain active. Assuming that there are no changes to the research, its procedures, and its documents (e.g., consent form, measures, surveys, MOUs), no continuing IRB review is required. The purpose of the email notification, at the exempt level, is to alert the IRB Administrator that the records of the original IRB approval should remain active and available. Unlimited continuations can be registered for exempt research under federal and SUNY Cortland IRB guidelines.
Expedited research continuation requests are reevaluated by the IRB using expedited procedures, not less than once a year for a total of three years.
Full review research continuation requests are reevaluated by the Full Board, using full review procedures, at intervals appropriate to the degree of risk, but not less than once a year for a total of three years.
Information and documents required for continuing review, at expedited and full review levels, are to be sent to firstname.lastname@example.org. Investigators are to include information identified by OHRP as important to continuing review, which includes:
- the number of subjects accrued;
- a summary of adverse events and any unanticipated problems involving risks to subjects or others*;
- any withdrawal of subjects from the research;
- any complaints about the research since the last IRB review*;
- a summary of any relevant recent literature;
- preliminary or interim findings (published or unpublished);
- planned amendments or modifications to the research since the last review;
- any relevant multi-center trial reports (if applicable);
- any other relevant information, especially information about risks associated with the research;
- copy of the current informed consent document and any newly proposed consent document; and
- copies of new measures, materials, apparatus, or any other materials that may assist the IRB in their review.
*This information should be submitted at the time the incident occurs. If the information was not forwarded to the IRB at that time, the investigator is obligated to provide that information at the time of continuing review.
All new information and supporting documents are to be forwarded to the IRB by email to email@example.com. Signature-bearing documents are to be sent to the IRB, PO Box 2000, Miller Building Room 402, Cortland, NY 13045. If investigators have any questions about continuing review, they can consult the OHRP web site or contact the IRB.