The Approval Period
The approval period is the period during which an investigator has active IRB approval to conduct human subjects research. The longest duration for the approval period that is permitted under the regulations for studies that are federally funded or subject to FDA oversight is one year. The IRB can require more frequent review (shorter duration of approval), particularly for high-risk studies or situations where there has been research non-compliance. Since the CHOP IRB has not checked the box on its FWA, it can choose to use longer approval period for studies that are not federally funded and which are not subject to FDA regulation.
What do the different dates mean in approval letters and consent form stamps?
The date that the study meets all of the regulatory requirements for approval.
When a study is reviewed at a convened meeting of the IRB, then the approval date is the date of the meeting. Modifications, if required cannot be substantive (require review at another full board meeting).
When a study is reviewed using expedited procedures, the approval date is the last date an IRB member reviews the study to confirm that it meets the regulatory requirements. Modifications that only require simple confirmation and which are reviewed by a non-IRB member (e.g. IRB Office staff) do not change the approval date.
The date that all required modifications have been made and confirmed.
The effective date for a full board study is the date when all conditions for release of approval have been met including completion of meeting minutes and all required modifications, clarifications, consent form edits, Ancillary approvals, and Conflict of Interest review have been received and confirmed.
The effective date for a study that receives expedited review differs in that there are no meeting minutes generated.
The date which ends the approval period and is based on the approval date, not the effective date.
Full Board Study:
The full board reviews a new protocol on June 13, 2011 and approves the protocol with modifications to the consent form and eIRB application required. The approval date is June 11, 2011. The meeting minutes are completed on June 15, 2011, the Radiology Review C. approval is received on June 16, 2011, the required modifications are received and reviewed on the evening of June 30, 2011. The approval letter is sent on July 3, 2011. The effective date is the date that all outstanding issues were met which was June 30, 2011. This is the date that will appear on the consent form stamped and released by the IRB Office.
A new study is reviewed by the chair using expedited procedures on June 13, 2011. The study requires modifications that must be reviewed by an IRB member. The IRB receives the responses on June 20, 2011, which are reviewed on June 25, 2011 by an IRB member. Additional changes are required to the consent form that require simple acceptance of the IRB's proposed changes. These are received and reviewed by IRB Office staffer on June 30, 2011. The approval date is June 25, 2011, which is the date an IRB member determined that the study met the conditions of approval. The effective date is June 30, 2011, which was the date that all conditions for approval were met. This is the date that will appear on the consent form stamped and released by the IRB Office.
Obligations During the Approval Period
During the approval period investigators are required to submit progress reports at least annually (Continuing Review), obtain IRB approval for any changes in the research and to report notable events (SAEs, unanticipated problems involving risk to subjects, protocol deviations, etc.) that occur in accordance with the IRB's guidelines.
The IRB must review all approved research at least annually. It can require more frequent review depending on the risks of the research or other factors.
Approximately half of all submissions to the IRB are amendments - modifications, changes or clarifications - to approved research. IRB approval is required before making any changes to approved research. The only time changes can be made without prior IRB approval, is to protect the rights and welfare of the subject.
If there is a need to make an exception to the protocol requirements on a one-time basis, a request for approval is still needed from the IRB. These one-time amendments are also referred to as a prospective protocol deviations.
This page provides information and general guidance about those events that need to be reported promptly to the IRB during the conduct of research activities. These events include unanticipated problems involving risks to subjects or other, changes in subject status, protocol deviations and new information that might affect the IRB's assessment of risks or benefits.
Research documents must be retained for varying periods of time depending on which regulations apply - 45 CFR 46, FDA regulations, or HIPAA.