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Conducting the Study after IRB Approval
The Approval Period
The approval period is the period during which an investigator has active IRB approval to conduct human subjects research. Research that is FDA regulated or greater than minimal risk must be reviewed at least annually. The IRB can require more frequent review based upon the nature of the research and the IRB's experience with the individual investigator.
What do the different dates mean in approval letters and consent form stamps?
Approval Date: 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, the approval date is the date of the meeting. Modifications, if required, cannot be substantive (otherwise require review at another full board meeting).
When a study is reviewed using expedited procedures, the approval date is the last date that 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.
Effective 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.
Expiration Date: The date that ends the approval period and is based on the approval date, not the effective date. Not all research will have an expiration date.
Full Board Study
The full board reviews a new protocol on June 13, 2016 and approves the protocol with modifications to the consent form and eIRB application required. The approval date is June 13, 2016. The meeting minutes are completed on June 15, 2016, the Radiology Review Committee approval is received on June 16, 2016, the required modifications are received and reviewed on the evening of June 30, 2016. The approval letter is sent on July 3, 2016. The effective date is the date that all outstanding issues (IRB as well as ancillary committees) were met which was June 30, 2016. 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 or designee (i.e. IRB member) using expedited procedures on June 13, 2016. The study requires modifications that must be reviewed by an IRB member. The IRB receives the responses on June 20, 2016, which are reviewed on June 25, 2016 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 staff on June 30, 2016. The approval date is June 25, 2016, which is the date an IRB member determined that the study met the conditions of approval. The effective date is June 30, 2016, 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 obtain IRB approval for any changes in the research and to report in accordance with the IRB's guidelines notable events (SAEs, unanticipated problems involving risk to subjects, protocol deviations, etc.) that occur.
- Need to make changes (Amendments): 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 eliminate an immediate hazard to the subject. Proposed changes can apply to the study in general or can be a one-time change. If there is a need to make an exception to the protocol requirements on a one-time basis, prior IRB approval is needed. These one-time amendments are also referred to as prospective protocol deviations. Some of these prospective protocol deviations can be minor, e.g., changes to study visit windows to accommodate subjects' schedules, obtaining a second blood sample after loss of a prior sample, while others are major and involve modifications to the inclusion or exclusion criteria or other study procedures.
- Continuing Reviews/Progress Updates and Completions: Investigators must submit a Continuing Review or completion for any study that has an expiration date. For studies without an expiration date, a "Progress Update" may be required.
- Reportable Events: 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 (Reporting Unanticipated Problems). These events include unanticipated problems involving risks to subjects or others (e.g. SAEs), changes in subject status, protocol deviations that have already occurred and new information that might affect the IRB's assessment of risks or benefits.
- Document Retention: Research documents must be retained for varying periods of time depending on which regulations apply - 45 CFR 46, FDA regulations, or HIPAA.
- Institutional Certification to share data
Resources to Assist with Approval Period Obligations
Guidance on amendments, prospective protocol deviations, and when it’s better to submit a new study ...
Submitting continuing reviews or progress reports, study reactivation and closures.
Guidance on events that may need to be reported to the IRB during the conduct of research activities ...
Guidance on the regulatory and institutional requirements for document retention.
Information on obtaining an institutional certification to share data with the NIH.