Conduct Research

Modifications to the Protocol

The Institutional Review Board (IRB) must approve all modifications to the research activities and applications prior to implementation.

Minor changes proposed for previously approved research may be reviewed using the expedited review procedure. A minor modification is defined as a change that would not materially affect an assessment of the risks and benefits of the study or does not substantially change the specific aims or design of the study.

When a proposed change in a greater than minimal risk research study is not minor, the IRB Committee must review and approve changes at a convened meeting before implementation. A major modification is defined as any change which materially affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.

Promptly report all adverse events or deviations from the IRB-approved study using the appropriate form. Investigators are responsible for reporting non-compliance to the IRB using the standard reporting form. Any change, divergence, or departure from the study design or procedures of a research protocol that affects the subject's rights, safety, or well being and/or the completeness, accuracy, and reliability of the study data constitutes non-compliance. Forms are accessible online in the iRIS progam.

Changes or alterations in the conduct of the trial which do not have a major impact on the subject's rights, safety, or well-being, or on the completeness, accuracy, and reliability of the study data also represent non-compliance. For example, enrollment of more subjects than the number approved by the IRB is non-compliance and must be reported promptly.

Continuing Review

In its initial review of a protocol, the IRB will consider how often continuing review will be required. Federal regulations (45 CFR 46) require review to occur on or before the 12-month anniversary date of the previous IRB approval. All protocols shall be reviewed at least annually, but in certain research the subjects are exposed to more than usual risk; such projects will be reviewed at more frequent intervals consistent with the research. This review interval is automatically set as annually, unless otherwise designated by the IRB, and may be changed at the discretion of the IRB.

Closing the Study

If all research-related activities with human subjects have been completed, and all data collection and analysis of identifiable private information described in the IRB-approved research plan have been finished, then the human subjects research study has been completed.

When a human subjects research study has been completed, the investigators no longer are required to obtain continuing review and approval of that study by the IRB. Researchers should inform the IRB that a study has ended by submitting an IRB completion report following the end of the study.