What Happens After Submission?

Beginning your research

Research may not begin until final written approval is received from the Institutional Review Board. This means that there can be no collection of data and no recruitment of and/or contact with human subjects until the investigator has received written notification of approval. The regulations governing research involving human subjects and IU Health Bloomington’s Letter of Assurance with the federal government prohibit granting retroactive approval.

IRB Actions


Approve

The IRB may approve a research study or study action when it finds that no additional changes are needed and it meets the standard criteria for approval.

Provisional Approval

The IRB may provisionally approve a research study or study action when specific revisions requiring simple concurrence by the investigator can be stipulated. In this case, subsequent review by the convened IRB is not required. The IRB Chair may approve the investigator’s response on behalf of the IRB under an expedited review procedure. This approval will be reported to the IRB at its next meeting.

Table (for studies reviewed by the convened IRB only)

The IRB may table a research study or study action when substantive clarifications or modifications regarding the protocol or informed consent document that are directly relevant to the determinations required by the IRB are necessary. In this case, subsequent review by the convened IRB is required.

Disapprove

If the IRB disapproves a research study or study action, written notification will be provided to the investigator, which will include the reasons for the determination.

Approval Period

When the IRB approves a new research study, it must determine the study’s approval period, which is set at intervals appropriate to the degree of risk, but not less than once per year. In some circumstances, a shorter review period (e.g., biannually, quarterly, or after accrual of a specific number of subjects) may be required. The IRB will require review more frequently than annually for those studies deemed “high risk."

Suspend/Restrict/Terminate Approval

The IRB may also suspend, place restrictions upon, or terminate approval of research that is not being conducted in accordance with IRB requirements or that have been associated with unexpected serious harm to subjects.