Research Integrity and Assurance

Review Process

Review process

ASU’s review process is designed to efficiently assess the risk of a study to human subjects. Studies involving higher risk undergo greater scrutiny while low risk studies can be reviewed and approved more quickly. Some low risk studies can be reviewed and approved within 5-10 business days. Studies involving higher risk or studies specifically targeting protected populations like prisoners or Native Americans can take longer to approve.

The pre-review and review process

After the study is submitted by the PI, it will be assigned to an IRB coordinator for a pre-review.  The pre-reviewer will work with the investigator to make any revisions and improvements to the study through clarification requests. The pre-reviewer will be able to respond to any questions or concerns the investigator has as well.

Once the pre-reviewer believes the study is ready for a final review, it will be sent to a designated reviewer who will serve as the final reviewer (and a second set of eyes). The designated reviewer may request additional clarification, may approve the study or may forward the study for a Full Board review.

Clarification requests

During the review process, most studies receive one or more clarification requests with points or concerns that need to be addressed before the study is resubmitted for review.

When clarifications are requested, the PI and primary contact will receive a notification and the study will be returned to the research team for revisions. The study will then be in an editable state and most members of the study team will be able to make edits.

Once edits have been made, the PI will need to be re-submit before the IRB reviews the changes. The IRB will review the edits only after PI re-submits the study.  The study will be locked for further edits.  

Review categories

All studies sent to the ASU IRB are reviewed using the same templates and materials. There are three levels of review outlined in the federal regulations: Exempt, Expedited, and Full Board. The level of review at ASU is determined by the designed reviewer. Researchers do not need to apply or cater their materials to a certain level – there is not a separate application process for exempt studies. The level of review will determine whether the researcher will need to submit continuing reviews or if modifications to the study will need to be submitted and approved. When the approval letter is received, it should be reviewed carefully to note the level of review.

Approval

When the study is approved, the software will generate an approval letter and will watermark PDF versions of the consent forms and recruitment materials. Whenever reasonable, use the watermarked materials (especially consent forms).

Level of Review Expires Requires Modifications Requires Adverse Events (RNI) Requires Yearly Continuing Review or Study Closure
Exemption Determination No Some* Yes No
Expedited Determination 1 year (can be renewed) Yes Yes Yes
Approved as Full-Board 1 year (can be renewed) Yes Yes Yes (continuing review must be done by a convened full board)

*Changes to exempt studies do not need review unless change would make the study non-exempt. Contact us to determine if a modification is necessary.

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