Tutorial Chapter 17: What types of decisions can the UCAIHS make?

The UCAIHS must first decide whether a new application meets the criteria for exempt status under one of the federally defined categories or whether it needs to be considered for full review.

Once a proposal is reviewed by the UCAIHS and no outstanding questions or requests for revision remain, the UCAIHS may deem an application approved as:

• Approved
• Approved, Continuing
• Approved, Exempt
• Approved, Modified

If the UCAIHS does not consider that an Application for Review may yet be approved, it may deem the Application as Pending and request revisions and / or clarification that it feels are necessary to bring the proposed project into full compliance with the requirements for involving human subjects.

In these cases, the application will be considered either:

• Approved, Pending
• Exempt, Pending

Pending status may also be applied to Continuations and Requests for Changes if the UCAIHS feels that it needs more information or clarification to complete reviews in this category.

It is important to note that there are two levels of pending status:

• Technical: The requested changes are such that review and approval or requests for further revisions may be delegated to a UCAIHS subcommittee which usually meets weekly.
• Substantive: The requested changes are of sufficient seriousness that the UCAIHS has decided that responses must be reviewed by the UCAIHS in a full meeting of the Committee.

The UCAIHS may also deem an application:

• Deferred
• Noncompliant

Decisions of the UCAIHS are final and binding for the University. They are not subject to change by other University offices or authorities.

Chapter Review

Question 1

The UCAIHS must first decide whether a new application meets the criteria for (select all that are correct):

• Exempt status
• Abeyance
• Full review

Question 2

When an application to the UCAIHS is approved as exempt it is not subject to an annual review provided no changes are made to the protocol.

• True
• False

Question 3

When an application is granted pending status, it can be (select all that are correct):

• Pending, approved
• Pending, continuing
• Pending, exempt
• Pending, modifications

Question 4

When an application is deemed Deferred by the UCAIHS, the principal investigator may work with a UCAIHS member to revise the Application and procedures to resubmit it for a second round of review.

• True
• False

Next Chapter: What should investigators do during the application process and the course of their projects?