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:

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:

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:

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.

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.

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

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Take the Certification Exam!
  • Glossary
  • References