More Information

Contract Types
Working with Budgets
PI-Initiated Studies
IRB Role
Financial Dislosure
FDA Inspections
Registration
Other Web Resources
Research-Related Injury

The Institutional Review Board

Beginning on November 1, 2005, Western IRB (WIRB) will be the IRB of record for all corporate-sponsored clinical trials (with a very few exceptions such as PI-initiated studies). Marty Barrows will coordinate the process of sending the initial application to WIRB. Please see the Human Subjects Office site to learn about submitting to WIRB.

For studies that will be reviewed by the University's IRB:

When submitting documents to the Clinical Trials Office, it is wise to submit your application to the Institutional Review Board (IRB) at the same time. Our two offices maintain close contact, often alerting each other about an upcoming study. In addition, although it is not mandatory, in order to avoid confusion it is highly advisable that the Principal Investigator on the study be the Principal Investigator on the IRB application.

Be advised that, if your IRB application is approved before the contract is executed, the Human Subjects Office will not release the approved documents until the CTO has notified them that the contract has been fully executed. The two offices will also interact to ensure that research-related injury language is consistent in the contract and the consent document.

IRB Workshop Schedule

The purpose of The IRB Workshop is to familiarize staff with UI policies and procedures governing the use of human subjects in research. The Human Subjects Office will do the following:

• discuss federal regulations and how they have shaped University policies
• present a history of ethical guidelines in human subjects protections, and how the regulations have evolved
• eview the composition of an institutional review board (IRB), the regulatory requirements for the content of an Informed Consent Document, and the different types of IRB review
• describe the human subjects review application forms, informed consent templates, and the process of review and approval at the University of Iowa
• prepare a certificate of completion for those who attend

If Company Requests IRB Roster

The company may request a roster of IRB members who reviewed their protocol. Rosters are available on the web page of the Human Subjects Office.

(top)