1. The Institutional Review Board: Who, What, When, Where, Why, and How
Prepared by
Susan Brater, IRB Coordinator

2. Why do we need to protect human subjects?
Nazi experiments during World War II
Tuskegee study of syphilis
Failed to treat syphilis with penicillin
Failed to tell men they were infected
Stanford prison experiment

3. In 1979, the Belmont Report outlined three Basic Ethical Principles
Respect for persons
Obtain informed consent
Beneficence
The benefits outweigh the risks
Justice
Who bears the costs, who bears the rewards?

4. What does the IRB do?
The HSU IRB reviews all research involving human subjects.
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
The IRB ensures that all participants in research are protected and have the opportunity to voluntarily consent to their participation.
The IRB ensures that research is conducted ethically and meets all IRB regulations.

5. What Is Human Subjects Research?
A human subject is a living individual about whom an investigator conducting research obtains information through intervention or interaction, or obtains identifiable private information.
Includes applicable undergraduate independent study projects, graduate projects, theses and pilot studies
Research by students must be sponsored by a member of the faculty.

6. Who is on the Institutional Review Board (IRB)?
The IRB is comprised of:
A committee whose members are appointed by the President for five-year terms
Members from HSU and the community
Both male and female members
At least one member whose primary expertise is in a nonscientific area
At least one member who is not affiliated with HSU in any way

7. IRB Process Start with CITI training:
Training is provided through the Collaborative Institutional Training Initiative (CITI).
Training is free, web-based, and takes a few hours to complete.
Contact the IRB office ( ) for tips on taking the CITI course most efficiently.

8. How do you begin the IRB application?
Go to the IRB Home Page and follow the instructions to complete your application.
Be sure to complete your informed consent for participants.

9. How do you submit an application?
Complete the online Drupal application and click submit.
All review and communication with the IRB occurs electronically.

10. What is the HSU IRB Review Process?
Applications are submitted to the IRB Coordinator.
The Coordinator reviews the applications to make sure the primary required elements are included.
If there are omissions, the Coordinator contacts the researcher.
The Coordinator either reviews the application or sends it to the IRB reviewer for review and approval.

11. How do you Receive IRB Approval?
Once approved, the Coordinator sends an approval letter to the researcher via .
The Coordinator tracks all contacts, requests, renewals, modifications, etc.

12. Thank you from the IRB
If you have any questions, please contact