IRB

Not all graduate student research needs an IRB review, but for research that involves human subjects and/or the handling of sensitive data, an IRB review may be required legally to ensure your research is allowed to be conducted at UW! 

What is an IRB?

The Institutional Review Board (IRB) is a research ethics committee tasked with ensuring that human subjects research conducted under UW is ethical. They don’t exist for no reason! A long history of ethical misconduct in human subjects research has led to the creation of federal regulations that requires federally funded institutions like UW to have an IRB process to ensure that the rights and protection of human subjects are guaranteed. If you’re working with human subjects and/or sensitive data, your research may need an IRB.

UW IRB Basics

There are two main elements to consider when you’re determining if your project needs an IRB review. While these terms may be fairly simple, their legal definitions may be different from what you assume them to be.

• Is your project a Research?
  • Research: A systematic investigation that develops or contributes to generalized knowledge.
• Does your research involve Human Subjects?
  • Human Subject: An individual about whom an investigator conducting research obtains: (1) information or biospecimens through interaction or intervention with the individual; or (2) identifiable private information about individuals.

There are always special cases to these definitions as well. If you are ever concerned or confused about whether your project fits into these definitions, you can use this worksheet guide provided by the Human Subjects Division. Additionally, as the principal investigator you can request for a formal determination by the IRB. Visit the following website for more information on applying for an IRB: Apply for Review – UW Research

 

3 Types of IRB Reviews

There are three types of determinations that the IRB Review Board can make: Exempt, Expedited, and Full Board Review. The IRB Review Board comes to these determinations by considering the ethical principles of the proposals as well as relevant federal regulations.

• Exempt: The proposed research is determined to be a human subjects research but does not need to meet most of the federal regulations on human subjects due to minimal risk. UW has nine categories of exempt research. Applications are not subjected to continuing review after approval. For more information visit the Exempt Research Page on the UW Human Subjects Division website.
• Expedited: The proposed research is determined to have minimal risk to human subjects and potentially qualifies for one or more of the Office for Human Research Protections (OHRP) Expedited Review Categories. Expedited reviewer(s) are experienced IRB members that have jurisdiction to make a determination, allowing the application to be reviewed by one or more members instead of through a full board review. Applications may still be referred for a full board review for various reasons, such as for disapproval. Only the Full Board can disapprove applications.
• Full Board Review: The proposed research is determined to need a full board review due to the research being identified as having more than minimal risk to human subjects OR it was referred to the committee for review by an expedited reviewer or the Chair. Applications are reviewed by the full board on scheduled meeting dates. It is advised that researchers give ample time for the potential that the review board requires additional changes to the application.

External IRBs

Sometimes, certain UW research may be more fitted to go through an external IRB instead. While UW IRB is normally the right IRB to use, your research may require an external IRB instead. UW IRB can accept other IRBs after review and permission from their Human Subjects Division. 

Determine if the UW IRB is Right For You on the UW Human Subjects Division website.

Additional Resources and Links

For more in-depth information on UW’s IRB, visit the following websites linked below:

• UW IRB Resources:
  • UW Human Subjects Division
  • HSD – Do I Need IRB Review? 
  • IRB 101 Online Tutorial
  • IRB Guidance page
  • Exempt Research guide 
  • UW IRB Meeting Schedule
• Federal Regulations:
  • U.S. Department of Health and Human Services (HHS) regulations for the protection of human subjects in research
  • Washington State Department of Health and Human Services regulations on the protection of human subjects in research
  • OHRP Expedited Review Categories