Basics of Human Subjects Research and the IRB

What is the IRB at Yale?

The IRB, or Institutional Review Board, is a board at an institution that oversees research involving human subjects. At Yale, there are five IRBs for biomedical research, and one IRB for social, behavioral, and educational research known as the Human Subjects Committee. The Human Subjects Committee is the board that will oversee most of the research done by researchers at Yale Law School.

How do I know if I’m doing human subjects research?

Per federal guidelines as cited by Yale’s IRB

Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(d)).

A human subject is defined as a “living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) obtains identifiable private information” (45CFR46.102(f)).

For a project to require IRB review and approval, or IRB determination of exemption, the project must qualify as “research” and involve “human subjects” as defined above.

If you’re not sure whether your project meets these definitions, feel free to contact Empirical Services Librarian, Michelle Hudson (michelle.hudson@yale.edu), or the Human Subjects Committee directly (human.subjects@yale.edu). 

How do I apply for IRB approval?

Applications

All research involving human subjects needs to be submitted to the IRB for approval or exemption. If you’ve determined that you need to submit your project to the IRB for review, all submissions are made using the IRES IRB system online. For help navigating this process from start to finish, contact Empirical Services Librarian, Michelle Hudson (michelle.hudson@yale.edu), and she can walk you through the steps. 

Human Subjects Training

Before your submission will be approved, you and any team members will need to complete human subjects research training, and fill out the External Interests Disclosure Form which you can do online at any point before submission (even today, if you want!). 

Updated Date: 
Tuesday, October 9, 2018