IRB Protocol Submission and Review

The Institutional Review Board (IRB) conducts review and approval of research that involves human participants. A protocol is considered Human Subjects Research if it meets the below definitions:

Human Subject

According to 45 CFR 46, a human subject is "a living individual about whom an investigator (whether professional or student) conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
    • Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
    • Interaction includes communication or interpersonal contact between investigator and subject.
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

Research

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Additional guidance may be reviewed at Levels of IRB Review.

You should complete human subjects research training at the earliest stages of planning your research. Understanding and implementing foundational principles of human subjects research, such as informed consent and potential risks in data collection/storage, will help you design a sound protocol.

Principal Investigators and research personnel are required to complete the Collaborative Institutional Training Initiative (CITI) Human Subjects Research training course(s) prior to approval of their protocol:

  • If you conduct studies that obtain data through intervention or interaction with a living individual or their identifiable private information; or
  • If you are an IRB committee member. You will need to complete the "IRB Committee Members" course.

Documentation of this training can be uploaded as a pdf in the training section in the IRB protocol in Cayuse IRB, or verified by the Compliance Administrator at the time of the review of the protocol. When you complete all of the required modules successfully, you may print your completion report through the "Print" link on the learner’s menu. The PI on the protocol should keep a copy of research personnel training for their records.

Additional CITI training guidance can be found here.

Request a Classroom or Lab Presentation

The Human Research Protection Program provides educational resources and training opportunities for those involved in human subjects’ research. Faculty can arrange for class or lab presentations to discuss ethics, the history of human subjects’ research and/or application process. To schedule a presentation, please contact the IRB Compliance Administrator at irb@rice.edu.