Human Subjects Research at Cal Poly

The Cal Poly Institutional Review Board (IRB) is responsible for ensuring the ethical and responsible conduct of research involving human subjects on campus. The IRB reviews research protocols to ensure compliance with ethical regulations such as the rights and wellbeing of all human subjects.

**If you have a concern related to the conduct of human subjects research at Cal Poly, please report it via this form.  The form will be reviewed by the Director of Research Integrity and Compliance.**

Importance of the IRB

History

In 1932, the US Public Health Service and the Tuskegee Institute began work on a project now know as the Tuskegee Syphilis Study which involved studying the effects of untreated syphilis in the bodies of 600+ black men. Participants in this study were not properly consented and were not informed about what the study entailed. The study lasted for nearly 40 years, despite the creation of a well-known treatment for syphilis being introduced to the public decades earlier.

After stories were published broadly in 1972 about the Tuskegee Study, the US Government condemned the actions of the researchers involved and formed the Office for Protection from Research Risks (now known as the Office for Human Research Protections) as part of the National Health Institute (NIH). Throughout the rest of the 70’s, we saw the creation of multiple regulations to protect human subjects, including the National Research Act, 45 CFR 46 subpart A, and the Belmont Report.

Regulations have continued to be introduced and adapted as research as continued to evolve. However, all regulations and compliance continue to follow the basic principles written in the 1979 Belmont Report.

Belmont Report

The Belmont Report is based on three main principles:

• Respect for Persons: Protecting the autonomy of all people and requiring informed consent.

• Beneficence: Maximizing the benefits of the research while minimizing the risks of harm to research participants.

• Justice: Ensuring fair recruitment of subjects and fair distribution of both the benefits and burdens of research.

Today

It is the job of every IRB to review human subjects research and ensure that the principles of the Belmont Report and all other regulations are upheld. The unethical history of research is one that we must remember to ensure that it does not happen again.

 

IRB Submissions

What is Human Subjects Research?

Human Subjects Research is defined as the following: "Any systematic investigation of human subjects, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge."

Does My Project Need Review?

If your project follows the definition of human subjects research, it is likely that you will need to submit your project to the IRB. Please review our Human Subjects Determination Chart HERE to see determine if your project will require review.

New Research Protocols

Working with human subjects? Click HERE for more information on how to submit an IRB protocol, what we require, and what the review process looks like.

Modifications, Status Checks, and Continuing Reviews

For instructions on when and how to submit a modification, please click HERE.