Institutional Review Board (IRB)

What is the IRB?

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The Franklin University IRB comprises faculty and staff members, as well as a community member not otherwise affiliated with the University, who are responsible for overseeing research projects involving human subjects.

What does the IRB do?

The IRB reviews protocols and has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. The IRB makes its independent determination whether to approve or disapprove the protocol based upon whether or not human subjects are adequately protected.

Does my research require IRB review?

The Franklin University IRB reviews and approves any undertaking in which an individual affiliated with the University (faculty, staff, or student) conducts human research.

For purposes of determining which projects require IRB review, Franklin University adheres to the definitions of ‘research’ and ‘human subject’ presented in the Department of Health and Human Services (DHHS) Code of Federal Regulations (45 CFR part 46). 

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(l)]. 

Human subject means a living individual about whom an investigator (whether professional or student) conducts research and (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)].

Where can I find more information about the regulations and human subjects research?

The Department of Health and Human Services (HHS) regulations at 45 CFR part 46 stipulate substantive and procedural requirements for investigators and institutions engaged in research. You can read the Code of Federal Regulations regarding the Protection of Human Subjects here.

Check out the Office for Human Research Protections (OHRP) to learn more about protecting the rights, welfare, and wellbeing of human subjects involved in research.

Additional Information