The Code of Federal Regulations is a compendium of the general and permanent rules and regulations published in the Federal Register by the federal executive departments and agencies. The CFR is divided into 50 titles that represent broad areas subject to Federal regulations. Title 45 CFR encompasses regulation of Public Welfare. Title 21 CFR is administered by the FDA and covers regulations of Food and Drugs. Title 45 CFR 46 (The Common Rule) is a core set of regulations defining protection of Human Subjects in clinical research.

The U.S. Department of Health and Human Services (HHS) is the government’s principal agency for protecting the health of all Americans. It comprises several public health services agencies including the FDA (Food and Drug Administration), OHRP (Office of Human Research Protection), the NIH (National Institutes of Health), and the Centers for Medicare and Medicaid Services (CMS).

To learn about IRB approvals associated with multi-site research and external collaborations, see the IRB page on single IRBs and authorization agreements.

Depending on the nature of your study, the IRB may require other approvals:

Clinical Research Center Advisory Committee: Research involving the use of services at the Clinical Research Center (CRC) for any reason, including the use of personnel as back up to the research team or plans to use personnel in the event of an emergency, need to be reviewed by the CRC Advisory Committee. CRC Advisory Committee approval is not required before the IRB will approve the study.

The Pennsylvania State University Embryonic Stem Cell Research Oversight (ESCRO) Committee is charged with reviewing, approving and overseeing human embryonic stem cell (hESC) research. 

Anyone handling regulated biohazardous materials in teaching or research at Penn State must submit an application to Institutional Biosafety Committee (IBC) before handling the materials. Biohazardous materials include human biological specimens, infectious agents, recombinant material, and gene therapy. Biological toxins and carcinogens are also included if they are used in conjunction with animals.

The role of the IRB is to review and to make determinations on all research involving human subjects. All Penn State employees (faculty/staff/administrators) and students conducting human subjects research need to submit required materials to the IRB for review and approval before beginning any research activity.  For an overview of the IRB submission and approval process, see the IRB website.

In addition to the information below, please see RPG03 Payments to Human Participants in Research for Penn State guidance on payment methods.