Main Content

Federal Regulations

You are here

All research involving human subjects that is conducted at or sponsored by the University of Illinois at Urbana-Champaign, whether funded or unfunded, and whether conducted by Illinois faculty or others, must comply with applicable policies for the protection of human subjects. Under a formal assurance made by the campus and approved by the federal Office for Human Research Protections (OHRP), and per federal regulations, the Institutional Review Board (IRB) is given broad authority and wide-ranging responsibilities for ensuring the ethical and legal conduct of human subject research at Illinois.

  • This guidance, prepared by OPRS, provides in-depth information to University of Illinois at Urbana-Champaign investigators who may be uncertain if their study meets the definitions of human subjects research stated in the federal regulations (45 CFR 46.102).

  • The COPPA rule gives parents control over what information websites can collect from their children, as well as establishes additional protections and procedures that companies covered by the rule need to follow. Though the rule was designed to protect those under 13, it applies to operators of commercial websites and online services aimed at general audiences that collect, use, or disclose personal information from children, or on whose behalf such information is collected or maintained.

  • Research funded or supported by the Department of Defense (DoD) must be reviewed by the IRB under an additional set of federal regulations [32CFR219]. The DoD follows the DHHS and FDA regulations on human subjects research, but also applies DoD regulations for protection of human subjects at 32 CFR 219 and DoD Instruction 3216.02 "Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research."

  • A registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. is a service of the U.S. National Institutes of Health and provides information about a trial's purpose, who may participate, locations, and phone numbers for more details.

  • The Family Educational Rights and Privacy Act (FERPA) is a Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education.

  • The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by HHS. OHRP has published a variety of policy and regulatory guidance materials to assist the research community in conducting ethical research that is in compliance with the HHS regulations.

  • The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule protects personal health information and gives patients a variety of rights. The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes.

  • The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA regulations are published as part of chapter 21 of the CFR, and FDA's human subject protection regulations are in parts 50, 56, 312 and 812.

    For FAQs drafted by FDA please click here.

  • The U.S. Department of Health and Human Services (HHS) issues and enforces rules pertaining to the protection of human subjects in research. All regulations issued by federal agencies under the statutory authority established by Congress are published in the Code of Federal Regulations (CFR). Regulations pertaining to the protection of humans subjects can be found in Title 45 Part 46 (45 CFR 46) and is divided into four subparts: A, B, C, and D.