Effective November 1, 2022, all human subject research applications must be submitted on the “Protocol Form”. Any projects submitted on the old “Exempt Form” will no longer be accepted. OPRS will continue to make Exempt determinations for all eligible protocols. Exempt forms submitted to OPRS prior to November 1, 2022, will be reviewed.

The general statement of policy outlines the University of Illinois at Urbana-Champaign's basic responsibility to ensure the protection of human subjects and is applicable to all research involving human subjects.

Campus Administrative Manual: The policy describes the role of the Institutional Review Boards and the responsibilities of the investigators engaged in university-sponsored research activities involving human subjects, human tissues, or medical records of human subjects.

The Office for the Protection of Research Subjects (OPRS), while performing administrative functions of the Institutional Review Board (IRB), serves as the official oversight office for human subject research at Illinois. The office is the central point of contact for investigators, research subjects, and regulatory agencies. OPRS organizes and documents the IRB review process, monitors research regulations, produces educational resources for faculty and staff, and provides assurance that the Urbana campus is in compliance with federal, state, and campus policies.

OPRS requires all faculty, IRB members, staff, students, and researchers listed on an IRB protocol complete IRB training.

The IRB ensures that appropriate safeguards exist to protect the rights and welfare of research subjects [45 CFR 46.111]. In fulfilling these responsibilities, the IRB reviews all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The application or protocol, the consent/assent document(s), research equipment form, tests, surveys, questionnaires and similar measures, and recruitment documents are examples of documents that the IRB reviews.

International human research refers to research conducted outside the United States using participants from the local community. Such research involving UIUC investigators remains subject to the review and approval authority of the UIUC IRB and the obligations under the registration of the UIUC Federal Wide Assurance with OHRP.

Tool to guide researchers on methods for obtaining PHI from a HIPAA covered entitiy for research needs.

Individuals in a covered component of the University of Illinois Covered Entity may request a Box Health Data Folder (BHDF) that is capable of securely storing protected health information.

Key points, links to policies and guildeines

Per the University of Illinois HIPAA Privacy and Security Directive: “Each [Health Care Component] (HCC) must encrypt all HCC laptops and any HCC portable data storage devices used to access, process or store ePHI or has the potential to access, process or store ePHI, including but not limited to, flash drives, handheld devices, removable media, and backup media. Data encryption storage specifications must meet or exceed the minimum standard specified by the Security Official.“

Links to 1996 Act, Privcacy Rule, Security Rule and more.

In this section, you will find educational materials to help you learn more about the HIPAA Security Rule and other sources of standards for safeguarding electronic protected health information (e-PHI)

This page provides guidance about methods and approaches to achieve de-identification in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule.

With the proliferation and widespread adoption of cloud computing solutions, HIPAA covered entities and business associates are questioning whether and how they can take advantage of cloud computing while complying with regulations protecting the privacy and security of electronic protected health information (ePHI). This guidance assists such entities, including cloud services providers (CSPs), in understanding their HIPAA obligations.

Elsevier Author Information

General principles around consent and consent forms for editors to use when developing forms for their journals' purposes.