Human Research Protection Program

Purpose

To protect the rights and welfare of human subjects in research; to establish Institutional Review Boards (IRBs), other review units, oversight functions, and educational and quality assurance activities involved in the oversight of research involving human subjects; and to comply with applicable federal, state, and international policies, laws, and regulations.

Scope

This policy applies to all members of the campus community including but not limited to university faculty (tenure system, specialized faculty at the professorial ranks of assistant, associate, and full, and modified professorial ranks such as adjunct and visiting), staff, students, postdoctoral appointees, visiting scholars, and visiting scientists who are engaged in research with human subjects, human tissue, and/or the individually identifiable, private information of human subjects (such as medical records) conducted under the university’s purview and irrespective of the risks, project scope, funding, or location of the research.

Authority

Office of the Vice Chancellor for Research and Innovation

Policy

All human research conducted by members of the university community, using university facilities or resources, or involving use or disclosure of identifiable private information created or maintained by the university will be performed in compliance with applicable federal and state law and be guided by the ethical principles of the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” (the “Belmont Report”). These principles include:

1. Respect for Persons, which involves the acknowledgment and support of autonomy, and protection of those with diminished autonomy
2. Beneficence, which involves ensuring that possible benefits of research are maximized, and possible harms are minimized
3. Justice, which involves the fair distribution of the benefits and burdens of research through the equitable selection of subjects

All individuals engaged in university-sponsored research activities involving human subjects, human tissues, and/or medical records of human participants, must:

1. Comply with applicable federal, state, and international laws and regulations relating to human subjects research
2. Be appropriately qualified and trained
3. Conduct human subjects research activities in accordance with approved protocols

The Principal Investigator (PI) of a proposed research activity that involves human subjects is responsible for the following activities, as applicable:

1. initiating and submitting new or amended IRB protocols, Not Human Subject Research (NHSR) determination requests, and/or reliance agreement requests
2. promptly submitting protocol amendments, continuing review requests, progress reports, final reports, adverse event reports, and protocol deviation reports to OPRS
3. coordinating Postapproval monitoring activities with OPRS
4. coordinating with other offices and units
5. ensuring that any external sponsor requirements are met

Processes/Procedures/Guidelines

The university has an institutional obligation to protect participants in human subjects research.  The university has therefore established the Office for the Protection of Research Subjects (OPRS) to coordinate its Human Research Protection Program (HRPP), three Institutional Review Boards (IRBs), and other functions related to human subjects research.

No research or clinical investigations involving human subjects as defined by applicable federal regulations can proceed without prior approval by an IRB or OPRS. It is important to note that while many areas of research and scholarship involve engagement with humans in some fashion, OPRS policy, guidance, and IRB review requirements are focused on the subset of research activities that fall under the federal definitions related to human subjects research that require review by an IRB as described in the Definitions section below.

The university’s institutional review boards are authorized to review and to approve, require modifications to, or disapprove any research involving human subjects in accord with their own standard operating procedures and applicable laws, regulations, and institutional policies. The IRBs also have the authority to monitor, suspend, reinstate, and terminate protocols.

As part of its HRPP, OPRS facilitates the activities of the IRBs, adopts and enforces written policies and procedures governing the conduct of human subjects research, facilitates continuous HRPP improvements, carries out quality assurance and quality improvement functions such as compliance monitoring, handles complaints and inquiries by research participants, supports management of multisite research studies with other institutions via the reliance / singleIRB process, and coordinates with other review committees and offices as applicable.

The senior vice chancellor for Research & Innovation serves as the institutional official and is responsible for appointing qualified members to serve on IRBs in accordance with federal regulatory requirements.  The University of Illinois Urbana-Champaign supports three IRBs: the Social Behavioral IRB (IRB #1), the Biomedical IRB (IRB #2), and an administrative IRB for expedited research (IRB #3).

Principal Investigators and their research team members must use the IRBOnline system to submit new IRB protocols (New Study Applications), amendments, other reports related to current IRB protocols, and requests for NHSR determinations to OPRS.

Additional reviews are required for certain types of studies. Information on ancillary review processes can be found on the OPRS website. Common examples of these include, but are not limited to:

• Research that involves human blood or tissue samples must also be reviewed and approved by the Institutional Biosafety Committee that is managed by the Division of Research Safety.
• Research that involves teachers or students from K-12 schools in the State of Illinois should be coordinated with the Office of School-University Research Relations (OSURR). Researchers working with K-12 schools in other states or internationally are encouraged to contact the OSURR for recommendations on how to approach and maintain positive relationships with school research partners.
• Research that involves collecting personal information from persons in the European Union must also engage with the Privacy Team in Technology Services to conduct a privacy impact assessment consistent with the European Union’s General Data Protection Regulations (GDPR).
• Research that involves collecting personal information from persons in mainland China must also be reviewed by the Personal Information Protection Law (PIPL) Research Oversight Committee.

Required online training about conducting human subjects research compliant with the applicable regulations can be accessed via the OVCRI’s Training Portal.  Additional in-person customized trainings can be requested by contacting OPRS.

More procedural guidance is provided on the OPRS website.

Definitions

• A Human Subject (also known as “Research Participant” or “Participant”) is defined as a living individual about whom an investigator conducting research either (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes that information or those biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.  Under U.S. Food and Drug Administration (FDA) regulations, a human subject is an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.
• Clinical Investigation is defined as any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
• Research is defined by the federal regulations as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
  • Human subjects research is classified as either exempt or nonexempt. Exempt human subjects research is minimal risk research that fits one or more federally defined exemption categories. Otherwise, human subjects research is nonexempt.
• Not Human Subjects Research (NHSR) is a specific determination that can be made by the Office for the Protection of Research Subjects or an Institutional Review Board signifying that the activities do not meet one or more of the federal definitions of human subjects research requiring review by an IRB or requiring a formal exemption determination. Examples of NHSR scholarly activities include journalism, program evaluation, and public health surveillance activities.
• Institutional Review Board (IRB) is a university committee that reviews and dispositions IRB protocols, amendments, and reports. IRB membership requirements and functional duties are defined by federal regulations.
• Human Research Protection Program (HRPP) is the mission of the Office for the Protection of Research Subjects (OPRS). OPRS provides staff support for IRB operations and also coordinate other matters including reliance agreements, biological safety, management of participant complaints and inquiries, and financial conflicts of interest management in accordance with the University of Illinois System policy on Financial Conflicts of Interest in Research.
• Federal Regulations on Human Subjects Research are from the Department of Health and Human Services (HHS) (Code of Federal Regulations Title 45 Part 46) and the Food and Drug Administration (FDA) (Code of Federal Regulations Title 21 Part 50). Additional regulations may be applicable depending on the nature of the proposed research.
• The Principal Investigator is the university employee who is ultimately responsible for the conduct of the research study. The university defines eligibility to serve as a Principal Investigator differently for externally sponsored research (see CAM policy RP-06) versus research that may be unfunded and is governed by compliance requirements such as those for human subjects research (see CAM policy RP-19).
• A Reliance Agreement (or “Single IRB” agreement) is used for multi-institutional studies conducting nonexempt human subjects research.
• Post-Approval Monitoring is a type of internal audit to verify that research procedures are being conducted in accordance with the applicable approved IRB protocol.

Exceptions

There are no exceptions to this policy.

Contact

Contact OPRS at irb@illinois.edu