Introduction

All research involving human subjects that is conducted at or sponsored by the University of Illinois at Urbana-Champaign (UIUC), whether funded or unfunded and whether conducted by UIUC faculty or others, must comply with applicable policies for the protection of human subjects. Under a formal assurance made by the UIUC 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 subjects research at UIUC. The IRB follows widely accepted ethical principles, legally binding federal regulations, campus policies, procedures, and practices, and other guidelines in carrying out this important responsibility.

The UIUC IRB Office, while performing administrative functions of the IRB, also serves as the official oversight office for human subjects research. The IRB Office is the central point of contact for investigators, research subjects, and regulatory agencies. The IRB Office is responsible for organizing and documenting the IRB review process, monitoring research regulations, producing educational programs and materials for faculty and staff, and providing assurance that the UIUC is in compliance with federal, state, and campus policies. The IRB Office is part of the Office of the Vice Chancellor for Research. The Vice Chancellor for Research is the federally authorized institutional official charged with overseeing human subjects research and IRB functions at UIUC.

UIUC Policy Statement

Consult the UIUC Investigator Handbook, the IRB Web site (www.irb.uiuc.edu), and other formal UIUC policy documents for details. This is a summary statement.

Applicability of the Policy

This policy applies to any human subjects research activity that is conducted by any UIUC employee or agent, or otherwise conducted at or sponsored by the University of Illinois at Urbana–Champaign (UIUC), irrespective of the risks, scope, funding, or location of the research. The policy is applicable to research involving living human beings whose physical, emotional, or behavioral conditions, responses, speech, tissues, or fluids are investigated for research purposes. It is applicable to the use of interviews, tests, observations, and inquiries designed to elicit or obtain nonpublic information about individuals or groups. It also applies to the study of existing records where the identity of individuals is known or could be readily ascertained, if the information was provided by the individual(s) under the reasonable expectation that it would not be made public (e.g., a medical record).

The policy is applicable to research undertaken on either a large or small scale, whether it is externally funded, internally funded, or not funded, and regardless of where it occurs. Pilot projects, student dissertation and thesis projects, and independent study projects must follow this policy if they involve human subjects.

Top

Summary Statement of the Policy

The University of Illinois at Urbana-Champaign (UIUC) recognizes its basic responsibility to ensure the protection of human subjects. To this end, it has adopted the following statement of policy applicable to all research involving human subjects that is conducted at or sponsored by the UIUC or conducted by any UIUC employee or agent:

1. Anyone responsible for such research must
   1. adhere to the principles of respect for persons, beneficence, and justice embodied in the Belmont Report;
   2. adhere to all UIUC policies and procedures set forth in the UIUC Handbook for Investigators and elsewhere;
   3. adhere to the policies, principles, and procedures set forth in the UIUC's Federalwide Assurance, on file with the Office for Human Research Protections; and
   4. adhere to all applicable federal, state, and local requirements for the conduct of human subjects research.
2. The decision of human subjects to participate in research governed by this policy must meet the standards of informed consent. If children are involved as subjects and are capable of assent, their assent to participate must be solicited in addition to the consent of their parents. The decision to participate must be
   1. voluntary—it must occur as the result of free choice, without compulsion or obligation;
   2. based on full disclosure of the information needed to make an informed decision about whether or not to participate; and.
   3. based on the subject's comprehension of the information provided.
3. The selection of research subjects must be fair. Subjects should not be selected for potentially beneficial research on the basis of favoritism, nor should risky research be targeted to subjects who are less powerful.
4. The procedures for recruiting subjects must protect their privacy and be reasonable in terms of their conditions or circumstances. No coercion, explicit or implicit, should be used to obtain or maintain cooperation.
   1. Any payment made to subjects should not be so large as to constitute excessive inducement for participation.
   2. When access to subjects is gained through cooperating institutions or individuals, prior commitments made to the subjects about the confidentiality or other terms of the primary relationship should not be abridged.
5. Risks to subjects must be minimized and should be justified by the anticipated benefits to the subject or society.
6. Adequate provision must be made to protect the privacy of subjects and to maintain the confidentiality of identifiable information.
7. Approval for conducting research with human subjects must be obtained prior to any involvement of subjects. All such research must be reviewed by the UIUC Institutional Review Board (IRB) or an approved entity appropriately delegated by the IRB. All approved projects must be periodically reevaluated.
8. This policy does not generally apply to routine course, workshop, or curriculum development using accepted educational practices sponsored by the University of Illinois at Urbana–Champaign or to aid or services provided by professionals to their clients.

Date Issued: January 2003
Approved by: Vice Chancellor for Research
Academic Policies: Section II-15

Top