UIUC Human Subjects Research Policy Statement

UIUC Research Subject to Institutional Review Board (IRB) Review
Scope of IRB Review
Research Conducted by "Affiliated" Faculty
Projects for which the Researcher is a Consultant
Human Participants and Class Assignments
Research Conducted at non-UIUC Sites
Research in Multicenter Clinical Trials
Pilot and Feasibility Studies
Research involving a Secondary Use of Data
Research using "Waste" or "Extra" Material
UIUC Federal Assurance of Human Subjects Protection
UIUC Distribution of Responsibilities in Human Subjects Research
UIUC Subject Pools
Research Records Retention
UIUC Campus Administrative Manuals
UIUC Conflicts of Interest Policy
UIUC Family Educational Rights and Policy Act (FERPA) Policies
University of Illinois Social Security Number Policy

UIUC Human Subjects Research Policy Statement

Consult the UIUC Investigator Handbook, this 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, independent study projects, and course projects must follow this policy if they involve human subjects.

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. Further information on the limits to this policy is described in the Handbook for Investigators.

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

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UIUC Research Subject to Institutional Review Board (IRB) Review

Scope of IRB Review

The scope of the IRB's charge is broad. Generally, any research involving living humans, human tissues, or humans' records that is conducted by any employee or agent of the University of Illinois at Urbana–Champaign (UIUC), or otherwise conducted at or sponsored by the UIUC, requires IRB review, irrespective of the risks, scope, funding, or location of the research. Specifically, IRB review is required for any human subjects research that

Research Conducted by "Affiliated Faculty"

Investigators with emeritus, clinical, adjunct, or "zero-percent" appointments should contact the IRB Office.

Projects for which the Researcher is a Consultant

When the UIUC researcher is a consultant, he or she is deemed to be "conducting" research and IRB approval is required, unless all three of the following are true:

  1. The UIUC researcher consults or is hired on his or her own time,
  2. the UIUC researcher holds no rights in the work, and
  3. neither the UIUC researcher nor the UIUC retains any data.

Research Conducted at non-UIUC Sites

Irrespective of the research site, any human subjects research conducted by any UIUC employee or agent requires UIUC IRB review and approval. UIUC researchers who participate in off-campus research must receive approval from the UIUC IRB and from the IRBs at any outside institutions participating in or sponsoring the research. If no IRB or IRB-like committee exists at a given institution, researchers should consult the UIUC IRB Office on how to document the outside institution's approval. Researchers might be required to provide formal, written assurance that the research will be conducted according to ethical standards. The UIUC's approval of off-campus research is made contingent on outside institutions' approvals and assurances.

Off-campus research at sites that are not formally affiliated with an institution, government, or other agency (e.g., in foreign countries or remote locations) must still receive approval from the UIUC IRB. The research must be approved by the local equivalent of an IRB for the off-campus site or, where there is no equivalent group, by local experts or community leaders. Appropriate permissions must be documented.

Research in Multicenter Clinical Trials

National level approval of a research proposal is not sufficient to bypass UIUC IRB approval. Researchers who conduct multicenter clinical trials sponsored by the National Institutes of Health (NIH) or the National Cancer Institute (NCI), for example, should include protocols and consent forms approved at the national level with their IRB applications. Although the documents will be identified as having been approved by a national IRB, the UIUC IRB must review the material as it would any other submission (OPRR Report Number 93-01).

Pilot and Feasibility Studies

Pilot and feasibility studies, regardless of the number of subjects, require the same scrutiny as full-scale research projects and must be submitted for IRB review and approval. Pilot and feasibility studies should be identified as such in the IRB application. Subjects should be told that the study is a pilot.

Research involving a Secondary Use of Data

Projects that use previously gathered human subjects data, and that meet the definition of human subjects research, require IRB review.

Research using "Waste" or "Extra" Material

Research conducted on waste or extra human tissues or fluids must be submitted for IRB review.

Waste material is material originally collected for clinical or diagnostic purposes but that is no longer needed for that purpose.

Extra material is material collected during a clinical or diagnostic procedure but, solely for investigative purposes, in quantities above and beyond what was needed for the procedure.

UIUC Distribution of Responsibilities in Human Subjects Research

The responsibility for the protection of subjects in research is distributed among several parties: the responsible project investigator (RPI), the departmental executive officer, the Institutional Review Board (IRB) and IRB-approved departmental review bodies, and those at cooperating institutions who participate in UIUC-approved research or provide access to subjects.

Responsible Project Investigator

The primary responsibility for the day-to-day protection of the rights and welfare of human subjects lies with the responsible principal investigator (RPI). Specifically, the RPI is charged with assuring that

  1. the information provided in the IRB application is complete and correct.
  2. as Responsible Project Investigator, she(he) takes ultimate responsibility for the protection of the rights and welfare of human subjects, the conduct of the study, and the ethical performance of the project.
  3. she(he) will comply with all UIUC policies and procedures, the terms of its Federalwide Assurance, all applicable federal, state, and local laws, and policies of the sponsoring agency and cooperating institutions, as applicable, regarding the protection of human subjects in research.
  4. the project will be performed by qualified personnel according to the UIUC IRB-approved protocol.
  5. no change will be made to the human subjects protocol or consent form(s) until approved by the UIUC IRB.
  6. legally effective informed consent or assent will be obtained from human subjects as required.
  7. adverse events, unanticipated problems, complications, and injuries involving subjects will be promptly reported to the UIUC IRB Office.
  8. she(he) is familiar with the latest edition of the UIUC Handbook for Investigators and will adhere to the policies and procedures explained therein.
  9. student and guest investigators on the project are knowledgeable about the regulations and policies governing this research.
  10. she(he) will meet with the project's other investigator(s) on a regular basis to monitor study progress.
  11. if she(he) will be unavailable, as when on sabbatical or other leave, including vacation, she(he) will arrange for an alternate faculty sponsor to assume responsibility during her(his) absence and will advise the UIUC IRB by letter of such arrangements.
  12. the proposed research has not been done, is not underway, and will not begin before IRB approval has been obtained.
  13. required research records are retained for a period of at least three years.

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UIUC IRB

The UIUC IRB is responsible for

Individual or Institution Providing Access to Subjects

If access to research subjects is obtained through cooperating institutions, the authorized official of the cooperating institution must be informed of the research and should satisfy herself or himself that the subjects' rights and welfare will be protected and that institutional commitments to the subjects will not be abridged. For federally funded research, the cooperating institution may be required to provide a formal, written assurance that human subjects research will be done in accordance with ethical and regulatory guidelines.

If professional practitioners or service agencies provide access to subjects, the individual providing access should ensure that his or her professional commitments to the clients are not abridged.

If the individual responsible for conduct of the activity is not a UIUC employee or student, but the UIUC is the cooperating institution providing access to research subjects, the individual providing access to the subjects is responsible for ensuring that UIUC policies and procedures, including review requirements, are met.

UIUC Subject Pools

No UIUC department may establish a student subject pool without prior written authorization from the IRB Office. When UIUC students are enrolled in a course in which participation as human subjects forms an integral part of the course, the official University course catalogue and timetable shall state that fact in the course description. A statement such as the following shall be included in the course description: "Includes limited voluntary participation as a subject in research activities." This statement will serve to alert registrants, but it does not suffice as the only means of ensuring that the subjects' participation in a specific research activity is voluntary. Detailed guidelines are available from the IRB Office.

Research Records Retention

Federal regulations require the retention of all records relating to the IRB and to human subjects activities for at least three years after completion of the research. Records, including applications, amendments, signed consent forms, and collected data, must be accessible for inspection at any time and for copying by authorized representatives of the UIUC, HHS, or the specific agencies sponsoring the research.

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