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
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 UrbanaChampaign (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:
- Anyone responsible for such research must
- adhere to the principles of respect for persons, beneficence, and justice embodied in the Belmont Report;
- adhere to all UIUC policies and procedures set forth in the UIUC Handbook for Investigators and elsewhere;
- 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
- adhere to all applicable federal, state, and local requirements for the conduct of human subjects research.
- 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
- voluntaryit must occur as the result of free choice, without compulsion or obligation;
- based on full disclosure of the information needed to make an informed decision about whether or not to participate; and.
- based on the subject's comprehension of the information provided.
- 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.
- 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.
- Any payment made to subjects should not be so large as to constitute excessive inducement for participation.
- 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.
- Risks to subjects must be minimized and should be justified by the anticipated benefits to the subject or society.
- Adequate provision must be made to protect the privacy of subjects and to maintain the confidentiality of identifiable information.
- 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.
- This policy does not generally apply to routine course, workshop, or curriculum development using accepted educational practices sponsored by the University of Illinois at UrbanaChampaign 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
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 UrbanaChampaign (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
- is conducted by UIUC faculty, staff, student, or visiting researchers (including but not limited to intern, postdoctoral, and sabbatical researchers);
- is conducted on the premises of or is sponsored by the UIUC;
- is performed with or involves the use of facilities or equipment belonging to the UIUC;
- involves UIUC faculty, staff, students, or patients;
- satisfies a requirement imposed by the UIUC for a degree program or for a course of study; or
- is certified by a dean or department head to satisfy an obligation or a faculty appointment at the UIUC, including clinical and adjunct appointments.
Investigators with emeritus, clinical, adjunct, or "zero-percent" appointments should contact the IRB Office.
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:
- The UIUC researcher consults or is hired on his or her own time,
- the UIUC researcher holds no rights in the work, and
- neither the UIUC researcher nor the UIUC retains any data.
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.
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, 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.
Projects that use previously gathered human subjects data, and that meet the definition of human subjects research, require IRB review.
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.
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
investigator (RPI). Specifically, the RPI is charged
with assuring that
- the information
provided in the IRB application
is complete and correct.
- 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.
- 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.
- the project
will be performed by qualified personnel according to the
UIUC IRB-approved protocol.
- no change
will be made to the human subjects
protocol or consent form(s)
until approved by the UIUC IRB.
- legally effective
consent or assent
will be obtained from human subjects
problems, complications, and injuries involving subjects
will be promptly reported to the UIUC
- she(he) is familiar
with the latest edition of the UIUC Handbook for Investigators
and will adhere to the policies and procedures explained
- student and
on the project are knowledgeable about the regulations and
policies governing this research.
- she(he) will
meet with the project's other investigator(s)
on a regular basis to monitor study progress.
- 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
- the proposed
research has not been done,
is not underway, and will not begin before IRB
approval has been obtained.
- required research
records are retained for a period of at least three years.
The UIUC IRB is responsible for
- providing initial
review of human subjects
acceptability of proposed research
in terms of UIUC policies and
that reviews are conducted
according to university policy;
- providing advice
and information to investigators
engaged in research involving
- developing policy, procedures, information, and instructions regarding human subjects research;
- ensuring compliance with externally mandated policies and regulations;
- aducating differences and reviewing problems arising in research involving human subjects, and
- reporting to
the appropriate institutional officials and, for research
governed by HHS
regulations, to the Secretary
of HHS, any serious or continuing adverse
events or investigator
noncompliance with the requirements and determinations of
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.
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.
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.