Investigator Handbook Part I
Part I: Research Subject to Institutional Review Board (IRB) Review
- A. Scope of IRB Review
- B. Research Conducted by "Affiliated" Faculty
- C. Projects for which the Researcher is a Consultant
- D. Research Conducted in Courses
- E. Individual Research Projects Conducted by Students
- F. Research Conducted at non-UIUC Sites
- G. Research in Multicenter Clinical Trials
- H. Pilot and Feasibility Studies
- I. Research involving a Secondary Use of Data
- J. Research using "Waste" or "Extra" Material
- Back to Handbook Contents
The scope of the IRB's charge is broad. Generally, any research involving living humans, human tissues or specimens, or humans' records or data that is conducted by any faculty, staff, student, 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
- is conducted by UIUC faculty, staff, student, or visiting researchers (including but not limited to intern, postdoctoral, and sabbatical researchers);
- is sponsored by the UIUC;
- is performed with or involves the use of facilities or equipment belonging to the UIUC;
- involves UIUC faculty, staff, or students as part of the research team;
- satisfies a requirement imposed by the UIUC for a degree program; or
- is certified by a dean or department head to satisfy an obligation or a faculty appointment at the UIUC
B. Research Conducted by "Affiliated" Faculty or Staff
Investigators with emeritus, clinical, adjunct, or "zero-percent" appointments should contact the IRB Office.
C. 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:
- the UIUC researcher/consultant consults or is hired on his or her own time,
- the UIUC researcher/consultant holds no rights in the work (including publication) and
- neither the UIUC researcher/consultant nor the UIUC retains any data.
D. Research Conducted in Courses
IRB approval is required for some but not all class assignments that involve human subjects. A detailed explanation of when research conducted by students in conjunction with a UIUC course requires IRB approval is described in the following document: Human Subjects and Class Assignments.
When designing a project, students should be instructed on the ethical conduct of research and on the preparation of the IRB application when such is required. In particular, instructors and students should
- understand the elements of informed consent,
- develop appropriate consent documents,
- plan appropriate recruitment strategies for identifying subjects,
- identify and minimize potential risks to subjects,
- assess the risk-benefit ratio for the project,
- establish and maintain strict guidelines for protecting confidentiality, and
- allow sufficient time for IRB review and completion of the project.
E. Individual Research Projects Conducted by Students
Independent class projects, senior theses, undergraduate research projects, master's and advanced degree research, and similar exercises must be independently submitted for IRB review. The responsible principal investigator must be a non-visiting UIUC faculty member or staff who is serving as advisor or mentor to the student and will directly oversee the research.
TopF. 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.
G. 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.
H. 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.
I. 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.
J. 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.