Investigator Handbook Part I
Part I: Research Subject to Institutional Review Board (IRB) Review
- A. Scope of IRB Review
- B. UIUC IRB Review and Affiliated Researchers
- 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 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 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
Researchers employed by another institution who have a partial University appointment ("Affiliated Researchers") must submit their proposed research to the UIUC IRB for review when the University is "engaged" in human subjects research (see OHRP Guidance on Engagement of Institutions in Human Subjects Research [October 2008]). In other words, Affiliated Researchers are not required to submit the research to the UIUC IRB simply because they have a partial University appointment.
Generally, the University will be engaged in human subjects research under any of the following circumstances:
- The research is funded, in whole or in part, through or by the University.
- University employees or students (other than the Affiliated Researchers) will intervene or interact with the human subjects for research purposes by:
- Performing non-invasive or invasive procedures;
- Manipulating the environment (e.g., controlling environmental light, sound, or temperature; presenting sensory stimuli; and orchestrating environmental events or social interactions;
- Engaging in protocol-dictated communication or interpersonal contact with the subjects, such as conducting interviews or administering questionnaires;
- Obtaining the informed consent.
- University employees or students (other than the Affiliated Researchers) will obtain or have access to identifiable private information or identifiable biological specimens. Obtaining identifiable private information or identifiable specimens includes, but is not limited to:
Private information or specimens are considered individually identifiable when they can be linked to specific individuals by the investigator either directly or indirectly through coding systems.
- Observing or recording private behavior;
- Using, studying, or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution;
- Using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the investigators.
If any of these conditions applies to a research protocol, the PI must submit an IRB application to the UIUC IRB Office. Affiliated Researchers are urged to contact the UIUC IRB office if they have any questions about this requirement.
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.
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.
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.
Irrespective of the research site, any human subjects research conducted by any UIUC employee or agent requires IRB review and approval. In general, UIUC investigators planning to conduct research at non-UIUC sites must obtain approval from the UIUC IRB. There may be some exceptions to this rule. When investigators plan to conduct research at or plan to collaborate in research activities at other institutions with a Federalwide Assurance (FWA), the UIUC IRB or the IRBs at these institutions may, under specific situations, enter into a formal agreement between the institutions allowing the review to be carried out by just one institution. Researchers should contact the UIUC IRB for specific information.
When investigators plan to conduct or collaborate in human research at an institution or entity that does not have an FWA, UIUC IRB Approval is required. 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 may also need to 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.
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.