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IRB (Institutional Review Board)

Overview

The University of Chicago requires that all proposals for research or pedagogical development projects using human subjects must be reviewed by an Institutional Review Board (IRB) even if they do not use Federal funding. IRBs evaluate project protocols and human subject consent forms to determine whether a project can proceed. All projects using human subjects and the LLA facilities must have IRB approval.

There are two Institutional Review Boards (IRBs) at the University of Chicago:

The IRBs meet monthly during the academic year and one or two times in the summer. Protocols must be submitted to the appropriate IRB office by a set deadline before the monthly meeting.  Please contact the IRB office directly for specific dates. Protocols are approved for a twelve-month period and may be submitted for renewal for additional twelve-month periods.

Specifications

1. Risk factors
Certain risk factors to human subjects are of interest to an IRB. These include:

  • Physical risks (e.g., asking political questions of a subject in a dictatorial regime)
  • Psychological risks (e.g., asking a respondent to revisit painful episodes)
  • Privacy/confidentiality risks

If one can demonstrate that the benefits to a subject or subject's group outweigh the risk factors, the IRB may determine that the project can go forward.

2. Protection of vulnerable populations
There is a particular emphasis on the protection of "vulnerable" populations; for example: children under 18, handicapped individuals (especially when the research is motivated by the handicap), and institutionalized populations such as prisoners and hospital patients.

3. Consent form
It is very important to solicit the informed consent of any human subject. Actual consent forms must be presented to an IRB. It is taken on trust that they are given to participants and read. Passive consent is not acceptable; oral consent may be acceptable under certain conditions.

4. Attracting respondents
The IRB is interested in the use of advertising to attract respondents. For example, is too much compensation offered? That is, are people drawn to respond to questions they might not want to by the lure of money?

5. Paying Subjects
The preferred method for paying human subjects, whose identities must remain confidential, is by cash. If the investigator has a funding source, s/he should provide that source along with the estimated number of subjects who will participate in the study and the amount of money required to pay them. If an advance (a travel advance is usually appropriate) is approved, the investigator will receive the funds to pay the subjects prior to the interviews. Once the subjects have been paid, the signed consent forms (which should indicate the amount the subject will be paid) should be presented to the chair of the Social and Behavioral Sciences IRB. The chair should be asked to write a letter indicating the number of subjects who signed consent forms and the total amount paid; to clear the advance the letter should then be submitted to the person who prepared the advance as evidence of payment. If the chair of the IRB does not provide this letter, or if there are funds remaining from the advance, the money needs to be returned to the funding source.

6. Use of data
The future use/storage of collected data is also of interest to an IRB. If the data is archived, there must be built-in protections for respondents in the event of subsequent use. The archives of the LLA are an IRB-approved repository for research and project data.

For those using existing/archival data, IRB approval is still required if the study meets the definitions of both "human subjects" and "research" (as noted on pp. 6-7 in the University of Chicago Social and Behavioral Sciences IRB & Investigator Interim Manual). If no identifiers exist in the data set, then the research may be exempt from review by the IRB. The exemption decision chart states that if a project uses "solely existing data or specimens" and "those data or specimens are NOT publicly available" (e.g., data that require some sort of special permission for access), and the information is NOT "recorded by the investigator in such a way that it can be linked to the subject," then the research is exempt from Federal human subjects regulations (45 CFR Part 46). Additionally, if identifiers exist but the investigator will not record them as part of the research, the research may be exempt from review by the IRB. If the data could be considered "educational records", additional rules from the U.S. Department of Education--the Family Educational Rights Privacy Act (FERPA)--may also be applicable. The requirement for IRB review also applies to identifiable records a researcher may have access to in their daily duties either at work or school (i.e., a teacher has access to student grades but cannot use those records for research without the approval of the IRB).

Sample protocol submission forms are available at the LLA. A file of successful submissions is also available for review. For more information contact Michael Berger, manager of the LFRC.

 

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