It may be sometimes difficult to tell if a project needs to be reviewed by the IRB. Your research project should be submitted to the IRB if it involves the collection of data from human subjects and fits the definition listed as follows. “Research” is defined as a systematic investigation designed to develop or contribute to generalizable knowledge through public dissemination such as published articles, presentations, and poster displays.

NOTE: If there is a possibility that the results will be published, cited in another paper, presented on a poster display, used in a thesis or essay, for example, the project should be reviewed by the IRB; retrospective review is NOT possible.

The following research proposals that fit the criteria listed above should be filed with the IRB:

  • All research involving human subjects conducted on campus by anyone, i.e., University-affiliated researchers (including faculty, staff, students, and administrators) and outside personnel.
  • All research involving human subjects conducted by anyone affiliated with the University whether the research is conducted on campus or off campus.

Project review is generally required for: 

I. SURVEY, INTERVIEW, FOCUS GROUP, & OBSERVATIONAL RESEARCH
Most survey, interview, focus group, and observational research involving human subjects should be reviewed by the IRB.

II. EVALUATION RESEARCH
The IRB will review evaluation projects such as those which collect data on a new course, technique, or pilot study to assess the effectiveness of the method or material, especially if the results are likely to be presented or published. The IRB will not review standard course evaluations. See also Departmental Research.

III. ORAL HISTORY
The IRB will review some oral history projects for risk of harm or loss of privacy to the subject. Projects must be considered as research resulting in generalizable knowledge. Single subject oral history projects do not fall under IRB jurisdiction because they are not generalizable.

Items of consideration during a review of oral history projects would include:

  • Who is being interviewed (any members of a special population group?)
  • The topic of the interview (anything likely to cause distress during the interview or in the event of a breach of privacy?)
  • What will be done with the tapes from the interview (destroyed? made publicly available?)
  • Is the subject fully informed of the content and intent of the project and the disposition of the tapes?

The IRB does not want to prevent research but does want to ensure that research is conducted ethically with full informed consent of the subject as appropriate.

IV. RESEARCH ON EXISTING DATA
If you are conducting research on human subjects through the study of already existing non-public data, documents, or records, the project must be reviewed by the IRB. If the secondary data is taken from a publicly available source (e.g., published census data or test scores; newspaper articles), you do not need to file with the IRB.

V. THESIS & ESSAY RESEARCH
IRB approval is necessary for human subject research which will result in publication in a graduate or senior student essay or thesis. NOTE: the project cannot be started until IRB approval has been obtained.

VI. STUDENT PROJECTS
Independent and internship research projects involving human subjects to be conducted by graduate or undergraduate students are normally reviewed by the IRB. Approval must be obtained before the project can be initiated. If the student is working on an established project already approved by the host institution’s IRB (e.g., at the Cleveland Clinic), the student should submit a copy of the approval memo with the request for credit or with the thesis/essay.

VII. CLASSROOM PROJECTS
In most cases, class projects involving human subjects are not intended to contribute to generalizable knowledge and therefore are not covered under the federal regulations for IRBs. However, IRB approval should be obtained for class research projects if (1) data will be collected from a human subject (e.g., opinions, behaviors, feelings, personal information), regardless of the sensitivity of the data, AND (2) the results of the classroom research project will contribute to generalizable knowledge (e.g., by publishing — including master’s theses; presenting outside the class; citing in another paper; poster presentations).
Project review may not be required for:

Listed below are types of projects which do not normally require IRB review. If you have any concerns or questions, the IRB welcomes consultations. Note that the IRB may be concerned if members of special population groups (e.g., prisoners, children, incapacitated adults) are contacted during a project. Even though the project may not require IRB review, the researcher is expected to adhere to the ethical guidelines of the subject area.

I. JOURNALISM PROJECTS
Journalistic investigation, such as a project conducted with the intent to publish a newspaper article, is not reviewed by the IRB. However, if the data collected during the project will be used in a thesis or essay or later published in a scholarly article, the project must be reviewed by the IRB prior to the start of the project.

II. CLASSROOM PROJECTS
In most cases, class projects involving human subjects are not intended to contribute to generalizable knowledge and therefore are not covered under the federal regulations for IRBs. However, IRB approval should be obtained for class research projects if (1) data will be collected from a human subject (e.g., opinions, behaviors, feelings, personal information), regardless of the sensitivity of the data, and (2) the results of the classroom research project will contribute to generalizable knowledge (e.g., by publishing — including master’s theses; presenting outside the class; citing in another paper; poster presentations).

III. NON-HUMAN STUDIES
Projects in which the focus is a business, event, or topic do not normally need IRB review. For example, if you are interviewing bookstore managers to determine how many copies of the new Betsy Ross biography are displayed in the store window, IRB review is not required since data on human subjects is not collected. However, if you ask the managers how they feel about the American flag or what their salary or social security number is, the IRB will need to review the project since opinions or private data are being collected.

If you are researching the history of tree planting in the eastern suburbs of Cleveland and want to talk to landscapers on species, methods, and soil quality, IRB review is not necessary. If, however, you want respondents to describe any traumatizing accidents they have witnessed while planting trees, IRB review will be necessary since data on personal experiences will be collected.

If the project collects private data in a manner which may cause harm or loss of privacy to the subject, the IRB should be consulted to minimize the risk to the individual.

IV. DEPARTMENTAL (INTERNAL) RESEARCH
If you are conducting research for use by your department which will not be disseminated publicly, the project may not need IRB review. Focus group, interview, or survey research, for example, which will be used to collect information on campus for NCA accreditation, does not need to be reviewed by the IRB. However, if data collected for accreditation will be published or shared with other universities, the IRB would review the project.

Projects which collect data to evaluate and improve services are not normally reviewed by the IRB. However, the data cannot be presented at a conference or referenced in a published article. See also Evaluation Research.

If the project collects private data in a manner which may cause harm or loss of privacy to the subject, the IRB should be consulted to minimize the risk to the individual.

V. ORAL HISTORY PROJECTS AND CASE STUDIES
Single subject studies will not result in generalizable knowledge are therefore do not fall under IRB jurisdiction.

 

The University of Chicago’s Social & Behavioral Sciences IRB Guidelines were helpful in preparing this page.