Office of Sponsored Research

Does My Project Need IRB Review?

It may be sometimes difficult to tell if a project needs to be reviewed by the IRB. Your research project must be submitted to the IRB if it involves the collection of data from human subjects and fits the following definition of “human subject research”:

What is HUMAN SUBJECT RESEARCH?

human subject is defined as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information about a human subject, which includes a subject’s opinion on a given topic. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

In order to be considered human subject research, the Private information that is collected must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information through coding).

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Research can include a wide variety of activities, including experiments, observational studies, surveys, tests, and recordings designed to advance the knowledge of a particular field. It generally DOES NOT INCLUDE such operational activities such as quality assurance, quality improvement, certain aspects of public health practice, program evaluations, marketing studies, fiscal or program audits, journalism, history, biography, philosophy, “fact-finding” inquiries (such as criminal investigations, intelligence gathering), and simple data collection for other purposes.

What you do with your results matters…

If you plan to publish, present, or archive your research, or otherwise share the results of the study, including the uploading of your results to an online or cloud-based platform, IRB review will likely be required. Please be aware that you must submit your research project application to the IRB for approval prior to initiating the research. However, human subject research that is not disseminated (e.g., it is conducted as part of coursework and is not shared outside of the classroom; university or departmental assessments that are not shared beyond the university; etc.) is NOT subject to review by the IRB.

Project review is generally required for: 

  • Survey, Interview, Focus Group, & Observational Research
  • Evaluation Research: 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.
  • 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. Items of consideration during a review of oral history projects would include:
    • Who is being interviewed (any members of a vulnerable 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 any recordings 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 recordings?
  • Research on Existing Data: the study of already existing non-public data, documents, or records, 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.
  • Graduate Thesis, Master’s Essay, Capstone Project, Honors Project, etc.

 

Project review may not be required for:

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.

Classroom Projects:
In many academic programs, a course in research methods/methodology is part of the curriculum. Instructors may encourage their students to design small projects simply to teach them how to properly conduct research. In many cases, the data will not be used to contribute to generalizeable knowledge and may not require IRB review. 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 be disseminated — including master’s theses; presenting outside the classroom; citing in another paper; poster presentations; or including in a resume, online portfolio, graduate school application, etc.

Program Evaluations:
Investigators may gather data from human subjects through direct or indirect interaction to evaluate a program, a specific policy, or marketing campaign. The information they collect will not be used to contribute to generalizeable knowledge, rather the results will be used to improve or develop an internal program.

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.

Departmental or University-Wide Studies:
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.

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.

Biographies and Case Studies:
Single subject studies will not result in generalizable knowledge are therefore do not fall under IRB jurisdiction.

 

RETROSPECTIVE IRB APPROVAL IS NOT PERMITTED:
Investigators are strongly cautioned to consider whether or not the information collected will be used to contribute to generalizeable knowledge; the investigator must decide in advance, as it is not possible to retrospectively review and approve a project once data collection has begun. If an investigator is unsure about how the data will be used, it is better to err on the side of caution and submit an application for review.

Final Note:

Even when projects do not qualify as “human subjects research”, as defined by federal regulations, they must be conducted with the utmost regard for University policies, Jesuit values, ethical standards, and the welfare of human participants.