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Human Subjects Research

Does my project require IRB Review?

New faculty/staff/students with existing research projects

If you are new to Northern Illinois University and are still recruiting subjects or continuing to analyze identifiable research data from human subjects that was collected while you were at your previous institution, you will need to obtain IRB approval from NIU’s IRB before resuming work on your project.

Collaborative research with other institutions

If you are collaborating with other researchers on a single study conducted at multiple sites, and the principal or lead investigator for the project is not affiliated with Northern Illinois University, NIU may choose to designate the IRB of one of the other sites in the study as the IRB of record for the project. Although you would not then be required to complete the full IRB review process, you must contact the Office of Research Compliance (815-753-8588, jgommel@niu.edu) so that the appropriate agreement can be drafted. 

New research projects

If your project meets the definition of “research with human subjects,” IRB review is required. This determination is actually made by asking two separate questions:

  1. Does my project meet the definition of “research”
  2. Does my project involve human subjects?

Your project requires IRB review if you answer “Yes” to both questions.

If you are unsure if your project requires IRB review, please complete the IRB screening form and submit it to the Office of Research Compliance (ORC).  You may also submit the screening form if you wish to have a letter from the ORC verifying that IRB review is not required.

Is it research?

Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Research encompasses work that is conducted on or off campus, in person or online, and includes questionnaires, interviews, tests, observations, surveys, and other experimental methodologies, regardless of the content or routine nature of the topic and whether the work is a preliminary (such as pilot studies) or a fully developed study.

  • Systematic investigation:  the use of step-by-step, purposeful procedures in order to reduce partiality (error) in the data and increase control over the results, allowing the knowledge to be applied to populations and settings different from the ones from which it was collected.  Through this process, the researcher is seeking underlying principles or laws of nature that can predict future outcomes.
  • Generalizable knowledge:  new information that has relevance beyond the population or program from which it was collected because impartial procedures were used, and the information is intended for professional presentation outside the classroom setting. 

Here are some examples of projects that do NOT meet the definition of research because they do not contribute to generalizable knowledge:

  1. Projects that are conducted only as a classroom assignment and will not be shared outside of the student’s department.
  2. Projects whose results will only be used for evaluation of the effectiveness or acceptance of an existing program.
  3. Projects whose data will only be shared with clients or stakeholders, such as an evaluation of a community’s attitudes about a proposed new program or service.

*Please note that research conducted for a thesis or dissertation does contribute to generalizable knowledge, as the thesis or dissertation will be made available to other scholars.

Does my project involve human subjects?

Human Subject:  a living individual about whom an investigator (whether professional or student) conducting research obtains:

1) data through intervention or interaction with the individual; OR

2) individually identifiable private information (information that is not publicly available). 

  • Intervention: includes both physical procedures by which data are gathered (for example, heart rate, weight measurement, blood sample) and manipulations of the subject or the subject's environment that are performed for research purposes (for example, placement in one of three learning conditions, use of a room with and without a mirror present, application of different muscle development therapies).
  • Interaction: includes communication or interpersonal contact between investigator and subject (for example, interviews, focus groups, surveys – including mailed and on-line).

Private information: includes 1) information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, 2) information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record, g.p.a.), or 3) information provided specifically in response to data collection (for example, responses to a survey).