Human Subject Research
The Office of Research Compliance and Integrity promotes the protection of human subjects in research by requiring Institutional Review Board (IRB) approval for all research projects that meet the definition of human subject research.
IRB Review Requirements
Your project requires IRB review if it meets both of the following criteria:
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:
- Projects that are conducted only as a classroom assignment and will not be shared outside of the student’s department.
- Projects whose results will only be used for evaluation of the effectiveness or acceptance of an existing program.
- 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.
Human Subject: a living individual about whom an investigator (whether professional or student) conducting research obtains:
- data through intervention or interaction with the individual; or
- 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:
- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place,
- 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, GPA), or
- information provided specifically in response to data collection (for example, responses to a survey).
Cooperative Research with Other Institutions or Outside Investigators
If you are working on a research project in cooperation with researchers who are not affiliated with NIU, you must contact the Office of Research Compliance, Integrity and Safety (ORCIS) at 815-753-8588 or firstname.lastname@example.org so that the appropriate agreements and IRB review processes are completed before the research begins.
In general, if NIU personnel are the primary investigator for the research, the IRB review should be conducted by the NIU. Where the primary investigator is from another institution, NIU may choose to designate the IRB of another institution as the IRB of record for the project, but an IRB authorization agreement must be put in place between NIU and the reviewing IRB before any recruitment or data collection takes place.
If you are collaborating with an independent investigator who is not affiliated with an institution that has an IRB, the IRB requires that the outside investigator sign an independent investigator agreement verifying that they will adhere to NIU IRB policies prior to their involvement in the research.
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 were 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.
Common Rule Revision
Final version of the revised Common Rule 45CFR46 subpart A becomes effective January 21, 2019
Northern Illinois University has a Federal Wide Assurance (FWA) with the Office for Human Research Protection (OHRP). Our FWA# is FWA00004025. The OHRP has assigned NIU the IORG #0000317.