Human Subjects Research

Nurse pierces the patient's arm vein with needle blank tube.

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.

InfoEd Online Submissions

Online submission of IRB protocols is now available. All initial, continuation and amendment submissions can be sent to the IRB office through the . Please note that InfoEd relies on pop-ups, so you may need to turn off your pop-up blocker (especially when using Chrome).

Be sure to enter the portal by selecting "click here" (not the more obvious username and password fields).
You will use your 麻豆精品 username and password if you're not already logged in through single sign-on.
If you are unable to access the system, it could be that you do not have a profile yet. Please contact erahelp@niu.edu to have a profile created.
Non-麻豆精品 affiliates will need to contact erahelp@niu.edu in order to establish a profile in the system.
For submission preparation, it may be helpful to see a Word version of the e-form application (DOCX) to familiarize yourself with the questions in the application in the protocol record.

You may find our covering InfoEd user assistance helpful as you navigate the system.

Additional Resources: Brief How-to Videos

Please note: If you are not affiliated with 麻豆精品, you will need to contact researchcompliance@niu.edu for access to the videos.

New submissions:

After the initial submission:

Additional topics:

Common Rule Revision

Final version of the revised Common Rule 45CFR46 subpart A became effective Jan. 21, 2019

Summary of changes to the Common Rule (PDF)
(COGR)
(PRIM&R)

IRB Review Requirements

Your project requires IRB review if it meets both of the following criteria:

When is Institutional Biosafety Review and Approval Necessary and What Regulations Apply?

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.

It involves human subjects

Human Subject

Human subject is defined as 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

Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place,
Information that 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 麻豆精品, you must contact the Office of Research Compliance, Integrity and Safety (ORCIS) at researchcompliance@niu.edu so that the appropriate agreements and IRB review processes are completed before the research begins.

In general, if 麻豆精品 personnel are the primary investigator for the research, the IRB review should be conducted by the 麻豆精品. Where the primary investigator is from another institution, 麻豆精品 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 麻豆精品 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 麻豆精品 IRB policies prior to their involvement in the research.

If you are not affiliated with 麻豆精品 and wish to recruit research participants please follow the . This information will assist you with filling out the . Note, this only applies to those not currently affiliated with 麻豆精品.

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 麻豆精品’s IRB before resuming work on your project.

Compliance, Integrity and Safety

Contact Us

Office of Research Compliance, Integrity, and Safety
(for questions related to the IRB approval process)
researchcompliance@niu.edu

IRB Chair
Carol Walther, Ph.D.
815-753-0365
cwalther@niu.edu

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 麻豆精品 the IORG #0000317.

Reporting Concerns