IRB FAQs

The goal of the Institutional Review Board, or IRB, is to protect the rights of research participants or human subjects. 

The IRB also works to educate and inform researchers on their responsibilities regarding human subjects research. 

What is research?

The IRB defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” 

What is a human subject?

A human subject is a living individual about whom an investigator obtains data. This may be in the form of information or biospecimens. The investigator may obtain this data through intervention or interaction with the individual.

If the investigator does not interact directly with the human subject, they may still be conducting human subject research. For example, if an investigator conducts research involving identifiable private information or identifiable biospecimens, they are engaging in human subjects research.

Intervention includes the gathering of physical data through a procedure or action. These could be biospecimens such as saliva, urine, blood, tissues, or cells. Intervention also includes manipulation that affects the participant or their environment to gauge the participant's reaction, such as changing lighting or noise levels to observe effects on performance or behavior.

Interaction includes communication or interpersonal contact between the researcher and participant, typically in the form of surveys, interviews, or focus groups. This can be done by phone, email, video conference, or online. 

What is private information?

Any information gathered in a context where an individual could reasonably expect not to be observed is considered private information. For example, a conversation that takes place in a participant's home is private, while the way a person behaves while riding a public bus is not. Private information is shared with researchers for study purposes with the understanding that identifying characteristics will not be published.   

What is meant by identifiable private information?

Private information is identifiable if any member of the research team can easily determine the participant's identity. Even if names are not used, other identifiable features may be included. These could be pieces of information that individually would not identify a participant, but when presented together make that subject’s identity easily discoverable. For example, including participants’ demographic information and the area where they live could make them identifiable. For other examples, review the IRB's guidance for de-identification of datasets.

Private information is also considered identifiable if the researcher knows or can find out the identity of the participant through a code list.

Yes. Even anonymous surveys require IRB review if they involve human subjects research. The IRB will review the project and determine whether it qualifies for exemption or requires further review. If you are unsure, contact the IRB office before beginning your study.

A determination of “not human subjects research” (NHSR) is a formal written determination following an initial administrative review of the submission. It confirms that the activity does not meet the federal definition of human subjects research and does not require IRB review or approval.

This often includes program evaluation, quality improvement activities, and secondary analysis of de-identified data. If the project changes in scope or intent, contact the IRB for a new determination.

The IRB cannot issue a NHSR determination after a project has begun. If you need a formal written NHSR determination, the project must be submitted for IRB review prior to initiating any research activity.

Some class projects may include human subjects research and therefore require IRB review. Please contact the IRB before conducting any human subjects research. Helpful guidance on class projects can be found here.

The IRB requires all online surveys to be conducted through Qualtrics or SurveyMonkey.  

The Office of Information Technology has a software guide for creating a survey through SurveyMonkey, which can be found here.  

If researchers need to share files with participants, the IRB requires that those files be shared through the researchers' SIU OneDrive, SharePoint, or Teams accounts. All SIU students and faculty have access to an Microsoft OneDrive account through the university.  

If using grant or state funds to pay participants or purchase participant incentives, PIs should first consult with procurement and/or OSPA.

When researchers from more than one institution with a Federal-Wide Assurance (FWA) are involved in research, each institution is responsible for safeguarding the rights and welfare of human subjects and federal regulations compliance. One institution may delegate the other to act as the IRB of record by a written IRB Authorization Agreement. It is the responsibility of the investigator to seek their IRB counsel prior to engaging in research with an investigator at another institution. If an investigator’s IRB chooses to delegate to another institution, the IRB office will initiate an reliance agreement per OHRP regulations.