Some researchers find IRB review to be intimidating. Misconceptions fuel much of the anxiety. Below are clarifications about the review process that are frequently misunderstood:
Does “Exempt” mean IRB review is not needed?
Researchers often interpret the word exempt to mean there is no IRB review needed.
At USC, a study must be reviewed by an IRB in order to be designated as exempt from further review.
Does an “Expedited” submission get a faster review?
No, expedited is a level of review named and defined by federal regulation. The speed of review depends on thoroughness of the application, speed of responses from the applicant to information and edits requested by the IRB.
There are 7 categories of expedited review.
Does my project need IRB review?
IRB review is required when a study can be described by both of the federal definitions below. A very short application is provided in iStar (the IRB submission system) that will determine if a project needs IRB review.
Human subjects research definitions:
- research – a systematic investigation for the purpose of developing or contributing to generalizable knowledge then criteria for research has been met.
- Involvement of human subject – data is obtained from a living individual through intervention/interaction or private information is identifiable.
Do I need approval from more than one IRB for a research project involving multiple locations?
It depends on whether the other location is only a site for the research or if the location is engaged in the research. A permission letter may be required for locations used as a site at which the USC investigator conducts research. If an institution is engaged in the research an agreement can be enacted between the relevant IRBs so that only one IRB review is performed. The principal investigator should indicate in the IRB application the activities conducted at the other site(s).
Generally, an institution is considered engaged in human subjects research when its employees, students or other agents for the purposes of the research project obtain one of the following:
- HHS funding for the human subjects research (even where all activities
involving subjects are carried out by employees or agents of another institution)
- data about subjects through intervention or interaction (including non-invasive interactions such as manipulating the subject’s environment for research purposes)
- identifiable private information about the subjects (including using, studying, or analyzing identifiable private information or identifiable
specimens provided by another institution)
- informed consent for the research
Are all IRB applications reviewed by a committee?
All IRB applications/submissions are reviewed initially by the IRB administrative staff. The IRB Administrator may issue exempt determinations. Expedited studies must be reviewed by both an IRB Administrator and also by a member of the IRB committee. The minority of IRB submissions are reviewed by the “Full Board” at a committee meeting.
Does the complexity of research determine how its reviewed?
No, the level of IRB review is primarily determined by the level of risk and the population under study. Populations such as children, prisoners, pregnant women and neonates require added protections per federal regulation.
How long will it take to get IRB approval?
All IRB applications should be submitted a month before the intended start of research. IRB review is an iterative process. A typical IRB application undergoes multiple rounds of revisions before approval. The length of the process is impacted by the level of review, thoroughness of the application and, speed of responses from the applicant for information and edits requested by the IRB.
What is informed consent?
Consent is permission or approval from the participant. The required contents of a consent form are specified by federal regulation. Consent is more than just the form – it is an ongoing process that starts with the first contact and ends when the participant’s role in the study ends. Lear more about consent requirements
Is informed consent required for all research projects?
Consent is generally required for all human subjects research except exempt projects. Signed consent can be waived for some situations. Elements of informed consent can be waived or altered if the IRB determines that the study meets criteria for no more than minimal risk. Learn more about consent requirements
What level of IRB review is right for my project? What if I pick the wrong level?
The level of IRB review is determined by the level of risk to participants. If the wrong level was marked, the IRB will correct the level of review and ask the researcher to submit additional information.
- Full board reviews are conducted when more than “minimal risk” is present to subjects.
- Expedited reviews are conducted when no more than minimal risk is present to subjects and the research fits one of the Expedited Review Categories.
- Exempt designation is granted if there is less than minimal risk to subjects and it fits one of the exemption categories.
Does the IRB review the science and methodology of a project?
The IRB is obligated to consider the design and methods in terms of demands on the subjects and whether the research questions can be answered by the proposed methods.