The IRB performs three types of review involving varying degrees of scrutiny according to the potential risk posed by the project.  A project’s potential risk is determined by a collection of factors, including the study methodology, the population being studied, and the research topic.  Studies involving invasive techniques, vulnerable populations, and/or sensitive topics require more intensive levels of review because of the higher level of risk involved.  

Brief descriptions of each type of review are provided below, along with examples of projects that may qualify for each.  However, it should be reiterated that study methodology alone does not determine the appropriate level of a review for a project.  The investigator is responsible for determining the appropriate level of review and following the correct procedures for requesting that review.

Researchers are sometimes uncertain which type of review to request for projects using instruments such as questionnaires or surveys.  The answer to this question depends on several factors:

• If the instrument asks questions about potentially illegal activities, such as drug use or criminal behavior, then full review is required.
• If the instrument asks questions about potentially distressing topics (e.g., mental illness, traumatic events) that may require intervention, then either expedited or full review is required.
• If individual subjects can be identified based on their answers or other information such as demographic data, then either expedited or full review is required.
• If the subjects will be children or other vulnerable populations, then either expedited or full review is required depending on the content of the survey.

Secondary research refers to research use of private human subject information that was not initially collected for that purpose.  Examples include using assessment data for research purposes and examining a qualitatively different research hypothesis than was initially indicated in an approved project. Literature reviews and meta-analyses of existing research studies are not considered secondary research under this definition because they do not involve accessing human subjects data. Additionally, studies of publicly available information such as public use data sets, public posts on social media, or letters to the editor published in newspapers are also not considered secondary research under this definition because they do not involve the use of private data.

Secondary research requires IRB approval.  Additionally, if the information to be used contains details that could identify the subjects, then the researchers must either obtain informed consent or use a Waiver of Consent form to explain why this consent cannot be obtained.  Secondary research that does not include potentially identifiable data does not require consent or a Waiver of Consent form, but IRB approval is still necessary.

Not all projects that collect information from human subjects require IRB review. Some examples of these projects are included below, although this should not be considered an exhaustive list. In general, the unifying feature of these projects is that there is no attempt to generalize these findings to a larger group. However, this aspect alone cannot be used as the sole justification for not seeking IRB review. 

Regardless of whether or not a particular project requires IRB review, investigators are still encouraged to follow informed consent procedures with their subjects and to take appropriate measures to maintain the confidentiality of their data.

It should also be recognized that some projects may initially not require IRB review, but could evolve into projects requiring review. For example, if investigators notice an interesting phenomenon in their assessment data and decide to publish or present these findings, then the investigators should request IRB review for the project involving the data to be published/presented. This would fall under the category of “secondary research” previously mentioned.