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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.

  • Exemption: This category of review encompasses projects that are considered noninvasive and of minimal risk to the subjects.  Types of projects typically eligible for an exempted review include but are not limited to comparisons of instructional strategies, analyses of existing data sets, and studies of food taste and quality (a more definitive list is provided on the Exemption Application).  However, exemption must be formally granted and not merely assumed by the investigator.  
  • Expedited Review: This category of review is intended for research activities that involve no more than minimal risk to the subjects.  Types of projects typically eligible for expedited review include but are not limited to moderate exercise by healthy individuals, minimally invasive medical procedures, and studies of perception or cognition (a more definitive list is provided on the Expedited Review application).
  • Full Review: This category of review is reserved for projects that are considered to pose significant potential risk to the subjects.  Types of projects that may require full review include but are not limited to projects involving invasive medical procedures, emotionally distressing topics, investigational devices or drugs, and studies of children or other vulnerable populations.

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.

Limited Review

The term limited review refers to situations in which the IRB reviews only certain aspects of a proposed study.  A limited review is a requirement for certain Exemption categories in which it is necessary to determine that subjects’ privacy and confidentiality are maintained.

Secondary Research

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.

 

 

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