Exempt Research Categories

• Commonly accepted educational settings can be almost anywhere as long as the setting is one in which the specific educational offering normally takes place (soccer field for learning soccer).
• Normal educational practices are educational activities that would occur regardless of the research. These practices cannot be untested in the setting or with a specific population. They also cannot involve novel methods, software, or curriculum.

• Research involving prisoners or deception/interventions cannot be exempt under category 2.
• When research participants are under the age of 18, the research cannot be exempt under category 2, unless it involves educational tests or observations of public behavior when the investigator(s) do not participate in the activities being observed. Observations must occur in truly public places (e.g., a public park, a library, city sidewalk). Federal guidance indicates that classrooms are not considered public places.
• Even if anonymous, surveys containing invasive questions that may cause emotional distress and/or discomfort or research otherwise employing psychologically invasive cognitive or diagnostic testing, cannot be exempt under category 2.
• Category 2 allows for the collection of sensitive identifiable data but requires limited IRB review to ensure that adequate protections are in place to protect participant privacy and confidentiality of data. The IRB must review data management and security procedures when sensitive information is collected with either direct or indirect identifiers, (e.g., a code that can link back to the participant, or data elements that could be combined to readily re-identify a participant).

• Data collection methods are limited to verbal or written responses (e.g., surveys or interviews, test responses, or data entry), observation, and audiovisual recording. Data cannot be collected via physical procedures, such as blood pressure, EEG, activity trackers (e.g., Fitbit), eye trackers and blood draws.
  
  This exemption does not permit the use of deception unless participants prospectively agree that they will be unaware of or misled about the nature or purposes of the research.
  
  If a debriefing script or document will be used, also add: “After the study, you will receive more information and have the option to withdraw from the study if you so choose.”
• Brief in duration requires that benign interventions must occur on the same day.
• Category 3 allows for the collection of sensitive identifiable data but requires limited IRB review to ensure that adequate protections are in place to protect participant privacy and confidentiality of data. The IRB must review data management and security procedures when sensitive information is collected with either direct or indirect identifiers, (e.g., a code that can link back to the participant, or data elements that could be combined to readily re-identify a participant).
• The revised Common Rule updated category 3 to focus on benign behavioral interventions. Research that previously qualified for the former exempt category 3 (interviews with publicly elected officials) can now be approved under exempt category 2.

Existing data or specimens means that the materials must be on the shelf at the time the research is submitted for exemption determination. Ongoing collections, or serial applications (e.g., applying to obtain data at the end of each year) are not permitted.

• The data collected/received must not include direct or indirect identifiers. For research involving protected health information (PHI), these identifiers ( e.g. dates or zip codes) can not be included. For more information, please see the HIPAA Guidance page. 
• The ability to de-identify data depends on the specific project, the data point(s) in question and the potential for indirect identification. For projects involving patient information to be considered potentially able to be de-identified, there must be at least 25 potential subjects at Ohio State that fit the inclusion criteria; however projects with more than 25 individuals may still be considered potentially identifiable. Materials are de-identified when all direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the information or materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s).
• In some instances, investigators can create and use a temporary list or key to access information from more than one location, but only if it is part of the same record (e.g. the patient’s medical record information is housed in two different databases). Only a simple list (e.g., a list of MRNs) or a simple key (e.g., MRN = random study number) can be created and this list/key must be destroyed immediately after collection, prior to analysis, processing or use of the data/specimens. IRB review is required if investigators need to retain a link. The link can only be used to access information for a single source (e.g. the patient’s medical record), and it cannot be used to combine completely separate sources of data (e.g. a hospital medical record with a private physician’s record).

Research that qualifies under this category must be on federal programs and subject to the approval of federal department or agency heads. Local or state programs do not qualify under this exemption (though it may fall under another exemption category).  If your research is eligible for this exemption, the federal agency will generally provide a letter indicating such or post the information on a public website.

This exemption is not available at Ohio State.

This exemption is not available at Ohio State.