Under the current federal regulations for human subjects research, Exemption Category #2 is defined as:
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects
- Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. 45 CFR 46.101(b)(2)
Some studies under the oversight of IRBMED employ research designs that involve a minimal risk, non- invasive intervention such as viewing a video, reading a story, playing an economic game, using a computer program, using an experimental tool (eg, a robot arm or mechanical object), or being exposed to stimuli such as sound, color, or light, followed by data collection via a survey, interview, test, or observation. Data may also be collected by automated or researcher observation; for example, a computer may record objective data such as how long a subject views each screen in a program, or a researcher may subjectively “rate” how comfortably/readily a subject manipulates a device.
OHRP’s position on Exemption #2 is that it cannot be applied to projects that involve an intervention of any kind in conjunction with a survey, interview, test, or observation, regardless of the risk associated with the project.