The previous exemption regarding public officials has been removed from the regulations all together in favor of a completely new exemption category permitting benign behavioral interventions. This exemption is quite long, and we encourage you to read the full text here
. In this section, we will summarize key information regarding what is permitted under this new, as of 2019, exemption.
Data collection can only take place with adult subjects who are able to consent for themselves. Please note that several states do not use 18 as the age of majority, so this might be something you need to take into account in your recruitment plan (e.g. use of MTurk participants). The participants must prospectively agree to the specific intervention, although deception (or withholding of full information) is permitted as long as the participant also prospectively agrees to be deceived or to proceeding without full information. Example language for this is included in our Informed Consent for Exemption template.
As with Exemption 1, this does not mean that you may not ever use deception or lack of full information in a study. If your study does not allow participants to be alerted to the deception or lack of full information, it simply means that it must take place under Expedited or Convened IRB review.
The exemption is quite restrictive in terms of the ways data can be collected. Data collection is limited to: verbal or written responses by the subject, data entry by the subject themselves, or observation of the subject including audiovisual recording. No devices, medical procedures, sensors, passive data collection methods (other than AV recording) etc. would be permitted under this exemption.
The intervention itself is limited to one (or a combination) of the following: (1) communication or interpersonal contact with the participant; (b) performance of a cognitive, intellectual, educational, or behavioral task; or (3) manipulation of the subject’s physical, sensory, social, or emotional environment. The examples HHS has given include manipulating a keyboard, doing a puzzle, or the introduction of music during a participant’s regular walking activities. Physical exercise, range of motion activities, or other physical tasks or manipulations cannot be included under this exemption.
Additionally, the intervention must be brief in duration, harmless, painless, unlikely to have adverse effects on the participant following participation, and unlikely to cause emotional discomfort, offense, or embarrassment. Brief in duration means that the intervention with any given participant will not span more than three hours (separate sessions are okay), and will be contained within a single day. Data collection can be distinct from the intervention in terms of the time permitted: if there is an hour and a half of assessments, followed by a two hour intervention, and then another hour and a half of assessments, the project could be eligible for exemption if the assessments are covered by Exemption #2.
Privacy & Confidentiality
The same restrictions that exist within subsections (i) – (iii) of Exemption 2 also exist here. The data researchers collect must be either anonymous, benign, or the collection and storage procedures must be reviewed and approved by the IRB.