Common Rule Changes and Exempt Review

 

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Common Rule Changes and Exempt Review

As we are getting closer to the implementation of changes to the Common Rule we would like to continue communicating upcoming changes to the research community. Another major change to the Common Rule is the increased ability to use the exempt category. There are more types of research that now qualify for these expanded exempt categories than in the past. These include the following:

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if the following criteria is met:
-The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.
-For these types of studies, the IRB would conduct a “limited IRB review” to determine that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.

Research involving what is called “benign behavioral interventions”** (see below for definition) in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
-Identity of subject cannot readily be ascertained.
-A disclosure of subject responses outside the research would not place the subject at risk. In this type of research, and the identity of subjects cannot readily be ascertained.
-The information obtained is recorded in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.

For studies meeting this last criteria, the IRB would conduct a “limited IRB review” to ensure that there are adequate protections to protect privacy of subjects and confidentiality of the data

Research in this category can also receive an exemption if the research involves deceiving the subjects regarding the nature or purposes of the research. However, an exemption is not applicable unless
the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the
nature or purposes of the research.

**A benign behavioral intervention is an intervention that is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.

Provided all such criteria are met, examples of such benign behavioral interventions would include having the subject play an online game, having the subject solve puzzles under various noise conditions, or having the subject decide how to allocate a nominal amount of received cash between themselves and someone else.

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