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Important Changes to the Common Rule on Human Subjects Research go into Effect

January 24, 2019

After many years in the making, the compliance date – January 21, 2019 – for the revised Federal Policy for the Protection of Human Subjects (45 CFR 46 Subpart A), known as the Common Rule, has finally come.

FABBS societies welcome two key changes to the Common Rule: exemption for benign behavioral interventions and limited IRB review option, when appropriate.

The new rule creates an exemption from IRB review for research involving benign behavioral interventions.  The exemption is limited to research with adults who prospectively agree to the research, when the information collected is limited to verbal or written responses, including data entry or audiovisual recordings.

Furthermore, a benign behavioral intervention must be

  • Brief in duration (although data collection may take longer).
  • Harmless, painless, and not physically invasive.
  • Unlikely to have a significant adverse lasting impact on subjects.
  • Believed by the investigator not to be offensive or embarrassing to subjects.

 

The criteria for when this Exemption 3 applies to such research (1) the subject could not be easily identified from responses, (2) the subjects would not be exposed to risk of certain harms as a result of information collected, or (3) the information is recorded in an identifiable manner, even if sensitive, provided that an IRB determines through limited review that, when appropriate, there are adequate privacy and confidentiality protections in the study.

A second important improvement is the addition of a limited IRB review process for certain exemptions, when all criteria have been met. Limited IRB review may be done using the expedited review mechanism, by the Chair or an experienced IRB member designated by the Chair (although it can also be conducted by the full IRB). Continuing review is not required.

University IRBs are likely beginning to make changes to relevant policies and procedures in accordance with the new Common Rule.

For more information see the Office for Human Research Protections website.

For research initiated before the January 21 deadline, the Office for Human Research Protection released draft guidelines for investigators willing to comply voluntarily with the revised guidelines. Comments can be submitted online or mailed and are due February 11th.

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