New Common Rule Regulations in Effect as of January 21
 
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January 2019

As of January 21, Common Rule revisions issued in 2017 are in effect for research involving human subjects. The provisions apply to research supported by many federal agencies, including the Department of Education and the National Science Foundation.

Several of the changes are of interest to education researchers:

  • Allowing broad consent for storage and secondary research use of identifiable private information with limited review by institutional review boards (IRBs)
  • Removing the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data
  • Allowing use of identifiable information with limited IRB review for research involving educational tests, survey or interview procedures, or observation of public behavior

The compliance date for the updated Common Rule was delayed a year to provide institutions time to prepare for the changes. In July 2018, the Department of Health and Human Services Office for Human Research Protections (OHRP) released guidance for applying three burden-reducing provisions during the delay period between July 19, 2018, and January 21, 2019. To assist institutions in complying with the updated Common Rule, OHRP issued updated draft guidance for studies that began before January 21, 2019, and are transitioning to the new requirements.

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