HHS Releases Draft Guidance for Burden-Reducing Provisions in Revised Common Rule
HHS Releases Draft Guidance for Burden-Reducing Provisions in Revised Common Rule

July 2018

In June, the Department of Health and Human Services (HHS) delayed the general compliance date for the 2018 requirements of the revised Common Rule to January 20, 2019. In extending the time frame within which institutions must comply with the new requirements, HHS is allowing the implementation of three burden-reducing provisions for research studies.

On July 19, the HHS Office for Human Research Protections released three draft guidance documents related to the revised Common Rule:

  1. Scholarly and Journalistic Activities Deemed Not to Be Research: 2018 Requirements

The guidance clarifies that activities that do not develop generalizable knowledge about a community or group would not be considered research subject to the Common Rule.

  1. When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements

The guidance provides flexibility for institutional review boards (IRBs) in handling continuing review for studies eligible for expedited review and nonexempt research that has progressed to the point of data analysis or accessing follow-up clinical data. Research in these categories would not be subject to continuing review from IRBs under the 2018 requirements, and IRBs would be required to document the need for conducting reviews after January 20, 2019. In the transition period, IRBs do not need to document decisions to maintain continuing review for studies complying with the 2018 rule.

  1. Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements

The guidance states that research proposals do not need to be reviewed or approved by an IRB for certification. Once a grant proposal is funded, certification of IRB review and approval is required before research can start, unless the research is waived or exempted under the regulations.

While HHS is the lead agency for producing the regulations guiding the protection of human subjects in research, the Common Rule provisions also apply to research supported by the Department of Education and the National Science Foundation.

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