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On July 19, the HHS Office for Human Research Protections released three draft guidance documents related to the revised Common Rule: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