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Possible Delay in Common Rule (45 CFR 46) Revisions

On January 19, 2017, the US Department of Health and Human Services (HHS) and 15 other federal agencies (excluding the Department of Justice and the Food and Drug Administration) submitted the final revisions for the Protection of Human Subjects regulations (the Common Rule) to the Office of Management and Budget (OMB) – the final step in rule making.  These revisions are intended to reflect changes in the human subjects research landscape since the original rule was published in 1974 and last revised in 1991. The changes also aim to reduce the administrative and regulatory burden, as well as better protect human subjects in research.  A brief summary of key proposed final rule changes is located at the end of this message.

In October 2017 and again on January 4, 2018, HHS requested a delay in implementation of the final rule as critical guidance, assistance, and other clarifying information about the revised rule has not been provided by the Office for Human Research Protections or any other signatory agency to the research community. It appears that these requests for delay are being reviewed by the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB).

Please know that the Office of Research is monitoring the status of the Final Rule and potential changes to its implementation and will keep the UCI research community informed. 

Should the Final Rule proceed as published, the Office of Research plans to conduct an update of our Human Protocol System (HPS) and the Continuing Review application in response to the Final Rule beginning on Thursday night, January 18, 2018.  In addition, we will be updating our webpages accordingly. Please know that complete updates may require more than a day. Also during this time you may experience delays in accessing the IRB systems.

Key rule changes include:

§Establishing new exempt categories of research based on level of risk posed to subjects

§Eliminating continuing review for certain minimal risk research

§Allowing the use of broad consent for future research for secondary studies on stored identifiable data or identifiable biospecimens

§Adopting the definition of “clinical trial” that includes behavioral health-related outcomes

§Improving the informed consent document and process to increase subject understanding

§Requiring that consent forms for certain federally funded clinical trials be posted on a publicly available federal website

§Requiring single Institutional Review Board (sIRB) review for cooperative research for some studies (implementation January 2020)

Resources

§Federal Register: Federal Policy for the Protection of Human Subjects (01/19/2017)

§HHS Press Release About the Final Rule

§PRIM&R’s Revised Common Rule Information

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Human Research Protections

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