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Notice of proposed rulemaking - updates to the common rule

On January 18, 2017 the Department of Health and Human Services (HHS) through the Office of Human Research and Protection (OHRP) issued final regulations (the Final Rule) implementing changes to the Federal Policy for the Protection of Human Subjects (the Common Rule).

These revisions were proposed in September of 2015 and published in the Federal Register for public comment through the Notice of Proposed Rulemaking (NPRM). There were over 2,100 comments received, many expressing concern about some of the proposed changes. The intent of these proposed changes was to modernize the federal policy on human subject research, and align the regulations with the changes that have taken place in research since the Common Rule was first finalized in 1991. 

In response to concerns raised in the public comments and review process, the final rule was modified and contains a number of changes compared to the original proposal. Some provisions were adopted, some modified, and some proposed changes were eliminated. 

Provided that these regulations do not get overturned, this will mean a variety of changes in IRB consent templates and IRB policies and procedures. These changes will be implemented gradually, after thorough review of the final changes. As changes are made within the IRB office in response to the Final Rule we will communicate these to the research community in a variety of ways, and we will continue to provide education, post information, and provide additional helpful resources, on the specifics of the changes over the next year. 

Summary of revisions:
• Required additional content in informed consent documents
• Required use of a single IRB for most multi-institution research studies
• New options for the use of "broad consent" documents for research involving identifiable data or identifiable biospecimens
• New categories of "exempt" research
• Elimination of continuing review requirements for certain human research studies
• Required posting of consent documents for certain federally-funded trials to a public website
• Elimination of grant congruency review by the IRB
• New criteria for limited IRB review required for certain exempt categories

Proposed changes not incorporate into the Final Rule:
• The definition of human subject to include non-identifiable biospecimens, as well as most of the proposed changes to biospecimen research requirements
• Use of federally-developed templates for "broad consent" forms and decision tools for making exemption determinations will not be implemented
• The proposal that non-federally funded clinical trials be subject to the revised Common Rule
• The "excluded" categories of research
• The requirement for standardized privacy safeguards for identifiable private information and identifiable biospecimens

Resources for more details and reference:
Full text of the Final Rule
OHRP Press Release regarding the Final Rule
WIRB Webinar "Understanding the Final Common Rule" (Free webinar - you will need to complete a registration form to access)
WIRB Powerpoint "Understanding the Final Common Rule"

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