January 2017

This week, the Department of Health and Human Services released the final rule to modernize the Common Rule governing human research protections. The finalization of the rule was the result of an effort to improve the Common Rule regulations that began several years earlier, in 2011. The final rule aims to strengthen protections for patients involved in studies while simultaneously reducing administrative burdens for researchers. Most requirements of the rule will go into effect in 2018.

The final rule includes some key changes from the proposed rule, most notably:

• The proposed rule would have required researchers to obtain patient consent before using before using non-identified biospecimens. The final rule removed this proposal and continues current practice.
• The final rule requires consent forms to include a brief explanation of key information such as purpose of the research, risks and benefits and alternative treatments that may benefit patient subjects.
• The final rule does not include stricter criteria for securing waivers of patient consent requirements, as proposed in the proposed rule.
• The final rule does not require new standardized privacy mechanisms as proposed under the previous rule and instead maintain current privacy requirements.
• The final rule does not extend the Common Rule to clinical trials that are not federally-funded, as was proposed under the previous rule.
• The final rule does not adopt some of the tools and standards such as a template for broad consent forms and a decision tool for making exemption determinations that were proposed under the first rule.

The final rule's main elements are:

• Requirement for the use of single IRB review for multi-site studies, with a modification from the proposed rule to increase flexibility to permit broader groups of studies to be exempt from this requirement
• Researchers will have the option of using broad patient consent for future studies with stored identifiable data or identifiable biospecimens, rather than consent waivers.
• The final rule creates new exempt research categories based on risk level to study participants.
• Ending continuing review requirements for some studies where it is determined that additional review will not benefit research participants.
• The final rule requires public website posting of patient consent forms for certain clinical trials.

Several ATS committees reviewed and drafted comments on the previous iterations of the rule including the Research Advocacy Committee, Drug, Device Discovery and Development committee, Quality Improvement and the Scientific Advisory committee. The committee members supported most of the changes outlined in the proposed rule, such as proposals to streamline the patient informed consent process and use of single IRB's for multi-site studies.