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Changes to the Common Rule Regulations and Implications for Human Research
Madden, M. Changes to the Common Rule Regulations and Implications for Human Research. Society of Toxicology, San Antonio, Texas, March 11 - 15, 2018.
This presentation introduces the rationale for a session on potential changes to the Common Rule for human research, and introduces the topics and speakers in this session at SOT.
The regulations that govern research involving human subjects are known as the “Common Rule,” because they are shared in common by 18 federal departments and agencies that conduct and support such research. [The US FDA is not a signatory to the Common Rule.] These regulations have not changed substantively since 1981. During that time, the research they cover has evolved considerably, with new scientific techniques and new ethical challenges that don’t always fit well under the established structure. These include an evolving concept of what constitutes identifiable information and biospecimens, techniques like whole genome sequencing, and concerns over commercialization and informed consent. A six-year rulemaking process began in 2011, with preliminary draft noticed released and over 3000 public comments received. This process culminated in the publication of a revised final rule on January 19, 2017. The majority of changes will take effect in January 2018, bringing sweeping changes for scientists and their institutions, funding agencies, and the Institutional Review Boards (IRBs) that oversee this work. This informational session will review the reasons for change, the rulemaking process, and the major changes in the revised regulations, presented by the US EPA representative on the Interagency Working Group that crafted the new Rule. The daily experiences of implementing the Rule changes in a timely manner into human subject research at an academic institution, and areas where the new Rule is not clear, will be presented by staff of the Office of Clinical Research locally at UT Health at San Antonio. UT Health SA has several IRB authorization agreements with nearby institutions, such as Brooke Army Medical Center and the Southwest Research Institute, to serve as the single IRB of record for collaborative research. Potential issues with implementation of the new Rule with studies at collaborative sites will be presented. A third speaker from the NIEHS IRB will discuss the potential impact of the new Rule on the submission and implementation of grant applications, and also with insights on possible upcoming changes in the NIH processes for human studies. This session will present extremely important ethics information to those attending SOT who perform research with human subjects including industry, government, and academia, and will facilitate discussions about applicability of the changes to the attendees’ current research and potential research designs and submissions.[This proposed abstract may not reflect official US EPA policy.]