717. Revising the Common Rule: Changes to the Federal Policy Protecting Human Subjects

Abstract

The protection of human subjects involved in research in the United States (U.S.) is based on the Belmont Report. The current regulations governing these protections were published in 1991 and are followed by 18 federal agencies. These regulations are referred to as the Common Rule. In July of 2011 the U.S. Department of Health and Human Services (HHS) issued an Advance Notice of Proposed Rulemaking (ANPRM) asking for public comment on proposed changes to the Common Rule. The comment period for the ANPRM ended in October 2011. In September 2015 HHS released a Notice of Proposed Rulemaking (NPRM) that included clarifications and modifications based on the feedback they received from the ANPRM. The NPRM also asked for public comment on the now modified proposed changes to the Common Rule. The comment period for the NPRM ended on January 2016. The NPRM document is quite long and detailed however a summary of the changes can be categorized into three major categories. The first category is increasing subject ability and opportunity to make informed decisions through modifications of requirements for informed consent documents. The second category is reducing the potential for harm and increasing justice for all subjects by increasing requirements for privacy protections inclusive of biospecimen research, expanding coverage of the protections to be inclusive of all clinical trials regardless of funding source, and expanding requirements for compliance with the Common Rule to all Institutional Review Boards (IRBs) inclusive of those not affiliated with an assurance holding institution. The third major category is facilitating current/evolving research that offers promising approaches by reducing ambiguity in the interpretation of the regulations, increasing efficiencies in the performance of the review system most specifically in the area of continuing review requirements and reducing burdens on researchers that do not appear to provide commensurate protections to human subjects (inclusive of re-defining exempt research categories and proposing a new research category identified as excluded research). Implementation of the Final Rule will be one year following publication allowing for voluntary application of provisions that provide regulatory flexibility to occur as early as 90 days after publication while other categories allow for implementation to occur as long as 3 years after publication. Many of the proposed changes relate to the use of biospecimens which will have significant impact on cell and gene therapy researchers. The regulatory community anticipates that the Final Rule will be released in 2016. If the Final Rule is released prior to the ASGCT meeting this presentation will focus on the Final Rule. If the Final Rule is not release prior to the ASGCT meeting this presentation will provide more in-depth information regarding the NPRM.