The U.S. Department of Health and Human Services and 15 other federal departments and agencies have jointly published this proposed rule updating the “Common Rule” governing participation in human subjects research.  The current regulations that protect individuals who participate in research, which have been in place since 1991, are followed by all the 16 federal agencies, and are often referred to as the Common Rule. They were developed at a time when research was predominantly conducted at universities, colleges and medical institutions, and each study generally took place at a single site. The expansion of research into new scientific disciplines, such as genomics, along with an increase in multisite studies and significant advances in technology, has highlighted the need to update the regulatory framework. Notably, a more participatory model of research has also emerged, with individuals looking for more active engagement with the research enterprise.  The proposed rule modernizes the current regulations by enhancing the ability of individuals to make informed decisions about participating in research, while reducing unnecessary burdens by streamlining the regulatory requirements for low-risk research.

The changes proposed in the proposed rule include:

  • Strengthened informed consent provisions to ensure that individuals have a clearer understanding of the study’s scope, including its risks and benefits, as well as alternatives to participating in the study
  • Requirements for administrative or institutional review board (IRB) review that would align better with the risks of the proposed research, thus increasing efficiency.
  • New data security and information protection standards that would reduce the potential for violations of privacy and confidentiality
  • Requirements for written consent for use of an individual’s biological samples, for example, blood or urine, for research with the option to consent to their future use for unspecified studies
  • Requirement, in most cases, to use a single institutional review board for multisite research studies

The proposed rule would apply to all clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding for research involving human participants from a Common Rule agency. The Department of Housing and Urban Development and the Consumer Product Safety Commission will implement parallel rulemaking to adopt the revised Common Rule.  The Central Intelligence Agency also will adopt the revised Common Rule through an existing executive order. Comments on the proposed rule are due on December 7, 2015.

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