On September 2, the US Department of Health and Human Services (HHS), along with 15 other government agencies, proposed changes to the Common Rule, to enhance protections for individuals involved in research, while modernizing rules and improving efficiency. The rule will be published in the Federal Register on September 8. The Common Rule is currently followed by 18 agencies and has been in place since 1991 to address the ethics of biomedical research involving human subjects. It was developed at a time when research was predominantly conducted at universities, colleges and medical institutions, and each study generally took place at only one study site. The increase in multi-site studies, significant advances in technology, and the expansion of research into new scientific disciplines necessitates revisions to the Rule.
In July 2011, HHS issued an Advanced Notice of Proposed Rulemaking to seek the public’s input on updates to the Common Rule. Fast forward four years and now we have the agency’s consolidation and incorporation of that input. The proposed changes seek to enhance research subjects’ ability to make informed decisions about participating in research while simultaneously reducing unnecessary burdens by easing the regulatory requirements for low-risk research. Notable proposed changes 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 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; (currently, researchers can use leftover samples by removing personal identifying information)
- Requirement, in most cases, to use a single institutional review board for multisite research studies; and
- 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.
- While some feel that these rules promote efficiency, others are concerned about their real-life application. For example, it may not be feasible, and certainly won’t be practical, for one IRB to review clinical trials conducted at multiple institutions with hundreds of study sites. This rule may overburden the IRB and thereby increase the risk to subject safety. For smaller studies with fewer sites, this may be a welcomed change. Public comments may be submitted for 90 days, beginning on September 8.