US agency releases finalized ‘Common Rule’, which governs human-subjects research.
In a blow to patient-privacy advocates, the US government has abandoned a plan that would have required scientists to obtain the consent of people who donate biological samples before using the material in subsequent studies.
The US Department of Health and Human Services (HHS) had proposed the change in 2015, as part of an overhaul of the ‘Common Rule’, a set of regulations that govern clinical trials and patient consent in research. But the provision was not included in the final version of the rule released on 18 January.
Most of the changes to the 26-year-old Common Rule are intended to lessen the regulatory burden on researchers. They eliminate requirements that researchers obtain individual approval from ethics boards at every institution where a study will be performed, for instance. This allows individual government agencies to decide whether a study needs multiple approvals or not.
The HHS first released its proposed revisions to the Common Rule in September 2015. That version would have required researchers to obtain consent from patients before using biological samples such as blood and tissue in studies, even if those specimens could not be identified.
The US National Academies of Sciences, Engineering and Medicine blasted that requirement and others in a June 2016 report, arguing that the changes would impose an undue burden on researchers. The academies said that the government's plan was “marred by omissions and a lack of clarity”, and recommended that it be withdrawn.
The final version of the Common Rule shows that the government listened to scientists’ fears about increased research burdens, says Ellen Clayton, a bioethicist and lawyer at Vanderbilt University in Nashville, Tennessee. “I went into my chair’s office and did a happy dance, I’m thrilled.”
The updated Common Rule does still require that patients be informed if the research might include whole-genome sequencing, which could make the specimens they donate identifiable. Clayton cautions that the idea of ‘identifiability’ may change in the future as genomic analysis and electronic security technologies evolve, and the law may need to evolve as well.
But the decision to drop the consent requirement is a disappointment to Twila Brase, president and co-founder of the Citizens' Council for Health Freedom in St Paul, Minnesota. The group has campaigned to have blood spots used in infant disease screenings classified as human subjects, and require consent for their use in research. Under US law, Congress has 60 days to retract the updates to the Common Rule, and Brase says that her group will ask it to do so and reinstate the consent requirement.
The new version of the Common Rule does require that researchers include a description of the study, along with the risks and benefits, on the consent forms used by patients. It also stipulates that some federally funded trials must post patient consent forms online. However, the requirements do not extend to trials that do not receive federal funds.
The agency decided that extending the rule to non-federally funded trials would be an unnecessary burden, says Jerry Menikoff, director of the HHS Office for Human Research Protections. Most institutions that receive federal money apply the Common Rule to all of their trials regardless of who funds them, he says.
That decision is a disappointment, says Michael Carome, director of health research at the consumer-advocacy group Public Citizen in Washington DC. “We think human subjects deserve protection whether or not they're in a federally funded trial.”
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Reardon, S. Controversial patient-consent proposal left out of research-ethics reforms. Nature 541, 449 (2017). https://doi.org/10.1038/nature.2017.21330