Professor Barbara J. Evans
Jan. 12, 2016 – UH Law Center Professor Barbara J. Evans calls for caution in implementing proposed changes to the Common Rule, a major federal research regulation, to avoid unintended impacts on healthcare quality improvement activities and informational research that uses health data and biospecimens.
“Everybody seems to agree that the Common Rule is out-of-date and needs to be modernized, but as with any major regulatory change, there is considerable debate about the details,” Evans notes. As of January 8, more than 2,100 public comments had been posted to critique changes that the U.S. Department of Health and Human Services (HHS) proposed on September 8, 2015.
In a Discussion Paper posted on the National Academy of Medicine’s Perspectives page, Evans joined a team of medical researchers and health industry leaders to explore how the changes may affect healthcare quality improvement activities. The team, led by Dr. Richard Platt of Harvard Medical School, included several participants in the National Academy of Medicine’s Clinical Effectiveness Research Innovation Collaborative (CERIC). They adopted a “learning health system” perspective and considered impacts on continuous learning efforts that harness clinical experience to improve future health care.
“Quality improvement (QI) activities aim to identify ways to improve the health care services people receive when they go to a hospital or other healthcare provider,” Evans explains. “Some QI studies amount to research--for example, if a study examines novel approaches to patient care. But many QI activities merely implement already-accepted healthcare practices. An example would be a study of how can you get doctors to wash their hands more often. Such a study poses no research-related risks for patients, beyond what patients already face in the regular healthcare setting, and the study may actually make them safer.”
Subjecting this latter category of QI activities to extensive research regulations could discourage activities that ought to be encouraged: low-risk activities that strive to make healthcare safer. The Discussion Paper and a companion set of Comments that the authors filed in the regulatory proceeding recommend ways to nuance the Common Rule to avoid those unwanted impacts.
In separate comments Evans addressed the Common Rule’s controversial waiver provisions, which allow a person’s health data and biospecimens—samples of tissue and bodily fluids--to be used in research without consent if an Institutional Review Board approves the waiver.
The proposed rule would severely restrict researchers’ access to biospecimens, but not place similar restrictions on access to people’s sensitive health data. “There is no rational basis for this distinction. There also is a lingering question of whether Congress ever granted HHS statutory authority to make such a distinction,” Evans says. “At a big-picture level, though, I agree that the Common Rule should be amended to make its waiver provisions more restrictive than they presently are.”
Under the current regulation, when a person’s specimens or data are used without consent in research, the person has no assurance that the research will at least serve an important scientific purpose that offers meaningful benefits for other patients or the public. HHS proposed to add a requirement that biospecimen waivers can only be granted if there is a ‘compelling scientific reason’ to do the research. Evans notes two problems with that proposal: “In 2000, HHS inserted a similar provision in the HIPAA Privacy Rule and had to remove it two years later after Institutional Review Boards complained it was unworkable in practice. It isn’t clear why this criterion would be workable now, when it did not work 15 years ago. My comments proposed alternative ways to formulate the criterion to make it more workable.”
The second problem is that surveys show people want their data as well as their specimens to be used only for research that offers a public benefit. “Whatever criterion HHS ultimately chooses to adopt should protect our data as well as our specimens,” Evans says, “People don’t want their data used in garbage science, particularly when it is being used without their consent.”