EXECUTIVE SUMMARY

The Notice of Proposed Rulemaking to Revise the Common Rule should be withdrawn, according to a report from the National Academies of Science, Engineering and Medicine. Some recommendations include the following:

  • an independent national commission is needed,
  • guidance is needed on how to apply ethical principles to “big data” and genomics, and
  • unresolved questions involving new technologies need to be addressed.

The Notice of Proposed Rulemaking (NPRM) to Revise the “Common Rule,” (formally known as the Federal Policy for Protection of Human Subjects), should be withdrawn, according to a new report from the National Academies of Science, Engineering, and Medicine.1

“One of the important areas of government regulation is of human subjects research and human subjects protections,” says Steven Joffe, MD, MPH, a member of the committee that developed the report. Joffe is vice-chair of the Department of Medical Ethics and Health Policy at University of Pennsylvania’s Perelman School of Medicine.

The report says an independent national commission is needed to make recommendations on how the ethical principles governing human subjects research should be applied to unresolved questions and new research contexts. Examples include the following:

  • research involving genomic datasets,
  • research within learning healthcare systems,
  • research using “big data” from electronic health records, administrative data from health systems and other settings, sensors, and wearables,
  • emergency research with no possibility of consent,
  • research involving biospecimens, and
  • research involving adults with reduced decision-making capacity.

The report covers a wide range of issues affecting the partnership between the federal government and the academic research community.

“Its basic conclusions are that the increasing profusion of regulations, and the duplications and lack of harmonization among them, are compromising the ability of academic research to fulfill its mission,” says Joffe. This mission is to produce science and scholarship that benefits the nation. To do this effectively, he says, the regulation and oversight of human subjects research needs updating.

“We recognized that the basic framework that underlies our regulations is almost 40 years old,” says Joffe.

There are numerous unresolved questions that could not have been anticipated in the 1970s, given enormous growth in technologies and capabilities.

“We judged it was time to take a systematic, multi-stakeholder, independent look at the numerous questions that confront the enterprise, as well as the basic structures for research oversight, to bring them into the 21st century,” says Joffe.

Many important questions go unaddressed in the NPRM, he says. “Recognizing the controversy that surrounds it, we recommended that it be withdrawn so the commission can do its work with an open field,” says Joffe.

Ruth Macklin, PhD, distinguished university professor emerita in the Department of Epidemiology and Population Health at Albert Einstein College of Medicine in Bronx, NY, sees de-identified human specimens as one of the central ethical concerns.

According to the current regulations, researchers may use human biological materials from which personal identifiers have been removed without obtaining consent from the individuals from whom the specimens were taken.

“The current regulations do not consider this as ‘human subjects research,’” says Macklin. The proposed change would require that individuals provide “broad” consent for any future use of de-identified specimens.

“This would not only be burdensome on researchers — it could also thwart progress in important research ongoing today,” Macklin adds.

Research involving human specimens and other novel techniques is beyond the scope of the current regulations. “An independent, multidisciplinary, high-level national commission is the most appropriate way to ensure that scientific progress continues, while at the same time protecting the rights and welfare of human participants,” says Macklin.

REFERENCE

  1. National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the nation’s investment in academic research: A new regulatory framework for the 21st century. Washington, DC: The National Academies Press.

SOURCES

  • Steven Joffe, MD, MPH, Vice-Chair, Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia. Phone: (215) 898-3055. Fax: (215) 573-3036. Email: joffes@exchange.upenn.edu.
  • Ruth Macklin, PhD, Professor Emerita, Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY. Phone: (718) 430-3574. Fax: (718) 430-3076. Email: ruth.macklin@einstein.yu.edu.