Proposal to Revise US Regulations on Human-Subject Research Should be Withdrawn, Say National Academies

The United States government is planning to amend "Common Rule," a set of regulations on research involving human subjects, but an independent science group says the proposal to make the changes should be withdrawn. Instead, it suggests that the government create an independent national commission first.

"A new report from the National Academies of Sciences, Engineering, and Medicine that examines the regulations governing federally funded research recommends that Congress authorize and the president appoint an independent national commission to examine and update the ethical, legal, and institutional frameworks governing research involving human subjects," the group's press release posted on June 29 reads. "The commission should make recommendations for how the ethical principles governing human subjects research should be applied to unresolved questions and new research contexts."

The National Academies of Sciences, Engineering, and Medicine are private institutions that analyze problems and give advice in policy decisions in the areas of medicine, technology and science. They submitted the first part of their report in September last year, and the new one titled "Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century (2016)" contains the full report.

It is urging the executive branch to withdraw the "Notice of Proposed Rulemaking" for the Common Rule, formally called the Federal Policy for Protection of Human Subjects. The press release explains that the proposed national commission should give its recommendations first and then the public, patients groups, and the research community should be given the chance to react to those recommendations. Only after these steps are taken should the current regulations that protect human subjects be amended.

The Common Rule, introduced in 1991, is based on the Belmont Report, a research conducted by a national commission in 1978. It identifies three principles, namely: respect for persons; beneficence; and justice. While the report says that these are still central when it comes to protecting human research subjects, a lot of time has already passed since the Belmont Report was issued.

"In the nearly four decades since the Belmont Report was issued, the biomedical and socio-behavioral research enterprises have grown enormously and witnessed profound changes in knowledge and technologies," the press release says. "Today, many developments -- new research contexts and capabilities; the profusion, sharing, and accessibility of personal data; and increasing privacy concerns -- raise important questions about how the principles should be applied."

According to Nature, the US Department of Health and Human Services is currently reviewing responses to its proposal. These comments, totaling to more than 2,100, were submitted during the allotted 90-day period, but many of these are reportedly not supportive of the proposed revisions.