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Rules governing research involving human subjects have become a source of controversy.

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U.S. should abandon controversial effort to update human research rules, National Academies panel says

Stop what you are doing—now!—and wait for more discussion and instruction.

That’s the blunt message that a National Academies of Sciences, Engineering, and Medicine committee on reforming federal regulation of U.S. research sent today to the National Institutes of Health (NIH) and other government agencies. In one part of a wide-ranging report on ways to reduce research red tape, the panel calls on U.S. agencies to abandon a controversial proposal to update rules that protect human research participants, then wait for the president and Congress to create a new high-level commission to recommend improvements.

The proposal, which was released last year and has received extensive criticism from science groups, “is marred by omissions, the absence of essential elements, and a lack of clarity,” the report states. And its “inadequacies signal a pressing need for a comprehensive review of the nation’s ethical, legal, regulatory and institutional frameworks for protecting research subjects.”

To conduct that review, the panel calls on the White House and Congress to appoint an expert panel modeled on a similar 1978 commission that produced a landmark report—known as the Belmont Report—that led to many of today’s rules governing human research.

Although some researchers have called on the United States to pause its efforts to update what is known as the Common Rule, the sweeping nature of the report’s cease-and-discuss recommendation has caught many science and university groups by surprise. But early reaction has been supportive.

“It is an interesting idea and worth considering,” says Lizbet Boroughs, an associate vice president for federal relations at the Association of American Universities in Washington, D.C., one of the groups that has raised concerns about proposed changes to the Common Rule.

A pause and rethink would be worthwhile if it produces a “thoughtful process” for improving the rule, adds Heather Pierce, the senior director of science policy at the Association of American Medical Colleges, also based in Washington, D.C. “There is wide recognition that the Common Rule as it exists now doesn’t meet the needs of subjects and researchers,” she says, “but there are some real concerns about the proposed rule, not so much in the motivation behind it, but in the implementation and possible unintended consequences.”

In a statement, a spokesperson for the Department of Health and Human Services (HHS), NIH's parent agency, said officials "look forward to reviewing the report." The statement noted that the Common Rule proposal has "received more than 2,100 public comments. [HHS]—and the 18 other federal agencies involved in this effort—have spent the past few months reviewing all of these comments. We take all public comments seriously and are considering them as we develop the final rule."

Many groups have criticized the proposal. One issue, they say, is that it could create potentially unworkable systems for tracking approvals to use biological specimens taken from humans. Another concern is that the government has failed to make clear how certain systems would work—such as one that would allow social science researchers to determine whether their studies that involve humans would be exempted from regulation.

It is not clear, however, whether NIH, the Obama administration, and lawmakers will be willing to put the brakes on the effort to update the Common Rule, which has been underway for years, and which officials have been pushing to complete by the end of 2016.

“Congress and the administration have an opportunity for a course correction that can yield significantly greater value to the public from the nation's investment in research, and we hope our recommendations will guide that effort,” said Larry Faulkner, chair of the committee that wrote the report and president emeritus at the University of Texas, Austin. 

The Common Rule recommendation is just one of dozens included in today’s report, which also examines federal efforts to regulate research on potentially dangerous biological agents and toxins, control the export of technologies that could potentially be used by U.S. adversaries, and promote the commercialization of academic research. Other notable recommendations include:

  • put the Federal Select Agent Program under the control of a single federal agency. The program, which covers biological materials and toxins that could potentially be used as bioweapons or pose serious public health threats if they escaped from a laboratory, is currently run by several agencies, including the Centers for Disease Control and Prevention and the U.S. Department of Agriculture;
  • move a system for tracking inventions produced by federally funded research, known as iEdison, from NIH to the Department of Commerce; and
  • continue efforts to streamline export controls so that they protect key technologies but don’t interfere with university research.

Today’s report is the second half of a report examining ways to cut research red tape, which has become a major concern of the academic community. The first part was released this past September, and has helped create momentum in Congress and the administration for reforms.

With reporting by Dianne Lugo.

*Update, 29 June, 2:55 p.m.: This item has been updated to include a statement from the U.S. Department of Health and Human Services, and to clarify that the Common Rule proposal involves many U.S. government agencies, and not just the National Institutes of Health.