The paperwork and time it takes for researchers to comply with government regulations are out of control, according to a report from the US National Academies of Sciences, Engineering and Medicine. Unless the government fixes inconsistencies between agencies’ regulations and lowers their burdens, it concludes, even well-intentioned rules could be harmful to research and education.
“We are worried that the sum of all the demands is going far beyond the prudent,” said Larry Faulkner, president emeritus of the University of Texas at Austin, and chair of the committee that released the report at a 22 September briefing in Washington DC.
According to a June 2014 analysis by the non-profit Council on Governmental Relations, funding agencies have imposed more than 90 new regulations since 1991. The problem has increased over time: in the 1990s, the government instituted 1.5 research regulations per year, but between 2003 and 2012, that was nearly six per year.
Concerned about the cost of compliance in time and money, the US Congress commissioned the report from the National Academies in 2014. The report committee studied federal rules governing issues such as the disclosure of conflicts of interest and oversight of 'dual-use' research that could be used for nefarious purposes. While the committee says that it recognizes that regulations are essential for protecting human subjects of research, for instance, many rules were sparked by a single event, such as a particularly egregious case of research misconduct. Faulkner says that it is unclear how many regulations have effectively addressed wider problems.
The committee also found fault with the roughly two dozen US government funding agencies’ differing regulations on issues such as animal welfare, grant submission formats and even the way that scientists fill out their CVs. Scientists who work with multiple agencies must take extra time to accommodate those differences. “That’s not time well spent,” says committee member Barbara Bierer, co-director of the Multi-regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital in Boston, Massachusetts.
In some areas, this lack of consistency and clarity has caused serious problems. A 2011 slate of reforms to the US Department of Health and Human Services’ rules on disclosing financial relationships with industry clarified the types of relationships that needed to be disclosed, yet made the process stringent and burdensome. Other agencies’ guidelines have left researchers confused about ethics rules such as those governing acceptance of travel money or gifts.
To remedy the situation, the National Academies committee proposes that Congress and the White House’s Office of Science and Technology Policy work with funding agencies to develop single policies and forms for processes such as grant submission. Such a system is currently in place in the United Kingdom through Research Councils UK, which oversees public research funding.
Finally, the report calls for the establishment of a public-private research policy board whose director would report to the White House. In addition to working with universities and agencies to implement regulatory reform, Faulkner says that such a board could quantitatively assess whether current regulations have improved research practices.
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