Research

At Long Last, Agency Completes Overhaul of Rules on Use of Humans in Research

January 18, 2017

With two days left in the Obama administration, the federal agency charged with protecting human beings in research on Wednesday issued an overhaul of rules that had been caught up in more than five years of acrimonious debate.

The rule changes, which will begin to take effect next year regardless of the change in presidents, will generally allow for a single review of human protections in studies that occur at multiple universities, and will allow broader exemptions from such reviews for researchers whose study interactions are limited to interviews.

Many of the changes enjoyed wide support in the research community but were delayed by extended debate over the details. The federal Office for Human Research Protections, which oversees the rules, received more than 2,100 public comments on the plan, which it first announced in 2011.

The office removed one of the most potentially significant obstacles to eventual enactment of the rules with its decision not to impose proposed new privacy safeguards for biospecimens that may contain identifiable private information.

The biospecimens issue was seen as the most likely to draw attention from Republicans in the House of Representatives who might have tried to intervene to block the rules before they start taking effect, in January 2018, said Zachary M. Schrag, a professor of history at George Mason University.

Its inclusion would have been highly disappointing to social-sciences researchers, who eagerly await the promised changes to exempt most oral discussions with human participants from the authority of universities' institutional review boards, or IRBs, Mr. Schrag said.

The Association of American Universities and the Association of Public and Land-Grant Universities issued a joint statement emphasizing that point. A rule requiring universities to track and retain the personal information of the millions of people who had donated tissue samples would have imposed "enormous" cost and time burdens, slowing overall research, the two associations said. "The most important element of the rule is something it does not contain," they said.

The final version of the rules also was designed to mollify objections to the plan for allowing a single institutional review board to approve studies occurring at multiple locations, rather than requiring each institution’s IRB to weigh in. As part of the final compromise, funding agencies will be given wide discretion on when a single IRB review is not appropriate. That provision takes effect in three years.

The timing of the announcement had nothing to do with the conclusion of the Obama administration, said the director of the Office for Human Research Protections, Jerry A. Menikoff, a career government official whose job does not change with the presidential transition.

"We have been working on this, and we finally reached a point where we had a document and it was ready to go public," Dr. Menikoff said of the five-year effort. "And we think it’s a good result."

Paul Basken covers university research and its intersection with government policy. He can be found on Twitter @pbasken, or reached by email at paul.basken@chronicle.com.