University Associations Praise Final Rule on Protection of Human Research Subjects

The Obama Administration today issued a final rule that amends the “Common Rule,” the set of regulations governing federally funded research using human subjects. The Association of American Universities (AAU) and the Association of Public and Land-grant Universities (APLU) commented on the earlier proposed rule in December 2015. Following is a statement by the two association heads, AAU President Mary Sue Coleman and APLU President Peter McPherson, praising the new rule.

“When conducting research using people as subjects, there is no higher priority than the safety and privacy of those individuals. Our universities, which conduct a majority of research sponsored by the National Institutes of Health, are committed to protecting these subjects, who make an enormous contribution to science and the advancement of human health. For these reasons, we were very pleased with the final regulation making changes in the Common Rule governing such research.

“The most important element of the rule is something it does not contain – an earlier proposal that would have made it very difficult to conduct the lifesaving research that our universities carry out every day. That provision, by requiring ongoing consent for the use of perhaps billions of non-identifiable human biospecimens, or tissue samples, would have forced universities to track and retain the personal information of the millions of people who had donated those samples. The administrative time and cost for both universities and scientists would have been enormous and would inevitably have forced reductions in vital research.

“We are also pleased that the final rule effectively provides exemptions from continuing reviews of ongoing research for several categories of low-risk social sciences research.

“We appreciate the time and effort the Obama Administration took to solicit and carefully review the concerns of universities and other stakeholders.”