What do revised U.S. rules mean for human research

Following a contentious 5½-year process, the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a revised “Common Rule,” which governs federally funded research involving human subjects ( 1 ). The updated rule includes a number of welcome changes for U.S. institutions and researchers, and their scientific collaborators abroad. Annual protocol review by an institutional review board (IRB) is eliminated for many studies that pose minimal risk to participants following initial approval; IRBs no longer need to review and document concordance between grant proposals and study protocols; and, pertinent to research conducted with international collaborators, the rule recognizes that there may be cultural groups or communities for which signing a consent form is not usual. Concerns remain, however, regarding some elements of the revised rule and their implications. With preparations under way in advance of the rule's taking effect on 19 January 2018, and in light of lingering uncertainty, we highlight provisions that will present the greatest challenges to institutions and researchers.