Photo of Suzanne RiveraSuzanne Rivera, vice president for research and assistant professor of bioethics at Case Western Reserve University, co-authored a paper to be published in the Aug. 18 issue of the journal Science, highlighting new rules for federally funded research the authors expect will present the greatest challenges to institutions and researchers.

The U.S. Department of Health and Human Services’ Office for Human Research Protections has released a revised “Common Rule,” which governs federally supported research involving human subjects. The updated rule was published in the Federal Register on Jan. 19, 2017, with an effective date of Jan. 19, 2018.

In their paper, “What do revised U.S. rules mean for human research?: The updated Common Rule raises many questions,” Rivera and her co-authors raise concerns about some elements of the revised rule and their implications.

“The effort to update our decades-old system for oversight of human research took more than five years, and the resulting revisions are very controversial,” Rivera said. “I was part of a team that analyzed the public comments made to the government before a final updated rule was issued. Our commentary in Science highlights the aspects that are most concerning to the research community. It is not known whether they will go into effect, though, because the Trump administration put the changes on hold pending administrative review.”

The co-authors were:

  • Lisa Nichols, director of research and regulatory reform for the Council on Governmental Relations;
  • Lois Brako, assistant vice president for research, regulatory and compliance oversight at the University of Michigan;
  • Ara Tahmassian, chief research compliance officer at Harvard University;
  • Martha Jones, executive director of the human research protection office at Washington University in St. Louis;
  • Heather Pierce, senior director and regulatory counsel at the Association of American Medical Colleges; and
  • Barbara Bierer, senior vice president for research at Brigham and Women’s Hospital.