Health Care Attorneys Author Comment Letter on Proposed Changes to Federal Regulations on Research Misconduct

Health care partner Mark Barnes and health care counsel Minal Caron co-authored, with Dr. Barbara Bierer of Harvard Medical School, a comment letter to a recent Notice of Proposed Rulemaking issued by the U.S. Department of Health and Human Services’ Office of Research Integrity (ORI) relating to proposed changes to federal regulations on research misconduct. 

The comment letter was signed by officials from the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), Association for the Accreditation of Human Research Protection Programs (AAHRPP), Children’s National Hospital, Cornell University, Kennedy Krieger Institute, Public Responsibility in Medicine and Research (PRIM&R), Tulane University, University of Utah, Washington University in St. Louis, and Research Integrity Partners, LLC.  Some of these institutions also filed their own separate comment letter on these proposed changes to the research misconduct regulations.

The comment letter seeks to highlight ways that ORI could refine its proposed changes to ensure clarity and efficiency in implementation for institutions that conduct reviews of allegations of research misconduct.