A Message from the ORI Director on Proposed Revisions to the 2005 Public Health Service Policies on Research Misconduct (42 CFR Part 93)

Dear Colleagues,

The current PHS Policy on Research Misconduct, familiarly known as “ORI’s Reg”, was brand new when I first became a research integrity officer (RIO) in the summer of 2005. The 2005 regulation greatly improved the previous, two-page regulation and provided clarity on the proper handling of research misconduct allegations. I worked with my employer, Johns Hopkins University, the leading recipient of federal funds for research at that time, to revise its policies to be in compliance with the new ORI regulation.

That was 18 years ago. Flip phones were the craze. We listened to music on iPod Minis with wired headphones. Technology in general has taken great leaps since that time, and so have the research and the research integrity landscapes. We must work together to update the ORI Reg to keep up with the evolving research environment using lessons learned living under the 2005 regulation. To do this, we need your help.

On October 5, 2023, we released a Notice of Proposed Rulemaking (NPRM) that contains several updates to clarify complex processes, vague concepts, and undefined terms in the existing regulation. Is self-plagiarism research misconduct? Who falls under the category of the “need-to-know” basis? What needs to go into your policies and procedures? This is just a very small sample of questions and issues that ORI hopes to address in the proposed rule.

ORI spent several months drafting the proposed changes and now it is your turn. I invite you to review the NPRM using the link below and send your comments. I pledge that every comment will be read, be considered, and whenever possible, be implemented into the new rule or be considered for further guidance in the future.

Federal Register :: Public Inspection: Public Health Service Policies on Research Misconduct

Sincerely,
Sheila Garrity
Director, Office of Research Integrity
Office of the Assistant Secretary for Health
U.S. Department of Health and Human Services