Washington Update

FASEB Underscores Institutional Support and Flexibility in Response to HHS NPRM

By: Kamille Rasche and Naomi Charalambakis
Wednesday, December 20, 2023
On November 30, FASEB submitted comments in response to the Department of Health and Human Services Office of Research Integrity's (ORI) Notice of Proposed Rulemaking regarding updates to the Public Health Service Policies on Research Misconduct. The proposed revisions stem from knowledge the office has gained since implementing the regulation in 2005 and largely aim to both improve clarity and streamline processes for institutions.

FASEB’s comments focus on proposed revisions to institutional responsibilities, including how to handle misconduct proceedings across the assessment, inquiry, and investigation phases. For example, through the proposed rule, ORI will require all institutions to submit an “Institutional Record” that includes all supporting documentation collected during a proceeding. While FASEB recognizes such comprehensive recordkeeping and reporting will facilitate streamlined review, we suggest ORI issue supplementary guidance or best practices on how to generate, maintain, and submit institutional records. Such guidance is particularly important in alleviating administrative burden for institutions with limited resources.

Additionally, FASEB thanks ORI for clarifying that institutions can add additional respondents or allegations to an existing investigation rather than opening a separate inquiry. Considering that small institutions may not have the capacity to restart investigations if new information or additional respondents are discovered, this flexibility enables institutions to dedicate time and resources toward other aspects associated with misconduct proceedings.