BBA: New Rules to Research Misconduct? How the Office of Research Integrity’s Proposed Revisions to PHS Rules on Research Misconduct May Affect You

Marylana Saadeh Helou, Associate, co-presents "New Rules to Research Misconduct? How the Office of Research Integrity’s Proposed Revisions to PHS Rules on Research Misconduct May Affect You," a webinar hosted by the Boston Bar Association (BBA).

Allegations of research misconduct deeply threaten academic research enterprises and individual investigators responsible for conducting responsible research and whose eligibility to receive federal funding rely upon assuring that this is the case year after year. Nevertheless, the numbers of reported research misconduct allegations continue to rise and demand growing attention of institutional grant recipients who must address the allegations to the satisfaction of federal oversight agencies.

Since 2005, the Public Health Service (PHS) Policies on Research Misconduct have provided the sole framework for how an institution must respond to purported research misconduct in PHS-funded research. The 2005 PHS Regulations have served as a model for countless institutions in implementing internal guidance and expectations on the topic of research integrity. Investigators facing research misconduct allegations regularly consult the 2005 PHS Regulations for guidance on procedure, substantive definitions, and for exercise of their due process rights, in addition to applicable institutional policies.

In October 2023, HHS and ORI issued a Notice of Proposed Rulemaking to update the 2005 PHS Regulations for the first time since enacted.

Among other notable changes, the Proposed Rules:

• Clarify and further define key terms and responsibilities of the parties
• Clarify responsibilities of federal agencies in overseeing the research misconduct process
• Suggest a streamlined appeal process for respondents seeking to dispute ORI’s findings or administrative actions
• Require sub-recipients of PHS funding comply with the regulation.

Panelists will discuss how the Proposed Rules will impact the evaluation of research misconduct claims and new challenges that may arise as a result of these changes in an interactive discussion.

To learn more, please visit the Boston Bar Association.