The Office of Research Integrity (ORI) has issued a Notice of Proposed Rulemaking (NPRM) to update the 2005 Public Health Service (PHS) Policies on Research Misconduct. The current regulation establishes the requirements for addressing research misconduct in PHS-funded research. Its purpose is to promote integrity in research, establish the definitions and processes to assess and investigate allegations of research misconduct, ensure the appropriate handling of research misconduct by PHS-funded institutions, and authorize administrative actions, when necessary. Proposed revisions to the policy build upon previous regulations and make necessary improvements to meet the demands of dynamic changes in biomedical and behavioral research.
“ORI’s work is crucial for maintaining the integrity of research, protecting the health and safety of the public, conserving public funds, and building the foundation for pioneering medical breakthroughs,” said HHS Assistant Secretary for Health, ADM Rachel Levine. “It is imperative that research be carried out at the highest standard to instill trust, garner public support, and better the lives of everyone across our nation and the world. Upholding the principles of research integrity is intrinsic to the process and the core of scientific discovery.”
ORI policies on research misconduct have not been revised since 2005. Prior to the NPRM release, ORI published a Request for Information (RFI) to solicit views on the 2005 regulations from the public, including key stakeholders and collaborative groups.
ORI proposes the following revisions:
- Clarifying and adding definitions of key terms to help institutions make research misconduct findings.
- Clarifying responsibilities of HHS, ORI, and PHS-funded institutions and agencies in addressing research misconduct allegations, including assessment, reporting, inquiry, investigation, documentation, and record-keeping.
- Developing a streamlined appeals process for respondents who wish to dispute ORI’s findings and administrative actions.
- Supporting streamlined assurance and compliance processes for institutions to meet mandatory PHS funding requirements.
- Requiring subrecipients to comply with the regulation.
- Establishing ORI’s responsibilities in issuing timely guidance to support institutional implementation and compliance with the regulation.
“The NPRM is an opportunity for ORI and PHS-funded institutions to establish a mutual understanding about how we will work together to protect the integrity of research,” said Sheila Garrity, ORI Director. “This is why it is absolutely critical for the research community to provide comments. The public needs to know that every comment will be read and considered as we work on the final rule or develop further guidance in the future.”
The NPRM expresses ORI’s stake and intent in developing and issuing research integrity guidance to support PHS-funded organizations in implementing measures to ensure research integrity. Key topics likely to be included in future guidance include assistance with institutional policy revision, issuance of template policies, release of short videos on ORI’s website, and continued offering of education conferences/experiences.
The comment period on the NPRM will be open until December 5, 2023. ORI seeks feedback from individuals, institutions, organizations, research funding agencies, and other members of the public on the proposed revisions and how to improve the clarity of the provisions contained in 42 CFR part 93.
HHS has the press release.
