The Department of Health and Human Services (HHS), through its Office of the Secretary and the Office of Research Integrity (ORI), has recently issued a Notice of Proposed Rulemaking (NPRM) to revise the Public Health Service (PHS) Policies on Research Misconduct. This significant step comes as a response to the accumulated experience and insights gained by the ORI and institutions since the initial release of the regulation in 2005.
Why the Revision?
The proposed revisions result from a comprehensive evaluation of the existing policies and practices related to research misconduct. The aim is to enhance the effectiveness of the regulations by incorporating the knowledge gained over the years and making adjustments that reflect the evolving landscape of research integrity.
Public Participation is Encouraged
The NPRM actively encourages public participation in the rulemaking process. It invites interested individuals, institutional officials, organizations, research funding agencies, and the public to provide their views, opinions, recommendations, and data. This inclusive approach seeks to gather diverse perspectives and insights, fostering a collaborative effort to improve the clarity of the substantive and non-substantive aspects of the proposed revisions. The notice has a comment period that ends on December 5, 2023.
How to Participate
Those interested in contributing to the rulemaking process can submit written comments. It is essential to note that all comments, including any attachments or supporting materials, will become part of the public record and subject to public disclosure. This initiative emphasizes the key principle of transparency and advises participants to avoid including any information they do not wish to disclose publicly.
Legal Foundation and Authority
The primary legal foundation for these revisions is 42 USC 289b, which is section 493 of the Public Health Service Act, as amended. This legislation empowers the ORI as an independent entity within HHS. It mandates the Secretary to issue regulations defining the term “research misconduct” and implementing the associated provisions of the statute. The 2005 Final Rule established the PHS Policies on Research Misconduct, and the current revision process is an opportunity to build upon the experience gained since its inception.
Ongoing Compliance and Impact on Institutions
As part of the proposed revisions, all recipients of PHS biomedical and behavioral research awards must continue to comply with reporting and record-keeping requirements outlined in the NPRM. The regulatory analysis emphasizes that the burdens on institutions, as demonstrated in the Paperwork Reduction Act analysis, encompass essentially all the activities required under the proposed rule.
The release of this NPRM marks a significant step in the ongoing commitment to upholding the highest standards of research integrity. The HHS invites active participation from the public to ensure that the proposed revisions are thorough, effective, and reflective of the collective wisdom of the research community and the public. This collaborative effort underscores the importance of transparency, accountability, and continuous improvement in maintaining the integrity of scientific research funded by the Public Health Service.