HHS proposed rule to update policies on research misconduct

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The Office of Research Integrity has issued a Notice of Proposed Rulemaking (NPRM) to update the 2005 Public Health Service Policies on Research Misconduct. The current regulation establishes the requirements for addressing research misconduct in PHS-funded research.

Its purpose, according to the Department of Health and Human Services, 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.

The proposed revisions to the policy build upon previous regulations and make what HHS called "necessary improvements" to meet the demands of 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."

WHAT'S THE IMPACT?

ORI policies on research misconduct have not been revised since 2005. Prior to the NPRM release, ORI published a Request for Information to solicit views on the 2005 regulations from the public, including stakeholders and collaborative groups.

Based on that, ORI is proposing a number of revisions, including clarifying and adding definitions of key terms to help institutions make research misconduct findings.

The revisions would also clarify the responsibilities of HHS, ORI and PHS-funded institutions in addressing research misconduct allegations – including assessment, reporting, inquiry, investigation, documentation and record-keeping.

Among the other revisions are 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; and establishing ORI's responsibilities in issuing timely guidance to support institutional implementation and compliance with the regulation.

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 the continued offering of education conferences, HHS said.

THE LARGER TREND

The comment period on the NPRM will be open until December 5. ORI seeks feedback from individuals, institutions, organizations, research funding agencies and other members of the public on the proposed revisions and about ways to improve the clarity of the provisions contained in 42 CFR part 93.

ON THE RECORD

"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 ORI Director Sheila Garrity. "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."
 

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Email the writer: Jeff.Lagasse@himssmedia.com