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Exploring the U.S. Department of Health and Human Services Office of Research Integrity’s Final Changes to Research Misconduct Regulations
September 23, 2024
Ropes & Gray LLP and the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) held a1.5-hour webinar last Thursday, titled “ORI Issues Final Changes to Research Misconduct Regulations: Key Reforms and Lingering Complexities.”
U.S. Department of Health and Human Services released a final rule on research misconduct on September 12, which was published in the Federal Register on September 17. During the webinar four experts reviewed 32 pages of slides and answered a series of questions to address possible interpretations and approaches to compliance with the new revision to research misconduct rules (Part 93) drafted by HHS’ Office of Research Integrity.
The panelists included Mark Barnes, a partner at Ropes & Gray, who has extensive experience guiding clients on a wide range legal issues including research misconduct, research fraud, stem cell and genetic research, federal research grants and contracts, international research collaborations and data privacy; Barbara Bierer, MD, a Professor of Medicine at Harvard Medical School, and the co-founder for MRCT Center; Minal Caron, Counsel in Ropes & Gray’s health care practice group; and Madhu Purewal, who is the Senior Legal Officer and Executive Director of Research Compliance at MD Anderson Cancer Center in Texas.
“We have until January 1, 2026 essentially to digest what's in it and to figure out how we're going to change our processes and comply with the final rule,” Caron told the webinar attendees.
“The research landscape has changed over the past 20 years, thanks to new technology, scientific advances, and the globalization of research. To preserve the integrity of the research that we help to fund, it is necessary to update the regulations around how that research is conducted. And that is what we are doing today,” HHS Secretary Xavier Becerra said on Sept. 12 when the new rule was announced.
In response to questions from PRIM&R after the webinar about the new rule, Barnes said, “Many institutions have taken extremely literally the confidentiality obligations in the HHS research misconduct regulations (Part 93) and have essentially forbidden the sharing of any information with anyone about an ongoing research misconduct case. This has, in our experience, disadvantaged IRBs and IACUCs that are, simultaneously with the research misconduct process, considering allegations of inappropriate conduct in human or animal research – conduct whose nature also gave rise to the research misconduct allegations.”
Barnes, who won the PRIM&R Service Award last year, elaborated, “The revisions of Part 93, however, have greatly eased this problem, because the revision now expressly includes the IRB among the persons and entities who may have a ‘need to know’ about a research misconduct process and its details, and thus are allowed to receive that information.”
As a result, he said, “the revised Part 93 will facilitate interactions between IRBs, RIOs and research misconduct committee members, when there is a common factual nexus between their activities and concerns.”
Barnes also noted, “the revised Part 93 specifically calls out academic and scientific journals and their editors as among those who may have a ‘need to know’ … thus making it possible and allowable for RIOs and academic institutions to contact journal editors to discuss data reliability issues in published papers, as well as the corresponding need for correction, retraction, or posting of notice of concern, for those papers.”
In the HHS Sept. 12 press release, ORI Director Sheila Garrity stated: “ORI is committed to keeping up with the needs of the research community. The Final Rule aims to adapt to our current time, support our colleagues in the research community, and fortify ORI’s role in fostering research integrity and preserving public trust in science for future generations.”
To watch the webinar, click here: Webinar Replay
To read the webinar’s presentation slides, click here: Presentation Slides