In This Month’s E-News: October 2023

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, no. 10 (October, 2023)

The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) will have two new members when it meets this month. In an email sent to its listserv on Sept. 11, the Office for Human Research Protections announced that Alison Bateman-House, Ph.D., an assistant professor in the Division of Medical Ethics at New York University’s Grossman School of Medicine, and Neal W. Dickert, M.D., Ph.D., professor of medicine in the Division of Cardiology at Emory University School of Medicine, were appointed to SACHRP.

SACHRP’s charter calls for 11 members who meet three times a year and serve three- or four-year terms. The announcement did not indicate the terms of the new members. Dickert’s appointment means SACHRP now has two physicians serving on it—he joins SACHRP Chair Doug Diekema, M.D., professor of pediatrics and adjunct professor in the Departments of Bioethics and Emergency Medicine in the University of Washington School of Medicine. Three other new members appointed in July also represent universities, replacing three individuals who were affiliated with pharmaceutical companies. With the newest appointments, SACHRP is still down two members but will have enough to conduct committee business. Its next meeting is scheduled for Oct. 18-19 and is planned to be held in person. Details, including the agenda, have not been released. Information about the new members was not posted online as of Sept. 13. (9/14/23)

The HHS Office of Research Integrity (ORI) recently issued three misconduct findings against investigators, two of whom were working together. Kotha Subbaramaiah, formerly a professor of biochemistry research in medicine at Weill Cornell Medical College (WCMC), “engaged in research misconduct by intentionally, knowingly, or recklessly falsifying and/or fabricating data” in a dozen papers published from 2008 to 2015, all of which have been retracted. Subbaramaiah “reused Western blot images from the same source and falsely relabeled them to represent different proteins and/or experimental results,” ORI said. He agreed to exclude himself from federal funding for seven years, beginning Aug. 16, according to ORI’s Sept. 7 announcement.

The same day, ORI announced that Subbaramaiah’s coauthor on the papers, Andrew Dannenberg, M.D., formerly a WCMC professor of medicine, agreed to a seven-year supervisory period should he receive Public Health Service (PHS) funding. ORI said Dannenberg’s misconduct consisted of “recklessly reporting” the false or fabricated data in the papers. His supervisory period began Aug. 14. Retraction Watch reported that both retired from WCMC, Dannenberg in 2020 and Subbaramaiah a year later.

An attorney for Dannenberg told Retraction Watch that the questioned data was “generated and prepared by a faculty member in Dr. Dannenberg’s former laboratory, not by Dr. Dannenberg. Dr. Dannenberg believed the data produced in each of the implicated papers/grants were accurate and reliable when they were submitted. Dr. Dannenberg would never have published the data had he suspected or known that the data were manipulated or fabricated. “Although Dr. Dannenberg believes he was careful and thorough in supervising data generation in his lab, he has reached a settlement with the Office of Research Integrity to allow him to continue pursuing his scientific endeavors in PHS-funded science and avoid the time and burden of further litigation.” Subbaramaiah declined to comment on the finding, the website reported, adding that the two were the recipients of millions in NIH funding.

A misconduct finding ORI released on Aug. 30 involved Ivana Frech, who the agency said was formerly called Ivana De Denico. Frech was an assistant professor in the Department of Medicine at the University of Utah. “ORI found by a preponderance of the evidence that [Frech] intentionally, knowingly, or recklessly falsified and/or fabricated western blot and autoradiogram images related to mechanisms of cellular iron regulation by reusing, relabeling, and manipulating images to falsely report data” in three published papers. Eight Western blots and other images were fabricated, ORI said. The agency debarred Frech from governmentwide funding or contracting for three years beginning Aug. 21. (9/14/23)

Too many papers fail to describe the research practices in a study, information such as outcome measures and the use of control groups, or define “clear measures of uncertainty” and “study limitations such as possible confounding factors,” according to an Aug. 10 NIH blog post. “If the study is exploratory, if the above practices are not reported or performed, or if other relevant reporting guidelines have not been followed, the results should be interpreted as preliminary or tentative, and any conclusions should be communicated accordingly,” wrote Devon Crawford, program director in NIH’s National Institute of Neurological Disorders and Stroke’s Office of Research Quality.

Addressing study design as well, Crawford said research lacking such practices is “likely to be at high risk for unconscious biases that can lead to incorrect conclusions.” When appropriate, papers should highlight “measures…taken to reduce bias” and “important experimental design and planning elements.” She noted that “communicating science accurately and responsibly is a balance between engaging the audience and providing enough important details.” Crawford added that “a study’s rigor, transparency, and robustness not only provides important information about reliability, but it also signals to the audience that context, and by extension the ongoing process, is central to science.” (8/31/23)

The Office of Management and Budget (OMB) has revised its guidance for grants and agreements “to support implementation of the Build America, Buy America Act provisions of the Infrastructure Investment and Jobs Act and to clarify existing provisions related to domestic preferences,” the agency announced in the Aug. 23 Federal Register. “These revisions provide further guidance on implementing the statutory requirements and improve Federal financial assistance management and transparency,” OMB said. The guidance finalizes a draft issued in February—which generated nearly 2,000 comments—and listening sessions OMB held in April 2022. The effective date of the guidance is Oct. 23.

In a summary, the Congressional Research Service (CRS) explained that, prior to the infrastructure act becoming law in 2021, “Buy America requirements attached to federal funds in the provision of highways, public transportation, intercity passenger rail (e.g., Amtrak), aviation, and water and sewage construction.” Now they apply to “other types of infrastructure projects funded by federal awards, such as electric power transmission facilities and broadband infrastructure. The law also broadened Buy America product coverage to ‘construction materials’ including nonferrous metals (e.g., copper used in electric wiring), plastic- and polymer-based products, glass (including optical fiber), and other materials (e.g., lumber, drywall).” Further, it “creates a new section in the Code of Federal Regulations (Title 2, Part 184) and includes the requirements for construction materials, iron and steel products, and manufactured products to be considered domestic in origin. Although OMB’s final guidance clarifies several issues raised by public commenters, some issues remain unresolved,” CRS said. (8/31/23)

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Health Care Compliance Association (HCCA)

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