Report on Research Compliance 21, no. 9 (September, 2024)
◆ Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to provide information about the “major U.S. biopharmaceutical companies [that] have conducted hundreds of clinical trials alongside” a People’s Liberation Army (PLA) entity “over the last 10 years,” as well as about trials U.S. companies have conducted in Xinjiang. There, the Chinese Communist Party “forces ethnic minorities…to participate in gruesome medical procedures, which likely overlap with FDA-approved research,” they said in an Aug. 20 news release announcing their letter to FDA Commissioner Robert Califf sent the previous day. U.S. firms have affiliated with PLA health care facilities, including a hospital “directly operated by the PLA’s Academy of Military Medical Sciences,” the letter said. The academy is on the Commerce Department’s Entity List, “which precludes U.S. companies from transferring technology to [it] due to the threat it poses to U.S. national security. The transfer of early-stage clinical trial data, including the chemical composition of the therapeutic itself, involves incredibly sensitive data,” according to the letter signed by Reps. John Moolenaar, R-Mich., and Raja Krishnamoorthi, D-Ill., chair and ranking member, respectively, of the Select Committee on the Chinese Communist Party, and by two other House members.
Without providing specifics, the letter said FDA “has previously declined to approve oncology treatments based on clinical trial data solely produced from clinical trial sites in China, suggesting the FDA should also impose similar scrutiny to clinical trial work done in cooperation with the PLA.” The representatives asked for responses by “no later than” Oct. 1 to seven questions, including “how many PLA-owned, operated, or affiliated facilities has the FDA reviewed for clinical trial work?” and whether the agency has been denied access to sites in China. “Given FDA’s regulations for ensuring that clinical trials are conducted according to ethical and safety standards, has the FDA ever notified any U.S. biopharmaceutical organization that it has conducted studies with the PLA or in the [Xinjiang region]? If so, please provide the number of notices and time periods when they were issued, and if companies were responsive,” the letter asked. The representatives also requested that FDA explain the metrics it uses “when assessing [intellectual property] and technology transfer risks,” adding, “Within those metrics, how are the risks calculated when research studies identify collaborations with the PLA or involve PLA-owned facilities as the setting for the research?” (8/22/24)
◆ An audit by the National Science Foundation (NSF) Office of Inspector General (OIG) of some $10.8 million in expenses Iowa State University (ISU) claimed on 34 awards concluded that ISU inappropriately charged $9,709 in costs on six awards expended as of Aug. 10, 2022. The Aug. 12 audit focused on 40 transactions totaling $773,048 auditors selected “by identifying potentially high-risk transactions, such as costs charged near the end of an award period across several budget categories.”
The largest portion of the questioned costs was $6,247 for a graduate student’s tuition expense; the individual was initially assigned to an award and then removed, but the tuition was not. Second was $2,159 for 31,200 envelopes purchased to mail 17,000 questionnaires. ISU “could not explain how the remaining 14,200 envelopes benefited the award.” ISU charged $656 of indirect costs “that did not correspond to any associated direct costs”; charged $268 of indirect costs as participant support costs, which is unallowable; and double-charged $36 of indirect costs to an award. Some of the questioned costs occurred due to system errors, ISU officials said, according to the audit—although this is not mentioned in ISU’s three-page response to draft audit findings appended to the audit report. ISU made repayment of all questioned costs and detailed specific changes it implemented in response to auditors’ recommendation that it strengthen internal controls. (8/22/24)
◆ John L. Eckert, hailed by the University of Maryland, Baltimore (UMB), just five years ago as a “preeminent scientist and investigator with continuous funding” from NIH, agreed to the equivalent of an eight-year, governmentwide debarment following an investigation by the HHS Office of Research Integrity (ORI) that concluded he committed research misconduct dating to at least 2010, ORI announced Aug. 12. Eckert, formerly deputy director of UMB’s Stewart Greenebaum Comprehensive Cancer Center and chair of the Department of Biochemistry and Molecular Biology, “intentionally, knowingly, or recklessly falsify[ed] and/or fabricat[ed] data” in 13 published papers and two Public Health Service (PHS) grant applications.
According to ORI, the falsifications and/or fabrications involved Western blot and microscopy image data that were relabeled and reused in papers published from 2010 to 2018. Eckert agreed to request that eight papers be corrected or retracted. In 2020 and 2021, the National Cancer Institute (NCI) administratively withdrew two applications Eckert submitted in 2018. Awards were from NCI, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Eye Institute and National Institute of General Medical Sciences. During the exclusion period, which began Aug. 1, Eckert also will not serve as an advisor to PHS. At the time of his appointment in 2019, UMB also said Eckert—promoted from the post of associate director for basic sciences he had held since 2014—had “principal responsibility for scientific and research leadership, as well as recruitment and strategic planning, working with the leaders of the [the cancer center] to set priorities and future direction.” An interim chair of the biochemistry department was appointed in July 2023. According to Retraction Watch, Eckert had $19 million in NIH awards, and the misconduct was committed in research funded by “every NIH grant on which he served as principal investigator.” (8/15/24)
◆ Last summer, NIH issued a notice prohibiting peer reviewers from using artificial intelligence (AI) “for analyzing and formulating peer review critiques for grant applications and R&D contract proposals,” banning “natural language processors, large language models” and other generative AI technologies. NIH maintained that such use violates its confidentiality policy, as they require “substantial and detailed information inputs. AI tools have no guarantee of where data are being sent, saved, viewed, or used in the future.” NIH has issued few other, if any, policies addressing the use of AI in research.
Although “NIH’s current policy landscape is well positioned to ensure the responsible use of AI technologies,” its policy office “know[s] that sometimes new policies are indeed warranted to capture new risks as science and technology progresses,” Lyric Jorgenson, director of the Office of Science Policy (OSP) wrote in an Aug. 6 blog post. She noted that “policy often moves slower” than technology but promised, “NIH is committed to monitoring the field of AI and other emerging technologies and we will continue to update this resource to make sure we are keeping pace from a policy perspective.” OSP created a website Jorgenson referred to as a “centralized NIH policy resource illustrating the applicability of existing policies to AI, including policies related to participant protections, intellectual property, peer review, and many other topics.” Links to the Common Rule, HIPAA rules and others are provided, which are lacking in AI-related additions. One exception is found on a U.S. Patent and Trademark Office information webpage. (8/15/24)
◆ Members of Emory University’s institutional review board (IRB) may not always have a “clear” understanding of “all conditions required to secure IRB approval” prior to voting on research under consideration, according to a recent determination letter posted by the HHS Office for Human Research Protections (OHRP). OHRP officials made this “determination” following an evaluation conducted in May 2023 during which they attended three IRB meetings and reviewed documentation for 30 studies. But they also stated in a June 27 letter that “no determination of noncompliance is made regarding the observation described.” OHRP recommended that, “immediately prior to a vote, the IRB recap an explicit list of any changes or clarifications required by the IRB as a condition of IRB approval, consistently across IRB panels.”
OHRP referenced previous Emory correspondence in which officials said, in OHRP’s words, that “IRB staff take notes throughout all IRB meetings to capture the discussion of all agenda items. Requested changes are documented by IRB staff throughout the discussion. Prior to the vote, the Chair summarizes the motion and general categories of pending issues and calls for a vote.” Moreover, “in July 2023 Emory conducted another formal training for their IRB members and staff at the start of each of that month’s IRB meetings, which was also shared with all members via email and posted on Emory’s website for future review. Emory’s IRB staff and Chairs continue to reiterate this guidance during meeting discussions when needed, to ensure that outcomes are compliant with OHRP guidance,” OHRP said Emory officials told the agency. Emory’s “corrective actions adequately address the determination,” OHRP said. Emory’s is the third determination letter OHRP has issued so far this year; in 2023, it issued only two. In the past, OHRP posted a dozen or more per year. It has been without a permanent director since December 2022, and officials have often lamented a lack of funding. (8/8/24)
◆ “If a multiyear gift or a contract spanning more than one year from a foreign source in a foreign country of concern is initiated during the reporting period (July 1, 2023, to June 30, 2024), and $50,000 or more is received during the reporting period (July 1, 2023, to June 30, 2024), only the amount received during this reporting period must be reported” in fields for gift or contract amount in the Foreign Financial Disclosure Report portal, according to an email sent to the NSF policy email list by Jean Feldman, policy head, on Aug. 5. “If a multiyear gift or a contract spanning more than one year from a foreign source in a foreign country of concern was initiated prior to the reporting period (July 1, 2023, to June 30, 2024) but $50,000 or more is received during the reporting period (July 1, 2023, to June 30, 2024), the amount received during the reporting period must still be reported” in the gift or contract amount fields. She added that “amounts received in future years must be reported in future years, not in this reporting period (July 1, 2023, to June 30, 2024).”
NSF “understands that the new guidance regarding reporting of multiyear gifts or contracts spanning more than one year is a departure from previously issued guidance,” Feldman said, and reflects “additional questions from the community” and “further review” by NSF. Previously, NSF said “multiyear gifts or contracts spanning more than a year are only required to be reported in the first year the gift was received by, or the contract was entered into with a foreign source in a foreign country of concern. In such cases, the total value of the multiyear gifts or contracts spanning more than a year must be disclosed,” according to the email. She also addressed steps to take institutions wish to amend previously submitted reports in light of the new guidance. The FFDR portal will be updated to reflect on changes on Aug. 26, according to Feldman. The deadline to submit FFDR disclosure reports in Research.gov is Sept. 3. (8/8/24)
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