Report on Research Compliance 19, no. 10 (October, 2022)
◆ Beginning Oct. 1, Renee Wegrzyn will be the first permanent director of the Advanced Research Projects Agency for Health (ARPA-H), the new HHS agency modeled after the Defense Advanced Research Projects Agency (DARPA) for which Wegrzyn formerly worked, President Joe Biden announced Sept. 12. Since August 2020, she has been vice president of business development at Ginkgo Bioworks, a biotech firm focused on cell programming based in Boston. Wegrzyn, who has a Ph.D. in applied biology from the Georgia Institute of Technology, was the program manager in DARPA’s Biological Technologies Office from April 2016 until joining Ginkgo Bioworks. Acting Deputy Director Adam Russell has led ARPA-H since May 25.
"I am deeply honored to have the opportunity to shape ARPA-H's ambitious mission and foster a vision and approach that will improve health outcomes for the American people, including President Biden's Cancer Moonshot," Wegrzyn said in a statement released by Ginkgo Bioworks. “Some of the problems we face every day—especially in health and disease—are so large they can seem insurmountable. I have seen firsthand the tremendous expertise and energy the U.S. biomedical and biotechnological enterprise can bring to solve some of the toughest health challenges. ARPA-H will create the transformative and collaborative space that is required to support the next generation of moonshots for health—not only for complex diseases like cancer, but also systemic barriers like supply chain gaps and equitable access to breakthrough technologies and cures for everyone." (9/15/22)
◆ Ritankar Majumdar, a former postdoctoral fellow in NIH’s intramural research program, engaged in research misconduct by “knowingly or recklessly falsifying and/or fabricating data in the following one (1) published paper, one (1) manuscript, three (3) PHS grant applications, and fifteen (15) presentations,” the HHS Office of Research Integrity (ORI) recently announced. Majumdar falsified and/or fabricated electron microscopic images, presenting such images “from the same source and falsely relabeling them to represent different experimental results,” “falsified and/or fabricated immunoblot image data,” and “falsified and/or fabricated time-lapse confocal microscopic image data for nuclear envelope vesicle formation by falsely presenting still images in reverse order from the original movies” in one manuscript, ORI said.
According to a notice in the Sept. 7 Federal Register, Majumdar agreed to have his research supervised for three years, should it be supported by Public Health Service (PHS) agencies, beginning Aug. 15. “Prior to the submission of an application for PHS support for a research project on which [Majumdar’s] participation is proposed and prior to [Majumdar’s] participation in any capacity in PHS-supported research,” he will submit a plan for supervision to ORI that calls for a committee of two or three senior faculty members with expertise in his research but who are not supervisors or collaborators. Supervisors are required to review Majumdar’s primary data from his lab every six months; they will certify “that the data presented in the proposed application, report, manuscript, or abstract are supported by the research record.” He also will not serve as a reviewer or advisor to PHS during the supervisory period. (9/15/22)
◆ In compliance with the 21st Century Cures Act, the Food and Drug Administration (FDA) issued final guidance on Sept. 8 to assist with its framework for evaluating “the potential use” of real world data (RWD) and real world evidence (RWE) in its safety and efficacy reviews of investigational new drug applications, new drug applications, and biologics license applications. The Cures Act “is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them,” FDA explained.
FDA defines RWD as that which relates to “patient health status and/or the delivery of health care that are routinely collected from a variety of sources” and includes data from electronic health records, claims systems, product or disease registries, digital health technologies and questionnaires. “RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated from RWD using many different study designs, including but not limited to, interventional studies (clinical trials) or non-interventional (observational) studies,” according to the guidance. RWD and RWE may be part of randomized clinical trials, single-arm trials or observational trials. The guidance, which includes a sample presentation of information to be included with a submission containing RWD or RWE, finalizes the draft guidance issued in January. (9/15/22)
◆ Six months after finding that Massachusetts Institute of Technology (MIT) was inappropriately charging tuition to participants in the National Science Foundation’s (NSF) Graduate Research Fellowship Program (GRFP), auditors for NSF’s Office of Inspector General (OIG) said MIT also is not properly paying fellows, nor is it accurately accounting for cash drawdowns, among other issues. In an Aug. 23 memo to NSF, OIG officials made five recommendations for changes in policies and procedures; MIT agreed to all of them.
Regarding payments to fellows, OIG said MIT overpaid some and underpaid others because it “prorated stipend payments by the day, instead of whole month increments as required.” Additionally, auditors found MIT drew down $6.8 million more for one award than it recorded. Moreover, institutions are required to “submit an annual completion report certifying the completion status—in progress, completed, graduated, transferred, or withdrawn–of fellows at the institution and degree, if awarded. MIT did not submit completion reports between 2016 and 2021,” according to the memorandum. The findings are part of an overall OIG audit of NSF’s oversight of GRFP that it began in 2020. To date, OIG has not released the audit, just these two memorandums about MIT. (9/1/22)
◆ Under new guidance the White House Office of Science and Technology Policy (OSTP) issued Aug. 25 to federal agencies, researchers will be allowed to “include publication and data sharing costs in their research budget proposals.” This is just one part of an effort to “ensure more equitable access to federally funded research,” Christopher Steven Marcum, assistant director for open science and data policy, and Ryan Donohue, senior policy advisor, wrote on the OSTP blog. “All members of the American public should be able to take part in every part of the scientific enterprise—leading, participating in, accessing, and benefitting from taxpayer-funded scientific research. That is, all communities should be able to take part in America’s scientific possibilities,” they wrote.
In addition to allowing for these costs, the guidance eliminates the “optional 12-month publication embargo for federally funded peer-reviewed research articles,” which Marcum and Donohue said, “has limited immediate equitable access of federally funded research results to only those able to pay for it or have privileged access through libraries or other institutions.”
Third, the guidance calls for “making data published in peer-reviewed research articles immediately available upon publication and other research data available within a reasonable timeframe.” The guidance itself “recommends that federal agencies” eliminate the embargo “as soon as possible” or by Dec. 31, 2025. It also sets interim deadlines for agencies to submit new policies to the Office of Management and Budget for approval. (9/1/22)
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