Report on Research Compliance 16, no. 12 (December 2019)
◆ NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and efficient data management and sharing to further NIH’s commitment to making the results and accomplishments of the research it funds and conducts available to the public.” NIH said in its Nov. 6 announcement that it hoped to do this “while minimizing burden on the research community.” Applicable to “all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data,” the proposed policy would also include “research funded or conducted by extramural grants, contracts, intramural research projects, or other funding agreements regardless of NIH funding level or funding mechanism.” (11/14/19)
◆ When it convenes for a two-day meeting next week, the National Science Board is scheduled to hear updates from the National Science Foundation (NSF) Office of Inspector General regarding OIG’s semiannual report to Congress, expected to be released later this month. The report covers OIG activities from April 1 to Sept. 30, and it is the only public acknowledgement by the agency of any investigations and findings of research misconduct among NSF awardees and staff. In contrast, the HHS Office of Research Integrity, which publishes findings that include names of sanctioned investigators. (11/14/19)
◆ Gerwin Schalk, a research scientist employed by New York State and deputy director of the National Center for Adaptive Neurotechnologies, pled guilty Oct. 31 to making false statements, admitting he “knowingly and repeatedly lied about, and failed to disclose, payments he was receiving from a company whose products [he] regularly purchased and used in connection with his research,” the U.S. Attorney’s Office for the Northern District of New York announced. “Schalk admitted that the company paid him at least $70,000, from July 2013 to April 10, 2019, and that he signed at least 15 conflict of interest forms during that time, never once disclosing a payment from the company as he was required to do.” Schalk was arrested in August.[1] (11/7/19)
◆ Maysam Ghovanloo, formerly a professor at Georgia Tech’s School of Electrical and Computer Engineering, will be confined to his home for eight months and repay $40,000 in connection with his guilty plea for wire fraud involving awards from NSF. Ghovanloo, who pled guilty in August, “also was barred from doing business with the federal government for a period of three years,” the U.S. Attorney’s Office for the Northern District of Georgia announced Nov. 5. (11/7/19)
◆ Following guilty pleas for wire fraud, sentencing is scheduled for January in the case of a Purdue University professor and his wife indicted for falsely obtaining and misspending $1.3 million in NSF Small Business Innovation Research and Small Business Technology Transfer awards. The trial of Qingyou Han and Lu Shao on the charges had been scheduled to begin Oct. 21. The U.S. Attorney’s Office for the Northern District announced the guilty pleas Oct. 18. (10/31/19)
◆ The Food and Drug Administration is moving away from its “inefficient and labor intensive” current practice of accepting adverse event reports in a PDF or paper format and plans to implement a new system using a data standard consistent with international guidelines, FDA announced in the Federal Register on Oct. 30. Sponsors of research conducted under an investigational new drug application are required to submit “safety reports for serious and unexpected suspected adverse reactions” to the FDA. (10/31/19)