January 23, 2022

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Clinical Researchers Sentenced in Connection with Scheme to Falsify Drug Trial Data

7 min read
<div>A federal judge sentenced a Florida nurse practitioner and a Florida woman to prison terms today in connection with their participation in a conspiracy to falsify data related to clinical drug trials.</div>
A federal judge sentenced a Florida nurse practitioner and a Florida woman to prison terms today in connection with their participation in a conspiracy to falsify data related to clinical drug trials.

More from: August 11, 2021

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  • Federal Research: NIH Should Take Further Action to Address Foreign Influence
    In U.S GAO News
    What GAO Found U.S. research may be subject to undue foreign influence in cases where a researcher has a foreign conflict of interest. Federal grant-making agencies, such as the National Institutes of Health (NIH), can address this threat by implementing conflict of interest policies and requiring the disclosure of information that may indicate potential conflicts. GAO found that NIH's policy focuses on financial conflicts of interest but does not specifically address or define non-financial interests, which may include multiple professional appointments. In the absence of agency-wide policies and definitions on non-financial interests, universities that receive federal grant funding may lack sufficient guidance to identify and manage conflicts appropriately, potentially increasing the risk of undue foreign influence. In its report, GAO noted that NIH also requires researchers to disclose information—such as foreign support for their research—as part of grant proposals, and that such information could be used to determine if certain conflicts exist. National Institutes of Health Disclosure Requirements for Grantees as of December 2020 NIH relies on universities to monitor financial conflicts of interest, and the agency collects information, such as foreign collaborations, that could be used to identify non-financial conflicts. NIH has taken action in cases where it identified researchers who failed to disclose financial or non-financial information. Such actions included referring cases to the Department of Justice for criminal investigation. Additionally, NIH has written procedures for addressing allegations of failures to disclose required information. In interviews, stakeholders identified opportunities to improve agency responses to prevent undue foreign influence in federally funded research. For example, agencies could harmonize grant application requirements and better communicate identified risks. NIH has taken steps to address the issue of foreign influence in the areas stakeholders identified. Why GAO Did This Study The federal government reported expending about $44.5 billion on university science and engineering research in fiscal year 2019. The Department of Health and Human Services funds over half of all such federal expenditures, and NIH accounts for almost all of this funding. Safeguarding the U.S. research enterprise from threats of foreign influence is of critical importance. Recent reports by GAO and others have noted challenges faced by the research community to combat undue foreign influence, while maintaining an open research environment. This testimony discusses (1) NIH's conflict of interest policy and disclosure requirements that address potential foreign influence, (2) NIH's mechanisms to monitor and enforce its policy and requirements, and (3) the steps NIH has taken to address concerns about foreign influence in federally funded research identified by stakeholders. It is based on a report that GAO issued in December 2020 (GAO-21-130).
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    In Crime News
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  • Fair Lending: CFPB Needs to Assess the Impact of Recent Changes to Its Fair Lending Activities
    In U.S GAO News
    What GAO Found In January 2018, the Consumer Financial Protection Bureau (CFPB) announced a reorganization of its fair lending activities that moved its Office of Fair Lending and Equal Opportunity (Fair Lending Office) from the Supervision, Enforcement, and Fair Lending Division to the Office of the Director and reallocated certain of its responsibilities (see figure). As CFPB planned and implemented the reorganization, it did not substantially incorporate key practices for agency reform efforts GAO identified in prior work—such as using employee input for planning or monitoring implementation progress and outcomes. GAO identified challenges related to the reorganization (including loss of fair lending expertise and specialized data analysts) that may have contributed to a decline in enforcement activity in 2018. However, CFPB has not assessed how well the reorganization met its goals or how it affected fair lending supervision and enforcement efforts. Collecting and analyzing information on reorganization outcomes would help CFPB determine the impact of the changes and identify actions needed to address any related challenges or unintended consequences. Key Changes in Fair Lending Responsibilities under CFPB's 2018 Reorganization As of February 2019, CFPB stopped reporting on performance goals and measures specific to fair lending supervision and enforcement—such as the number of completed examinations and the percentage of enforcement cases successfully resolved. Without these goals and measures, CFPB is limited in its ability to assess and communicate progress on its fair lending supervision and enforcement efforts, key components of CFPB's mission. CFPB has used additional Home Mortgage Disclosure Act data that some lenders have had to report since 2018 to support supervisory and enforcement activities and fair lending analyses. CFPB incorporated these new loan-level data into efforts to identify and prioritize fair lending risks and support fair lending examinations. For example, the new data points improve CFPB's ability to compare how different institutions price loans, which helps its staff identify potentially discriminatory lending practices. Why GAO Did This Study Under the Dodd-Frank Wall Street Reform and Consumer Protection Act, CFPB is responsible for two federal fair lending laws that protect consumers from discrimination: the Equal Credit Opportunity Act and the Home Mortgage Disclosure Act. In January 2019, CFPB completed a reorganization of its fair lending activities. GAO was asked to review issues related to CFPB's oversight and enforcement of fair lending laws. This report examines how CFPB has (1) managed the reorganization of its fair lending activities, (2) monitored and reported on its fair lending performance, and (3) used Home Mortgage Disclosure Act data to support its fair lending activities. GAO reviewed CFPB documents related to its fair lending activities (such as strategic and performance reports, policies and procedures) and to the reorganization of its Fair Lending Office. GAO evaluated implementation of this reorganization against relevant key practices identified in GAO-18-427. GAO also interviewed CFPB staff.
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    In Crime News
    A Texas physician was sentenced to five years in prison today for her role in a multi-million Medicare fraud scheme.
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  • Spare Parts Contracts: Collecting Additional Information Could Help DOD Address Delays in Obtaining Cost or Pricing Data
    In U.S GAO News
    What GAO Found When the Department of Defense (DOD) awards contracts without competition, contracting officers may rely on cost or pricing data that contractors certify as accurate, current, and complete to determine if the prices are reasonable. DOD uses data other than certified cost or pricing data when certified cost or pricing data are not required. GAO found that, during fiscal years 2015 to 2019, the Defense Logistics Agency (DLA) obtained data other than certified data for 77 of the 136 sole-source spare parts contracts it awarded. As the 77 contracts were for commercial items, statute prohibits contracting officers from requiring certified cost or pricing data. DLA also waived the requirement to obtain certified cost or pricing data in two cases, citing the exceptional need for the spare parts. DLA obtained certified cost or pricing data for the remaining sole-source contracts. In March 2019, DOD issued a memorandum requiring defense agencies to report when contractors outright refuse to provide cost or pricing data, but it is not collecting data on the extent that delays in obtaining data affect the time that it takes to award contracts. DLA, Air Force, and Navy contracting officers said that while they were able to determine if prices were reasonable, delays in obtaining contractors' cost or pricing data contributed to the length of time needed to award seven of the 10 sole-source spare parts contracts GAO reviewed (see figure). Length of Time to Award 10 Sole-Source Contracts in Fiscal Year 2019 That GAO Reviewed DOD's March 2019 memorandum highlighted the need to understand, DOD-wide, the extent that contractors do not comply with contracting officer requests for data other than certified cost or pricing data. However, the focus was on outright refusals and not delays. Without a means to monitor or identify the nature and extent of delays, DOD is missing opportunities to develop approaches to effectively address these issues and potentially award contracts faster. Why GAO Did This Study DOD spends billions of dollars each year on spare parts for planes, ships, and other equipment. While DLA buys the bulk of the spare parts, the military departments also acquire them to support specific weapon systems. DOD seeks to negotiate a reasonable price for these spare parts to award contracts in a timely manner. DOD uses data other than certified cost or pricing data if it determines certified cost or pricing data are not required to determine prices are reasonable. The National Defense Authorization Act for Fiscal Year 2020 included a provision for GAO to review DOD's efforts to obtain contractor cost or pricing data. This report 1) describes how often DLA obtained cost or pricing data on sole-source contracts for spare parts; and 2) assesses the extent to which DOD tracks delays in obtaining these data and the reasons for those delays. GAO reviewed federal and DOD acquisition regulations and analyzed data for 136 DLA spare parts contracts awarded between fiscal years 2015 to 2019. For fiscal year 2019, GAO also selected 10 sole-source contracts awarded by DLA, Air Force, and the Navy, based on dollar value and other factors, to identify challenges in obtaining cost or pricing data. GAO also interviewed DOD and contractor officials.
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    In U.S Courts
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    In Crime News
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