Federal Research: NIH Should Take Further Action to Address Foreign Influence

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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    What GAO Found Since fiscal year 2015, the Department of Homeland Security (DHS) Office of Inspector General (OIG) has not adhered to a number of professional standards for federal OIGs and key practices for effective management. Frequent leadership turnover and associated shifts in leadership priorities have contributed to DHS OIG's long-standing management and operational weaknesses and impeded efforts to address them. DHS OIG senior leaders acknowledge that various challenges have contributed to these weaknesses, and have taken steps to begin to address some of them, as follows: Organizational performance management: DHS OIG has operated for 4 of the past 6 years without a strategic plan. This limits its ability to implement other organizational performance management activities, such as annual planning and performance assessment. In the absence of a strategic plan, GAO found that DHS OIG staff may not understand its oversight priorities and goals, which can negatively affect operations and staff performance. In 2020, DHS OIG contracted with a nonprofit academy of government experts to develop a strategic plan for fiscal years 2021–2025, with expected completion in June 2021. Quality assurance: DHS OIG has not developed or implemented organization-wide roles and responsibilities for quality assurance. DHS OIG retracted some reports in recent years because they did not adhere to professional standards. Because there is no overarching system of internal quality assurance for audit, inspection, evaluation, and other work, DHS OIG cannot know if its internal processes ensure that its work (1) adheres to its policies and (2) meets established standards of performance. Report timeliness: Project time frames have increased in recent years, and DHS OIG has not taken steps to understand the causes of such increases or determine how to address them. For example, in the Office of Audits, eight of 102 projects completed in fiscal year 2017 took more than 18 months, compared to more than half (35 of 67) of projects completed in fiscal year 2020. Without timely DHS OIG reports, DHS's ability to respond to such oversight efforts and Congress's ability to conduct effective oversight of DHS operations are limited. Coordination with DHS: DHS OIG does not have a consistent process for coordinating with DHS components to receive and respond to technical and management comments on DHS OIG audit, inspection, and evaluation work. Further, DHS officials do not have confidence in DHS OIG's processes to (1) correct factual errors before finalizing reports and (2) redact sensitive but unclassified information before publicly issuing reports. As a result, the process by which DHS OIG resolves DHS's comments is at risk of miscommunication and misunderstandings. These and additional weaknesses GAO identified are of particular concern given that OIGs need to maintain high standards of professionalism and integrity in light of their mission, according to quality standards for federal OIGs. Without addressing these and other long-standing management and operational weaknesses, DHS OIG is not well positioned to fulfill its oversight mission. Why GAO Did This Study DHS OIG plays a critical role in overseeing DHS, which encompasses multiple components and programs and has tens of billions of dollars in annual budgetary resources. However, DHS OIG has faced a number of long-standing management and operational challenges that have affected its ability to carry out its oversight mission effectively. GAO was asked to review DHS OIG's management and operations. This report addresses the extent to which DHS OIG adheres to professional standards and key practices in its management and operations, among other objectives. GAO reviewed DHS OIG management and operations from fiscal year 2015 through fiscal year 2020. GAO evaluated DHS OIG's processes against quality standards for federal OIGs, relevant federal standards for internal control, and human capital and organizational change leading practices. To do so, GAO reviewed DHS OIG documents, interviewed officials, and analyzed DHS OIG data and published reports.
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  • Science & Tech Spotlight: Air Quality Sensors
    In U.S GAO News
    Why This Matters Air quality sensors are essential to measuring and studying pollutants that can harm public health and the environment. Technological improvements have led to smaller, more affordable sensors as well as satellite-based sensors with new capabilities. However, ensuring the quality and appropriate interpretation of sensor data can be challenging. The Technology What is it? Air quality sensors monitor gases, such as ozone, and particulate matter, which can harm human health and the environment. Federal, state, and local agencies jointly manage networks of stationary air quality monitors that make use of sensors. These monitors are expensive and require supporting infrastructure. Officials use the resulting data to decide how to address pollution or for air quality alerts, including alerts during wildfires or on days with unhealthy ozone levels. However, these networks can miss pollution at smaller scales and in rural areas. They generally do not measure air toxics—more localized pollutants that may cause cancer and chronic health effects—such as ethylene oxide and toxic metals. Two advances in sensor technologies may help close these gaps. First, newer low-cost sensors can now be deployed virtually anywhere, including on fences, cars, drones, and clothing (see fig. 1). Researchers, individuals, community groups, and private companies have started to deploy these more affordable sensors to improve their understanding of a variety of environmental and public health concerns. Second, federal agencies have for decades operated satellites with sensors that monitor air quality to understand weather patterns and inform research. Recent satellite launches deployed sensors with enhanced air monitoring capabilities, which researchers have begun to use in studies of pollution over large areas. Figure 1. There are many types of air quality sensors, including government-operated ground-level and satellite-based sensors, as well as low-cost commercially available sensors that can now be used on a variety of platforms, such as bicycles, cars, trucks, and drones. How does it work? Low-cost sensors use a variety of methods to measure air quality, including lasers to estimate the number and size of particles passing through a chamber and meters to estimate the amount of a gas passing through the sensor. The sensors generally use algorithms to convert raw data into useful measurements (see fig. 2). The algorithms may also adjust for temperature, humidity and other conditions that affect sensor measurements. Higher-quality devices can have other features that improve results, such as controlling the temperature of the air in the sensors to ensure measurements are consistent over time. Sensors can measure different aspects of air quality depending on how they are deployed. For example, stationary sensors measure pollution in one location, while mobile sensors, such as wearable sensors carried by an individual, reflect exposure at multiple locations. Satellite-based sensors generally measure energy reflected or emitted from the earth and the atmosphere to identify pollutants between the satellite and the ground. Some sensors observe one location continuously, while others observe different parts of the earth over time. Multiple sensors can be deployed in a network to track the formation, movement, and variability of pollutants and to improve the reliability of measurements. Combining data from multiple sensors can increase their usefulness, but it also increases the expertise needed to interpret the measurements, especially if data come from different types of sensors. Figure 2. A low-cost sensor pulls air in to measure pollutants and stores information for further study. How mature is it? Sensors originally developed for specific applications, such as monitoring air inside a building, are now smaller and more affordable. As a result, they can now be used in many ways to close gaps in monitoring and research. For example, local governments can use them to monitor multiple sources of air pollution affecting a community, and scientists can use wearable sensors to study the exposure of research volunteers. However, low-cost sensors have limitations. They operate with fewer quality assurance measures than government-operated sensors and vary in the quality of data they produce. It is not yet clear how newer sensors should be deployed to provide the most benefit or how the data should be interpreted. Some low-cost sensors carry out calculations using artificial intelligence algorithms that the designers cannot always explain, making it difficult to interpret varying sensor performance. Further, they typically measure common pollutants, such as ozone and particulate matter. There are hundreds of air toxics for which additional monitoring using sensors could be beneficial. However, there may be technical or other challenges that make it impractical to do so. Older satellite-based sensors typically provided infrequent and less detailed data. But newer sensors offer better data for monitoring air quality, which could help with monitoring rural areas and pollution transport, among other benefits. However, satellite-based sensor data can be difficult to interpret, especially for pollution at ground level. In addition, deployed satellite-based sensor technologies currently only measure a few pollutants, including particulate matter, ozone, sulfur dioxide, nitrogen dioxide, formaldehyde, and carbon monoxide. Opportunities Improved research on health effects. The ability to track personal exposure and highly localized pollution could improve assessments of public health risks. Expanded monitoring. More dense and widespread monitoring could help identify pollution sources and hot spots, in both urban and rural areas. Enhanced air quality management. Combined measurements from stationary, mobile, and satellite-based sensors can help officials understand and mitigate major pollution issues, such as ground-level ozone and wildfire smoke. Community engagement. Lower cost sensors open up new possibilities for community engagement and citizen science, which is when the public conducts or participates in the scientific process, such as by making observations, collecting and sharing data, and conducting experiments. Challenges Performance. Low-cost sensors have highly variable performance that is not well understood, and their algorithms may not be transparent. Low-cost sensors operated by different users or across different locations may have inconsistent measurements. Interpretation. Expertise may be needed to interpret sensor data. For example, sensors produce data in real time that may be difficult to interpret without health standards for short-term exposures. Data management. Expanded monitoring will create large amounts of data with inconsistent formatting, which will have to be stored and managed. Alignment with needs. Few of the current low-cost and satellite-based sensors measure air toxics. In addition, low-income communities, which studies show are disproportionally harmed by air pollution, may still face challenges deploying low-cost sensors. Policy Context and Questions How can policymakers leverage new opportunities for widespread monitoring, such as citizen science, while also promoting appropriate use and interpretation of data? How can data from a variety of sensors be integrated to better understand air quality issues, such as environmental justice concerns, wildfires, and persistent ozone problems? How can research and development efforts be aligned to produce sensors to monitor key pollutants that are not widely monitored, such as certain air toxics? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
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  • Drinking Water: EPA Could Use Available Data to Better Identify Neighborhoods at Risk of Lead Exposure
    In U.S GAO News
    GAO's statistical analysis indicates that areas with older housing and vulnerable populations (e.g., families in poverty) have higher concentrations of lead service lines in the selected cities GAO examined. By using geospatial lead service line data from the selected water systems and geospatial data from the U.S. Census Bureau's American Community Survey (ACS), GAO identified characteristics of neighborhoods with higher concentrations of lead service lines. The Environmental Protection Agency's (EPA) guidance for water systems on how to identify the location of sites at high-risk of having lead service lines has not been updated since 1991 and many water systems face challenges identifying areas at risk of having lead service lines. By developing guidance for water systems that outlines methods for identifying high-risk locations using publicly available data, EPA could better ensure that public water systems test water samples from locations at greater risk of having lead service lines and identify areas with vulnerable populations to focus lead service line replacement efforts. (See figure for common sources of lead in home drinking water.) Common Sources of Lead in Drinking Water within Homes and Residences EPA has taken some actions to address the Water Infrastructure Improvements for the Nation (WIIN) Act requirement, which include developing a strategic plan regarding lead in public water systems. However, EPA's published plan did not satisfy the statutory requirement that the agency's strategic plan address targeted outreach, education, technical assistance, and risk communication undertaken by EPA, states, and public water systems. For example, the plan does not discuss public education, technical assistance or risk communication. Instead, EPA's plan focused solely on how to notify households when EPA learns of certain exceedances of lead in their drinking water. Moreover, EPA's plan is not consistent with leading practices for strategic planning. For example, EPA's plan does not set a mission statement or define long-term goals. Developing a strategic plan that meets the statutory requirement and fully reflects leading practices for strategic planning would give EPA greater assurance that it has effectively planned for how it will communicate the risks of lead in drinking water to the public. Lead in drinking water comes primarily from corrosion of service lines connecting the water main to a house or building, pipes inside a building, or plumbing fixtures. As GAO reported in September 2018, the total number of lead service lines in drinking water systems is unknown, and less than 20 of the 100 largest water systems have such data publicly available. GAO was asked to examine the actions EPA and water systems are taking to educate the public on the risks of lead in drinking water. This report examines, among other things: (1) the extent to which neighborhood data on cities served by lead service lines can be used to focus lead reduction efforts; and (2) actions EPA has taken to address WIIN Act requirements, and EPA's risk communication documents. GAO conducted a statistical analysis combining geospatial lead service line and ACS data to identify characteristics of selected communities; reviewed legal requirements and EPA documents; and interviewed EPA officials. GAO is making four recommendations, including that EPA develop (1) guidance for water systems on lead reduction efforts, and (2) a strategic plan that meets the WIIN Act requirement. EPA agreed with one recommendation and disagreed with the others. GAO continues to believe the recommendations are warranted, as discussed in the report. For more information, contact J. Alfredo Gómez at (202) 512-3841 or gomezj@gao.gov.
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  • COVID-19: Brief Update on Initial Federal Response to the Pandemic
    In U.S GAO News
    As of August 20, 2020, the U.S. had over 5.5 million cumulative reported cases of COVID-19, and 158,000 reported deaths, according to federal agencies. The country also continues to experience serious economic repercussions and turmoil. Four relief laws, including the CARES Act, were enacted between March and July 2020 to provide appropriations for the response to COVID-19. The CARES Act includes a provision for GAO to report bimonthly on its ongoing monitoring and oversight efforts related to COVID-19. This second report examines federal spending on the COVID-19 response; indicators for monitoring public health and the economy; and the status of matters for congressional consideration and recommendations from GAO’s June 2020 report (GAO-20-625). GAO reviewed data through June 30, 2020 (the latest available) from USAspending.gov, a government website with data from government agencies. GAO also obtained, directly from the agencies, spending data, as of July 31, 2020, for the six largest spending areas, to the extent available. To develop the public health indicators, GAO reviewed research and federal guidance. To understand economic developments, GAO reviewed data from federal statistical agencies, the Federal Reserve, and Bloomberg Terminal, as well as economic research. To update the status of matters for congressional consideration and recommendations, GAO reviewed agency and congressional actions. In response to the national public health and economic threats caused by COVID-19, four relief laws making appropriations of about $2.6 trillion had been enacted as of July 31, 2020. Overall, federal obligations and expenditures government-wide of these COVID-19 relief funds totaled $1.5 trillion and $1.3 trillion, respectively, as of June 30, 2020. GAO also obtained preliminary data for six major spending areas as of July 31, 2020 (see table). COVID-19 Relief Appropriations, Obligations, and Expenditures for Six Major Spending Areas, as of July 2020 Spending area Appropriationsa ($ billions) Preliminary obligationsb ($ billions) Preliminary expendituresb ($ billions) Business Loan Programs 687.3 538.1 522.2c Economic Stabilization and Assistance to Distressed Sectors 500.0 30.4 19.2c Unemployment Insurance 376.4 301.1 296.8 Economic Impact Payments 282.0 273.5 273.5 Public Health and Social Services Emergency Fund 231.7 129.6 95.9 Coronavirus Relief Fund 150.0 149.5 149.5 Total for six spending areas 2,227.4 1,422.2 1,357.0 Source: GAO analysis of data from the Department of the Treasury, USAspending.gov, and applicable agencies. | GAO-20-708 aCOVID-19 relief appropriations reflect amounts appropriated under the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, Pub. L. No. 116-123, 134 Stat. 146; Families First Coronavirus Response Act, Pub. L. No. 116-127, 134 Stat. 178 (2020); CARES Act, Pub. L. No. 116-136, 134 Stat. 281 (2020); and Paycheck Protection Program and Health Care Enhancement Act, Pub. L. No. 116-139, 134 Stat. 620 (2020). These data are based on appropriations warrant information provided by the Department of the Treasury as of July 31, 2020. These amounts could increase in the future for programs with indefinite appropriations, which are appropriations that, at the time of enactment, are for an unspecified amount. In addition, this table does not represent transfers of funds that federal agencies may make between appropriation accounts or transfers of funds they may make to other agencies. bObligations and expenditures data for July 2020 are based on preliminary data reported by applicable agencies. cThese expenditures relate to the loan subsidy costs (the loan’s estimated long-term costs to the United States government). The CARES Act included a provision for GAO to assess the impact of the federal response on public health and the economy. The following are examples of health care and economic indicators that GAO is monitoring. Health care. GAO’s indicators are intended to assess the nation’s immediate response to COVID-19 as it first took hold, gauge its recovery from the effects of the pandemic over the longer term, and determine the nation’s level of preparedness for future pandemics, involving subsequent waves of either COVID-19 or other infectious diseases. For example, to assess the sufficiency of testing—a potential indicator of the system’s response and recovery—GAO suggests monitoring the proportion of tests in a given population that are positive for infection. A higher positivity rate can indicate that testing is not sufficiently widespread to find all cases. That is higher positivity rates can indicate that testing has focused on those most likely to be infected and seeking testing because they have symptoms, and may not be detecting COVID-19 cases among individuals with no symptoms. Although there is no agreed-upon threshold for the test positivity rate, governments should target low positivity rates. The World Health Organization recommends a test positivity rate threshold of less than 5 percent over a 14-day period. As of August 12, 2020, 12 states and the District of Columbia had met this threshold (38 states had not). Resolve to Save Lives, another organization, recommends a threshold of less than 3 percent over a 7-day period, and 11 states and the District of Columbia had met this threshold (39 states had not) as of August 12, 2020. GAO also suggests monitoring mortality from all causes compared to historical norms as an indicator of the pandemic’s broad effect on health care outcomes. Mortality rates have tended to be consistent from year to year. This allows an estimation of how much mortality rose with the onset of the pandemic, and provides a baseline by which to judge a return to pre-COVID levels. According to Centers for Disease Control and Prevention data, about 125,000 more people died from all causes January 1–June 13 than would normally be expected (see figure). CDC Data on Higher-Than-Expected Weekly Mortality, January 1 through June 13, 2020 Note: The figure shows the number of deaths from all causes in a given week that exceeded the upper bound threshold of expected deaths calculated by CDC on the basis of variation in mortality experienced in prior years. Changes in the observed numbers of deaths in recent weeks should be interpreted cautiously as this figure relies on provisional data that are generally less complete in recent weeks. Data were accessed on July 16, 2020. Economy. GAO updated information on a number of indicators to facilitate ongoing and consistent monitoring of areas of the economy supported by the federal pandemic response, in particular the COVID-19 relief laws. These indicators suggest that economic conditions—including for workers, small businesses, and corporations—have improved modestly in recent months but remain much weaker than prior to the pandemic. In June and July initial regular unemployment insurance (UI) claims filed weekly averaged roughly 1.4 million (see figure), which was six and a half times higher than average weekly claims in 2019, but claims have decreased substantially since mid-March, falling to 971,000 in the week ending August 8, 2020. Increasing infections in some states and orders to once again close or limit certain businesses are likely to pose additional challenges for potentially fragile economic improvements, especially in affected sectors, such as the leisure and hospitality sector. National Weekly Initial Unemployment Insurance Claims, January 2019–July 2020 Note: See figure 5 in the report. As GAO reported in June, consistent with the urgency of responding to serious and widespread health issues and economic disruptions, federal agencies gave priority to moving swiftly where possible to distribute funds and implement new programs designed to help small businesses and the newly unemployed, for example. However, such urgency required certain tradeoffs in achieving transparency and accountability goals. To make mid-course corrections, GAO made three recommendations to federal agencies: To reduce the potential for duplicate payments from the Paycheck Protection Program (PPP)—a program that provides guaranteed loans through lenders to small businesses—and unemployment insurance, GAO recommended that the Department of Labor (DOL), in consultation with the Small Business Administration (SBA) and the Department of the Treasury (Treasury), immediately provide information to state unemployment agencies that specifically addresses PPP loans, and the risk of improper unemployment insurance payments. DOL issued guidance on August 12, 2020, that, among other things, clarified that individuals working full-time and being paid through PPP are not eligible for UI. To recoup economic impact payments totaling more than $1.6 billion sent to decedents, GAO recommended that the Internal Revenue Service (IRS) consider cost-effective options for notifying ineligible recipients of economic impact payments how to return payments. IRS has taken steps to address this recommendation. According to a Treasury official, nearly 70 percent of the payments sent to decedents have been recovered. However, GAO was unable to verify that amount before finalizing work on this report. GAO is working with Treasury to determine the number of payments sent to decedents that have been recovered. Treasury was considering sending letters to request the return of remaining outstanding payments but has not moved forward with this effort because, according to Treasury, Congress is considering legislation that would clarify or change payment eligibility requirements. To reduce the potential for fraud and ensure program integrity, GAO recommended that SBA develop and implement plans to identify and respond to risks in PPP to ensure program integrity, achieve program effectiveness, and address potential fraud. SBA has begun developing oversight plans for PPP but has not yet finalized or implemented them. In addition, to improve the government’s response efforts, GAO suggested three matters for congressional consideration: GAO urged Congress to take legislative action to require the Department of Transportation (DOT) to work with relevant agencies and stakeholders, such as HHS, the Department of Homeland Security (DHS), and international organizations, to develop a national aviation-preparedness plan to ensure safeguards are in place to limit the spread of communicable disease threats from abroad, while also minimizing any unnecessary interference with travel and trade. In early July 2020, DOT collaborated with HHS and DHS to issue guidance to airports and airlines for implementing measures to mitigate the public health risks associated with COVID-19, but it has not developed a preparedness plan for future communicable disease threats. DOT has maintained that HHS and DHS should lead such planning efforts as they are responsible for communicable disease response and preparedness planning, respectively. In June 2020, HHS stated that it is not in a position to develop a national aviation-preparedness plan as it does not have primary jurisdiction over the entire aviation sector or the relevant transportation expertise. In May 2020, DHS stated that it had reviewed its existing plans for pandemic preparedness and response activities and determined it is not best situated to develop a national aviation-preparedness plan. Without such a plan, the U.S. will not be as prepared to minimize and quickly respond to future communicable disease events. GAO also urged Congress to amend the Social Security Act to explicitly allow the Social Security Administration (SSA) to share its full death data with Treasury for data matching to help prevent payments to ineligible individuals. In June 2020, the Senate passed S.4104, referred to as the Stopping Improper Payments to Deceased People Act. If enacted, the bill would allow SSA to share these data with Treasury's Bureau of the Fiscal Service to avoid paying deceased individuals. Finally, GAO urged Congress to use GAO's Federal Medical Assistance Percentage (FMAP) formula for any future changes to the FMAP—the statutory formula according to which the federal government matches states' spending for Medicaid services—during the current or any future economic downturn. Congress has taken no action thus far on this issue. GAO incorporated technical comments received the Departments of Labor, Commerce, Health and Human Services, Transportation, and the Treasury; the Federal Reserve; Office of Management and Budget; and Internal Revenue Service. The Small Business Administration commented that GAO did not include information on actions taken and controls related to its loan forgiveness program or its plans for loan reviews. GAO plans to provide more information on these topics in its next CARES Act report. For more information, contact A. Nicole Clowers at (202) 512-7114 or clowersa@gao.gov.
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