September 28, 2021

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Upholding Research Integrity at HHS

11 min read

The mission of the HHS Office of the Assistant Secretary for Health’s Office of Research Integrity (ORI) is to promote research integrity, prevent research misconduct, and protect science, public health, and Public Health Service (PHS) funds. ORI works to prevent research misconduct in and promote the integrity of PHS-funded research through: (i) oversight review of research misconduct investigations conducted at PHS-funded research institutions, and (ii) outreach activities that support these institutions in their efforts to foster research integrity and the responsible conduct of research. ORI also works with grantee institutions to help train Research Integrity Officers to handle allegations of research misconduct and provides educational resources on the responsible conduct of research. This role is critical to promoting research integrity and thus the mission of HHS.

This work is done year after year with impressive results that have been reported since ORI’s first Annual Report in CY1993. Now ORI is unveiling FY2020’s results. The report highlights ORI’s activities from the past fiscal year in the following areas:

  • Research misconduct investigations
  • Communications with stakeholders
  • ORI’s grant program and ORI-funded research projects
  • Research projects conducted by/in collaboration with ORI
  • ORI’s compliance programs

In FY2020, ORI received 204 new allegations related to research misconduct or integrity and closed 45 cases and 27 allegations (for a total of 72 closures). As estimated by a preliminary analysis within ORI, over $75 million in PHS funding was tied to published papers citing grants in which research misconduct had occurred. Of the cases closed in FY2020, 11 cases resulted in findings of research misconduct, 8 cases did not result in findings of research misconduct, and 26 cases were closed when ORI declined to pursue findings (due to insufficient evidence to establish culpability, sufficient action being taken by the institution, or lack of significance to the scientific community). When ORI makes findings of research misconduct, the administrative actions rendered can include federal-wide debarment, supervision of PHS-funded research, prohibition from PHS advisory service, and/or a requirement that the respondent request the correction/retraction of published papers. Also, it is important to note that although ORI may decline to pursue findings in a particular case, an institution may still draw its own conclusions about research misconduct for that case and implement administrative actions at the institutional level.  

ORI conducted a research project on retractions and corrections of published papers cited in its findings of research misconduct. ORI found that a group of 164 papers, all of which contain instances of fabrication, falsification, and/or plagiarism, had been cited by 7,318 research papers, and those 7,318 papers in turn had been cited in an additional 301,716 papers. By stopping misinformation early, ORI helps to keep faulty science out of the literature to ensure that future research is built on genuine data and research results.

ORI also conducted 361 technical assistance sessions to provide stakeholders at grantee institutions responding to allegations of research misconduct with guidance and information about forensic image analysis, statistical analyses of data, sequestration of research records, and review of institutional research misconduct proceedings.

While ORI’s work is often unseen, it protects the integrity of research conducted at HHS and by PHS-funded grantees. ORI remains committed to handling allegations of possible research misconduct in PHS-funded research, supporting the training and education of researchers on the responsible conduct of research, and supporting PHS-funded institutions as they work to foster research integrity and the responsible conduct of research. To learn more about the world of research integrity, visit ori.hhs.gov. The full FY2020 annual report is available in digital (PDF) format and can be viewed and downloaded here.

Disclaimer for ORISE Fellow:

This project was supported in part by an appointment to the Research Participation Program at the Department of Health and Human Services administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the Department of Health and Human Services.

More from: Office of the Assistant Secretary for Health (OASH)

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Forbearance was also more common among borrowers at a greater risk of mortgage default—specifically, first-time, minority, and low- and moderate-income homebuyers with mortgages insured by the Federal Housing Administration and rural homebuyers with loans guaranteed by the Rural Housing Service (see fig. 1). Figure 1: Estimated Percentage of Single-Family Mortgage Loans in Forbearance, by Loan Type (January 2020–February 2021) A small percentage of borrowers who missed payments during the pandemic have not used forbearance—less than 1 percent of those covered by the CARES Act. Yet, borrowers who have not used forbearance may be at a greater risk of default and foreclosure, according to GAO's analysis of the National Mortgage Database. For example, these borrowers tended to have lower subprime credit scores, indicating an elevated risk of default, compared to borrowers who were current or in forbearance, who tended to have higher prime or near prime credit scores. 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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. 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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. 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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. 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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. 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  • Depot Maintenance: Improved Strategic Planning Needed to Ensure That Army and Marine Corps Depots Can Meet Future Maintenance Requirements
    In U.S GAO News
    The Army and Marine Corps maintenance depots provide critical support to ongoing military operations in Iraq and Afghanistan and are heavily involved in efforts to reset the force. The Department of Defense (DOD) has an interest in ensuring that the depots remain operationally effective, efficient, and capable of meeting future maintenance requirements. In 2008, in response to direction by the Office of the Secretary of Defense (OSD), the Army and the Marine Corps each submitted a depot maintenance strategic plan. Our objective was to evaluate the extent to which these plans provide comprehensive strategies for meeting future depot maintenance requirements. GAO determined whether the plans were consistent with the criteria for developing a results-oriented management framework and fully addressed OSD's criteria.The depot maintenance strategic plans developed by the Army and Marine Corps identify key issues affecting the depots, but do not provide assurance that the depots will be postured and resourced to meet future maintenance requirements because they do not fully address all of the elements required for a comprehensive, results-oriented management framework. Nor are they fully responsive to OSD's direction for developing the plans. While the services' strategic plans contain mission statements, along with long-term goals and objectives, they do not fully address all the elements needed for sound strategic planning, such as external factors that may affect how goals and objectives will be accomplished, performance indicators or metrics that measure outcomes and gauge progress, and resources required to meet the goals and objectives. Also, the plans partially address four issues that OSD directed the services, at a minimum, to include in their plans, such as logistics transformation, core logistics capability assurance, workforce revitalization, and capital investment. Army and Marine Corps officials involved with the development of the service strategic plans acknowledged that their plans do not fully address the OSD criteria, but they stated that the plans nevertheless address issues they believe are critical to maintaining effective, long-term depot maintenance capabilities. The Army's and Marine Corps' plans also are not comprehensive because they do not provide strategies for mitigating and reducing uncertainties in future workloads that affect the depots' ability to plan for meeting future maintenance requirements. Such uncertainties stem primarily from a lack of information on (1) workload that will replace current work on existing systems, which is expected to decline, and (2) workload associated with new systems that are in the acquisition pipeline. According to depot officials, to effectively plan for future maintenance requirements, the depots need timely and reliable information from their major commands on both the amounts and types of workloads they should expect to receive in future years. Depot officials told us that the information they receive from their major commands on their future workloads are uncertain beyond the current fiscal year. Officials cited various factors that contribute to these uncertainties, such as volatility in workload requirements, changing wartime environment, budget instability, and unanticipated changes in customer orders. In addition, depot officials said that they are not involved in the sustainment portion of the life cycle management planning process for new and modified systems. No clear process exists that would enable them to have input into weapon system program managers' decisions on how and where new and modified systems will be supported and maintained in the future. Unless they are integrated in this planning process, these officials said, the depots will continue to have uncertainties about what capabilities they will need to plan for future workloads and what other resources they will need to support new and modified weapon systems.
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