August 12, 2022

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Scientific Integrity: HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference

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<div>What GAO Found The four agencies GAO reviewed do not have procedures that define political interference in scientific decision-making or describe how it should be reported and addressed. These agencies within the Department of Health and Human Services (HHS) are: the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Office of the Assistant Secretary for Preparedness and Response (ASPR). The absence of specific procedures may explain why the four selected agencies did not identify any formally reported internal allegations of potential political interference in scientific decision-making from 2010 through 2021. Through semi-structured interviews and a confidential hotline, employees at CDC, FDA, and NIH told GAO they observed incidents that they perceived to be political interference but did not report them for various reasons. These reasons included fearing retaliation, being unsure how to report issues, and believing agency leaders were already aware. HHS could strengthen its desired goal of sustaining a culture of scientific integrity by developing procedures for reporting and addressing political interference in scientific decision-making. Such procedures would ensure that employees know how to report allegations, and that HHS's agencies have a clear, consistent process for investigating and addressing such allegations. To help reduce employees' fear of retaliation and encourage appropriate reporting, agencies could include information on whistleblower protections, and clarify any reporting requirements for employees who believe they observed potential political interference in scientific decision-making. All four selected agencies—CDC, FDA, NIH, and ASPR—train staff on some scientific integrity-related topics, such as public health ethics, but only NIH includes information on political interference in scientific decision-making as part of its scientific integrity training (see figure). Training agency employees and contractors performing scientific activities would help agencies ensure that employees and contractors understand how to report allegations of political interference. Elements of Scientific-Integrity-Related Procedures and Training at Selected HHS Agencies aThe Office of the Assistant Secretary for Preparedness and Response follows HHS's Policies and Principles for Assuring Scientific Integrity . Why GAO Did This Study Since 2007, Congress and multiple administrations have taken actions to help ensure that federal science agencies have scientific integrity policies and procedures in place that, among other things, protect against the suppression or alteration of scientific findings for political purposes. GAO defined scientific integrity as the use of scientific evidence and data to make policy decisions that are based on established scientific methods and processes, are not inappropriately influenced by political considerations, and are shared with the public when appropriate. GAO was asked to review scientific integrity policies and procedures, and how allegations of political interference in scientific decision-making are addressed at CDC, FDA, NIH, and ASPR. This report examines the procedures in place to address such allegations and the extent to which agencies received them. It also examines training provided by selected agencies on scientific integrity policies and procedures, including those related to political interference. GAO analyzed the agencies' scientific integrity policies, procedures, and trainings; interviewed agency officials, and employees, which includes managers and non-managers; and deployed a confidential hotline.</div>

What GAO Found

The four agencies GAO reviewed do not have procedures that define political interference in scientific decision-making or describe how it should be reported and addressed. These agencies within the Department of Health and Human Services (HHS) are: the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Office of the Assistant Secretary for Preparedness and Response (ASPR).

The absence of specific procedures may explain why the four selected agencies did not identify any formally reported internal allegations of potential political interference in scientific decision-making from 2010 through 2021. Through semi-structured interviews and a confidential hotline, employees at CDC, FDA, and NIH told GAO they observed incidents that they perceived to be political interference but did not report them for various reasons. These reasons included fearing retaliation, being unsure how to report issues, and believing agency leaders were already aware. HHS could strengthen its desired goal of sustaining a culture of scientific integrity by developing procedures for reporting and addressing political interference in scientific decision-making. Such procedures would ensure that employees know how to report allegations, and that HHS’s agencies have a clear, consistent process for investigating and addressing such allegations. To help reduce employees’ fear of retaliation and encourage appropriate reporting, agencies could include information on whistleblower protections, and clarify any reporting requirements for employees who believe they observed potential political interference in scientific decision-making.

All four selected agencies—CDC, FDA, NIH, and ASPR—train staff on some scientific integrity-related topics, such as public health ethics, but only NIH includes information on political interference in scientific decision-making as part of its scientific integrity training (see figure). Training agency employees and contractors performing scientific activities would help agencies ensure that employees and contractors understand how to report allegations of political interference.

Elements of Scientific-Integrity-Related Procedures and Training at Selected HHS Agencies

Elements of Scientific-Integrity-Related Procedures and Training at Selected HHS Agencies

aThe Office of the Assistant Secretary for Preparedness and Response follows HHS’s Policies and Principles for Assuring Scientific Integrity .

Why GAO Did This Study

Since 2007, Congress and multiple administrations have taken actions to help ensure that federal science agencies have scientific integrity policies and procedures in place that, among other things, protect against the suppression or alteration of scientific findings for political purposes. GAO defined scientific integrity as the use of scientific evidence and data to make policy decisions that are based on established scientific methods and processes, are not inappropriately influenced by political considerations, and are shared with the public when appropriate. GAO was asked to review scientific integrity policies and procedures, and how allegations of political interference in scientific decision-making are addressed at CDC, FDA, NIH, and ASPR.

This report examines the procedures in place to address such allegations and the extent to which agencies received them. It also examines training provided by selected agencies on scientific integrity policies and procedures, including those related to political interference. GAO analyzed the agencies’ scientific integrity policies, procedures, and trainings; interviewed agency officials, and employees, which includes managers and non-managers; and deployed a confidential hotline.

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