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

GAO-22-104613 Published: Apr 20, 2022. Publicly Released: Apr 20, 2022.
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Fast Facts

Public health agencies regularly use scientific methods and evidence to inform decisions. How do they protect scientific decision-making from being interfered with for political purposes?

The policies and procedures for ensuring scientific integrity at 4 agencies we reviewed do not define political interference or describe how it should be reported and addressed.

Employees told us they observed potential political interference but they didn't report it because they:

  • feared retaliation
  • were unsure how to report issues
  • believed agency leaders were already aware

Our 7 recommendations would help the agencies better protect scientific integrity.

person working a lab using a syringe to drop a liquid into a test tube

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Highlights

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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Recommendations

GAO is making seven recommendations to CDC, FDA, NIH, and HHS, including that they develop procedures for reporting and addressing allegations of political interference and train staff on how to report such allegations. HHS concurred with the recommendations.

Recommendations for Executive Action

Agency Affected Recommendation Status
Centers for Disease Control and Prevention The CDC Director should ensure that procedures for reporting and addressing potential political interference in scientific decision-making are developed and documented, including adding a definition of political interference. (Recommendation 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Centers for Disease Control and Prevention The CDC Director should ensure that CDC employees and contractors performing scientific activities are trained on how to report allegations of political interference in scientific decision-making. (Recommendation 2)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Food and Drug Administration The FDA Commissioner should ensure that procedures for reporting and addressing potential political interference in scientific decision-making are developed and documented, including adding a definition of political interference. (Recommendation 3)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Food and Drug Administration The FDA Commissioner should ensure that FDA employees and contractors performing scientific activities are trained on how to report allegations of political interference in scientific decision-making. (Recommendation 4)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
National Institutes of Health The NIH Director should ensure that procedures for reporting and addressing potential political interference in scientific decision-making are developed and documented, including adding a definition of political interference, and that its scientific integrity trainings on these procedures are updated. (Recommendation 5)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should ensure that procedures for reporting and addressing potential political interference in scientific decision-making are documented, including adding a definition of political interference, and that the procedures are communicated to the Assistant Secretary for Preparedness and Response. (Recommendation 6)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services, in coordination with the Assistant Secretary for Preparedness and Response, should ensure that ASPR employees and contractors performing scientific activities are trained on how to report allegations of political interference in scientific decision-making. (Recommendation 7)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

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