Scientific Integrity Policy Research Articles

Shattering the Mirage: The FDA’s Early COVID-19 Pandemic Response Demonstrates a Need for Reform to Restore Agency Credibility

The power afforded to the administrative state is heavily reliant on public trust and the perception of evidence-based agency decision-making. Organizational reputation is key to preserving regulatory power. However, recent investigations reveal that existing scientific integrity policies may not be sufficient to preserve the credibility of many federal agencies. In fact, a significant number of career scientists across various entities - including the FDA - have observed unreported incidents of political interference. While political influence exerted by the executive branch to set policy goals and determine agency priorities can be beneficial, political pressures must not undermine public trust in scientific agencies. Recently, public perception regarding the FDA's COVID-19 response threatened to weaken the agency's longstanding reputation as the gold standard of review. The COVID-19 pandemic publicized vulnerabilities that exist across agencies, as well as those that are unique to the FDA. The FDA's evolution as an increasingly public health-focused agency that must function in the landscape of politicized science exposes the agency to a greater risk of political interference. After all, the FDA's involvement in public health requires increased participation in non-ideal, value-based decision-making. Throughout its history, the FDA has managed to maintain its reputation through its firm responses to scandal. The COVID-19 pandemic provides a platform for the FDA to - once again - look introspectively and institute safeguards addressing vulnerabilities that plagued the agency's pandemic response. This Article examines the FDA's early COVID-19 response to propose reforms that promote meaningful transparency, public accountability, and scientific integrity.

Trump appointees swayed dicamba approval, report says

The US Environmental Protection Agency did not follow established procedures in 2018 when it extended approval for herbicides containing dicamba, a report by the EPA’s inspector general (IG) office concludes. The failure to follow procedures that ensure scientifically sound decisions regarding pesticide registrations violated the agency’s scientific integrity policy, the report says. Specifically, the investigation found that the EPA did not internally peer review scientific documents used to support dicamba registrations. Senior-level Trump appointees were also more involved in the dicamba decisions than in those regarding other pesticides, according to staff scientists interviewed by the IG office. The staff scientists told the office that they had concerns about political appointees’ omitting conclusions about the potential for dicamba to drift to nontarget plants but said they felt constrained from sharing those concerns. Environmental groups challenged the EPA’s 2018 dicamba decision , and a federal appeals court ruled in their favor last

Restrictions on the Use of Public Health Research at US Government Agencies in the Name of Transparency

Transparency measures at government agencies are essential in order to ensure scientific integrity and public trust in the government’s scientific output. Agency scientists, supported by a commitment to a rigorous independent science process, scientific integrity policies, and appropriate transparency measures, should be trusted to analyze available data and issue policies that consider and value the weight of the evidence. We evaluated how recent initiatives at the Environmental Protection Agency (EPA) and the Department of the Interior (DOI) would block the agencies from using many kinds of scientific studies vital to decisionmaking, including studies that rely on personal health data, confidential business information, intellectual property, or older studies for which the authors or data sources may not be accessible. Comparing requirements for industry and all other submissions, we found that these proposals would protect industry data and confidential business information more adequately than public health information. Both directives would allow agencies to use the degree to which the underlying data is public to judge a study’s credibility, which would mean many types of studies done in the environmental health field would be discounted. We analyzed how the placement of unnecessary restrictions on the kinds of studies that agencies can consider stands to affect decisionmaking on everything from air pollution standards to water quality issues to chemical regulation in consumer products. The speaker will discuss the difference between genuine transparency needs in government science and these two misguided agency rules. Examples of how these policies could impact the foundation of public environmental and public health protection will be outlined and alternative recommendations for improved government scientific transparency that is protective of public health will be laid out.

US EPA contractors must follow scientific integrity policy

US EPA contractors must follow scientific integrity policy

US EPA contractors must adhere to scientific integrity policy

US EPA contractors must adhere to scientific integrity policy

Perceived losses of scientific integrity under the Trump administration: A survey of federal scientists.

President Trump and his administration have been regarded by news outlets and scholars as one of the most hostile administrations towards scientists and their work. However, no study to-date has empirically measured how federal scientists perceive the Trump administration with respect to their scientific work. In 2018, we distributed a survey to over 63,000 federal scientists from 16 federal agencies to assess their perception of scientific integrity. Here we discuss the results of this survey for a subset of these agencies: Department of Interior (DOI) agencies (the US Fish and Wildlife Service (FWS), the US Geological Survey, and the National Park Service); the Centers for Disease Control and Prevention (CDC); the US Environmental Protection Agency (EPA); the Food and Drug Administration (FDA); and the National Oceanic and Atmospheric Administration (NOAA). We focus our analysis to 10 key questions fitting within three core categories that relate to perceptions of integrity in science. Additionally, we analyzed responses across agencies and compare responses in the 2018 survey to prior year surveys of federal scientists with similar survey questions. Our results indicate that federal scientists perceive losses of scientific integrity under the Trump Administration. Perceived loss of integrity in science was greater at the DOI and EPA where federal scientists ranked incompetent and untrustworthy leadership as top barriers to science-based decision-making, but this was not the case at the CDC, FDA, and NOAA where scientists positively associated leadership with scientific integrity. We also find that reports of political interference in scientific work and adverse work environments were higher at EPA and FWS in 2018 than in prior years. We did not find similar results at the CDC and FDA. These results suggest that leadership, positive work environments, and clear and comprehensive scientific integrity policies and infrastructure within agencies play important roles in how federal scientists perceive their agency's scientific integrity.

Protecting Scientific Integrity and Public Policy Pronouncements on COVID-19

The SARS-CoV-2 virus and the associatedCOVID-19disease is a pandemic that has rocked the worldin terms of public health and medical issues, business, economics and finance Interesting and topical discussions regarding risk management of COVID-19 have been reported in leading business, economics, finance, and medical Journals, as well as information and misinformation, intended or not, in the mass media In this context, protecting the integrity of public policy pronouncements relating to the conduct andoutcomes of scientific clinical trials In terms of protecting the scientific integrity of clinical trials of COVID-19 patients, it is intentional to determine whether imperfectly collected data on clinical trials are more useful than having no data at all © 2020 Hindawi Limited All rights reserved

Scientific Integrity Act Passes House Committee

Legislation would require federal science agencies to adopt and enforce strong scientific integrity policies.

Federal scientific integrity policies need improvement

Policies designed to protect scientific integrity at US federal agencies are not being fully enforced, according to a new report from the Government Accountability Office (GAO), Congress’s investig...

Canada issues scientific integrity guidance

The Canadian government released new guidelines on July 30 to encourage federal scientists to speak freely about their work and to protect their research from political and commercial interference. The guidelines are the result of new scientific integrity provisions included in a 2017 agreement with the union representing federal scientists. They were issued as an example policy to help federal departments and agencies develop their own scientific integrity policies, which must be in place by the end of the year. Muzzling of federal researchers was a major political issue in the 2015 federal election after reports showed that the government under former prime minister Stephen Harper had restricted federal scientists from speaking publicly and presenting research at conferences. The new model policy emphasizes the need for openness and transparency. It also offers procedures for dealing with breaches of scientific integrity. Kathleen Walsh, director of policy at Evidence for Democracy, which

Defending the scientific integrity of conservation-policy processes.

Government agencies faced with politically controversial decisions often discount or ignore scientific information, whether from agency staff or nongovernmental scientists. Recent developments in scientific integrity (the ability to perform, use, communicate, and publish science free from censorship or political interference) in Canada, Australia, and the United States demonstrate a similar trajectory. A perceived increase in scientific-integrity abuses provokes concerted pressure by the scientific community, leading to efforts to improve scientific-integrity protections under a new administration. However, protections are often inconsistently applied and are at risk of reversal under administrations publicly hostile to evidence-based policy. We compared recent challenges to scientific integrity to determine what aspects of scientific input into conservation policy are most at risk of political distortion and what can be done to strengthen safeguards against such abuses. To ensure the integrity of outbound communications from government scientists to the public, we suggest governments strengthen scientific integrity policies, include scientists' right to speak freely in collective-bargaining agreements, guarantee public access to scientific information, and strengthen agency culture supporting scientific integrity. To ensure the transparency and integrity with which information from nongovernmental scientists (e.g., submitted comments or formal policy reviews) informs the policy process, we suggest governments broaden the scope of independent reviews, ensure greater diversity of expert input and transparency regarding conflicts of interest, require a substantive response to input from agencies, and engage proactively with scientific societies. For their part, scientists and scientific societies have a responsibility to engage with the public to affirm that science is a crucial resource for developing evidence-based policy and regulations in the public interest.

A Unifying Vision for Scientific Decision Making: The Academy of Nutrition and Dietetics’ Scientific Integrity Principles

In 2014, recognizing the need to have a single document to guide scientific decision making at the Academy of Nutrition and Dietetics (Academy), the Council on Research was charged with developing a scientific integrity policy for the organization. From the Council on Research, four members volunteered to lead this workgroup, which reviewed the literature and best practices for scientific integrity from well-respected organizations, including federal funders of research. It became clear that the scope of this document would be quite broad, given the many scientific activities the Academy is involved in, and that it would be unreasonable to set policy for each of these many situations. Therefore, the workgroup set about defining the scope of scientific activities to be covered and envisioned a set of guiding principles, to which policies from every organizational unit of the Academy could be compared to ensure they were in alignment. While many relevant policies exist already, such as the requirement of a signed conflict of interest disclosure for Food & Nutrition Conference & Expo speakers, the Evidence Analysis Library funding policy, and the Academy’s sponsorship policy, the scientific integrity principals are unique in that they provide a unifying vision to which future policies can be compared and approved based on their alignment with the principles. The six principles outlined in this article were approved by the full Council on Research in January 2015 and approved by the Academy’s Board of Directors in March 2015.This article covers the scope of the principles, presents the principles and existing related resources, and outlines next steps for the Academy to review and revise current policies and create new ones in alignment with these principles.

Newsmakers

The U.S. Environmental Protection Agency has selected Francesca Grifo, a longtime advocate with the Union of Concerned Scientists, to implement its scientific integrity policy.

AGU Launches Web Site for New Scientific Integrity and Professional Ethics Policy

AGU's Scientific Integrity and Professional Ethics policy, approved by the AGU Board of Directors and Council in December 2012, is now available online on a new Web site, http://ethics.agu.org. As the Web site states, the policy embodies a “set of guidelines for scientific integrity and professional ethics for the actions of the members and the governance of the Union in its internal activities; in its public persona; and most importantly, in the research and peer review processes of its scientific publications, its communications and outreach, and its scientific meetings.”

Scientific Integrity and Media Policies Assessed at U.S. Federal Agencies

Two new reports from the nonprofit Union of Concerned Scientists (UCS) provide analyses of U.S. government agencies’ policies on scientific integrity and media. An 8 March report, “Federal Agency Scientific Integrity Policies: A Comparative Analysis,” found that many of those policies at 22 agencies and departments that were written following a 2009 presidential directive “actively promote and support a culture of scientific integrity,” but a number of the policies have significant flaws.

New AGU scientific integrity and professional ethics policy available for review

The AGU Task Force on Scientific Ethics welcomes your review and comments on AGU's new Scientific Integrity and Professional Ethics Policy. The policy has at its heart a code of conduct adopted from the internationally accepted “Singapore Statement,” originally created by the Second World Conference on Research Integrity (http://www.singaporestatement.org/), held in 2010. The new policy also encompasses professional and publishing ethics, providing a single source of guidance to AGU members, officers, authors, and editors.

Defense Department scientific integrity policy

The U.S. Department of Defense (DOD) has issued a scientific and engineering integrity policy, becoming the latest federal agency to follow a March 2009 White House directive. The document, labeled as “DoD Instruction 3200.20,” was issued on 26 July.

NASA scientific integrity policy

On 16 December, NASA became the latest U.S. federal agency to issue a scientific integrity policy. It was issued less than 10 days after the U.S. National Oceanic and Atmospheric Administration (NOAA) issued its policy on the same topic (see “NOAA issues scientific integrity policy,” Eos Trans. AGU, 92(50), 467, doi:10.1029/2011EO500004, 2011). The agency policies respond to earlier White House memos on the topic issued in 2009 and 2010. NASA is the fifth federal department or agency that has finalized a scientific integrity policy; the Department of the Interior and the National Science Foundation also have finalized their policies. As Eos went to press, 13 other policies were in near–final draft form, including those from the departments of Agriculture and Energy; the Environmental Protection Agency and the Department of Labor had indicated that they expected to submit their policies to the White House Office of Science and Technology Policy (OSTP) soon, OSTP director John Holdren wrote in a 21 December note on the office's Web site.

NOAA administrator reviews agency progress and challenges

The approach of the new year is a traditional time to tally up successes, failures, and the path ahead. Jane Lubchenco, administrator of the U.S. National Oceanic and Atmospheric Administration (NOAA), examined some agency advances and significant challenges during the 7 December Union Agency Lecture at the AGU Fall Meeting, during a press briefing, and in an interview with Eos. Lubchenco focused on several key areas including the concern about monitoring, mitigating, and managing extreme events; budgetary pressures the agency faces in current fiscal year (FY) 2012 and in FY 2013, with President Barack Obama on 18 November having signed into law a bill, HR 2112, following congressional agreement on a budget legislation conference report; and NOAA's newly released scientific integrity policy (see “NOAA issues scientific integrity policy,” Eos Trans. AGU, 92(50), 467, doi:10.1029/2011EO500004, 2011).

NOAA issues scientific integrity policy

The U.S. National Oceanic and Atmospheric Administration (NOAA) announced the agency's first‐ever scientific integrity policy at a 7 December news briefing at the AGU Fall Meeting in San Francisco, Calif. The policy follows a December 2010 White House memorandum that issued guidance to federal agencies implementing scientific integrity policies (see “White House issues scientific integrity policies,” Eos Trans. AGU, 91(51), 503, doi:10.1029/2010EO510003, 2010). The purpose of the NOAA policy is “to promote a continuing culture of scientific excellence and integrity, and to establish a policy on the integrity of scientific activities that the agency conducts and uses to inform management and policy decisions,” the agency's administrative order states. “In addition, the intent of the policy is to strengthen widespread confidence—from scientists, to decisionmakers, to the general public—in the quality, validity, and reliability of NOAA science and to denote the agency's commitment to a culture of support for excellence of NOAA's principal science asset, its employees.”