Research integrity during the COVID-19 pandemic: Perspectives of health science researchers at an Academic Health Science Center.

During the coronavirus disease 2019 pandemic, a complex mix of political pressure, social urgency, public panic, and scientific curiosity has significantly impacted the context of research and development. The goal of this study is to understand if and how researchers are shifting their practices and adjusting norms and beliefs regarding research ethics and integrity. We have conducted 31 interviews with Health Science Researchers at the University of Texas Medical Branch which were then analyzed using integrated deductive and inductive coding. We categorized participant views into four main areas: 1) limitations to the research design, 2) publication, 3) duplication of studies, and 4) research pipeline. Although certain researchers were in keeping to the status quo, more were willing to modify norms to address social need and urgency. Notably, they were more likely to opt for systemic change rather than modifications within their own research practices.

Scientific priorities and relational dynamics during the COVID-19 pandemic: A qualitative study.

To rapidly respond to the COVID-19 public health crisis, researchers have been called upon to prioritize pandemic research, while simultaneously modifying their existing research to maintain the safety of all stakeholders. This study aims to explore the experiences of health science researchers in their scientific practices, research priorities, and professional relational dynamics due to COVID-19. Specifically, we interviewed 31 researchers from diverse fields at the University of Texas Medical Branch. Participants worked on COVID-19, non-COVID-19 related research, or both. We integrated inductive and deductive coding using a thematic coding method. The following four themes were explored: 1) impact of research, 2) research priorities, 3) professional relationships and 4) contextual influences on science. Participants were drawn to COVID-19 work for a diversity of reasons including social need, scientific interest, professional duty, and increased access to funding opportunities. While collaborations have increased for COVID-19 researchers, interpersonal relationships have been challenging for participants. Additionally, political, familial, and personal stresses due to the pandemic have taken a toll on researchers in very different and often inequitable ways. To ensure team cohesion, there is a need to develop research practices, policies and systems that value empathy, flexibility, and interdependence.

Reimagining the peer-review system for translational health science journals.

Retractions of coronavirus disease 2019 (COVID-19) papers in high impact journals, such as The Lancet and the New England Journal of Medicine, have been panned as major scientific fraud in public media. The initial reaction to this news was to seek out scapegoats and blame individual authors, peer-reviewers, editors, and journals for wrong doing. This paper suggests that scapegoating a few individuals for faulty science is a myopic approach to the more profound problem with peer-review. Peer-review in its current limited form cannot be expected to adequately address the scope and complexity of large interdisciplinary science research collaboration, which is central in translational research. In addition, empirical studies on the effectiveness of traditional peer-review reveal its very real potential for bias and groupthink; as such, expectations regarding the capacity and effectiveness of the current peer review process are unrealistic. This paper proposes a new vision of peer-review in translational science that, on the one hand, would allow for early release of a manuscript to ensure expediency, whereas also creating a forum or a collective of various experts to actively comment, scrutinize, and even build on the research under review. The aim would be to not only generate open discussion and oversight respecting the quality and limitations of the research, but also to assess the extent and the means for that knowledge to translate into social benefit.

How U.S. research institutions are responding to the single Institutional Review Board mandate.

One of the most significant changes to the Common Rule is the requirement that institutions use a single Institutional Review Board (IRB) for cooperative research in the United States, unless more than one IRB is required by state, local, or tribal law, or a signatory federal agency decides an exception is warranted. We surveyed Human Research Protection Program (HRPP) officials at the top U.S. research institutions to understand their knowledge and opinion of the mandate, what steps their institutions are taking, and difficulties their institutions are facing. One-hundred seven institutions (56.9%) responded to the survey. While support for the single-IRB mandate was positive overall, most respondents acknowledged that their institution is likely to face some difficulties complying with it. Regulatory agencies can help institutions to comply with the mandate by providing guidance concerning such issues as exceptions to the mandate, local context review, oversight, and implementation of reliance agreements, and development of policies, procedures, and best practices.

Ethical Dilemmas in Protecting Susceptible Subpopulations From Environmental Health Risks: Liberty, Utility, Fairness, and Accountability for Reasonableness.

Various U.S. laws, such as the Clean Air Act and the Food Quality Protection Act, require additional protections for susceptible subpopulations who face greater environmental health risks. The main ethical rationale for providing these protections is to ensure that environmental health risks are distributed fairly. In this article, we (1) consider how several influential theories of justice deal with issues related to the distribution of environmental health risks; (2) show that these theories often fail to provide specific guidance concerning policy choices; and (3) argue that an approach to public decision making known as accountability for reasonableness can complement theories of justice in establishing acceptable environmental health risks for the general population and susceptible subpopulations. Since accountability for reasonableness focuses on the fairness of the decision-making process, not the outcome, it does not guarantee that susceptible subpopulations will receive a maximum level of protection, regardless of costs or other morally relevant considerations.

What is Recklessness in Scientific Research? The Frank Sauer Case.

On May 22, 2017, administrative law Judge Leslie Rogall of the Department of Health and Human Services' Departmental Appeals Board, Civil Remedies Division, ruled in favor of the Office of Research Integrity (ORI) concerning its decision to charge former University of California at Riverside biochemistry professor Frank Sauer with research misconduct for fabricating or falsifying digital image data included in three papers and seven grant applications submitted to the National Institutes of Health. More specifically, Sauer was deemed responsible for manipulating, reusing, and falsely labeling images of autoradiograms and gels in his research in epigenetics. One month after this decision, ORI announced its final ruling concerning Sauer, which barred him from serving in any advisory capacity to the Public Health Services and required him to retract affected papers. The case raises some interesting and important questions concerning research integrity because it focused on the legal issue of what constitutes recklessness in scientific research.

Data-Intensive Science and Research Integrity.

In this commentary, we consider questions related to research integrity in data-intensive science and argue that there is no need to create a distinct category of misconduct that applies to deception related to processing, analyzing, or interpreting data. The best way to promote integrity in data-intensive science is to maintain a firm commitment to epistemological and ethical values, such as honesty, openness, transparency, and objectivity, which apply to all types of research, and to promote education, policy development, and scholarly debate concerning appropriate uses of statistics.