Research Misconduct Policy in Biomedicine: Beyond the Bad-Apple Approach

Introduction

Introduction Overview Public policy on research misconduct, which has developed contentiously in the United States and a few other countries over the past thirty years, remains largely untested as to whether it yields clearly specific outcomes; alternative policies that might reach those outcomes remain unexamined. Each widely publicized case of research misconduct creates a new scandal, leading to questions about whether current regulation is effective or just, and whether it supports the progress of science. It is important to remember the broader context of research misconduct, the system of incentives and disincentives embedded in the production and dissemination of research. Yet, in current public policy, all attention is on those individuals who have been caught fabricating, falsifying, or plagiarizing. Research Misconduct Policy in Biomedicine reviews a variety of frameworks, each of which provides options for preventing and controlling this phenomenon.The management of research misconduct policy and other reforms, such as the control of conflict of interest, can improve the quality of scientific research; they can help it to build trust in its conduct and the x Introduction knowledge it produces and thus to better fulfill its compact with the public, which provides much of its funding. We will start with the current regulatory framework of the Office of Research Integrity (ORI), whose purview is largely confined to the life sciences and to research funded by the Public Health Service (PHS). This framework has developed from an informal system of peer review to incorporate legal standards and processes. Similar systems are being formed across the globe, but as this subsystem of research ethics evolves (other subsystems include human and animal subject protection, and containment of conflicts of interest), a full range of policy options should be considered. Current research misconduct policy is built on the belief that individuals are able to control both the risk factors they encounter and their own destinies. The premise of this book is that a fair and effective policy must reflect both the context of research misconduct and the various conditions that affect it. In my view, the goals of a system regulating research misconduct should be (1) to protect scientific capital (knowledge, scientists, institutions, resources, norms of science); (2) to support fair competition in scientific research; and (3) to contain harms to end users (Redman 2009, 216). These specific goals make explicit what is implied in the broader goals set forth in the Code of Federal Regulations (42 CFR 93.101 (e), as in effect October 1, 2011): “To protect the health and safety of the public, promote the integrity of PHS supported research and the research process, and conserve public funds.” Current Regulation on Research Misconduct According to the Code of Federal Regulations (42 CFR 93.102–104, as in effect October 1, 2011): Introduction xi (a) Each institution that applies for or receives PHS support for biomedical or behavioral research, research training or activities related to that research or research training must comply with this part. (b)(1) This part applies to allegations of research misconduct and research misconduct involving: (i) Applications or proposals for PHS support for biomedical or behavioral extramural or intramural research, research training or activities related to that research or research training, such as the operation of tissue and data banks and the dissemination of research information; (v) Plagiarism of research records produced in the course of PHS supported research, research training or activities related to that research or research training. Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. (a) Fabrication is making up data or results and recording or reporting them. (b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. (c) Plagiarism is the appropriation of another person’s ideas, processes , results, or words without giving appropriate credit. (d) Research misconduct does not include honest error or differences of opinion. A finding of research misconduct made under this part requires that— (a) There be a significant departure from accepted practices of the relevant research community; and (b) The misconduct be committed intentionally, knowingly, or recklessly ; and (c) The allegation be proven by a preponderance of the evidence. As can be seen, the text of this regulation admits of no ambiguity in the standards of scientific research—it assumes that there is clear agreement as to what...