Corporations, high-stakes biomedical research, and research misconduct: yes they can (and sometimes do).

Abstract

Science has long been vulnerable to research misconduct (RM). Biomedical sciences, with vast financial stakes, carry heightened temptations. However, RM is standardly seen as an undertaking of individual scientists, not as something that could be committed by an organization such as a corporation or university. Rather, organizations are generally regarded merely as supervisors to encourage scientific integrity and investigate suspected RM. Indeed, federal regulations expressly embrace this perspective, and the federal Office of Research Integrity has never deemed an organization guilty of committing RM. This article aims to rewrite this corner of research integrity: organizations can directly commit RM and should be held accountable as such. Although the conclusions apply to organizations such as universities and government agencies, the focus here is on corporations in the biomedical sciences. After defining 'research misconduct' in Part II, Part III describes corporate-level RM and distinguishes it from individuals' misconduct. Part IV provides five case studies exemplifying corporate RM, while Part V discusses implications, describes ways in which federal regulations could already encompass organization-level RM, and identifies some needed legal and regulatory adjustments.