Clinical Trials, Ethics, and Human Protections Policies

Clinical trials raise two main sets of ethical challenges. The first concerns protecting human beings when they are used in scientific experiments. The second concerns protecting the welfare of downstream users of medical evidence generated in trials. The present chapter reviews core ethical standards and principles governing the conception, design, conduct, and reporting of clinical trials. This review concludes by suggesting that even the most technical decisions about design and reporting embed numerous moral judgments about how to serve the interests of research subjects and downstream users of medical evidence. Clinical trials are experiments on human beings. They involve two elements that make them ethically sensitive undertakings. First, the very reagent used in the experiment – the human being – has what philosophers call moral status. That is, human beings are sentient and self-aware, they have preferences and plans, and they have a capacity for suffering. Human beings are thus entitled to having their interests respected and protected when they are themselves the research reagents. Second, clinical trials are aimed at supporting decision-making in health care. Life and death decisions are ultimately based on the evidence we generate from human experiments. Human beings who use that evidence deserve protection from scientific findings that are misleading, incomplete, or biased. In what follows, I provide a very condensed overview of the ethics of clinical trials. Most writings on the ethics of clinical trials have centered on the protection of human volunteers, treating issues of research integrity as an afterthought, if at all. Two core claims ground this review – claims that perhaps differentiate it from similar overviews of human research ethics. The first is that scientific integrity is a complement to human protections; even the most technical decisions about design and analysis are laden with implicit ethical judgments. The second is that clinical trials present ethical challenges across their full life cycle – not merely in the brief window when a trial is open for enrollment, and where human protection regulations are directed. This review is thus organized according to the life cycle of a clinical trial.