The Evolution of Clinical Research Ethics: From Historical Abuses to Contemporary Challenges.

Abstract

Ethical standards are crucial in contemporary clinical research. The requirements with which researchers comply are a result of the long history of abuses and attempts to find solutions that eventually led to the introduction of a consistent ethical framework that now guides clinical research in the USA. This study critically analyzes this history. It reviews the history of clinical research ethics from the Nuremberg Code to the recent revisions of the Declaration of Helsinki and FDA regulations. The evidence presented in this study shows that ethical frameworks are reactive. Most policies were introduced in response to abuses and violations, such as the atrocities committed by the Nazi regime and the notorious Tuskegee Syphilis Study. After many changes, these standards evolved into relatively consistent principles, such as independent review, beneficence, and justice. The study shows that researchers generally adhere to these principles of research ethics. However, some do not fully address the reality of contemporary clinical research. This article advocates for more detailed consent procedures, specific clauses to address the ethical controversies of certain technologies, such as deep learning applications and big data tools, and strict conflict of interest disclosure requirements. The most important avenue for future research in this area is to revisit the balance of potential risks and benefits to determine the cases in which ethical requirements might be simplified to advance scientific interest. The arguments provided in this article can inspire researchers and physicians to reflect on contemporary trends in research ethics and design new strategies to address key ethical challenges.