Ethics of Clinical Research - A Historical Review

Authors

  • Liz Balint McMaster University
  • Ashlyn Leung

Keywords:

Ethical guidelines, human participation, clinical trials, Nuremburg Code, Declaration of Helsinki, Belmont Report, Holmesburg Prison, Tuskegee Syphilis Study

Abstract

Research that contributes to significant advancements in healthcare is often achieved through the analysis of data from human participants. Many researchers in this field seek participants of various factors, including age and health, to study the effects of new drug treatments, diets, or other related therapies. Clinical trials and studies involving human participants are important for the progression of science, but require extensive ethical consideration. Ethics are the moral principles that govern the conducting of an activity, in this case, performing tests on humans. The understanding of ethical regulations outlines the key responsibilities of the investigator, and more importantly, ensures the protection of the participant’s rights. This historical review examines the controversies that led to the development of ethical guidelines for human participation in research since the 1940s. It is through various major controversies that the documents containing these guidelines have continuously been shaped and edited over time. Analyzing the development of the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report contributes to a stronger understanding of current regulations and modern ethical controversies. These documents carefully considered the issues in their predecessors and include key points that aim to protect the rights of those who participate in research.   

References

Annas, G. and Grodin, M., 1992. The Nazi Doctors and the Nuremberg Code. USA: Oxford University Press.

Annas, G. and Grodin, M., 1998. Human rights and maternal-fetal HIV transmission prevention trials in Africa. 88(4), pp.560–563.

Anon 2013. World Medical Association Declaration of Helsinki. 310(20), p.2191.

Statistics Canada, 2015. Gross Domestic Expenditures on Research and Development in Canada (GERD), the Provinces and Territories. [online] Statistics Canada. Available at: <http://www5.statcan.gc.ca/olc-cel/olc.action?objId=88-221-X&objType=2&lang=en&limit=0>.

Carlson, R., Boyd, K. and Webb D, 2004. The revision of the Declaration of Helsinki: past, present and future. 57(4), pp.695–713.

Cohen, J., 1997. AIDS: Ethics of AZT Studies in Poorer Countries Attacked. 276(5315), p.1022.

Corbie-Smith, G., n.d. The Continuing Legacy of the Tuskegee Syphilis Study: Considerations for Clinical Investigation. 317, 1, pp.5–8.

Emanuel, E., Joffe, S., Grady, C., Wendler, D. and Persad, G., 2015. Clinical research: Should patients pay to play? 7(298).

Freyhofer, H., 2004. The Nuremberg Medical Trial. New York: Peter lang.

Goodyear, M., Krieza-Jeric, K. and Lemmens, T., 2007. The Declaration of Helsinki. 335(7621), pp.624–625.

Homblum, A., 2012. Acres of Skin. 1st ed. Hoboken: Routledge.

Kim, W., 2012. Institutional review board (IRB) and ethical issues in clinical research. 62(1), pp.3–12.

Lewis, J., Jonsson, B., Kreutz, G., Sampaio, C. and van Zwieten-Boot, B., 2000. Placebo-controlled trials and the Declaration of Helsinki. 359(9314), pp.1337–1340.

McIntyre, J., 1998. AZT trials to reduce perinatal HIV transmission: A debate about science, ethics and resources. 6(11), pp.129–130.

Ome, M., 2017. Victims of 1940s STD study sue University. The Johns Hopkins News-Letter. 14 Sep.

Shovers, V., Lynch, C. and Burmeister, L., 2000. Knowledge of the Tuskegee Study and its Impact on the Willingness to Participate in Medical Research Studies. 92(12), pp.563–572.

Shuster, E., 1997. Fifty Years Later: The Significance of the Nuremberg Code. 337(20), pp.1436–1440.

Simon, R., 2000. Are Placebo-Controlled Clinical Trials Ethical or Needed When Alternative Treatment Exists? 133(6), pp.474–475.

Singer, E. and Levine, F., 2003. Protection of Human Subjects of Research: Recent Developments and Future Prospects for the Social Sciences. 67(1), pp.148–164.

Stone, H., 2004. Prisoners as Research Subjects: A Reference Guide. 1st ed. Kentucky.

Wenner, D., Kimmelman, J. and London, A., 2015. Patient-Funded Trials: Opportunity or Liability? 17(2), pp.135–137.

Williams, J., 2008. The Declaration of Helsinki and public health. 86(8), pp.650–651.

Published

2018-10-05