Ethical Considerations of Biomedical Product Development

Part of the Learning Materials in Biosciences book series (LMB)


The importance of ethics can be perceived considering the immorality in terrible history of several projects in the field of biomedical research (e.g., Tuskegee, Willowbrook, Milgram, Stanford Prison, etc.). Tuskegee Syphilis Study, for instance, is conducted by the U.S. Public Health Service (1932–1972). In this study, 400 subjects out of 600 African-American males from a low social economic population were infected with syphilis and observed for 40 years. Free medical check-up was given; however, participants were not aware of their disease. Even though a proven treatment such as penicillin was available in the 1950s, the study continued until 1972 and subjects did not receive treatment. In some cases, when other physicians diagnosed that the participants had syphilis, researchers intervened to stop the treatment. During the research study, many participants died of syphilis. Finally, the study ended in 1973 by the US Department of Health, Education, and Welfare after disclosing its details and a political embarrassment. In 1997, President Clinton under mounting pressure apologized to the study subjects and their families. Because of the advertising from the Tuskegee Syphilis Study, the National Research Act of 1974 was legislated in the United States [1].


Research ethics  Plagiarism  Informed consent  Research ethics committee  Animal research  Human experimental studies 


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Further Reading

  1. For a simple but comprehensive review of ethical theory, see Gensler HJ. Ethics: a contemporary introduction. Routledge; 2011.Google Scholar
  2. For a booklet introducing core critical thinking concepts and principles as an empowering problem-solving framework, see Paul R, Elder L. The miniature guide to critical thinking concepts & tools. Rowman & Littlefield; 2019.Google Scholar
  3. For a classic text in biomedical ethics, see Beauchamp TL, Childress JF. Principles of biomedical ethics. Oxford University Press, USA; 2001.Google Scholar
  4. For discussions on applying evidence-based approach to research ethics see: Anderson EE, DuBois JM. The need for evidence-based research ethics: a review of the substance abuse literature. Drug Alcohol Depend. 2007;86(2–3):95–105; Kalichman M. Evidence-based research ethics. Am J Bioeth. 2009;9(6–7):85–7; Beagan B, McDonald M. Evidence-based practice of research ethics review. Health Law Rev. 2005;13(2–3):62–8; Anderson EE, DuBois JM. IRB decision‐making with imperfect knowledge: a framework for evidence‐based research ethics review. J Law Med Ethics. 2012;40(4):951–69.Google Scholar
  5. For International principles and standards, see: Nuremberg Code:; Council of Europe: Convention of Human Rights and Fundamental Freedoms; Declaration of Helsinki:; International Compilation of Human Research Standards covering over 100 countries:
  6. For International guidelines, see: Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects:; UNESCO Universal Declaration on Bioethics and Human Rights:; The International Conference on Harmonisation's Guide to Good Clinical Practice (GCP):; World Health Organization Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants:

Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.Evidence Based Medicine Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical SciencesTehranIran
  2. 2.Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical SciencesTehranIran

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