Ethical Considerations of Biomedical Product Development
- 417 Downloads
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 .
KeywordsResearch ethics Plagiarism Informed consent Research ethics committee Animal research Human experimental studies
- 1.Emanuel EJ, Grady CC, Crouch RA, Lie RK, Miller FG, Wendler DD, editors. The Oxford textbook of clinical research ethics: Oxford University Press. New York, USA; 2008.Google Scholar
- 2.Smith T. Ethics in medical research: a handbook of good practice: Cambridge University Press. Cambridge, UK; 1999.Google Scholar
- 3.Resnik DB. What is ethics in research & why is it important. Natl Inst Environ Health Sci. 2011;1(10):49–70.Google Scholar
- 4.Smith D. Five principles for research ethics. Monit Psychol. 2003;34(1):56.Google Scholar
- 5.Basic Information about Scientific Integrity, 2012, Feb. available at: https://www.epa.gov/osa/basic-information-about-scientific-integrity#definition.
- 6.Goodstein D. Scientific misconduct. Academe. 2002;88(1):28.Google Scholar
- 7.10 Types of Scientific Misconduct, 2015, July 19. available at: https://www.enago.com/academy/10-types-of-scientific-misconduct/.
- 8.Shewan LG, Coats AJ. Ethics in the authorship and publishing of scientific articles. Int J Cardiol. 2010;144:1.Google Scholar
- 10.Publication conduct available at: https://www.ndpublisher.in/publicationconduct.php.
- 11.Shamoo AE, Resnik DB. Responsible conduct of research: Oxford University Press. New York, USA; 2009.Google Scholar
- 12.Sugarman J, Sulmasy DP. Methods in medical ethics: Georgetown University Press. USA; 2010.Google Scholar
- 13.Beauchamp TL, Childress JF. Principles of biomedical ethics: Oxford University Press. New York, USA; 2001.Google Scholar
- 14.Ebbesen M, Andersen S, Pedersen BD. Further development of Beauchamp and Childress’ theory based on empirical ethics. J Clin Res Bioeth. 2012;6:e001.Google Scholar
- 16.Code N. The Nuremberg Code. Trials of war criminals before the Nuremberg military tribunals under control council law, vol. 10. Washington, D.C: U.S. Government Printing Office; 1949. p. 181–2.Google Scholar
- 19.Declaration Of Helsinki 1975. Available at: https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/doh-oct1975/.
- 20.Claudon M, Cosgrove D, Albrecht T, Bolondi L, Bosio M, Calliada F, Correas JM, Darge K, Dietrich C, D’onofrio M, Evans DH. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS)-update 2008. Ultraschall in der Medizin-European J Ultrasound. 2008;29(01):28–44.Google Scholar
- 22.World Health Organization, Research ethics committees: basic concepts for capacity-building. 2009. available at: http://www.fercap-sidcer.org/publications/pdf/201202/FERCAP-19-WHO%20REC%20Basic%20Concepts.pdf.
- 23.LaFollette H, Shanks S. Brute Science. New York: Routledge; 1996.Google Scholar
- 25.Moreno JD. Protectionism in research involving human subjects. In: National Bioethics Advisory Commission, editor. Commissioned papers and staff analysis. Bethesda: NBAC; 2001.Google Scholar
- 26.Manson NC, O’Neill O. Rethinking informed consent in bioethics: Cambridge University Press. New York, USA; 2007.Google Scholar
- 29.Morrow V, Richards M. The ethics of social research with children: an overview 1. Child Soc. 1996;10(2):90–105.Google Scholar
- For a simple but comprehensive review of ethical theory, see Gensler HJ. Ethics: a contemporary introduction. Routledge; 2011.Google Scholar
- 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
- For a classic text in biomedical ethics, see Beauchamp TL, Childress JF. Principles of biomedical ethics. Oxford University Press, USA; 2001.Google Scholar
- 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
- For International principles and standards, see: Nuremberg Code: www.hhs.gov/ohrp/archive/nurcode.html; Council of Europe: Convention of Human Rights and Fundamental Freedoms http://conventions.coe.int/Treaty/en/Treaties/html/005.htm; Declaration of Helsinki: www.wma.net/en/30publications/10policies/b3/; International Compilation of Human Research Standards covering over 100 countries: www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html.
- For International guidelines, see: Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects: www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm; UNESCO Universal Declaration on Bioethics and Human Rights: www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights/; The International Conference on Harmonisation's Guide to Good Clinical Practice (GCP): www.emea.europa.eu/pdfs/human/ich/013595en.pdf; World Health Organization Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants: http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf.