Ethics in Research: An Overview for Novice Researchers

Authors

  • Stacia Smith SUNY Canton

DOI:

https://doi.org/10.33423/jlae.v21i2.7062

Keywords:

leadership, accountability, ethics, institutional review board, human subjects, research, informed consent, The Nuremberg Code, The Declaration of Helsinki, The Belmont Report, The Common Rule

Abstract

Research studies involving human participants must be approved by the organization’s Institutional Review Board before data collection can begin. To a frustrated novice researcher who is struggling to obtain approval, this process can, at times, feel excessively rigorous. Inhumane and unethical experiments from the past have driven the evolution of research ethics regulations. Understanding the past and present requirements of ethical research helps novice and seasoned researchers alike to better appreciate the process. This paper will briefly introduce the history, landmark reports, current regulations, and ethical issues when conducting and publishing research that includes human subjects.

References

Bittker, B. (2021, June 14). The Ethical Implications of Clinical Trials in Low- and Middle-Income Countries. The American Bar Association. Retrieved from https://www.americanbar.org/groups/crsj/publications/human_rights_magazine_home/the-truth-about-science/the-ethical-implications-of-clinical-trials/

Brown, D. (2017, May 16). ‘You’ve Got Bad Blood’: The Horror of the Tuskegee Syphilis Experiment. The Washington Post. Retrieved from https://www.washingtonpost.com/news/retropolis/wp/2017/05/16/youve-got-bad-blood-the-horror-of-the-tuskegee-syphilis-experiment/

Carlson, R., Boyd, K., & Webb, D. (2004). The revision of the Declaration of Helsinki: Past, present and future. British Journal of Clinical Pharmacology, 57(6), 695–713. https://doi.org/10.1111/j.1365-2125.2004.02103.x

Dingwall, R. (2017). Social sciences lose out again in Common Rule reform. Nature Human Behaviour, 1(83). https://doi.org/10.1038/s41562-017-0083

Dunn, A., Coiera, E., Mandle, K., & Bourgeois, F. (2016). Conflict of interest disclosure in biomedical research: A review of current practices, biases, and the role of public registries in improving transparency. Research Integrity and Peer Review, 1(1). https://doi.org/10.1186/s41073-016-0006-7

Ezekiel, E., Grady, C., Crouch, R., Lie, R., Miller, F., & Wendler, D. (2008). The Oxford Textbook of Clinical Research Ethics. Oxford University Press. Retrieved from https://ebookcentral.proquest.com/lib/purdue/detail.action?docID=665420&pq-origsite=primo#

Ghooi, R. (2011). The Nuremberg Code–A critique. Perspectives in Clinical Research, 2(2), 72–76. https://doi.org/10.4103/2229-3485.80371

Gillis, J., Schwartz, J. (2015, February 21). Deeper ties to corporate cash for doubtful climate researcher. The New York Times. Retrieved from https://www.nytimes.com/2015/02/22/us/ties-to-corporate-cash-for-climate-change-researcher-Wei-Hock-Soon.html

Khin-Maung-Gyi, F. (2009). The history and role of institutional review boards: Local and Central IRBs, a single mission. AMA Journal of Ethics, 11(4), 317–321. https://doi.org/10.1001/virtualmentor.2009.11.4.pfor1-0904

Krugman, S. (1986). The Willowbrook Hepatitis studies revisited: Ethical aspects. Reviews of Infectious Diseases, 8(1). Retrieved from https://www.gvsu.edu/cms4/asset/F51281F0-00AF-E25A-5BF632E8D4A243C7/willowbrook_hepatitis_studies.pdf

Lapid, M., Clarke, B., & Wright, S. (2019). Institutional review boards: What clinician researchers need to know. Mayo Clinic Proceedings, 94(3), 515–525. https://doi.org/10.1016/j.mayocp.2019.01.020

Mandal, J., Acharya, S., & Parija, S.C. (2011). Ethics in human research. Trop Parasitol, 1(1). https://doi.org/10.4103/2229-5070.72105

Marco, C., & Larkin, G. (2008). Research Ethics: Ethical issues of data reporting and the quest for authenticity. Academic Emergency Medicine, 7(6). https://doi-org.ezproxy.lib.purdue.edu/10.1111/j.1553-2712.2000.tb02049.x

Metcalf, J. (2016). Computing ethics: Big data analytics and revision of the common rule. Communications of the ACM, 59(7), 31–33. https://doi.org/10.1145/2935882

Moon, M. (2009, April). The history and role of institutional review boards: A useful tension. AMA Journal of Ethics. Retrieved from https://journalofethics.ama-assn.org/article/history-and-role-institutional-review-boards-useful-tension/2009-04

Ndebele, P. (2013). The declaration of Helsinki, 50 Years later. JAMA, 310(20). https://doi.org/10.1001/jama.2013.281316

Nijhawan, L., Janodia, M., Muddukrishna, B.S., Bhat, K.M., Bairy, K.L., Udupa, N., & Musmade, P. (2013). Informed consent: Issues and challenges. Journal of Advanced Pharmaceutical Technology & Research, 4(3), 134–140. https://doi.org/10.4103/2231-4040.116779

Rodriguez, M., & Garcia, R. (2013). First, do no harm: The US sexually transmitted disease experiments in Guatemala. American Journal of Public Health, 103(12), 2122–2126. https://doi.org/10.2105/AJPH.2013.301520

Shuster, E. (1997). Fifty years later: The significance of the Nuremberg Code. The New England Journal of Medicine, 337, 1436–1440. https://doi.org/10.1056/NEJM199711133372006

Sims, J. (2010). A brief review of the Belmont Report. Dimensions of Critical Care Nursing, 29(4), 173–174. https://doi.org/10.1097/DCC.0B013E3181DE9EC5

SUNY Canton. (2022). Institutional Review Board (IRB). Retrieved from https://www.canton.edu/irb/

U.S. Department of Health & Human Services. (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

Vernon, L. (2020). Tuskegee syphilis study not America’s only medical scandal: Chester M. Southam, MD, Henrietta Lacks, and the Sloan-Kettering research scandal. Online Journal of Health Ethics, 16(2). http://dx.doi.org/10.18785/ojhe.1602.03

West, D. (2008). Radiation experiments on children at the Fernald and Wrentham schools: Lessons for protocols in human subject research. Accountability in Research, 6, 103–125. https://doi.org/10.1080/08989629808573922

World Medical Association. (2018, July 9). WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Retrieved from https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

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Published

2024-06-25

How to Cite

Smith, S. (2024). Ethics in Research: An Overview for Novice Researchers. Journal of Leadership, Accountability and Ethics, 21(2). https://doi.org/10.33423/jlae.v21i2.7062

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