Kosin Med J.  2022 Dec;37(4):278-282. 10.7180/kmj.22.132.

Ethical issues in clinical research and publication

Affiliations
  • 1Department of Otolaryngology-Head and Neck Surgery, Kosin University College of Medicine, Busan, Korea

Abstract

Clinical research including human participants should be based on truth, demonstrate scientific integrity, and follow ethical standards and guidelines to protect study participants. The publication of clinical research should be transparent and adhere to strict criteria for authorship. A thorough understanding and knowledge of ethical issues will limit investigator misconduct in clinical research and publication. In this article, basic ethical issues in clinical research and publication are reviewed and summarized based on recent guidelines.

Keyword

Clinical study; Publications; Research ethic

Reference

References

1. Masic I, Hodzic A, Mulic S. Ethics in medical research and publication. Int J Prev Med. 2014; 5:1073–82.
2. Code N. Informed consent in human research: ethical and legal aspects. In : Lebacqz K, Levine RJ, editors. Encyclopedia of bioethics. New York: Macmillan;1982. p. 757.
3. Annas GJ, Grodin MA. The Nazi doctors and the Nuremberg Code: human rights in human experimentation: human rights in human experimentation. New York: Oxford University Press;1992.
4. Beecher HK. Ethics and clinical research. 1966. Bull World Health Organ. 2001; 79:367–72.
5. Rosenberg SA. Secrecy in medical research. N Engl J Med. 1996; 334:392–4.
Article
6. Guraya SY, London NJ, Guraya SS. Ethics in medical research. J Microsc Ultrastruct. 2014; 2:121–6.
Article
7. Nys H. Towards an international treaty on human rights and biomedicine? Some reflections inspired by UNESCO's Universal Declaration on Bioethics and Human Rights. Eur J Health Law. 2006; 13:5–8.
Article
8. Nys H, Stultiens L, Borry P, Goffin T, Dierickx K. Patient rights in EU Member States after the ratification of the Convention on Human Rights and Biomedicine. Health Policy. 2007; 83:223–35.
Article
9. Dommel FW, Alexander D. The Convention on Human Rights and Biomedicine of the Council of Europe. Kennedy Inst Ethics J. 1997; 7:259–76.
Article
10. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2000; 284:3043–5.
11. Carlson RV, Boyd KM, Webb DJ. The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004; 57:695–713.
Article
12. Ndebele P. The Declaration of Helsinki, 50 years later. JAMA. 2013; 310:2145–6.
Article
13. Shrestha B, Dunn L. The Declaration of Helsinki on medical research involving human subjects: a review of seventh revision. J Nepal Health Res Counc. 2020; 17:548–52.
Article
14. Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N, Elsayed DE, et al. The structure and function of research ethics committees in Africa: a case study. PLoS Med. 2007; 4:e3.
Article
15. Fisher CB. Privacy and ethics in pediatric environmental health research-part I: genetic and prenatal testing. Environ Health Perspect. 2006; 114:1617–21.
Article
16. Mielke HW. Research ethics in pediatric environmental health: lessons from lead. Neurotoxicol Teratol. 2002; 24:467–9.
17. Mandl KD, Szolovits P, Kohane IS. Public standards and patients' control: how to keep electronic medical records accessible but private. BMJ. 2001; 322:283–7.
18. Avasthi A, Ghosh A, Sarkar S, Grover S. Ethics in medical research: general principles with special reference to psychiatry research. Indian J Psychiatry. 2013; 55:86–91.
Article
19. Shankar SV, Amita K. Plagiarism in medical research: knowns and unknowns. J Med Sci. 2015; 1:2.
Article
20. International Committee of Medical Journal Editors (ICMJE). Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Updated May 2022 [Internet]. ICMJE;c2022. [cited 2022 Sep 2]. http://www.icmje.org/icmje-recommendations.pdf.
21. World Association of Medical Editors (WAME). Recommendations on Publication Ethics Policies for Medical Journals [Internet]. WAME;c2022. [cited 2022 Sep 2]. https://wame.org/recommendations-on-publication-ethics-policies-for-medical-journals#Plagiarism.
22. Masic I. Plagiarism in scientific publishing. Acta Inform Med. 2012; 20:208–13.
Article
23. Kumar PM, Priya NS, Musalaiah S, Nagasree M. Knowing and avoiding plagiarism during scientific writing. Ann Med Health Sci Res. 2014; 4(Suppl 3):S193–8.
Article
24. Sarwar U, Nicolaou M. Fraud and deceit in medical research. J Res Med Sci. 2012; 17:1077–81.
25. Walt G, Brugha R, Haines A. Working with the private sector: the need for institutional guidelines. BMJ. 2002; 325:432–5.
Article
26. DuVal G. Institutional ethics review of clinical study agreements. J Med Ethics. 2004; 30:30–4.
Article
27. Davidoff F. Between the lines: navigating the uncharted territory of industry-sponsored research. Health Aff (Millwood). 2002; 21:235–42.
Article
28. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000; 283:2701–11.
Article
Full Text Links
  • KMJ
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr