Fraud and Misconduct in Clinical Research: A Step to Improve Ethical Practice in Research
Keywords:
clinical research, bioethics, guideline, bias, scientific MisconductAbstract
Strict compliance to ethical principles in conducting clinical research is mandatory to ensure safety and wellbeing of study participants and legal protection of researchers. Many instances of fraud and misconduct are reported in world literature that has harmed clients and also eroded the trust that society had on bioscience researchers. In the light of a review of international experience on ethical practice in clinical research, we prepared the ‘Guideline for Responsible Conduct of Clinical Studies and Trials’ which covers important aspects of clinical research including protection of the rights, safety, wellbeing and autonomy of study participants; role and responsibilities of the researchers, supervisors and sponsors including pharmaceutical agencies; documentations required; reporting of research findings and related issues. Clinical researchers must acquire and apply knowledge, attitude and skill in conducting ethically sound high quality clinical research as prescribed in this Guideline. This review and our Guideline will hopefully be useful resources to all researchers worldwide.
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3. Jaffer U, Cameron AE. Deceit and fraud in medical research. Int J Surg. 2006;4(2):122-6.
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19. Ernster V, Goodson 3rd W, Hunt T, Petrakis N, Sickles E, Miike R. Vitamin E and benign breast" disease": a double-blind, randomized clinical trial. Surgery. 1985;97(4):490-4.
20. Huang H, He M, Liu L, Huang L. Vitamin E does not decrease the incidence of chemotherapy-induced peripheral neuropathy: a meta-analysis. Contemp Oncol. 2016;20(3):237-41.
21. London RS, Sundaram G, Murphy L, Manimekalai S, Reynolds M, Goldstein P. The effect of vitamin E on mammary dysplasia: a double-blind study. Obstet Gynecol. 1985;65(1):104-6.
22. McNeil JJ, Robman L, Tikellis G, Sinclair MI, McCarty CA, Taylor HR. Vitamin E supplementation and cataract: randomized controlled trial. Ophthalmology. 2004;111(1):75-84.
23. George SL, Buyse M. Data fraud in clinical trials. Clin Investig (Lond). 2015;5(2):161.
24. Electronic Code of Federal Regulations. Title 42: Public Health. Part 93 - Public Health Service Policies on Research Misconduct. 2017 [cited 2017 November]; Available from: https://www.ecfr.gov/cgi-bin/text-idx?%20SID=0b07ed68cf889962cae6c2b45d89150b&node=pt42.1.93&rgn=div5.
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28. Eisen A, Berry RM. The absent professor: Why we don't teach research ethics and what to do about it. Am J Bioeth. 2002;2(4):38-49.
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30. Al Mawali AH, Al Qasmi AM, Al Sabahi SM, Idikula J, Elaty MA, Morsi M, et al. Oman vision 2050 for health research: a strategic plan for the future based on the past and present experience. Oman Med J. 2017;32:86.
31. Centre of Studies & Research - Ministry of Health Oman. Guidelines for Responsible Conduct of Clinical Studies and Trials, 2016. Available from: http://mohcsr.gov.om/clinical-trials-and-studiesguideline/.
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33. National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, Ryan KJP. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research-the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: US overnment Printing Office; 1978.
34. Fadel HE. Ethics of clinical research: an Islamic perspective. J IMA. 2010;42.
35. Savulescu J, Wartolowska K, Carr A. Randomised placebo-controlled trials of surgery: ethical analysis and guidelines. J Med Ethics. 42:776–783; 2016.
36. Sharav VH. Children in clinical research: a conflict of moral values. Am J Bioeth. 2003;3:1–59.
37. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360:816–823.
38. Macklin R. Double standards in medical research in developing countries: Cambridge, MA: University Press; 2004.
39. Shapiro HT, Meslin EM. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med. 2001;345:139–142.
40. Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004;189:930–937.
41. Al-Mawali A. Leukemic stem cells shows the way for novel target of acute myeloid leukemia therapy. J Stem Cell Res Ther. 2013;3:151.
2. Altman L, Melcher L. Fraud in science. Br Med J (Clin Res Ed). 1983;286(6383):2003.
3. Jaffer U, Cameron AE. Deceit and fraud in medical research. Int J Surg. 2006;4(2):122-6.
4. Al-Adawi S, Ali BH, Al-Zakwani I. Research Misconduct: The peril of publish or perish. Oman Med J. 2016;31(1):5.
5. Fanelli D. How many scientists fabricate and falsify research? A systematic review and meta-analysis of survey data. PloS One. 2009;4(5):e5738.
6. Lock S. Misconduct in medical research: does it exist in Britain? Br Med J. 1988;297(6662):1531.
7. Geggie D. A survey of newly appointed consultants' attitudes towards research fraud. J Med Ethics. 2001;27(5):344-6.
8. Steen RG. Retractions in the scientific literature: is the incidence of research fraud increasing? J Med Ethics. 2010:jme. 2010.040923.
9. Gupta A. Fraud and misconduct in clinical research: A concern. Perspect Clin Res. 2013;4(2):144.
10. International Committee of Medical Journal Editors. Defining the Role of Authors and Contributors. [cited 2017 November]; Available from: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html.
11. Pollock A, Evans M. Bias and fraud in medical research: a review. J R Soc Med. 1985;78(11):937-40.
12. Al-Lamki L. Plagiarism and other Types of Publication Misconduct: A case for teaching publication ethics in medical schools. Sultan Qaboos Univ Med J. 2009;9(1):1.
13. The Committee on Publication Ethics (COPE). (Available at http://publicationethics.org/about). [Accessed on March 15, 2017].
14. BMJ. A consensus statement on research misconduct in the UK. Br Med J. 2012;344.
15. Steen RG. Retractions in the medical literature: how many patients are put at risk by flawed research? J Med Ethics. 2011;37(11):688-92.
16. Weinstein PR, y Baena RR, Chater NL. Results of extracranial-intracranial arterial bypass for intracranial internal carotid artery stenosis: review of 105 cases. Neurosurgery. 1984;15(6):787-94.
17. Yarsergill M. Anastomosis between the superficial temporal artery and a branch of the middle cerebral artery. Microsurgery Applied to Neurosurgery Stuttgart, FRG, Georg Thieme Verlag. 1969.
18. Machlin L. Clinical uses of vitamin E. Acta Vitaminol Enzymol. 1984;7:33-43.
19. Ernster V, Goodson 3rd W, Hunt T, Petrakis N, Sickles E, Miike R. Vitamin E and benign breast" disease": a double-blind, randomized clinical trial. Surgery. 1985;97(4):490-4.
20. Huang H, He M, Liu L, Huang L. Vitamin E does not decrease the incidence of chemotherapy-induced peripheral neuropathy: a meta-analysis. Contemp Oncol. 2016;20(3):237-41.
21. London RS, Sundaram G, Murphy L, Manimekalai S, Reynolds M, Goldstein P. The effect of vitamin E on mammary dysplasia: a double-blind study. Obstet Gynecol. 1985;65(1):104-6.
22. McNeil JJ, Robman L, Tikellis G, Sinclair MI, McCarty CA, Taylor HR. Vitamin E supplementation and cataract: randomized controlled trial. Ophthalmology. 2004;111(1):75-84.
23. George SL, Buyse M. Data fraud in clinical trials. Clin Investig (Lond). 2015;5(2):161.
24. Electronic Code of Federal Regulations. Title 42: Public Health. Part 93 - Public Health Service Policies on Research Misconduct. 2017 [cited 2017 November]; Available from: https://www.ecfr.gov/cgi-bin/text-idx?%20SID=0b07ed68cf889962cae6c2b45d89150b&node=pt42.1.93&rgn=div5.
25. US Department of Health and Human Services. The Office of Research Integrity. Case Summaries. [cited 2017 November]; Available from: https://ori.hhs.gov/case_summary.
26. Lock S. Fraud in medical research. J Res Nurs. 1997;2(3):161-3.
27. Anestidou L. Research Ethics education: the view from below. Am J Bioeth. 2002;2(4).
28. Eisen A, Berry RM. The absent professor: Why we don't teach research ethics and what to do about it. Am J Bioeth. 2002;2(4):38-49.
29. Titus SL, Wells JA, Rhoades LJ. Repairing research integrity. Nature. 2008;453(7198):980-2.
30. Al Mawali AH, Al Qasmi AM, Al Sabahi SM, Idikula J, Elaty MA, Morsi M, et al. Oman vision 2050 for health research: a strategic plan for the future based on the past and present experience. Oman Med J. 2017;32:86.
31. Centre of Studies & Research - Ministry of Health Oman. Guidelines for Responsible Conduct of Clinical Studies and Trials, 2016. Available from: http://mohcsr.gov.om/clinical-trials-and-studiesguideline/.
32. World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ. 2001;79:373–374.
33. National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, Ryan KJP. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research-the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: US overnment Printing Office; 1978.
34. Fadel HE. Ethics of clinical research: an Islamic perspective. J IMA. 2010;42.
35. Savulescu J, Wartolowska K, Carr A. Randomised placebo-controlled trials of surgery: ethical analysis and guidelines. J Med Ethics. 42:776–783; 2016.
36. Sharav VH. Children in clinical research: a conflict of moral values. Am J Bioeth. 2003;3:1–59.
37. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360:816–823.
38. Macklin R. Double standards in medical research in developing countries: Cambridge, MA: University Press; 2004.
39. Shapiro HT, Meslin EM. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med. 2001;345:139–142.
40. Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004;189:930–937.
41. Al-Mawali A. Leukemic stem cells shows the way for novel target of acute myeloid leukemia therapy. J Stem Cell Res Ther. 2013;3:151.
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Published
2018-09-26
How to Cite
Al-Mawali, A., Idikula, J., & Daniel Pinto, A. (2018). Fraud and Misconduct in Clinical Research: A Step to Improve Ethical Practice in Research. Journal of Contemporary Medical Sciences, 4(3). Retrieved from https://jocms.org/index.php/jcms/article/view/449
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