Ethical Considerations in Interventional Studies: A Systematic Review Ethics and Interventional Study
Abstract
Interventional studies are necessary to gain new knowledge in medical sciences; they can also be associated with several risks and impose high costs on patients and healthy people, and ethical considerations must be considered, as well. Understanding the ethical challenges and issues of interventional studies is essential. Using placebo, ethical consent, and clinical trials in specific groups are some of these challenges. This systematic review study was conducted to determine ethical considerations in interventional studies with an emphasis on the four ethical principles, including autonomy, non-maleficence principle, beneficence, and justice. Researchers in interventional studies should pay attention to ethics and take the necessary steps in line with these four biological principles.
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19. Rosenthal SL, Morris MC, Hoffman LF, Zimet GD.
Inclusion of adolescents in STI/HIV biomedical prevention trials: Autonomy, decision making, and parental involvement. Clin Pract Pediatr Psychol 2018;6:299-307.
20. Kerpel-Fronius S, Becker S, Barrett J, Brun J, Carlesi R, Chan A, et al. The shared ethical responsibility of medically and non-medically qualified experts in human drug development teams. Front Pharmacol 2018;9:843.
21. Bos W, Westra A, de Beaufort I, van de Vathorst S. To stop or not to stop: dissent and undue burden as reasons to stop participation in paediatric research. J Med Ethics 2017;43:519-23.
22. Safaie S, Abbasi M. The Principle of Beneficence from the Perspective of Islamic Biomedical Jurisprudence. Bioeth J 2013;3:53-86.
23. Rowbotham MC, McDermott MP. Ethical considerations in the design, execution, and analysis of clinical trials of chronic pain treatments. Pain Rep 2019;4:e646.
24. Zong Z. Should post-trial provision of beneficial experimental interventions be mandatory in developing countries? J Med Ethics 2008;34:188-92.
25. Owonikoko TK. Upholding the principles of autonomy, beneficence, and justice in phase I clinical trials. Oncologist 2013;18:242-4.
26. Dal-Ré R, Katsanis N, Katsanis S, Parker LS, Ayuso. Managing incidental genomic findings in clinical trials: fulfillment of the principle of justice. PLoS Med 2014;11:e1001584.
27. Nepi L. Ethical Issues Concerning the Informed Consent Process in Paediatric Clinical Trials: European Guidelines and Recommendations on Minor's Assent and Parental Permission. BioLaw Journal-Rivista di BioDiritto 2019:53-63.
28. Skierka AS, Michels KB. Ethical principles and placebo-controlled trials - Interpretation and implementation of the Declaration of Helsinki's placebo paragraph in medical research. BMC Med Ethics 2018;19:24.
2. Jafari M, Pournourmohammadi S, Ghazavi M. Needing to" Research Methodology" as a course or workshop at University of Medical Sciences? J Med Hypotheses Ideas 2009;3:17.
3. De Meulemeester J, Fedyk M, Jurkovic L, Reaume M, Dowlatshahi D, Stotts G, et al. Many randomized clinical trials may not be justified: a cross-sectional analysis of the ethics and science of randomized clinical trials. J Clin Epidemiol 2018;97:20-5.
4. Resnik DB. Ethics of community engagement in field trials of genetically modified mosquitoes. Dev World Bioeth 2018;18:135-43.
5. Nardini C. The ethics of clinical trials. Ecancermedicalscience 2014;8:387.
6. Bothwell LE, Kesselheim AS. The Real‐World Ethics of Adaptive‐Design Clinical Trials. Hastings Cent Rep 2017;47:27-37.
7. Trung LQ, Morra ME, Truong ND, Turk T, Elshafie A, Foly A, et al. A systematic review finds underreporting of ethics approval, informed consent, and incentives in clinical trials. J Clin Epidemiol 2017;91:80-6.
8. Asghari F, Fotouhi A. Ethics in clinical trial. J Diabetes Metab Disord 2005;4:47-57.
9. Parsapoor A, Asghari F. Clinical trials on healthy volunteers: review of ethical considerations and a critique of acceptable risk. Iran J Med Ethics Hist Med 2012;5:19-26.
10. Hug K, Johansson M. The ethics of withdrawal: the case of follow-up from first-in-human clinical trials. Regen Med 2017;12:25-36.
11. Pinxten W, Dierickx K, Nys H. Ethical principles and legal requirements for pediatric research in the EU: an analysis of the European normative and legal framework surrounding pediatric clinical trials. Eur J Pediatr 2009;168:1225-34.
12. Armon C. Ethics of clinical research in patients with ALS: is there a risk of exploitation? Amyotroph Lateral Scler Frontotemporal Degener 2018;19:161-6.
13. Kaye DK, Chongwe G, Sewankambo NK. Ethical tensions in the informed consent process for randomized clinical trials in emergency obstetric and newborn care in low and middle-income countries. BMC Med Ethics 2019;20:27.
14. Sim J. Outcome-adaptive randomization in clinical trials: issues of participant welfare and autonomy. Theor Med Bioeth 2019;40:83-101.
15. Van der Wilt GJ, Grutters JP, Maas AH, Rolden HJA. Combining value of information analysis and ethical argumentation in decisions on participation of vulnerable patients in clinical research. BMC Med Ethics 2018;19:5.
16. Lipsman N, Giacobbe P, Bernstein M, Lozano AM. Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design. J Med Ethics 2012;38:107-11.
17. Leibson T, Koren G. Informed consent in pediatric research. Paediatr Drugs 2015;17:5-11.
18. Jones KA, Semple M. Ethics in clinical trials. Anaesth Intensive Care Med 2017;18:586-9.
19. Rosenthal SL, Morris MC, Hoffman LF, Zimet GD.
Inclusion of adolescents in STI/HIV biomedical prevention trials: Autonomy, decision making, and parental involvement. Clin Pract Pediatr Psychol 2018;6:299-307.
20. Kerpel-Fronius S, Becker S, Barrett J, Brun J, Carlesi R, Chan A, et al. The shared ethical responsibility of medically and non-medically qualified experts in human drug development teams. Front Pharmacol 2018;9:843.
21. Bos W, Westra A, de Beaufort I, van de Vathorst S. To stop or not to stop: dissent and undue burden as reasons to stop participation in paediatric research. J Med Ethics 2017;43:519-23.
22. Safaie S, Abbasi M. The Principle of Beneficence from the Perspective of Islamic Biomedical Jurisprudence. Bioeth J 2013;3:53-86.
23. Rowbotham MC, McDermott MP. Ethical considerations in the design, execution, and analysis of clinical trials of chronic pain treatments. Pain Rep 2019;4:e646.
24. Zong Z. Should post-trial provision of beneficial experimental interventions be mandatory in developing countries? J Med Ethics 2008;34:188-92.
25. Owonikoko TK. Upholding the principles of autonomy, beneficence, and justice in phase I clinical trials. Oncologist 2013;18:242-4.
26. Dal-Ré R, Katsanis N, Katsanis S, Parker LS, Ayuso. Managing incidental genomic findings in clinical trials: fulfillment of the principle of justice. PLoS Med 2014;11:e1001584.
27. Nepi L. Ethical Issues Concerning the Informed Consent Process in Paediatric Clinical Trials: European Guidelines and Recommendations on Minor's Assent and Parental Permission. BioLaw Journal-Rivista di BioDiritto 2019:53-63.
28. Skierka AS, Michels KB. Ethical principles and placebo-controlled trials - Interpretation and implementation of the Declaration of Helsinki's placebo paragraph in medical research. BMC Med Ethics 2018;19:24.
| Files | ||
| Issue | Vol 60 No 10 (2022) | |
| Section | Review Article(s) | |
| DOI | https://doi.org/10.18502/acta.v60i10.11550 | |
| Keywords | ||
| Interventional studies Ethical considerations Clinical trials Biological principles | ||
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Hosseini A, Jackson A, Bahramnezhad F. Ethical Considerations in Interventional Studies: A Systematic Review Ethics and Interventional Study. Acta Med Iran. 2022;60(10):609-614.
