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Ethics
[edit]Forming a trusting relationship can be used as a method of increasing recruitment. Patients tend to trust their physician and are more inclined to consent to a study they recommend. However, it is not considered ethical to leverage trusting relationships due to the power gap between patients and physicians.[1] It is similarly unethical for a physician to pressure a patient into joining a clinical trial.[2]
When the research subject is unable to understand the difference between research and regular care, this is described as therapeutic misconception.[3] It is also therapeutic misconception if a research subject overestimates the benefits of a trial or underestimates risks due to a misunderstanding of the research process.[4][3] This brings up concerns about the validity of informed consent because therapeutic misconception hinders informed decision-making.[3]
Avoiding bias is important when recruiting patients to maintain an ethical trial. Statistically, vulnerable populations, including women and ethnic minorities, are not as likely to be recruited to clinical trials.[2] Patients who are part of ethnic minority groups often have reservations about joining trials because they fear discrimination, especially if there is a history of unethical experimentation involving their population.[2] Confusion can arise due to language barriers, so communication must be in a manner that will be clearly understood.[2][5]
Child Recruitment
[edit]Different ethical concerns must be taken into consideration when recruiting children for clinical trials. Children are described as legally incompetent and are therefore unable to provide credible informed consent. The informed consent of one legal guardian is required to recruit children for clinical trials.[5] In some cases, parents do not understand randomization, do not know they can withdraw their child from the study, do not know they can decline participation in a study, or want their physician to make the decision to participate.[6] These misunderstandings make it questionable whether parental consent was informed. If children are over the age of 7, it is required that the child assent (agree) to participate in the research in addition to parent approval.[6] When discussing research with a child, all aspects of the study must be communicated in a clear way that they can understand.[5] Any written consent must be placed at an age-appropriate reading level.[6]
Globalization
[edit]As clinical trials begin to spread to developing countries, ethical concerns emerge regarding the validity of the informed consent process.[7][8] When working with vulnerable populations, researchers must be sure to fully engage with potential patients and clearly explain the research to obtain valid informed consent.[8] It is a legal requirement in some countries to obtain assent from children before they can participate in a study but this may be inappropriate if children do not normally have autonomy in those countries.[8] There are ethical concerns about the power gap between patients and their physicians and how this could affect decision-making.[8] A benefit of the globalization of clinical trials is that the recruitment process can be faster in some countries, making research more timely.[8] Due to cultural differences, recruitment processes in one country may not be applicable in another and alterations should be made accordingly.[8]
- ^ Al, Pepijn; Hey, Spencer; Weijer, Charles; Gillies, Katie; McCleary, Nicola; Yee, Mei-Lin; Inglis, Juliette; Presseau, Justin; Brehaut, Jamie (2023-03-28). "Changing patient preferences toward better trial recruitment: an ethical analysis". Trials. 24 (1): 233. doi:10.1186/s13063-023-07258-4. ISSN 1745-6215. PMC 10044713. PMID 36973759.
{{cite journal}}: CS1 maint: PMC format (link) CS1 maint: unflagged free DOI (link) - ^ a b c d Natale, Patrizia; Saglimbene, Valeria; Ruospo, Marinella; Gonzalez, Andrea Matus; Strippoli, Giovanni FM; Scholes-Robertson, Nicole; Guha, Chandana; Craig, Jonathan C; Teixeira-Pinto, Armando; Snelling, Tom; Tong, Allison (2021-06). "Transparency, trust and minimizing burden to increase recruitment and retention in trials: a systematic review". Journal of Clinical Epidemiology. 134: 35–51. doi:10.1016/j.jclinepi.2021.01.014. ISSN 0895-4356.
{{cite journal}}: Check date values in:|date=(help) - ^ a b c Lidz, Charles W. (2006-07). "The therapeutic misconception and our models of competency and informed consent". Behavioral Sciences & the Law. 24 (4): 535–546. doi:10.1002/bsl.700. ISSN 0735-3936.
{{cite journal}}: Check date values in:|date=(help) - ^ Kimmelman, Jonathan (2007). "The Therapeutic Misconception at 25: Treatment, Research, and Confusion". Hastings Center Report. 37 (6): 36–42. ISSN 1552-146X.
- ^ a b c Manti, Sara; Licari, Amelia (2018-06-01). "How to obtain informed consent for research". Breathe. 14 (2): 145–152. doi:10.1183/20734735.001918. ISSN 1810-6838.
- ^ a b c Afshar, Kourosh; Lodha, Abhay; Costei, Adriana; Vaneyke, Nancy (2005-09). "RECRUITMENT IN PEDIATRIC CLINICAL TRIALS: AN ETHICAL PERSPECTIVE". Journal of Urology. 174 (3): 835–840. doi:10.1097/01.ju.0000169135.17634.bc. ISSN 0022-5347.
{{cite journal}}: Check date values in:|date=(help) - ^ Thiers, Fabio A.; Sinskey, Anthony J.; Berndt, Ernst R. (2008-01-01). "Trends in the globalization of clinical trials". Nature Reviews Drug Discovery. 7 (1): 13–14. doi:10.1038/nrd2441. ISSN 1474-1784.
- ^ a b c d e f Lang, Trudie; Siribaddana, Sisira (2012-06-12). "Clinical Trials Have Gone Global: Is This a Good Thing?". PLOS Medicine. 9 (6): e1001228. doi:10.1371/journal.pmed.1001228. ISSN 1549-1676. PMC 3373653. PMID 22719228.
{{cite journal}}: CS1 maint: PMC format (link) CS1 maint: unflagged free DOI (link)