China
Africa
Explore chapters and articles related to this topic
Ethical considerations
Published in Hung N. Winn, Frank A. Chervenak, Roberto Romero, Clinical Maternal-Fetal Medicine Online, 2021
Frank A. Chervenak, Laurence B. McCullough
Making a reasonable effort to prevent what is known as the therapeutic misconception is one of the major responsibilities of clinical investigators in the informed consent process. The therapeutic misconception occurs when potential subjects fail to appreciate that some aspects of what they will experience in a study are not justified by a clinical judgment of what is in the patient’s health-related interest but by scientific considerations. Subjects, instead, confuse these scientific study design issues with regular medical care (25). For example, pregnant women being asked to enroll in a randomized fetal research trial should understand that intervention will be randomly selected rather than individually tailored by their physician’s clinical judgment.
A case study in ‘gene enhancement’: gene transfer to raise the tolerance to pain – a legitimate mode of enhancement, or illegitimate doping?
Published in Silvia Camporesi, Mike McNamee, Bioethics, Genetics and Sport, 2018
Silvia Camporesi, Mike McNamee
Therapeutic misconception arises where subjects misinterpret the primary purpose of a clinical trial as therapeutic, and conflate the goals of research with the goals of clinical care. As shown in a study of consent documents of gene transfer clinical trials, 20 per cent of consent documents for gene transfer trials fail to explain their purpose as establishing safety and dosage, while only 41 per cent of oncology trials identify palliative care as an alternative to participation. Moreover, the term ‘gene therapy’ is used with twice the frequency of the term ‘gene transfer’ (Kimmelman and Levenstadt 2005). As defined by Kimmelman, the concept of translational distance ‘is intended to prompt researchers, review committees, and policy-makers to contemplate the size of the “inferential gap” separating completed preclinical studies and projected human trial results’ (Kimmelman 2010, 118) and should inform both the design of the studies (which need to incorporate endpoints that make it possible for the knowledge produced to have an impact in terms of further research) and the ethical approval of the trial.
Regenerative medicine
Published in Yann Joly, Bartha Maria Knoppers, Routledge Handbook of Medical Law and Ethics, 2014
A favourable risk: benefit ratio is an important ethical requirement in clinical research (Niemansburg et al. 2013: 65–7). For many RM products, performing a definitive risk-benefit analysis is difficult since the products are novel and complex. It is challenging to compare these interventions to existing standards of care, and patient responses will vary depending on factors such as disease stage. Combine this with the prevalence of therapeutic misconception – the false belief in the clinical benefit of an experimental procedure – and obtaining genuine informed consent from participants becomes a significant challenge (Trommelmans 2010: 25). Considerations must also be made for vulnerable populations, as discussed in Chapters 5–7. Because of their long lifespan post treatment and the use of proxy consent, there are different ethical implications for research on children, which changes the risks tolerated and the procedures considered suitable for child participation (Oerlemans et al. 2013: 44). Even more concerning is consent for the use of experimental cell therapies in clinical situations where basic scientific evidence has not been obtained, where standard research protocols are not followed, and where regulatory and safety guidelines are not met (Bianco et al. 2013). This is a trend seen in the growing medical tourism industry, a topic discussed in Chapter 24.
Artificial Placenta – Imminent Ethical Considerations for Research Trials and Clinical Translation
Published in The American Journal of Bioethics, 2023
E. J. (Joanne) Verweij, Elselijn Kingma
We also note the risk of therapeutic misconception: where research participants mistakenly believe that research interventions are made on the basis of their individual therapeutic needs, rather than for research purposes (Lidz et al. 2015; McDougall et al. 2016; Sheppard, M. K. 2016; Verweij et al. 2021). Therapeutic misconception is common in research already. In the first AAPT trials, where experimental treatment and clinical practice will be intertwined, it will be even more difficult to draw a clear line (Verweij et al. 2021). Furthermore pregnant persons in disturbing situations are always looking for hope, and mothers will, and are socially strongly encouraged to, do anything necessary for their child to survive. It will be almost impossible not to escalate hope in this situation, and therefore doubtful that mothers who choose to participate in an AAPT will do so in the (required) proper and full understanding that the aim of this research is the generation of future knowledge—not the rescuing of their child. (McDougall et al. 2016; Verweij et al. 2021).
“If it benefits someone, it will be good:” perspectives on research participation from pregnant women living with HIV
Published in AIDS Care, 2023
Catherine G. Raciti, Joy Marsha, Amira A. Nafiseh, Eric R. Masese, Edith Apondi, Megan S. McHenry
Many participants viewed research as synonymous with enhanced clinical care. These findings align with the therapeutic misconception recorded by studies in different settings (Georgetown, n.d.). Therapeutic misconception exists when participants believe their healthcare is equally important to producing generalizable knowledge for medical advancements (Henderson et al., 2007). Historically, researchers differentiated research from enhanced clinical care by taking participants through the informed consent process to understand their role, the study’s purpose, and the potential consequences of participating (Kadam, 2017). Therapeutic misconception should not exist given the definition of informed consent. Yet, our results show that the current consent process might not effectively distinguish the intended benefits of each.
Avoiding Therapeutic Misconception and Reassessing the Concept of Vulnerability
Published in AJOB Neuroscience, 2021
Aimi Nadia Mohd Yusof, Noraiza Abdul Rahman
Labeling patients as vulnerable has the potential to exclude them from research and limit the potential benefits that research might develop in future (de Melo-Martín 2006). It is important in dealing with vulnerable groups that investigators do not ignore them but establish ways to provide proper safeguards (Eckenwiler et al. 2008). In the context of the paper by Mergenthaler et al., patient-participants described are those that are having serious neurological illness that are medically vulnerable because of their “desperation in the absence of established treatment options” for them. They may pay less attention to the risks. Their vulnerability is also closely linked to how the informed consent is obtained. If therapeutic misconception could be avoided, perhaps their vulnerability could also be reduced. On this basis, if we could confirm that patient-participants truly understand the risks, benefits and nature of the research, we can be assured that their participation in research would not be problematic. One important point that needs careful consideration is their understanding that their participation in research does not equate to their personalized medical care. If patient-participants ability to provide consent is not compromised, this could reduce or remove their vulnerability making them not vulnerable in this context of discussion.