A case study in ‘gene enhancement’: gene transfer to raise the tolerance to pain – a legitimate mode of enhancement, or illegitimate doping?
Silvia Camporesi, Mike McNamee in Bioethics, Genetics and Sport, 2018
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.
Mutual Benefit, Added Value?
Ann H. Kelly, P. Wenzel Geissler in The Value of Transnational Medical Research, 2013
Such policy language cuts across an assumption in ethical discourse that clinical work is distinct from experimental work because of their different aims. In this model one is understood to focus on ameliorating individual suffering, while the other seeks knowledge for the collective. This distinction has led to regulatory frameworks to protect the individual, who must be given information about the uncertainties involved in research before making an autonomous decision to participate. Procedures for seeking such ‘informed consent’ are intended to counter what became known as the therapeutic misconception – the belief among research participants that professionals are acting in their individual best interest (e.g. Lidz et al. 2004). Thus the current NHS application for review by a Research Ethics Committee requires that the chief investigator of any project should clarify the ‘risks and burdens’ attendant on trial participation, and set out how these will be shared with participants in consent forms and other documents. Applicants are advised that ‘Recruitment material should make few, if any, therapeutic promises, there should be no coercion or unacceptable inducement’ (IRAS 2009, p. 7).
Regenerative medicine
Yann Joly, Bartha Maria Knoppers in 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.
Avoiding Therapeutic Misconception and Reassessing the Concept of Vulnerability
Published in AJOB Neuroscience, 2021
Aimi Nadia Mohd Yusof, Noraiza Abdul Rahman
To ensure patient-participants do not misplace their trust on their clinicians who are at the same time also the investigators for research, a proper mechanism should be in place to make certain the consent process is adequate to allow patient-participants to properly understand the benefits and risks of the research and the difference between their medical or surgical treatment and their participation in research. It is important to note that therapeutic misconception affects patient-participants’ understanding of information and therefore affects the validity of informed consent. Hence, ensuring patient-participants receive adequate and proper information helps to verify that informed consent obtained from them is valid. It could be suggested that to avoid therapeutic misconception when dealing with clinician-investigators is to have someone independent of the research that could help evaluate the consent process (McCormick 2018). The independent person could be another expert in the field or a person who is educated in research ethics who would be able to critically provide feedback whenever information given by the clinician-investigators could compromise patient-participants’ understanding of their participation in research. This could lead to an enhanced process for obtaining informed consent that not only protects patient-participants but also ensures consent obtained from them is valid.
“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.
Getting into Their Heads: When the Investigator is also the Treating Physician
Published in AJOB Neuroscience, 2021
Stephanie R. Morain, Emily A. Largent, Anna Wexler
Second, concerns about therapeutic misconception seem likely to hold for both opportunistic and experimental trials. One might intuitively think that opportunity studies, which append research to care, carry a higher risk of therapeutic misconception. Yet, in recent empirical work examining the perspectives of twenty-two participants in an opportunity study, one of us (AW; paper under review) found no instances of therapeutic misconception. It remains to be seen what specifically drove this lack of therapeutic misconception—whether it was the nature of the study itself (i.e., opportunity vs. experimental) or some other factor. Nevertheless, these data suggest that the risks of therapeutic misconception might be overstated in the context of opportunity trials. At present, there is a lack of empirical evidence regarding therapeutic misconception in experimental trials. Therapeutic misconception might be mitigated through strategies other than prohibiting dual-role consent, for example, through the approach referenced by Mergenthaler et al. to differentiate informed consent processes for research procedures from processes used for clinically indicated treatments. This would be another path for future empirical research.
Related Knowledge Centers
- Clinical Trial
- Informed Consent
- Belmont Report
- Guidelines For Human Subject Research