Informed Consent Is the Essence of Capacity Assessment

Spike, Jeffrey P

doi:10.1177/1073110517703103

Cited by 15 publications

(6 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Some authors have rightly risen a problem of the capacity of vulnerable patients for making rational, informed decisions regarding treatment with IDs [ 44 ]. However, to resolve this concern, different methods can be employed in order to assess a patient’s capacity to appreciate his/her situation including potential consequences and to make rational choices [ 45 ]. Those methods seem to be particularly important in terminally-ill patients, a substantial percentage of whom may have their decision-making capacity impaired [ 46 ].…”

Section: Main Textmentioning

confidence: 99%

Ethics framework for treatment use of investigational drugs

Borysowski

Górski

2020

BMC Med Ethics

View full text Add to dashboard Cite

Background Expanded access is the use of investigational drugs (IDs) outside of clinical trials. Generally it is performed in patients with serious and life-threatening diseases who cannot be treated satisfactorily with authorized drugs. Legal regulations of expanded access to IDs have been introduced among others in the USA, the European Union (EU), Canada and Australia. In addition, in the USA an alternative to expanded access is treatment under the Right-to-Try law. However, the treatment use of IDs is inherently associated with a number of ethically relevant problems. Main text The objective of this article is to present a coherent framework made up of eight requirements which have to be met for any treatment use of an ID to be ethical. These include a justified need for the use of an ID, no threat to clinical development of the ID, adequate scientific evidence to support the treatment, patient’s benefit as the primary goal of the use of an ID, informed decision of a patient, fair access of patients to IDs, independent review, as well as the dissemination of treatment results. Conclusions While this framework is essentially consistent with the legal regulations of expanded access of the USA, the EU, Canada and Australia, it is substantially wider in scope because it addresses some important issues that are not covered by the regulations. Overall, the framework that we developed minimizes the risks and threats, and maximizes potential benefits to each of the four key stakeholders involved in the treatment use of IDs including patients, doctors, drug manufacturers, and society at large.

show abstract

Section: Main Textmentioning

confidence: 99%

Ethics framework for treatment use of investigational drugs

Borysowski

Górski

2020

BMC Med Ethics

View full text Add to dashboard Cite

show abstract

“…Capacity is considered a threshold element of informed consent. 21 Children presumptively lack capacity. Patients with neurologic or psychiatric conditions that impact their cognitive function may also lack capacity for decision making.…”

Section: From Informed Consent To Minor's Assentmentioning

confidence: 99%

“…This requires that patients be able to understand and appreciate their diagnosis and options, make a decision, and understand the consequences of their decision. 21,22 While both age and neurologic conditions might impair these abilities, they do not necessarily do so. Therefore, it is important, when determining whether a child is capable of providing assent, to consider whether the child can functionally meet the requirements for assent.…”

Section: From Informed Consent To Minor's Assentmentioning

confidence: 99%

Involving Minors in Medical Decision Making: Understanding Ethical Issues in Assent and Refusal of Care by Minors

Lang

Paquette

2018

Semin Neurol

View full text Add to dashboard Cite

When caring for minors, the clinician–patient relationship becomes more ethically complex by the inclusion of parents in the clinician–parent–patient triad. As they age, children become more capable of participating in the decision-making process. This involvement may lead them to either accept or refuse proposed care, both of which are ethically acceptable positions when the minor's capacity to participate in decision making is carefully considered in the context of their age, development, and overall health. Certain conditions may be more likely to impact their capacity for participation, but it is important for clinicians to avoid categorical presumption that minors of a certain age or with certain conditions are incapable of participating in decisions regarding their care. Understanding the ethical bases for decision making in pediatric patients and considerations for the involvement of minors who both assent to and refuse proposed treatment will equip clinicians to respect the growing autonomy of minor patients.

show abstract

“…The existing studies focus on legal and clinical assessments to arrive at an objective truth and meaning of the concepts of capacity and the ability to make decisions (Gerstenecker et al, 2016;Palmer and Harmell, 2016). Very few studies to date have discussed other factors like values, judgments, and emotions (Hermann et al, 2015;Spike, 2017).…”

Section: Introductionmentioning

confidence: 99%

The construction of incompetency: moving beyond embedded paternalism toward the practice of respect

Subramani¹

2018

Preprint

View full text Add to dashboard Cite

This paper illustrates the less-acknowledged social construction of the concept of “incompetency” and draws attention to the moral concerns it raises in healthcare encounters in the south Indian city of Chennai. Based on in-depth interviews with 16 surgeons, drawn from qualitative research, this study reveals that surgeons subjectively construct the idea of incompetency through their understanding of the perceived circumstantial characteristics of the patients and family members. The findings largely suggest that surgeons dismiss their capacity based on constructed assessments, which leads to paternalistic practice. The findings illustrate how these assessments structure the surgeons’ practices and provide the moral and practical justifications for their actions. The constructed knowledge becomes a source for drawing normative justification for surgeons’ actions and, in conjunction with socially enforced relationships, leads patients and family members to be on the receiving end of disrespectful attitudes. By employing the ethical framework, this paper argues for physicians to pursue “respect for persons,” beyond the framework of “capacity/autonomy,” and to practice respect in hospital settings.

show abstract

Informed Consent Is the Essence of Capacity Assessment

Cited by 15 publications

References 15 publications

Ethics framework for treatment use of investigational drugs

Ethics framework for treatment use of investigational drugs

Involving Minors in Medical Decision Making: Understanding Ethical Issues in Assent and Refusal of Care by Minors

The construction of incompetency: moving beyond embedded paternalism toward the practice of respect

Contact Info

Product

Resources

About