Drug Trials in Dementia: Challenging Ethical Dilemmas

Korczyn, Amos D.

doi:10.2174/156720507781788909

Cited by 3 publications

(1 citation statement)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Participants will need more intense monitoring compared to cognitively intact individuals. 17 There is concern about the robustness of the informed consent process for clinical trials for dementia conducted in LMICs with a population with limited baseline educational attainment. In some situations, it may be necessary that an independent clinician may undertake capacity assessments and informed consent to get involved in research instead of those research staff involved in the study.…”

Section: Clinical Trialsmentioning

confidence: 99%

Ethical Issues in Dementia Research

Chandra

Harbishettar²,

Sawhney

et al. 2021

Indian Journal of Psychological Medicine

View full text Add to dashboard Cite

Dementia is a global public health issue with an urgent need for developing newer and more effective treatment strategies. Research in the area of dementia, however, poses unique ethical and legal challenges. Epidemiological studies, studies on pharmacological and non-pharmacological interventions have to deal with obtaining consent from persons with cognitive impairments, those from diverse cultural groups and need to contend with privacy and confidentiality issues. The caregiver support intervention research has not yet translated into policy change and effective clinical care. Biomedical research that involves invasive procedures may not translate into short- or long-term therapeutic benefits but is necessary research. Palliative care research in dementia has to deal with ethical issues involving people at end-of-life research. Proposed research may not receive approval, citing necessary safeguards to the vulnerable older people against invasive studies even when it is least invasive. This article aims to review the ethical aspects for safeguarding vulnerable older people with dementia and the potential challenges in conducting dementia research from a researcher’s perspective. Some of the safeguards for ethical research include determining capacity to consent, obtaining advanced directives in early stages and proxy consent from caregivers, obtaining informed consent in cognitively impaired individuals. Future research policies need to consider the logistics of involving older people in research, enhancing caregiver support, and encouraging supportive decision-making. It will also need to address developing capacity assessment tools while addressing advanced care planning that will ensure the well-being of subjects in research. Background: Dementia has become a global public health issue, with hospitalization rates being 65% higher in seniors with dementia than others. 1 , 2 The pressures on healthcare systems mean an urgent need to develop robust preventive and treatment strategies for dementia, which requires multidisciplinary research. However, the patient’s stage of illness and ability to engage in discussions around the merits of participating in research and caregiver concerns is an important aspect of dementia research. Hence, dementia research poses unique ethical challenges compared to populations with other diseases, which has led to the evolution of an ethical framework for dementia research. This article aims to review and give a viewpoint on the ethical aspects for safeguarding vulnerable older people with dementia and the potential challenges in conducting dementia research from a researcher’s perspective.

show abstract

Section: Clinical Trialsmentioning

confidence: 99%

Ethical Issues in Dementia Research

Chandra

Harbishettar²,

Sawhney

et al. 2021

Indian Journal of Psychological Medicine

View full text Add to dashboard Cite

show abstract

Gesellschaftlicher Kontext

Helmchen¹

2013

Ethik Psychiatrischer Forschung

View full text Add to dashboard Cite

Ethische Erwägungen in der klinischen Forschung mit psychisch Kranken

Helmchen

2008

Nervenarzt

View full text Add to dashboard Cite

The review deals with present problems of protecting mentally ill patients who are incompetent to give informed consent to participating in clinical research, and of assessment of the capacity to consent. 1. Clinical trials of drugs on efficacy and safety in incompetent patients are ethically justified and legally admissible if the investigational drug can be expected to exert a direct potential individual benefit and if such trials will be performed under defined criteria to protect these vulnerable patients. In Germany it is questionable how far these prescriptions of the German Drug Law (AMG) are transferable to other than drug research. 2. Research with no direct potential individual benefit or only a group-specific benefit in incompetent patients is controversially discussed. However, it may be ethically justified as an exception, and is in Germany legally admissible only in minors, but not in adults. 3. However, internationally there exists a wide range of legal regulations, terms, interpretations, and practices of research with vulnerable persons. In the past years a shift seems to have developed from normatively oriented discussions to more empirically based investigations. Especially vague but clinically relevant terms in protection declarations or guidelines have been better specified, put in concrete form by anchor examples, and empirically studied. 4. In general the criteria of protecting the dignity and, even if impaired, the autonomy of incompetent patients as subjects for research appear to guarantee a high standard of protection. However, the application of these criteria must be improved by practicable procedures. This is valid particularly for the assessment of the basic criterion whether a patient is capable of consenting or not. 5. Open Questions are formulated as need of research.

show abstract

Drug Trials in Dementia: Challenging Ethical Dilemmas

Cited by 3 publications

References 15 publications

Ethical Issues in Dementia Research

Ethical Issues in Dementia Research

Gesellschaftlicher Kontext

Ethische Erwägungen in der klinischen Forschung mit psychisch Kranken

Contact Info

Product

Resources

About