Integrating Advance Research Directives into the European Legal Framework

Andorno, Roberto; Gennet, Éloïse; Jongsma, Karin; Elger, Bernice Simone

doi:10.1163/15718093-12341380

Cited by 19 publications

(15 citation statements)

References 11 publications

(6 reference statements)

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“…The topic has been discussed both in US, where the National bioethics advisory committee recommended official recognition of such directives [ 36 ], and in Europe, where organizations promoting care for patients suffering from dementia [ 37 ] have supported the use of advance directives for research, provided that a number of safeguards are in place. Although, at least in the European regulations governing biomedical research, the legal status of advance directives for research is unclear [ 38 ], I regard as indisputable the moral value (that does not differ from the moral value of advance directives for medical treatment) and practical utility of this tool. The practical utility of advance directives for research is even higher than for medical treatment as the balance between benefit (if any) and risk is more difficult to estimate and is therefore harder for medical doctors and family members to take decision on behalf of the patient without a clear indication of preference.…”

Section: Main Textmentioning

confidence: 99%

Advance directives as a tool to respect patients’ values and preferences: discussion on the case of Alzheimer’s disease

Porteri

2018

BMC Med Ethics

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BackgroundThe proposal of the new criteria for the diagnosis of Alzheimer’s disease (AD) based on biomarker data is making possible a diagnosis of AD at the mild cognitive impairment (MCI) or predementia/prodromal– stage. Given the present lack of effective treatments for AD, the opportunity for the individuals to personally take relevant decisions and plan for their future before and if cognitive deterioration occurs is one the main advantages of an early diagnosis.Main bodyAdvance directives are largely seen as an effective tool for planning medical care in the event the subject becomes incompetent. Nevertheless, their value has been questioned with regard to people with dementia by scholars who refer to the arguments of personal identity and of patient’s changing interests before and after the onset of dementia.In this paper, I discuss the value of advance directives in Alzheimer’s disease and other kind of dementia. Despite critics, I argue that advance directives are especially advisable in dementia and provide reasons in favor of their promotion at an early stage of the disease as a valuable tool to respect patients’ values and preferences on medical treatment, including participation in research and end of life decisions. I mainly support advance directives that include both decisions regarding health care and the appointment of an attorney in fact.ConclusionI conclude that patients with AD at a prodromal or early stage should be offered the opportunity to execute an advance directive, and that not to honor a demented individual’s directive would be an unacceptable form of discrimination towards those patients.

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Section: Main Textmentioning

confidence: 99%

Advance directives as a tool to respect patients’ values and preferences: discussion on the case of Alzheimer’s disease

Porteri

2018

BMC Med Ethics

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“…Advance research directives might provide a potential way to overcome these criticisms. However, although the topic of ARD has been frequently discussed since the end of the previous century, clear legal regulations are still lacking in most European countries as well as in the United States ( 14 – 16 ). In the next subsections, we summarize what is known in the ARD literature till today.…”

Section: Introductionmentioning

confidence: 99%

Practical and Ethical Aspects of Advance Research Directives for Research on Healthy Aging: German and Israeli Professionals’ Perspectives

Werner

Schicktanz

2018

Front. Med.

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BackgroundHealthy aging is the development and maintenance of optimal cognitive, social and physical well-being, and function in older adults. Preventing or minimizing disease is one of the main ways of achieving healthy aging. Dementia is one of the most prevalent and life-changing diseases of old age. Thus, dementia prevention research is defined as one of the main priorities worldwide. However, conducting research with persons who lack the capacity to give consent is a major ethical issue.ObjectiveOur study attempts to explore if and how advance research directives (ARDs) may be used as a future tool to deal with the ethical and practical issues in dementia research.MethodWe conducted focus groups and in-depth interviews with German and Israeli professional stakeholders from the fields of gerontology, ethics, medical law, psychiatry, neurology and policy advice (n = 16), and analyzed the main topics discussed regarding cross-national similarities and controversies within the groups, as well as across the two national contexts.ResultsWhile both countries are in the midst of a developmental process and have recognized the importance and need for ARD as a tool for expanding healthy aging, Germany is in a more advanced stage than Israel because of the EU regulation process, which indicates the influence of international harmonization on these research-related ethical issues. Consensual themes within the qualitative material were identified: the need for a broader debate on ARD, the ethical importance of autonomy and risk–benefit assessment for ARD implementation, the role of the proxy and the need for the differentiation of types of dementia research. Controversies and dilemmas aroused around themes such as the current role of IRBs in each country, the need for limits, and how to guaranty safeguarding and control.DiscussionImplementing a new tool is a step-by-step procedure requiring a thorough understanding of the current state of knowledge as well as of the challenges and hurdles ahead. As long as improving quality of life and promoting autonomy continue to be core elements in the process of healthy aging, efforts to advance knowledge and solve dilemmas associated with the implementation of ARD is of the utmost importance.

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“…Potential alternatives to having a POA-R include Advance Research Decisions or Directives (ARDs) that allow the person to prospectively consent to future research in specified situations should they lose capacity (Pierce, 2010). The legal situation regarding the permissibility of ARDs varies widely across the world, (Andorno, Gennet, Elger, & Jongsma, 2016;Lötjönen, 2006;Ries, Thompson, & Lowe, 2017) despite antecedent consent being a highly contested area (Buller, 2015). It is unlikely that determinative ARDs could offer a stand-alone solution without the additional appointment of a proxy to implement the advance directives in the light of the complete information at the time the research is conducted (Andorno et al, 2016).…”

Section: Discussionmentioning

confidence: 99%

“…The legal situation regarding the permissibility of ARDs varies widely across the world, (Andorno, Gennet, Elger, & Jongsma, 2016;Lötjönen, 2006;Ries, Thompson, & Lowe, 2017) despite antecedent consent being a highly contested area (Buller, 2015). It is unlikely that determinative ARDs could offer a stand-alone solution without the additional appointment of a proxy to implement the advance directives in the light of the complete information at the time the research is conducted (Andorno et al, 2016). A dual elt a d ra es approa h of a POA-R accompanied by an ARD has been supported in other jurisdictions, as it may increase the likelihood of gaining deeper u dersta di gs of pote tial parti ipa ts alues and priorities and how they might apply to foreseeable research opportunities (Heesters et al, 2016…”

Section: Discussionmentioning

confidence: 99%

‘There’s more to life than money and health’: Family caregivers’ views on the role of Power of Attorney in proxy decisions about research participation for people living with dementia

et al. 2019

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People living with dementia may experience difficulties when making decisions for themselves in the later stages of the condition. Whilst there are mechanisms in England and Wales for appointing an attorney to make decisions about welfare and finances on their behalf, there are no provisions for appointing an attorney to make future decisions about research participation. This is despite a growing focus on Advanced Care Planning and other processes that provide opportunities to discuss future preferences and ensure that decisions are made in line with those preferences. This qualitative study with 15 family caregivers who had acted as research proxies explored the role of Power of Attorney in their decisions about research, and their views about extending current legal arrangements to include research. Five themes were identified: the holistic nature of decision-making; the power of attorney; making decisions by putting yourself in their shoes; support for bringing research under the umbrella of attorney arrangements; and a unifying theme of trusting relationships. Legal provisions for prospectively appointing a research proxy may encourage discussion about future wishes and so e a le de isio s a out resear h to e ade that are i a orda e ith the perso s prefere es a d wishes. However, further consultation with the public including people living with dementia and their families, and a range of stakeholders is needed. Providing guidance to families, people living with dementia, and the wider research community may provide greater clarity and improve decisionmaking in the meantime.

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Integrating Advance Research Directives into the European Legal Framework

Cited by 19 publications

References 11 publications

Advance directives as a tool to respect patients’ values and preferences: discussion on the case of Alzheimer’s disease

Advance directives as a tool to respect patients’ values and preferences: discussion on the case of Alzheimer’s disease

Practical and Ethical Aspects of Advance Research Directives for Research on Healthy Aging: German and Israeli Professionals’ Perspectives

‘There’s more to life than money and health’: Family caregivers’ views on the role of Power of Attorney in proxy decisions about research participation for people living with dementia

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