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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform (Papers: Nola M. Ries, et al | 2017)0

Posted by Admin in on January 24, 2019
 

Abstract
Research is crucial to advancing knowledge about dementia, yet the burden of the disease currently outpaces research activity. Research often excludes people with dementia and other cognitive impairments because researchers and ethics committees are concerned about issues related to capacity, consent, and substitute decision-making. In Australia, participation in research by people with cognitive impairment is governed by a national ethics statement and a patchwork of state and territorial laws that have widely varying rules. We contend that this legislative variation precludes a consistent approach to research governance and participation and hinders research that seeks to include people with impaired capacity. In this paper, we present key ethical principles, provide a comprehensive review of applicable legal rules in Australian states and territories, and highlight significant differences and ambiguities. Our analysis includes recommendations for reform to improve clarity and consistency in the law and reduce barriers that may exclude persons with dementia from participating in ethically approved research. Our recommendations seek to advance the national decisionmaking principles recommended by the Australian Law Reform Commission, which emphasize the rights of all adults to make their own decisions and for those with impaired capacity to have access to appropriate supports to help them make decisions that affect their lives.

Keywords
Research ethics, Law. Dementia, Consent, Substitute decision-making, Advance directives

Ries, N. M., Thompson KA., & Lowe M. (2017) Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform. Journal of Bioethical Inquiry 14(3): 359-374.
https://link.springer.com/article/10.1007%2Fs11673-017-9794-9

Vulnerability in research subjects: a bioethical taxonomy (Kenneth Kipnis | 2001)0

Posted by Admin in on November 30, 2018
 

The concept of vulnerability appears to have been grandfathered into the lexicon, lore, and literature of research ethics without undergoing stringent certification. And yet the need for some such notion has long been appreciated. More than 50 years ago, reflecting on the ethical implications of the Nazi medical experiments, the authors of the Nuremberg Code emphasized the necessity of the subject’s informed consent, too hastily ruling out, as it quickly became apparent, medical research on children and those with cognitive impairments.

In the United States, widely studied episodes such as Willowbrook,1 the Brooklyn Jewish Chronic Disease Hospital Case,2 and the Tuskegee Syphilis Study3 provoked debates that eventually gave birth to our current methods for ensuring the ethical conduct of research. But despite the remarkable circumstances of the subjects involved in those studies—institutionalized children, hospitalized elderly, and impoverished and poorly educated black Alabama males—it is not much of an exaggeration to say that in the minds of many investigators the paradigmatic research subject remains more or less a mature, respectable, moderately well-educated, clearthinking, literate, self-supporting U.S. citizen in good standing—that is, a man who could understand a 12- page consent form and act intelligently on the basis of its contents. While I shall assume in what follows both that the existing guidelines are sufficient to deal ethically with the paradigmatic research subject, and, further, that all those standard protections are reliably in place, the vulnerable research subject nonetheless requires ethical consideration going beyond that baseline.

More recently, in the wake of the Nuremberg Code’s shortcomings, systematic attention has been accorded to a motley collection of vulnerable subpopulations. In 1979, for example, the seminal Belmont Report4 briefly considered children, the institutionalized mentally ill, and prisoners, mentioning dependency and compromised capacity for consent as representative hallmarks of vulnerability. There was no effort to be comprehensive. The more recent Federal Regulations on the Protection of Human Subjects (45 CFR 46) implement the requirement that Institutional Review Boards (IRBs) take into account the “special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons” (46–111). Criteria for vulnerability are not discussed although subparts are included with supplementary regulations for some of these groups. Finally, the Final Report of the Advisory Committee on Human Radiation Experiments,5 after reviewing patterns of unethical misconduct in military research, recommended special protections for enlistees.

Read the rest of this commissioned  paper

Kipnis K. (2001) Vulnerability in research subjects: a bioethical taxonomy. In: National Bioethics Advisory Commission, editor. Ethical and policy issues in research involving human participants. Bethesda: National Bioethics Advisory Commission. pp. G1–G13. http://www.aapcho.org/wp/wp-content/uploads/2012/02/Kipnis-VulnerabilityinResearchSubjects.pdf

Respect for Human Vulnerability: The Emergence of a New Principle in Bioethics (Papers: Henk ten Have | 2015)0

Posted by Admin in on November 30, 2018
 

Abstract
Vulnerability has become a popular though controversial topic in bioethics, notably since 2000. As a result, a common body of knowledge has emerged (1) distinguishing between different types of vulnerability, (2) criticizing the categorization of populations as vulnerable, and (3) questioning the practical implications. It is argued that two perspectives on vulnerability, i.e., the philosophical and political, pose challenges to contemporary bioethics discourse: they re-examine the significance of human agency, the primacy of the individual person, and the negativity of vulnerability. As a phenomenon of globalization, vulnerability can only be properly addressed in a global bioethics that takes the social dimension of human existence seriously.

Keywords
Global bioethics, Globalization, Vulnerability, Research ethics, Philosophy of medicine

ten Have, H. Respect for Human Vulnerability: The Emergence of a New Principle in Bioethics. Bioethical Inquiry (2015) 12: 395. https://doi.org/10.1007/s11673-015-9641-9
Publisher: https://link.springer.com/article/10.1007/s11673-015-9641-9

Vulnerability: new essays in ethics and feminist philosophy (Books: Catriona Mackenzie (Editor), et al | 2014)0

Posted by Admin in on November 30, 2018
 

The aim of this volume is to open up reflection on the nature of vulnerability, the responsibilities owed to the vulnerable, who bears these responsibilities, and how they are best fulfilled. In canvassing responses to these questions, the contributors engage with a range of ethical traditions and with issues in contemporary political philosophy and bioethics. Some essays in the volume explore the connections between vulnerability, autonomy, dignity, and justice. Other essays engage with a feminist ethics of care to articulate the relationship between vulnerability, dependence, and care. These theoretical approaches are complemented by detailed examination of vulnerability in specific contexts, including disability; responsibilities to children; intergenerational justice; and care of the elderly. The essays thus address fundamental questions concerning our moral duties to each other as individuals and as citizens. Contributing significantly to the development of an ethics of vulnerability, this volume opens up promising avenues for future research in feminist philosophy, moral and political philosophy, and bioethics.

Keywords:
Vulnerability, ethics, moral theory, bioethics, feminist philosophy, autonomy, dependence, justice, ethics of care, children

Mackenzie, C., Rogers, W. & Dodds, S.. (2014). Vulnerability: New Essays in Ethics and Feminist Philosophy, OUP USA.
Amazon: https://www.amazon.com/Vulnerability-Essays-Feminist-Philosophy-Studies/dp/0199316651
Google Books: https://books.google.com.au/books/about/Vulnerability.html?id=6W9MAQAAQBAJ&redir_esc=y
Publisher: https://global.oup.com/academic/product/vulnerability-9780199316649?cc=au&lang=en&

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