Informed Consent for the Human Research Subject with a Neurologic Disorder.

The doctrine of informed consent sits at the intersection of law, ethics, and neuroscience, posing unique challenges for human subject research involving neurological patients. These challenges are compounded by the variegated nature of both neurological injury and the law governing research consent. This article provides a framework for investigators likely to encounter subjects with some degree of neurological impairment, whose capacity to consent requires scrupulous assessment prior to enrollment in research trials. We consider several researches and disease contexts-from emergency epilepsy research to long-term dementia research-and clarify the ethical and legal principles governing consent for participation in each. We additionally explore empirical research on consent capacity and survey several areas of emerging ethical import that will require the attention of investigators in decades to come

Elder Law and Conflicts of Interest in the United States and Canada

This article considers the problem of conflicts of interest in elder law in the context of a larger discussion about elder law as a bounded legal subject. The problem of conflicts of interest is not particular to elder law. Conflicts, intentional and unintentional, have a special salience in this context, however. That salience is intensified by the expanded scope of elder law to include other classes of vulnerable clients, such as persons with disabilities. Despite the significance of conflicts as a real, perceived, or potential issue in this context, the issue has received relatively scant attention and discussion. This inattention to conflicts has distorted perceptions of elder law within the wider legal community, with unfortunate consequences for the development of elder law as a discrete field of practice and research. This article considers the issue of conflicts in the elder law discourse from both an American and Canadian perspective. Core practice areas for American elder law (areas not readily transportable to non-American jurisdictions) are areas in which the conflicts issue is especially prominent. From an international perspective, a perception may be created of elder law as a peculiarly American practice area, and one which is rife with real and potential conflicts that elder law practitioners-and those who would export the model-may prefer to ignore. This dynamic has frustrated the development of elder law as an international, multi-faceted, and interdisciplinary area of law. Confronting the issue of conflicts in elder law is an important first step in continuing the coherent development of elder law (perhaps within a rubric of law, policy and aging) as a bounded legal subject

Respecting the Right to Research: Proxy Consent and Subject Assent in Alzheimer\u27s Disease Clinical Trials

Alzheimer’s Disease is the sixth-leading cause of death in the United States and the only disease in the top ten causes of death with no prevention, treatment, or cure. To find any meaningful treatment or cure, researchers must conduct clinical trials on subjects with Alzheimer’s Disease. Subjects with Alzheimer’s Disease, however, generally lack legal capacity to consent to research due to diminished cognition. While informed consent standards for individuals who lack capacity are well settled in the medical treatment context, such standards are much less clear in the research context. A patchwork of legal and regulatory guidance addresses this issue, but no uniform framework exists. In January 2017, the federal government responded to the problem of unclear proxy consent standards by updating the Common Rule, which regulates human subjects research. Attempting to clarify prior vagueness, the regulation extended existing laws and policies on proxy consent in clinical treatment to the research context. While this was a welcome change, state laws and institutional policies remain inconsistent. Therefore, states should affirmatively enact legislation to ensure inclusion for all participants in medical research. Practically, this may be as simple as amending existing health care surrogate decisionmaking statutes—allowing proxy consent and substituted judgment in the research context explicitly. Additionally, federal regulators, Institutional Review Boards, and researchers should consider establishing an assent and dissent standard for research subjects who lack capacity, specifically in Alzheimer’s Disease clinical trials

Ageism In America

Ageism, the denial of basic human rights of older persons, is one of the most pervasive prejudices across human society. Although ageism is less acknowledged than racism or sexism, it is a harmful prejudice that negatively affects older Americans, who experience widespread mistreatment, ranging from stereotypic and degrading media images to physical and financial abuse, unequal treatment in the workforce, and denial of appropriate medical care and services

Living in the Gray: Why Today\u27s Supported Decision-Making-Type Models Eliminate Binary Solutions to Court-Ordered Guardianships

A guardianship or nothing. One option completely strips a person of his or her rights; the other option provides no protection. Both are extreme options; both are the only legal options in a majority of United States jurisdictions. Only providing legal recognition for two options aggravates the problem of granting unnecessary or overly broad guardianships for people with disabilities. Inappropriately granted guardianships consequently leads to violations of the Americans with Disabilities Act, individuals’ constitutional rights, and individuals’ human rights. However, viable intermediate options now exist that can be implemented in lieu of the two extreme options. Alternatives to guardianships simultaneously provide support for the individual, while maintaining as many rights as possible. One such example of a viable alternative is Supported Decision-Making (SDM). The first step the United States could take towards promoting an autonomy-focused system is ratifying the Convention on the Rights of Persons with Disabilities, which the United States signed in 2009 but has yet to ratify. Ratifying this document would require states to legally recognizes SDM-type models. In addition to providing legal recognition for guardianship alternatives, state legal systems should alter mental capacity determination framework to further avoid rights-capturing legal systems. But, should there be push back to ratifying the CRPD and providing legal recognition for alternatives, there is a more attainable solution: require school systems to provide students and families with information about every available support option. School systems have a unique role in an individual’s pathway to autonomy because the school is present during the student’s “transition” years. School systems can stop the problem before it even occurs. Support needs are not one-size-fits-all models, and states must work towards filling in the gap between granting a guardianship or nothing at all. Individuals should not be completely stripped of their rights simply because they have been categorically deemed “incapacitated.