Megan S. Wright

Guardianship and End-of-Life Decision Making

As the population ages, more adults will develop impaired decision-making capacity and have no family members or friends available to make medical decisions on their behalf. In such situations, a professional guardian is often appointed by the court. This official has no preexisting relationship with the impaired individual but is paid to serve as a surrogate decision maker. When a professional guardian is faced with decisions concerning life-sustaining treatment, substituted judgment may be impossible, and reports have repeatedly suggested that guardians are reluctant to make the decision to limit care. Physicians are well positioned to assist guardians with these decisions and safeguard the rights of the vulnerable persons they represent. Doing so effectively requires knowledge of the laws governing end-of-life decisions by guardians. However, physicians are often uncertain about whether guardians are empowered to withhold treatment and when their decisions require judicial review. To address this issue, we analyzed state guardianship statutes and reviewed recent legal cases to characterize the authority of a guardian over choices about end-of-life treatment. We found that most state guardianship statutes have no language about end-of-life decisions. We identified 5 legal cases during the past decade that addressed a guardians authority over these decisions, and only 1 case provided a broad framework applicable to clinical practice. Work to improve end-of-life decision making by guardians may benefit from a multidisciplinary effort to develop comprehensive standards to guide clinicians and guardians when treatment decisions need to be made.

Whither the “improvement standard”? Coverage for severe brain injury after Jimmo v. Sebelius

As improvements in neuroscience have enabled a better understanding of disorders of consciousness as well as methods to treat them, a hurdle that has become all too prevalent is the denial of coverage for treatment and rehabilitation services. In 2011, a settlement emerged from a Vermont District Court case, Jimmo v. Sebelius, which was brought to stop the use of an “improvement standard” that required tangible progress over an identifiable period of time for Medicare coverage of services. While the use of this standard can have deleterious effects on those with many chronic conditions, it is especially burdensome for those in the minimally conscious state (MCS), where improvements are unpredictable and often not manifested through repeatable overt behaviors. Though the focus of this paper is on the challenges of brain injury and the minimally conscious state, which an estimated 100,000 to 200,000 individuals suffer from in the United States, the post-Jimmo arguments presented can and should have a broad impact as envisioned by the plaintiffs who brought the case on behalf of multiple advocacy groups representing patients with a range of chronic care conditions.

Disorders of Consciousness, Agency, and Health Care Decision Making: Lessons From a Developmental Model

The health care decision-making framework applied to adolescents, a process that gives minors an increasing role in decision making as they mature, should be applied to patients recovering from disorders of consciousness. The flexibility afforded by this framework allows for participation to change over time in accordance with the patients evolution during the recovery process, unlike the rigid surrogate-focused model utilized for those with permanent incapacity. While the legal system may regard patients with disorders of consciousness and subsequent disability as incompetent to make decisions, respect for personhood and self-determination requires that the physician and surrogate involve the recovering patient in decision making to the maximal extent possible.

Heterogeneity in IRB policies with regard to disclosures about payment for participation in recruitment materials.

Although the Federal Common Rule requires that informed consent documents include all material information, it does not specify the content of materials used to recruit human subjects. In particular, there is no federal regulation relating to how payment for research participation is to be advertised. Rather, the FDA has issued guidance, advising researchers not to emphasize payment information. In order to determine how IRBs have interpreted this guidance, we coded the policies of the top 100 institutions by receipt of NIH funding, in order to determine whether they require, permit, or forbid researchers to disclose the amount of compensation in their recruitment materials. We found that the vast majority of institutions implicitly or explicitly permit such disclosures; however, there are a significant number of IRBs at each extreme, some discouraging or forbidding with others encouraging or mandating such disclosures. Such heterogeneity in local regulations suggests that IRB discretion may be imposing costs on human subjects and the scientific enterprise that outweigh the benefits. We suggest that this heterogeneity should be resolved towards a national consensus on permissibility.

Rights language and disorders of consciousness: a call for advocacy

ABSTRACT Drawing upon sources in neuroethics, civil rights, and disability rights law, we argue for the reintegration of people with severe brain injury back into the nexus of their families and communities consistent with the Americans with Disabilities Act (ADA) and the UN Convention on the Rights of Persons with Disabilities, both of which call for the maximal integration of people with disability into society. To this end, we offer a rights-based argument to address the care of people with severe brain injury. Instead of viewing the provision of rehabilitation as a reimbursement issue, which it surely is, we argue that it can be productively understood as a question of civil rights for a population generally segregated from the medical mainstream and from society itself. Their segregation in the chronic care sector constitutes disrespect for persons, made all the more consequential because recent advances in brain injury rehabilitation make reintegration into civil society an aspirational, if not achievable goal.

Guardianship and Clinical Research Participation: The Case of Wards with Disorders of Consciousness

ABSTRACT:We review relevant federal law about research on human subjects and state laws on guardian authority to determine whether guardians can consent on behalf of their wards to participation in research. The Common Rule is silent on the issue as are most state guardianship laws. Our analysis shows significant variation in guardians’ decision-making authority in the states that do regulate wards’ participation in research.We consider how the appointment of guardians for patients with disorders of consciousness (DOC) impacts such patients’ access to research. We assert that it is important that such persons be permitted to participate in research, so that their conditions and potential medical interventions can be studied, and that those with similar conditions can benefit from the knowledge gained from these studies. We argue that state guardianship laws should be adapted to specifically give guardians the authority to consent to research on behalf of wards who may be able to regain decisional capacity.