Ethical and legal issues in research involving human subjects: do you want a piece of me?

The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy, and privacy. These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and confidentiality. A topic of particular interest for pathologists is the handling of human tissue specimens that may be used for present, or stored for future, research purposes. This article examines the ethical and legal ramifications of obtaining and storing tissue samples for research purposes, with special attention to the issues of informed consent and confidentiality.

"At least Mom will be safe there": the role of resident safety in nursing home quality.

When family members admit a loved one to a nursing home, they expect that the facility will assure the physical safety of the residents. However, this does not always occur. Safety concerns persisting in at least some modern American nursing homes involve adverse drug events, injurious falls, pressure ulcers, problems with tube feeding, faulty communications or other breakdowns during transfer to or from hospital, and equipment breakdowns or mix-ups. The adversarial legal, economic, political, and media environment surrounding the US nursing home industry poses serious practical impediments to alleviating these safety concerns more effectively. However, resident safety comprises only one part of the larger quality improvement picture in the nursing home context. While the threat of negative legal repercussions may be necessary to address safety issues, a fuller concern about improving the quality of care and quality of life for nursing home residents will also involve the development and implementation of a combination of positive incentives for facilities to do better.

Decisional capacity in theory and practice: legal process versus 'bumbling through'.

The reform of guardianship law and practice remains an active topic of interest for service providers, policy makers, and advocates involved with older persons. Guardianship is a legal device designed to protect persons who lack the cognitive and emotional capacity to make their own life decisions. However, for most 'grey zone' individuals and even for many who are rather clearly and severely mentally disabled, the capacity issue never gets formally raised and the legal process of guardianship (or placement in a formal guardianship diversion program) never gets invoked. Instead, the various parties generally 'bumble through' extra-legally as best they can. When the capacity issue does get raised formally, it often is done so as a matter of legal self-protection for a health care provider or financial institution, rather than primarily for the ward's benefit. The central policy issue to be debated is whether we ought to be encouraging or discouraging extralegal, bumbling through-type handling of persons with questionable capacity rather than initiation of formal judicial involvement or a formalized guardianship diversion program. A closely related issue is what we ought to be teaching health care providers, financial officers, and other third parties who in reality are usually the ones who initially decide whether the formal guardianship system should be initiated for a particular person.

Consumer choice in home- and community-based long-term care: policy implications for decisionally incapacitated consumers.

There is a strong national and international movement to enhance the role of consumer choice, control, and direction regarding important aspects of publicly financed home- and community-based long-term care. The research project described in this article set out to examine, with a particular focus on Ohio, policy-relevant issues pertaining to how choices about publicly financed home- and community-based long-term care are actually made, implemented, and monitored under a consumer direction model, but when the care recipient is unable to act as an autonomous, independent consumer selecting rationally among various home- and community-based long-term care options competing for the consumer's business in the marketplace.

Medical mistakes and older patients: admitting errors and improving care.

The topic of medical errors has received substantial professional and public attention over the past few years. However, very little of this attention has focused specifically on the implications of this problem for older patients or on the healthcare professionals and settings specifically serving them. This article examines some of the most salient of those implications, with particular emphasis on the physician's ethical duty to admit and address errors. Practical obstacles, including physicians' legal anxieties, to admitting and thereby reducing and mitigating medical errors are outlined, along with potential strategies for effectively addressing and overcoming those barriers.

Legal interventions for persons with dementia in the USA: ethical, policy and practical aspects.

The US legal system has developed a number of methods by which the state or private parties may intervene to protect persons, including those with dementia, who lack sufficient cognitive or emotional capacity to make and express autonomous choices about various aspects of their lives. These interventions may be planned and voluntary or unplanned and involuntary. This article explores the ethical and cultural values underlying legal alternatives in the United States and their strengths and weaknesses when measured against those values. The article poses issues about which US policy makers, health and human service practitioners, and attorneys might seek wisdom from the various strategies that other countries have devised to deal with the challenge of protecting, but not overprotecting, their own citizens with dementia.

Economic influences on end-of-life care: empirical evidence and ethical speculation.

Although very little actual evidence on the issue is available, much ethical speculation has been voiced about the probable impact of the current cost containment-oriented economic climate in the United States on decisions that are being made and implemented in the context of end-of-life medical care. This article, after noting that numerous factors besides money drive the behavior of various actors in the health care system, turns to the economic influences on care for dying patients. These influences, both real and imagined, may be manifested in the amount of de facto health care rationing by age that occurs, the prevalent fears of older persons regarding both overtreatment and undertreament, the financial expectations as well as disappointments emanating from the practice of advance medical planning, and the paucity of options from which many impoverished individuals must choose at the end of their lives. It is too early to judge specifically the impact of managed care on end-of-life decisions, but positive opportunities as well as perils may materialize.

Professional development in law, health care, and aging: a model fellowship program.

There is a growing need for a strong core of professionals with the knowledge, skills, and sensitivities necessary to integrate the fields of law, health care, and gerontology. This article describes a unique professional development program that attempted to address this need by making it possible for a small number of recently graduated attorneys to observe, experience, and question on a firsthand level the provision of various forms of health care to older patients.