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.

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 and ethical standards in geriatric medicine.

Several examples of physicians' ethical and legal responsibilities toward older individuals desiring medical care are discussed. The focus is on the older person's ethical and legal right to access to medical services, and on the extent of corresponding obligations of physicians to actuate and fulfill the older person's access rights. The impact of current cost constraints in carrying out these obligations is also discussed.

The malpractice crisis. Relevance for geriatrics.

The adverse effects of the current American medical malpractice problem on the practice of geriatric medicine have thus far been relatively minor, but real. This article discusses some of the prominent public policy issues involved in the ongoing debate about malpractice, with special application to older patients and their physicians. Suggestions are made for appropriate actions by geriatricians individually and collectively, in response to the malpractice situation.

"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.

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.

Health care decision making by the elderly: I get by with a little help from my family.

Shared decision making about placement and medical interventions can be empowering to the older person involved, relieve burdens on the older person and family members, and facilitate better surrogate decision making later. Potential dangers of the shared process include coercion, conflicts of interest, and disagreements between family members. New legal concepts, similar to those governing property, could help our legal system better accommodate the realities of shared decision making.

Ethical aspects of guardianship.

One important device that has evolved within the legal system for dealing with the problem of cognitively incapacitated individuals and the concomitant need for some form of surrogate decision making on their behalf is guardianship. This article outlines the most salient ethical challenges related to guardianship for clinicians who interact professionally with older persons of diminished capacity and their families. Special attention is devoted to the clinician's role in initiating guardianships, questioning the guardian, in the guardianship proceeding, and evaluating the therapeutic impact of guardianship.

Decision making by and for nursing home residents. A legal view.

The law is concerned with a panoply of issues affecting the care and lives of nursing home residents. This article has outlined one area, that of decision making, which in many respects is the embodiment of and key to all other fundamental resident rights. The doctrine of informed consent applies with full force in the nursing home, both for mentally competent residents and for cognitively impaired residents for whom decision making rights must be exercised through a proxy. Long-term care institutions and professionals are obligated to insure that decisions made by or for residents are made voluntarily, competently, and knowingly.

The legal status of clinical practice parameters: an annotated bibliography.

An important recent development in American medicine has been the strong push in the last few years toward the formal creation, dissemination, and enforcement of explicit clinical practice guidelines or parameters relating to the quality and efficacy of various medical interventions, parameters that would guide the decisions and actions of physicians and other health care providers (1-3). Medical societies (4), governmental agencies such as the federal Agency for Health Care Policy and Research, and insurers are utilizing a variety of approaches to the development of practice parameters for medical diagnosis and intervention, including informal consensus development, formal consensus development, evidence-based guideline development, and explicit guideline development (5). The number and variety of practice parameters has burgeoned in response to the wide national variations in medical practice patterns, without corresponding differences in clinical outcomes, that have been documented by health services researchers. Several commentators have expressed serious skepticism about the probable impact of practice parameters, surmising that they will be used extensively in a negative manner in medical malpractice litigation (6, 7). Many physicians in particular have asked "how they [practice parameters] can be implemented without courting the ruin of the individual practitioner" (8). In response to these anxieties, a new medicolegal literature has arisen to address the relationship between the development of clinical practice parameters and the physician's exposure to malpractice litigation and adverse judgments, as well as the implications for malpractice insurance premiums. This growing literature has now achieved a critical mass. The major contributions to this corpus at present are listed and annotated below.

The legal status of clinical practice parameters: an updated annotated bibliography.

In response to extensive speculation about the probable liability implications for health care providers of the formal creation and dissemination of explicit practice parameters of guidelines, I prepared several years ago an annotated bibliography of emerging literature on that topic (1). Since preparation of that catalogue, little meaningful clarification of these issues has emerged from the courts, legislatures, or regulatory agencies.

Children's assent for participation in pediatric research protocols. Assessing national practice.

A survey instrument was used to gather and evaluate data from medical schools and children's hospitals concerning prevailing national practice on the issue of whether pediatric researchers should be required to obtain informed assent from a minor subject, in addition to parental consent, as a precondition to the participation of the minor in the research protocol. Implications are drawn from the survey results.

Treatment of residual dissociated vertical deviation with inferior rectus resection.

The effectiveness of an ipsilateral 4-millimeter resection of the inferior rectus muscle was evaluated as a treatment of recurrent dissociated vertical deviation. Thirty-six patients who had an unsatisfactory outcome after 7- to 9-millimeter recession of the superior rectus muscle had an ipsilateral inferior rectus muscle resection. The dissociated vertical deviation was fully corrected in 18 patients and improved in 15 patients. Only three patients (8%) had an unsatisfactory result. Multivariate analysis of four preoperative features including the amplitude of the dissociated deviation, the age at diagnosis, the age at surgery, and the degree of amblyopia failed to define any factors that could predict surgical success.

"A place like that": advance directives and nursing home admissions.

Decisions about admitting a mentally incapacitated person to a nursing home raise a variety of difficult legal, ethical, and public policy issues. A strategy for anticipating and addressing this contingency prospectively, by encouraging execution of formal advance planning directives while the individual is still capable, may mitigate some of the dilemmas associated with these issues. The author discusses the contours and feasibility of such a strategy, analyzing nursing home admission on one's behalf and for refusing such admission, or placing explicit conditions on such admission, in advance of the time that the actual decision must be made.

Informed consent for federal clinicians.

The principle of informed consent to medical care is by now well recognized but incompletely understood and implemented. This article discusses the ethical and legal foundations of the informed consent doctrine, the relevance of informed consent for health care providers employed by the federal government, the elements of valid consent, the concept of state substantive law as governing, different information disclosure standards, disclosure elements, exceptions to the consent requirement, and the proper documentation of consent.

Treatment and refusal rights in mental health: therapeutic justice and clinical accommodation.

The impact of recognition by courts and legislatures in the 1970s and early 1980s of patients' rights to receive or to refuse mental health treatment is evaluated. The implementation of these rights in practice does not appear to have exerted an unduly disruptive or destructive effect on mental health services or their clienteles. At the same time, their recognition has not led to the salutary therapeutic jurisprudence envisioned by their proponents.

Placebo therapy and the law: prescribe with care.

The use of placebos by physicians for therapeutic purposes is a common part of clinical medical practice. This Article examines the legal and ethical ramifications of placebo prescription. In particular, ethical concerns are related to substantive legal theories that may be advanced to attack or defend the practice of placebo therapy in particular cases. The author concludes that, under certain strictly defined circumstances, the use of placebos in patient care is ethically and legally justifiable. However, from any perspective, the rights and duties inherent in the physician-patient relationship must be respected by the physician when considering the clinical use of placebos.

Advocacy for the mentally impaired elderly: a case study analysis.

The authors present a case study to illustrate how a mentally impaired but socially intact nursing home resident, who had no one to act as an advocate for her, was denied appropriate treatment for an acute illness which ultimately resulted in her death. The case raises important questions about advocacy for the mentally-impaired, acutely-ill institutionalized patient. This Article explores the role of the advocate, how advocates are selected, what qualities and talents they should possess, and what responsibilities should be assigned to them. The authors suggest that nursing home residents should be encouraged to engage in self-advocacy to the greatest extent possible. The competent elderly should be urged to name their preferred advocates. Individuals who serve in advocacy roles should be advised to seek information regarding the patient's wishes from those who know the patient well. Furthermore, there is a need for quality education and training of those who serve in advocacy roles on behalf of nursing home residents, and state laws need to specify the responsibilities of persons who serve as advocates.

"Courtroom whores"?--or why do attorneys call us?: findings from a survey on attorneys' use of mental health experts.

Mental health professionals who serve as expert witnesses are repeatedly characterized as (in the words of one recent author) "Whores of the Court." However, scholars have published little systematically gathered data about why attorneys seek mental health opinions and the criteria they use for selecting experts. We investigated these issues using a mailed survey of attorneys and judges. A slight majority of attorney respondents had requested mental health professionals' opinion in the previous year. The most important factors in selecting experts were their knowledge, ability to communicate, and local reputation; national reputation and scholarly writings were least important. Forty-nine percent of the responding attorneys said that receiving a favorable opinion was a "very important" or "essential" consideration, although this did not necessarily mean they wanted a dishonest opinion. Our findings suggest that most forensic work is performed by mental health professionals who are chosen because of their knowledge, communication skills, and local reputations.

'Ageism' and right to die litigation.

This study examines 88 reported judicial decisions involving adult patients and decisions about life-prolonging medical treatments. The patient's age by itself does not appear to be a factor influencing findings of mental competency or incompetency or findings of the appropriateness or inappropriateness of abating life-prolonging medical treatments. Neither can an explicit ageist bias be extracted from an analysis of the text of judicial decisions in this arena. Various potential explanations for the lack of apparent ageist bias are suggested.