A model of community substituted consent for research on the vulnerable.

Persons of diminished capacity, especially those who are still legally competent but are de facto incompetent should still be able to participate in moderately risky research projects that benefit the class of persons with similar diseases. It is argued that this view can be supported with a modified communitarianism, a philosophy of medicine that holds that health care is a joint responsibility that meets foundational human needs. The mechanism for obtaining a substituted consent I call "community consent," and distinguish this from the usual family or surrogate consent for treatment. Care givers are included in the community that might consent for an individual who has no identifiable family members.

Public health law in a new century: part III: public health regulation: A systematic evaluation.

Public health interventions need justification because they intrude on individual rights and incur economic costs. Coercive interventions can be justified in only 3 cases: to avert a risk of serious harm to other persons, to protect the welfare of incompetent persons, and, most controversially, to prevent a risk to the person himself/herself. This article proposes a systematic evaluation of public health regulation. The article recommends that public health authorities should bear the burden of justification and, therefore, should demonstrate (1) a significant risk based on scientific evidence; (2) the intervention's effectiveness by showing a reasonable fit between means and ends; (3) that economic costs are reasonable; (4) that human rights burdens are reasonable; and (5) that benefits, costs, and burdens are fairly distributed. The 3 articles in this series have sought to provide a fuller understanding of the varied ways in which law can advance the public's health. Public health law should be seen broadly as the government's power and responsibility to ensure the conditions for the population's health. As such, public health law has transcending importance in how we think about government, politics, and policy. JAMA. 2000.

Challenges to human subject protections in US medical research.

United States regulations governing federally supported research with human subjects derive in part from 2 international codes, the Nuremberg Code and the Declaration of Helsinki. The Declaration of Helsinki states that "concern for the interests of the subject must always prevail over the interests of science and society." The concept of minimal risk and the principle of informed consent are the key means by which US federal regulations seek to protect the rights and welfare of the individual in the research setting. Current trends in medical research-including increased funding, ever-greater capabilities of computers, development of new clinical tools that can also be used in research, and new research tools developed through research itself are creating greater demand for human subjects, for easier recruitment and conscription of these subjects, and for unimpeded access to patient medical records and human biological materials. Nationally and internationally, there are new pressures to subordinate the interests of the subject to those of science and society. The National Bioethics Advisory Commission, which is about to undertake a comprehensive review of the US system of human subject protections, faces a daunting task.

Ethical considerations in a grounded theory study on the dynamics of hope in HIV-positive adults and their significant others.

The purpose of this article is to describe and reflect ethical challenges in a grounded theory study on the dynamics of hope in HIV-positive adults and their significant others. It concentrates on the justification of a research problem, sensitive research and the relationship between the researcher and the participants in data collection. The basis of ethically sound nursing research on the dynamics of hope in these two vulnerable groups lies in the relationship between the researchers and the participant. However, it is also obvious that the content, the process, the methods used and the ethics of the study cannot be divorced from this relationship. In conducting grounded theory research on the dynamics of hope in this research population, the researcher has to consider the surrounding world, that is, the reality in which these people live in hope or despair.

Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions.

The first part of this paper examines the practice of informed treatment decisions in the protective medical system in China today. The second part examines how health care professionals in China perceive and carry out their responsibilities when relaying information to vulnerable patients, based on the findings of an empirical study that I had undertaken to examine the moral experience of nurses in practice situations. In the Chinese medical ethics tradition, refinement [jing] in skills and sincerity [cheng] in relating to patients are two cardinal virtues that health care professionals are required to possess. This notion of absolute sincerity carries a strong sense of parental protectiveness. The empirical findings reveal that most nurses are ambivalent about telling the truth to patients. Truth-telling would become an insincere act if a patient were to lose hope and confidence in life after learning of his or her disease. In this system of protective medical care, it is arguable as to whose interests are being protected: the patient, the family or the hospital. I would suggest that the interests of the hospital and the family members who legitimately represent the patient's interests are being honoured, but at the expense of the patient's right to know.