Provision of HIV treatment in HIV preventive vaccine trials: a developing country perspective.

HIV treatment for participants who become infected during HIV vaccine trials has been the focus of ethical controversy. The obligations of sponsors to ensure that participants have access to antiretrovirals have been a particular focus of this debate. This paper presents three arguments that have been made in this regard, and some of their limitations, in anticipation of HIV vaccine trials in South Africa. The first argument is that HIV risk behaviour increases in such trials, and HIV infection can be viewed as a research-related injury, justifying sponsor provision of treatment on grounds of compensation for harm. We conclude that risk-behaviour studies to date do not show general increases in risk behaviour that could constitute the basis for a general obligation. Participation may well adversely impact on risk behaviour for some individuals, and conceivably this could be demonstrated. This argument may, therefore, have merit at the individual level; however, it seems a weak platform from which to argue that sponsors should treat all HIV infections acquired during trials. The second argument is that treatment should be provided based on distributive justice. We conclude that traditional concepts of "distributive justice" in research appear limited in justifying obligations of sponsors to ensure access to antiretrovirals. Further, using research initiatives to reduce global health care inequities is controversial, and even proponents may disagree about the fairest use of finite resources. The third argument is that sponsors should ensure antiretroviral access on grounds of beneficence; namely, the maxim that if one can do something beneficial without sacrificing anything of comparable significance, it ought to be done. Thus, sponsors should provide more interventions than those minimally required to conduct the research. However, beneficence may demand levels of altruism that exceeds what is reasonable. While the latter arguments may provide stronger justifications than the first, it is difficult to use these arguments to establish that sponsor provision of antiretrovirals to infected individuals is obligatory.

HIV vaccine trials: critical issues in informed consent.

Informed consent (IC), a fundamental principle of ethics in medical research, is recognized as a vital component of HIV vaccine trials. There are different notions of IC, some legally based and others based on ethics. It is argued that, though legal indemnity is necessary, vaccine trials should be founded on fully ethical considerations. Various contentious aspects of IC are examined, especially the problem of social desirability and of adequate comprehension. The need for sensitivity to cultural norms in implementing IC procedures is critically reviewed, and some of the potential conflict between ethos and ethics is considered. The transmission of information is examined as a particular aspect of IC in HIV vaccine trials.

Ethical issues in HIV vaccine trials in South Africa.

In this review we describe the ethical issues central to local and international debates about HIV vaccine trials. These issues include the physiological and psycho-social risks of trial participation, the preventative interventions to be provided to participants, access to treatment for participants who seroconvert, access to an effective vaccine after the trial, the role of placebo-controlled trials, and obtaining informed consent.

Psychologists' right to prescribe--should prescribing privileges be granted to South African psychologists?

Current changes in legislation regarding prescription rights increase the possibility of non-medical practitioners being authorized to prescribe medication. There has been ongoing debate about granting psychologists in South Africa a limited right to prescribe (RTP) psychotropic medication. The main reasons advanced for granting psychologists RTP include the advantage of delivering integrated treatments, with psychologists well placed to offer such treatment, and the shortage of mental health practitioners in South Africa. If psychologists were granted the RTP they would have to undergo extensive training in psychopharmacology. Curricula for such training are currently being prepared with the help of the American Psychological Association. But there is also considerable opposition to psychologists being granted the RTP, both from within psychology and from other quarters. Opposition from outside psychology is based largely on safety considerations relating to lack of relevant training among psychologists. Opposition from within psychology is based on a concern about the loss of the distinctive contribution of psychology to mental health care in South Africa. Various aspects of this debate are examined in this paper.

The AIDS crisis: review of psychological issues and implications, with special reference to the South African situation.

PIP: The HIV/AIDS pandemic intensified dramatically during the past decade. Risk reduction behavior, however, remains the only means of primary prevention. The behavioral sciences, especially psychology, can contribute a great deal to various aspects of AIDS and its prevention. This paper provides an overview of various behavioral aspects of HIV and AIDS through a presentation of the broad stages involved in the development of HIV infection and AIDS, with sequelae for the individual and society at each stage. Special attention is given to the unique South African situation with regard to AIDS, examining the present and prospective positions of psychology in South Africa with respect to AIDS.^ieng

Assessment and management of chronic pain.

The approach to the management of patients with a variety of chronic pain problems who present to the multidisciplinary Grey's Hospital Pain Clinic is outlined.