Udo Schüklenk

Protecting the vulnerable: testing times for clinical research ethics

This paper describes a number of historical breaches of research ethics. Typically the victims of such breaches belong to vulnerable populations, such as prisoners, mentally disabled people, women and people in developing countries. This article provides a brief introduction to the main ethical approaches in bioethics. Subsequently it looks at a number of currently discussed ethical issues in clinical research ethics, notably the ethics standards of clinical trials in developing countries, the use of prisoners and incompetent people in clinical research, and the modus operandi of research ethics committees.

Rethinking Mandatory HIV Testing During Pregnancy in Areas With High HIV Prevalence Rates: Ethical and Policy Issues

We analyzed the ethical and policy issues surrounding mandatory HIV testing of pregnant women in areas with high HIV prevalence rates. Through this analysis, we seek to demonstrate that a mandatory approach to testing and treatment has the potential to significantly reduce perinatal transmission of HIV and defend the view that mandatory testing is morally required if a number of conditions can be met. If such programs are to be introduced, continuing medical care, including highly active antiretroviral therapy, must be provided and pregnant women must have reasonable alternatives to compulsory testing and treatment. We propose that a liberal regime entailing abortion rights up to the point of fetal viability would satisfy these requirements. Pilot studies in the high-prevalence region of southern African countries should investigate the feasibility of this approach.

AIDS: Bioethics and public policy

(2003). AIDS: Bioethics and public policy. New Review of Bioethics: Vol. 1, No. 1, pp. 127-144.

Confronting an influenza pandemic: ethical and scientific issues.

The prolonged concern over the potential for a global influenza pandemic to cause perhaps many millions of fatalities is a chilling one. After the SARS (severe acute respiratory syndrome) scares [1], attention has turned towards the possibility of an avian influenza virus hybridizing with a human influenza virus to create a highly virulent, as yet unknown, killer, on a scale unseen since the Spanish flu outbreak of 1918, which produced more fatalities than the Great War. In deciding how countries should react to this potential pandemic, individually and collectively, a reasonable and practical balance must be struck between the rights and obligations of individual citizens and protection of the wider community and, indeed, society as a whole. In this communication, ethical issues are discussed in the context of some of the scientific questions relating to a potential influenza pandemic. Among these issues are the rights and obligations of healthcare professionals, difficulties surrounding resource allocation, policies that have an impact on liberty and trade, when and how to introduce any vaccine or other form of mass treatment, global governance questions and the role of health policies in contemporary society. By considering these issues and questions in advance of an influenza, or indeed any other, pandemic commencing, countries can be better prepared to deal with the inevitably difficult decisions required during such events, rather than dusting down outdated previous plans, or making and implementing policy in an ad hoc manner with a resultant higher risk of adverse consequences.

Bioethics and (Public) Policy Advice

Bioethics, more so than any other field of applied ethics, has been historically defined by government commissions in English speaking countries such as the United States, United Kingdom, and Australia. Governments, non-governmental organizations and international institutions increasingly call upon bioethicists to provide advice and assistance in the creation of targeted ethical guidelines, indicating an ever-growing importance of professional bioethicists in shaping public policy.

MODULE ONE: INTRODUCTION TO RESEARCH ETHICS

This module will introduce you to the ethical concepts underlying applied ethical decision-making in the area of research involving human participants. We will also learn what the issues are that people involved in research on research ethics are concerned with. Ethics without an understanding of historical and legal context makes arguably little sense. It is for this reason that this module will begin with a brief history of research ethics and ends with a brief overview of the relevant national and international guidelines pertaining to ethical issues in research involving human participants.

THE FUTURE OF BIOETHICS

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An uncomfortable truth: AIDS vaccine trials must continue.

AIDS prevention research has hit a road block. Some 150 plus prevention trials including vaccine and microbicide candidates failed to protect trial participants against infection with HIV. The author believes that HIV vaccine and microbicide trials should continue.

SCHUKLENK AND KLEINSMIDT RESPOND

We thank Groves et al. for their constructive, critical comments. Our paper acknowledges that compulsory HIV testing regimes might deter pregnant women from seeking antenatal care. At this point in time, we do not know whether this actually would be the case, or, if it did act as a deterrent, how many women might be deterred from seeking antenatal care (this kind of cost—as determined by the relevant regulatory authorities—would have to be balanced against lives saved). Our article proposed a pilot study designed to investigate this question, among others. All other things being equal, voluntary counseling and testing is preferable to coercive measures. As our review of the literature indicates, the problem is that, as yet, this has not translated into a particularly efficient means of reducing mother-to-child transmission prevention in high-HIV prevalence areas. We propose to test an alternative to this approach. Considering the continuing high numbers of infected newborns, it is worth investigating whether a coercive approach would yield better public health outcomes. It might not, but by not investigating whether such a strategy would be less suboptimal than the status quo, we are doing a disservice to those at risk of infection. The same holds true for the third concern raised by Groves et al. regarding the effect that a compulsory program could have on increase in risky behavior after pregnancy. They may or may not be right. A considered public health approach to this matter must rest on data as opposed to speculation about what may or may not happen. Hence our argument in favor of a pilot program designed to test what the impact of such a policy change would be. We are a bioethicist and a lawyer, respectively. Our objective was not to discuss the mechanics of such a change of policy. We tried to deal with counterarguments typically deployed to criticize the approach promoted by us. We note that Groves et al. do consider the ethicolegal analysis provided in our article to be “plausible.”

Clinical standards of care and the Declaration of Helsinki: The battle is over, or is it?

AbstractThis article briefly reviews the discussion over changes to the Declaration of Helsinki. It suggests that the final product the World Medical Association has adopted as its guiding research ethics document is superior to the version it has replaced, but falls short of what would be ethically desirable.