Medical/research ethics issues

As discussed in Section 4.7, stem cells have the potential to treat medical conditions beyond the scope that can be offered by drugs alone. However, there are many scientific and ethical hurdles to overcome. On the scientific front, stem cell research activities will intensify over the next decade. These challenges can broadly be divided into (1) determining how to develop stem cells into specific tissues and (2) implanting these tissues into the body without rejection by the recipient s immune system. On the ethical front, it is expected that there will be more debates on the ethical issues of stem cell research. Most scientists consent to therapeutic cloning (stem cell research) but not reproductive cloning. The ethical issue of stem cell research concerns harvesting cells from embryos that are a few days old. This action destroys the embryos. Some questions are ... 

Over the years, scientific research with human subjects has provided valuable information to help characterize and control risks to public health, but its use has also raised particular ethical concerns for the welfare of the human participants in such research as well as scientific issues related to the role of such research in assessing risks. Society has responded to these concerns by defining general standards for conducting human research. As an example, studies carried out for the authorization of a medical product, have to be conducted in line with the World Medical Association s Declaration of Helsinki, which describes the general ethical principles for medical research involving human subjects (World Medical Association 2004). The Helsinki Declaration was first issued by the World Medical Association in 1964 and has been revised several times since then. 

Ethical issues and randomisation There are ethical issues with randomisation. There are two t)rpes of ethics which are associated with human, medical research - individual and collective ethics. Individual ethics recognises the primacy of the individual and is aimed at doing what is best for the subjects in the current trial. In contrast, collective ethics is aimed at doing what is best for all future patients who will benefit from the results of the current trial. Clearly, there is a tension between these two principles that is recognised in the declaration of Helsinki, which comes down on the side of the individual ... 

A basic ethical issue in several areas of psychiatric research is whether participants are able to provide informed consent, particularly for protocols entailing medication washout and/or placebo treatment. The majority of psychiatric patients who are asked to participate in clinical trials have adequate capacity to provide consent. Thus, in a study specifically designed to examine the capacity of schizophrenic patients to give informed consent, cognitive dysfunction and negative symptoms (apathy and avolition). but not psychotic symptoms (hallucinations, delusions), were found to be associated with impaired decisional capacity (Moser et al., 2002). These features are probably not unique to schizophrenia but are likely to apply to many other forms of illness. 

About the Author Dr. Bentley is an Associate Professor in the Department of Pharmacy Administration and Research Associate Professor in the Research Institute of Pharmaceutical Sciences at the University of Mississippi School of Pharmacy. He received a B.S. in pharmacy and an MBA from Drake University and an M.S. and Ph.D. in pharmacy administration from the University of Mississippi. In addition to statistics, Dr. Bentley s teaching interests focus on the organization, delivery, financing, and outcomes of health care. His research interests include understanding the role of pharmacy practice in how medications and the medication consumption experience affect quality of life, the use of quality-of-life measures as clinical tools, and empirical investigations of ethical issues in pharmacy and research. 

The issue of (informed) consent looms large in discussions of the ethics of research involving human subjects and is a principal concern of the Research Ethics Committees that are now the norm in medical research. 

The most recent pressing ethical dilemma facing the clinical research scientist surroimds the increasing amoimt of research that is being conducted in biotechni-cal and genetic engineering. Ethical issues will continue to play important parts in the medical and legal worlds. Whereas pure science is value-neutral, its application is always open to debate. Undesirable extremes are likely to exist at both ends of the spectrum. 

The aim of this chapter is to describe the general framework for conducting good clinical practices (GCP)-compliant clinical research. As it is difficult to cover this broad topic in such a short chapter, the authors will focus on those areas that are most discussed, most problematic and most critical to achieving a GCP-compliant clinical study. Thus, there is particular emphasis on ethical issues, source data verification and data integrity, monitoring and safety review, and study medication/device management. 

Under what conditions is it permissible to delay the publication of promising results until more substantial evidence is available The reverse question is an ethical dilemma as well. That is, under what conditions is it permissible to publish promising results even though, according to accepted standards, more evidence is needed to validate the results The increasing newsworthiness of medical research has given this issue much attention, and conflicts directly with the established, albeit time-consuming, publication process manuscript preparation, peer review, and revision. 

Parallel to many technological developments, the twentieth century saw an evolution of medical ethics and medical legislation that went way beyond the content of the Hippocratic Oath. The need for all these considerations was precisely because the Hippocratic Oath provided no guidance to twentieth and early twenty-first century issues, such as the patient s rights, the ethics of experimentation, team care, and a medical researcher s or healthcare practitioner s societal or legal responsibilities. 

Porton Down in the UK was a biochemical research facility. In the mid-1950s, part of its research activities were concerned with the effects of nerve gases. One young serviceman was asked to participate in an experiment to find a cure for the common cold. It is claimed that he was actually exposed to a nerve toxin, sarin, and subsequently died. As recently as 2002 the British High Court gave the go-ahead for a new inquest into the death. Ethical issues in medical research have a habit of not going away until there is complete resolution. 

All clinical research is subject to these and other FDA regulations. Medical ethical issues are now enshrined in U.S. law. Let the final word on ethics come from the National Bioethics Advisory Commission It is essential that the research community come to value the ethics of research as central to the scientific process. ... 

To comprehend adequately the ethical issues posed by clinical use of unapproved medical devices outside the context of an IDE, it is necessary to utilize the distinctions between practice, nonvaUdated practice, and research elaborated in the previous pages. How do those definitions apply to feasibility studies ... 

McManus, J., et al., Informed Consent and Ethical Issues in Military Medical Research , Journal of Academic Emergency Medicine, 12 (2005), p. 1121. 

---