Ethical issues research

Ethical issues surrounding the design and conduct of genetic research with people, including the process of informed consent. 

Although IRB members can and should come from a variety of backgrounds, all board members should know the basic elements of clinical research and should stay focused on their role in the ethical review process. Any board member who does not have a research background should take the time to learn the basics of the industry. Books, such as this one, can introduce the language, regulations, and ethical issues in the conduct of research with humans. 

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 ... 

Bioethics is a discipline that deals with the moral issues of biological research and its application in medicine. The United Nations Educational, Scientific and Cultural Organization (UNESCO) in its 2005 Universal Declaration on Bioethics and Human Rights addresses ethical issues related to medicine, life sciences, and associated technologies as applied to human beings. The aim of the declaration is to provide a universal framework of principles and procedures... 

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 ... 

The conduct of clinical research in humans raises numerous legal and ethical issues of significant importance. After a lengthy process of gestation, the European Commission has now officially... 

The increased awareness of ethical issues relating to human research has led to the release in 2002 of the Human Research Ethics Handbook, including detailed commentary on the national statement and discussion of ethical and legal issues, to further assist H RECs to assess and facilitate the ethical conduct of research involving human participants, and resolve the challenges encountered during this process. 

Because ESCs are pluripotent and can proliferate indefinitely, they may have an important potential role in cardiac regeneration. Although ethical issues involving the use of human ESCs has slowed research in several countries, including the United States, enthusiasm about their future clinical utilization remains high. 

C., Hattab, J., Graham, P., Zametkin, A., Castellanos, F.X., McMahon, W., and Lechman, J.F. (1995) Ethical issues in biological psychiatric research with children and adolescents. J Am Acad Child Adolesc Psychiatry 34 929-939. 

Attkisson, C.C., Rosenblatt, A., and Hoagwood, K. (1996) Research ethics and human subjects protection in child mental health services research and community studies. In Hoagyvood, K., Jensen, P.S., and Fisher, C.B., eds. Ethical Issues in Mental Health Research with Children and Adolescents. Mahwah, NJ Lawrence Erlbaum Associates, pp. 43-58. 

Expert Panel Report to the National Institutes of Health (NIH) (1998) Research involving individuals with questionable capacity to consent ethical issues and practical considerations for institutional review boards (IRBs). Presented In Bethesda, MD, February 1998. 

Hoagwood, K., Jensen, P.S., and Fisher, C., eds. (1996) Ethical Issues in Child and Adolescent Mental Health Research. Mahwah, NJ Lawrence Erlbaum Associates. 

Vitiello, B. in press Ethical issues in pediatric psychopharmacology research. In Rosenberg, D., Gershon, S., Davanzo P., eds.. Pharmacotherapy for Child and Adolescent Psychiatric Disorders. 

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. 

Volume III, Pharmacology and Therapy, addresses developments in basic science, translational and clinical research that are underway to bring stem cell research to therapy, particularly for the treatment of Batten s diseases, graft-versus-host disease and adenosine deaminase deficiency. This volume covers the importance of stem cell research for the understanding of drug activities and design. It also addresses the ethical issues and constraints involved in stem cell research, and its commercial applications. 

Animal research (ethical issues) Bioethics and clinical research... 

Finding Biomonitoring research presents a number of ethical issues about informed consent and the interpretation of results. For example, biomonitoring research is conducted with anonymized samples that limit the communication of results and potential followup with study subjects. 

NBAC (National Bioethics Advisory Committee). 1999. Research Involving Human Biological Materials Ethical Issues and Policy Guidance, Vol. 1. Report and Recommendations of the National Bioethics Advisory Commission. Rockville, MD National Bioethics Advisory Commission. 

Despite the extensive experience with biomedical ethics, the infrastructure of institutional review boards (IRBs), and the equivalent for protection of human subjects (Schulte et al. 1997 but see Soskolne 1997), it is essential to address questions of ethics that may be particular to the design of biomonitoring studies. In this section, the committee considers some practical and research issues in biomonitoring ethics but makes no pretense that the list is exhaustive. Ethical issues can stop specific studies, and the field in general, dead in their tracks. Therefore, it is incumbent on investigators, policy-makers, and others to consider these issues carefully. 

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