Research ethics

Savulescu J. Two deaths and two lessons Is it time to review the structure and function of research ethics committees J Med Ethics 2002 28 1-2. 

This suggestion of group consent kicked off a lively debate that, five years later, persists in the literature of research ethics. The North American Committee s position has found many opponents (National Research... 

Emanuel, E., et al., "What Makes Clinical Research Ethical " JAMA, 283, 2701-2711... 

Bayer A and Tadd W (2000) Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval descriptive study. BMJ 321(7267) 992-993... 

Experimental use of animals is controlled under Good Laboratory Practice (GLP), and study protocols are submitted to the Animal Research Ethics Committee for approval. Studies using animals can only proceed with the approval of the Ethics Committee, which consists of technical personnel. 

Centrai Office for Research Ethics Committees (COREC)... 

Department of Health (UK). Governance Arrangements for NHS Research Ethics Committee. London Central Office for Research Ethics Committees (COREQ, 2001. 

Clinical trials in which registered or listed medicines (or medical devices) are used within the conditions of their marketing approval are not subject to CTN or CTX requirements but still need to be approved by a Human Research Ethics Committee (HREC) before the trial may commence. 

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. 

Research Ethics Committees (RECs) should be invited to review all materials used to recruit subjects for all phases of clinical trials, including, but not limited to ... 

Emanuel E, Wendler D, and Grady C. What Makes Clinical Research Ethical JAMA 2000 283(20) 2701-2711. 

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. 

Institutional Review Boards. In university clinics and other hospitals engaged in research, ethics committees (also called Institutional Review Boards, IRBs) have been formed over the last three decades to monitor clinical research activities from scientific, legal, ethical and social viewpoints. All protocols relating to clinical trials must be submitted to these committees, which are generally made up of one or several doctors, a lawyer, a representative of the nursing staff and also community representatives such as priests. This composition forces clinical researchers to set out their intentions in such a way as to be clear enough for a lay person to understand and to assess whether the inconvenience and risks involved for the patient are in a reasonable relationship to the possible benefit of the planned trial. 

The clinical part of the study was conducted with participation of 116 adolescent patients aged from 10 to 18 years hospitalized by the Department of Pediatrics for examination and treatment of chronic dyspeptic complaints. The control group comprised 38 age matched healthy volunteers. The Regional Research Ethics Committee of Ukraine approved the study. 

In Part V, we examine research and ethics. Increasingly, clinical research is undertaken in multi-center studies involving numerous countries and jurisdictions. Argentinian bioethicist Florencia Luna, a past president of the International Association of Bioethics, introduces one of the major issues debated in recent years in international research ethics in this context, namely the question of what constitutes appropriate standards of care for participating patients. The line taken by the U.S. National Institutes of Health and many American bioethicists has been that it is acceptable for developed world sponsors of such trials to provide less than the best proven therapeutic means of treatment to the trial participants. Developed world-based bioethicists do not always agree and Luna explains why. 

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

Human genomic research ethics changing the ruies... 

Current research ethics do not adequately address the issue of international research on the diversity of the human genome. Under current research standards, this research will widen the gap between developed and underdeveloped countries. New ethics standards for this research should frame this research so the market value of property rights from such research fosters the development of research institutions, a scientific workforce, and access to investment and venture capital within underdeveloped countries. The 1992 CBD offers just such a foundation. 

Benatar, S. R. 2002. Reflections and Recommendations on Research Ethics in Developing Countries. Social Science and Medicine 54 1131-1141. 

Benatar, S. R. and P. A. Singer. 2000. A New Look at International Research Ethics. British Medical Journal 321 824-826. 

Bonn, D. 2002. Research Ethics Fund for Developing Countries. Lancet Infectious Diseases 2 712. 

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