Nov 8, 2017 in Informative

Helsinki position on Placebo Comparators

Vrhovac Bozidar (2012).Ethical Considerations. National Bioethics Committee for Medicine of Croatia. Retrieved on October 1 2012, from http://www.iuphar.org/pdf/hum_5.pdf. In this article, the author discusses the various ethical aspects that come along with  clinical trials. A well-planned medical and clinical trial is ethical as it is designed to result  in reliable and efficient results that may be used in improving medical treatment to patients. According to the author, local EC/IRBs must come up with definite methodological and ethical aspects that must be considered during clinical trials. As a result, ethical committees must me set up to ensure that the set ethical principals are adhered to.                                                                                                                                 

The source is reliable as it has various consultation with medical and ethical committees, though biased in adhering to ethical regulations, the source is clear to clarify on the conflicting interest that arise from clinical trials. The source is useful in my research as the author critically evaluated measures and regulations that must be adhered t if ethical standards are to be maintained during clinical trials. Banzi R., Bertele V., Carne X., &Jacques D. (2006).ECRIN, an infrastructure supporting International Cooperation in Clinical Trials. Retrieved on October 1 2012, from http://www.wma.net/en/50events/20otherevents/10doh1/Demotes.pdf. The article proposes various amendments to be incorporated in the ethics committees on the declaration of Helsinki. The article proposes transparency on   protocol, incentive, recruitment and data. The article proposes further amendments to the trial design by proposing systematic review of used methodologies, ethical dimension and use of placebo. The author suggests change in use of wording on patients used for trial from participants to subjects. The author further calls for training and independence of research by the ethics committees. The source is useful in my research as it proposes various amendments on the declaration of Helsinki to ensure ethics are practiced during medical trials. The information is reliable considering that the source makes use of credible statistic obtained during the WMA Satellite meeting held in Netherlands. The source fits into my research as it critically opposes some of the issues in the declaration of Helsinki by proposing various amendments.
CIOMS (2008).International Ethical Guidelines for Epidemiological Studies. 
Council for International Organizations of Medical Sciences. Retrieved on October 1 2012, from http://www.ufrgs.br/bioetica/cioms2008.pdf. The article sets ethical guidelines on how epidemiologists, as well as other stakeholders participating in medical trials establish and respond to ethical issues raised during medical trials. The article applauds epidemiologists  for making improvements in the medical fields by making use of powerful medical tools. The article seeks to draw  attention on ethical implications of protocol used in research by proposing high levels of  scientific ethical standards to be maintained during epidemiological research. The article is suitable for my research as it provides clear guidelines, useful in conducting epidemiological research. The article provides wide source of information on all aspects encountered during medical trials.The article is valid as it is not prejudiced in presentation of ideas.The author acknowledges the efforts made by medics and researchers in providing excellent medical services while encouraging ethic during medical trials.

Emanuel E., Grady C., Crouch R., Lie R., Miller F.,Wendler  D.(2008). The Oxford Textbook of  Clinical Research Ethics.  Oxford: Oxford University Press. The book provides a solid guideline to ethical behavior of medical research on subjects.The author propose the use of medical experts and ethical committees during clinical trials. The source is useful in my research as it is not prejudiced in discussion of ideas. Berdaï1 D., Hotton J. Lechat P. (2010). Comparators (Medicinal and non Medicinal) for  Marketing Authorization, for Public Health, for Payers and at the European Level. Société Française de Pharmacologie et de Thérapeutique. The article discusses the choice of drug comparators during medical trials. The author  emphasizes on the importance of evaluating drugs used during clinical trials.  The article    provides concrete information on the use of medically evaluated drugs during clinical trials to enhance clinical benefit to subjects used.

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