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An Introduction to Clinical Research$
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Piers Page, James Carr, William Eardley, David Chadwick, and Keith Porter

Print publication date: 2011

Print ISBN-13: 9780199570072

Published to Oxford Scholarship Online: November 2020

DOI: 10.1093/oso/9780199570072.001.0001

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(p.109) Chapter 6 Ethics
An Introduction to Clinical Research

Alan Weir

Kate Macdougall

Oxford University Press

Ethics, as a whole, aim to create a framework upon which complex issues can be thought about and discussed in a reasoned manner. Medical ethics take these reasoned frameworks and apply them to problems that arise within healthcare, often focusing on the doctor–patient relationship. Medical research ethics are very closely related to medical ethics, but look at issues from the researcher–participant perspective. Medical research ethics have come to the fore in the past century with the regulation of medical research, which has focused on safeguarding research participants. The central concern has been to ensure that the interests of society and the researcher do not override the interests of the participant. Prior to the Second World War there was no internationally accepted code of conduct for research involving human subjects. The appalling experimentation carried out by some Nazi doctors led, in 1947, to the publication of the Nuremberg Code. This document outlined ten points that defined legitimate medical research, including voluntary consent and scientific validity. The following year these principles were tied to the Declaration of Geneva. This declaration was a statement of the physician’s ethical duty as a clinician, and has been amended several times since, the latest being in 2006. This declaration was intended as a revision of the Hippocratic oath into a formulation of morals that could be comprehended in the modern world. Following these first steps to create an ethical code for medical researchers came the document that is held to be the authority and basis of medical research ethics. In 1964 the 18th World Medical Association (WMA) General Assembly, held in Helsinki, developed and accepted the Declaration of Helsinki. The document is a statement of ethical principles governing medical research involving human subjects, including research on identifiable human material and data. It deals with the rights and protections of research participants, clearly making the distinction between participants and patients. This is not a legally binding document in international law but draws its authority from the degree to which it has been codified in, or has influenced, national or regional legislation and regulations.

Keywords:   Nuremberg Code, autonomy, beneficence, consent, data collection, ethical issues, informed consent, plagiarism

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