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Showing posts from May, 2009

Ethical issues in clinical research

Clinical research is defined as a systematic investigation in human beings designed to discover or contribute to a body of generalizable knowledge. As clinical research involves human participants, researchers and their teams are legally and ethically obligated to protect them. In clinical practice a physician would be expected to use interventions that have a reasonable expectation of success and are designed solely to enhance the wellbeing of an individual patient. As against this, clinical research is designed to test a hypothesis, permit conclusions to be drawn, and thereby develop or contribute to generalizable knowledge - here the participant therefore may not get the best known treatment and therefore the obligations on the researcher are more. The Declaration of Helsinki (available at http://www.wma.net/e/policy/b3.htm) which forms the basis of clinical research today was first accepted by the 18th World Medical Assembly in 1964 and has been revised five times since and the la