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Conflicts among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions

Published online by Cambridge University Press:  01 January 2021

Jacob M. Kolman ,
Nelda P. Wray ,
Carol M. Ashton ,
Danielle M. Wenner ,
Anna F. Jarman  and
Baruch A. Brody
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Extract

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences (CIOMS), the International Conference on Harmonization's standards for industry (ICH), and the CONSORT group's reporting norms (Consolidated Standards of Reporting Trials), in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's (FDA) body of regulations, and information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.

Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 1 , Spring 2012 , pp. 99 - 121
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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References

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