Ethics in clinical research: Should guidelines be universally replaced by laws

Lahon, K. and Bairagi, K.K. and Chaturvedi, R.K. (2010) Ethics in clinical research: Should guidelines be universally replaced by laws. Medico-Legal Update, 10 (2). pp. 33-37. ISSN 09741283; 0971720X

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Abstract

Ethics defines right and wrong behaviour in a civil society and comes from within. It is different from law which regulates the external behaviour. Clinical research is research involving human beings and is a multi-million dollar industry today. It is regulated by international guidelines on the conduct of clinical trials called ICH GCP guidelines, which direct that clinical trials on human subjects should be performed in an ethical manner. However, guidelines are only advisory in most cases and are yet to have the force of law in many countries. This is particularly relevant due to the alarming rise of ethical violations by pharmaceutical companies and research organizations wherein the safety and rights of clinical trial participants are jeopardized in their pursuit of commercial and scientific gains. Stronger regulatory framework, registration of trials and ethics committees, and above all, stronger enforcement of laws in such cases are the need of the hour. © 2020 Elsevier B.V., All rights reserved.

Item Type: Article
Subjects:
Divisions: Pharmacy > Vinayaka Mission's College of Pharmacy, Salem > Pharmacology
Depositing User: Unnamed user with email techsupport@mosys.org
Date Deposited: 11 Dec 2025 17:02
Last Modified: 11 Dec 2025 17:06
URI: https://vmuir.mosys.org/id/eprint/5581

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