Authors
Doris Schroeder
University of Central Lancashire
Abstract
In its essence, post-trial obligations describe a duty by research sponsors to provide a successfully tested drug to research participants who took part in the relevant clinical trials after the trial has been concluded. In some instances,this duty is extended beyond the research participants. This article is divided into three main parts. The first part outlines the legal basis for post-trial obligations by looking at international guidelines, including those issued by the World Medical Association. National legislation is exemplified through resolutions and guidelines issued by Brazil and South Africa respectively. The second part analyses the ethical foundation for post-trial obligations, in particular the attempt to minimize exploitation of research subjects. The third part raises obstacles and challenges for the implementation of post-trial obligations. The jury is still out on whether post-trial obligations in the form of access to drugs for clinical trial participants is the best, or even a good way, to avoid exploitation in medical research.
Keywords No keywords specified (fix it)
Categories (categorize this paper)
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 70,337
External links

Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
Through your library

References found in this work BETA

No references found.

Add more references

Citations of this work BETA

Introducción al problema de la continuidad del tratamiento beneficioso para los sujetos de investigación.Ignacio Mastroleo - 2015 - In Jorge Alberto Álvarez Díaz (ed.), Ensayos sobre ética de la salud. Ciudad de México: Universidad Autónoma Metropolitana - Unidad Xochimilco. pp. 67 - 99.

View all 6 citations / Add more citations

Similar books and articles

Post-Trial Access to Treatment: Corporate Best Practices.Irene Schipper & Silvia Colona - 2015 - SOMO Centre for Research on Multinational Corporations.

Analytics

Added to PP index
2016-05-26

Total views
64 ( #178,937 of 2,508,119 )

Recent downloads (6 months)
1 ( #416,711 of 2,508,119 )

How can I increase my downloads?

Downloads

My notes