Ethical and legal constraints to children's participation in research in zimbabwe: Experiences from the multicenter pediatric hiv arrow trial

BMC Medical Ethics 13 (1):17- (2012)

Abstract
Background: Clinical trials involving children previously considered unethical are now considered a necessity because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.DiscussionThe Zimbabwean parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in interpreting and obtaining informed consent for orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation if the Zimbabwean courts had not legally appointed them. The situation contrasted with general clinical practice where legal papers where not required for providing consent for surgical procedures for example.SummaryExperiences gained from this clinical trial revealed that while there may be internationally established guidelines governing the process of obtaining informed consent for children participating in research, there may be need to be cognizant of the culture within which the research is taking place. This may call for the development of an ethico-legal framework that governs research-involving children in Zimbabwe that would facilitate their participation in clinical research, while ensuring that they are protected from exploitation. The Medical Research Council of Zimbabwe has since started developing that framework in a process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers
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

Our Archive


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 39,545
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

View all 9 references / Add more references

Citations of this work BETA

Add more citations

Similar books and articles

Emergency Research Without Consent Under Polish Law.Joanna Różyńska & Marek Czarkowski - 2007 - Science and Engineering Ethics 13 (3):337-350.
Genetic Research, Adolescents, and Informed Consent.Robert F. Weir & Jay R. Horton - 1995 - Theoretical Medicine and Bioethics 16 (4).

Analytics

Added to PP index
2011-09-28

Total views
14 ( #515,236 of 2,325,370 )

Recent downloads (6 months)
4 ( #409,683 of 2,325,370 )

How can I increase my downloads?

Downloads

My notes

Sign in to use this feature