Double standards in special medical research: questioning the discrepancy between requirements for medical research involving incompetent adults, and medical research involving children

Stepanov, Nikola A. and Smith, Malcolm K (2013) Double standards in special medical research: questioning the discrepancy between requirements for medical research involving incompetent adults, and medical research involving children. Journal of Law and Medicine, 21 1: 47-52.

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Author Stepanov, Nikola A.
Smith, Malcolm K
Title Double standards in special medical research: questioning the discrepancy between requirements for medical research involving incompetent adults, and medical research involving children
Journal name Journal of Law and Medicine   Check publisher's open access policy
ISSN 1320-159X
Publication date 2013
Sub-type Critical review of research, literature review, critical commentary
Open Access Status File (Author Post-print)
Volume 21
Issue 1
Start page 47
End page 52
Total pages 6
Place of publication Rozelle, NSW, Australia
Publisher Lawbook
Language eng
Abstract Medical research represents a substantial departure from conventional medical care. Medical care is patient-orientated, with decisions based on the best interests and/or wishes of the person receiving the care. In contrast, medical research is future-directed. Primarily it aims to contribute new knowledge about illness or disease, or new knowledge about interventions, such as drugs, that impact upon some human condition. Current State and Territory laws and research ethics guidelines in Australia relating to the review of medical research appropriately acknowledge that the functions of medical care and medical research differ. Prior to a medical research project commencing, the study must be reviewed and approved by a Human Research Ethics Committee (HREC). For medical research involving incompetent adults, some jurisdictions require an additional, independent safeguard by way of tribunal or court approval of medical research protocols. This extra review process reflects the uncertainty of medical research involvement, and the difficulties surrogate decision-makers of incompetent adults face in making decisions about others, and deliberating about the risks and benefits of research involvement. Parents of children also face the same difficulties when making decisions about their child's research involvement. However, unlike the position concerning incompetent adults, there are no similar safeguards under Australian law in relation to the approval of medical research involving children. This column questions why this discrepancy exists with a view to generating further dialogue on the topic.
Keyword Adult
Biomedical research/ethics*
Biomedical research/legislation and jurisprudence*
Child advocacy/legislation and jurisprudence
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collection: School of Medicine Publications
 
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Created: Fri, 13 Jun 2014, 11:51:44 EST by Nikola Stepanov on behalf of School of Medicine