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

Stepanov, Nikola & 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, pp. 47-52.

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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.

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ID Code: 62347
Item Type: Journal Article
Refereed: Yes
Keywords: Phase one research, non-therapeutic research and children, special medical procedures, therapeutic misconception, approval for medical research, medical research and incompetent adults
ISSN: 1320-159X
Subjects: Australian and New Zealand Standard Research Classification > LAW AND LEGAL STUDIES (180000) > OTHER LAW AND LEGAL STUDIES (189900)
Divisions: Current > QUT Faculties and Divisions > Faculty of Law
Current > Research Centres > Australian Centre for Health Law Research
Copyright Owner: Copyright 2013 Thomson Reuters (Australia/NZ)
Deposited On: 08 Sep 2013 22:58
Last Modified: 26 Jun 2017 08:40

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