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.
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.
Impact and interest:
Citation counts are sourced monthly from and citation databases.
These databases contain citations from different subsets of available publications and different time periods and thus the citation count from each is usually different. Some works are not in either database and no count is displayed. Scopus includes citations from articles published in 1996 onwards, and Web of Science® generally from 1980 onwards.
Citations counts from theindexing service can be viewed at the linked Google Scholar™ search.
Full-text downloads displays the total number of times this work’s files (e.g., a PDF) have been downloaded from QUT ePrints as well as the number of downloads in the previous 365 days. The count includes downloads for all files if a work has more than one.
|Item Type:||Journal Article|
|Keywords:||Phase one research, non-therapeutic research and children, special medical procedures, therapeutic misconception, approval for medical research, medical research and incompetent adults|
|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
Current > Schools > School of Law
|Copyright Owner:||Copyright 2013 Thomson Reuters (Australia/NZ)|
|Deposited On:||08 Sep 2013 22:58|
|Last Modified:||10 Sep 2013 00:04|
Repository Staff Only: item control page