DSpace Repository

Protecting the vulnerable or advancing medicine? Evaluating New Zealand’s legal framework on non-consensual clinical research

Show simple item record

dc.contributor.author Rassam, Mina
dc.date.accessioned 2019-01-08T03:34:51Z
dc.date.accessioned 2022-07-11T23:18:44Z
dc.date.available 2019-01-08T03:34:51Z
dc.date.available 2022-07-11T23:18:44Z
dc.date.copyright 2018
dc.date.issued 2018
dc.identifier.uri https://ir.wgtn.ac.nz/handle/123456789/20902
dc.description.abstract In New Zealand, a significant tension exists between a person’s right not to be subjected to clinical research without their informed consent, and society’s interest in the advancement of medical knowledge.¹ The impetus for this paper was the recent release of a consultation document by the Health and Disability Commissioner, Anthony Hill. The consultation paper sought the public’s views on health and disability research involving adult participants who are incompetent and cannot provide informed consent.² Two questions were asked: are New Zealand’s current laws regarding non-consensual research appropriate and, if not, how should they be amended?³ This paper addresses these questions and traverses New Zealand’s legal framework in a bid to identify legal gaps in the area of non-consensual research. At present, the law greatly restricts and renders uncertain the circumstances in which clinical research can lawfully be carried out. The identified legal issues are summarised as follows: First, the NZBORA prohibits all research on individuals who cannot give consent. It is unclear whether the benefit of medical knowledge is a reasonably justified limit to the NZBORA. Second, legal representatives can never consent to any form of research on incompetent adults. A lower standard is needed for substitute decision-making to give effect to the wishes of incompetent adults. Third, where no legal representative is available, the best interests test is the only other option available for research to be lawfully carried out on incompetent adults. The research must prove a direct benefit before the best interests test can be satisfied. Research is inherently uncertain. A benefit to the participant cannot be guaranteed in order to meet the test. Fourth, the law needs to be clearer for ethics committees to ensure research is lawfully approved. Fifth, while the accident compensation scheme adequately compensates publically-funded clinical trials resulting in harm, industry trials remain excluded from cover. This paper will address these issues and concerns as follows: The next part addresses the general scope of the paper. Part III analyses the gaps in New Zealand’s legal framework. Party IV briefly examines the way research on incompetent adults has been approved by ethics committees under the current law. Part V assesses New Zealand’s compensation regime and identifies areas where it could better cater for participants who assume the risks of research. Part VI reviews the legal framework in England and Wales, and Scotland and identifies effective areas which can be implemented in New Zealand’s framework in Part VII. ¹ Joanna Manning Non-consensual clinical research in New Zealand: Law Reform Urgently Needed (2016) 23 JLM 516 at 522. ² Anthony Hill HDC Consultation Document: Health and Disability Research Involving Adult Participants Who Are Unable to Provide Informed Consent (Health and Disability Commissioner, 24 February 2017). ³ Sonia Scott “Health and Disability Commissioner Research Consultation” (1 March 2017) Health and Disability Commissioner <http://nzccss.org.nz/news/2017/03/16310/>. en_NZ
dc.format pdf en_NZ
dc.language en_NZ
dc.language.iso en_NZ
dc.publisher Te Herenga Waka—Victoria University of Wellington en_NZ
dc.subject Non-consensual research en_NZ
dc.subject NZBORA en_NZ
dc.subject Clinical research en_NZ
dc.subject New Zealand Bill of Rights Act en_NZ
dc.title Protecting the vulnerable or advancing medicine? Evaluating New Zealand’s legal framework on non-consensual clinical research en_NZ
dc.type Text en_NZ
vuwschema.contributor.unit Victoria Law School en_NZ
vuwschema.contributor.unit Faculty of Law / Te Kauhanganui Tātai Ture en_NZ
vuwschema.subject.anzsrcfor 180110 Criminal Law and Procedure en_NZ
vuwschema.subject.anzsrcfor 180114 Human Rights Law en_NZ
vuwschema.subject.anzsrcfor 180119 Law and Society en_NZ
vuwschema.subject.anzsrcfor 180122 Legal Theory, Jurisprudence and Legal Interpretation en_NZ
vuwschema.subject.anzsrcfor 189999 Law and Legal Studies not elsewhere classified en_NZ
vuwschema.subject.anzsrcseo 970118 Expanding Knowledge in Law and Legal Studies en_NZ
vuwschema.type.vuw Masters Research Paper or Project en_NZ
thesis.degree.discipline Law en_NZ
vuwschema.subject.anzsrcforV2 489999 Other law and legal studies not elsewhere classified en_NZ
vuwschema.contributor.school School of Law en_NZ

Files in this item

This item appears in the following Collection(s)

Show simple item record

Search DSpace


My Account