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Best Interests and Non-consensual Research
Brent Hyslop1,2
1Clinical Senior Lecturer, Department of Medicine, Dunedin School of Medicine, University of Otago.
Journal of Law and Medicine
|July 7, 2018
Summary
Clinical research with adults unable to consent (non-consensual research) faces legal challenges. This article argues a "best interests" legal standard can be met, advocating for its reconsideration and a dual approach to reform.
Area of Science:
- Legal and Ethical Frameworks in Clinical Research
- Medical Law and Bioethics
- Regulatory Standards for Human Subject Research
Background:
- Clinical research involving adults unable to provide informed consent (non-consensual research - NCR) presents significant legal and ethical complexities.
- Current legal standards, particularly the 'best interests' test used in New Zealand, are debated regarding their applicability to NCR.
- There is a prevailing view that existing legal standards are insufficient, necessitating new frameworks for valuable NCR to proceed.
Purpose of the Study:
- To critically evaluate the suitability of the 'best interests' test as a legal standard for non-consensual research (NCR).
- To argue that the 'best interests' test can indeed be satisfied within the context of NCR.
- To propose a dual approach for legal reform, potentially integrating the 'best interests' test with new, specific standards.
Main Methods:
- Legal analysis of the 'best interests' test in the context of non-consensual research (NCR).
- Examination of existing legal scholarship and arguments challenging the applicability of the 'best interests' test.
- Development of a theoretical framework supporting the satisfaction of the 'best interests' test in NCR and proposing reform recommendations.
Main Results:
- The article contends that the 'best interests' test is a viable and suitable benefit-harm standard for evaluating non-consensual research (NCR).
- It demonstrates that the 'best interests' test can be practically satisfied, contrary to existing claims.
- The study suggests that maintaining the 'best interests' test alongside a new, more specific legal standard offers a synergistic and effective reform strategy.
Conclusions:
- The 'best interests' test should be reconsidered as an appropriate legal standard for non-consensual research (NCR).
- A dual legal approach, combining the 'best interests' test with a new, specific standard, is recommended for current discussions on reforming NCR regulations.
- This integrated strategy can facilitate valuable research while upholding ethical and legal safeguards for participants unable to consent.
