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Journal of Long-Term Effects of Medical Implants
SJR: 0.332 SNIP: 0.491 CiteScore™: 0.89

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v18.i1.150
17 pages

Abstract of "An Ethical Analysis of Emerging Models of Consent for Genomics and Biobanking"

Kerry Bowman
University of Toronto Joint Centre for Bioethics Toronto, ON, M5G 1L4, Canada
Maxwell J. Smith
University of Toronto Joint Centre for Bioethics Toronto, ON, M5G 1L4, Canada


The informed consent process is a primary component of protecting the rights and welfare of individuals involved in human subjects research. This protection is grounded in the concept of the right to autonomy or self-determination, which is a fundamental ethical necessity in demonstrating genuine respect for human integrity and dignity. Each of the international documents that provide guidance for the informed consent process are foundational to ensure respect for persons and works from the presupposition that informed individual choice will always trump views of societal best interests. Consequently, the informed consent process has been a sacrosanct principle of all research in Western nations. Recent advances in the domain of genomics and biobanking have challenged this core principle. Large aggregate population studies require biological samples from large populations for cross-comparative and epidemiological purposes, creating the need for biobanks. With these advances in biobanking, informed consent in its traditional form becomes nearly impossible to implement since the ultimate direction and nature of such research continues to evolve long after original samples are taken. Responsible researchers and health-care professionals are struggling to adhere to the principles of informed consent yet do not wish to stand in the way of highly significant and socially useful research. This poses a true ethical dilemma. In recent years, several pragmatic models of alternative methods for establishing consent have emerged. Yet, the true ethical nature and moral validity of such models have not been well explored. As a means of finding future direction, this presentation analyzes the history of consent in relation to research ethics. It then systematically reviews emerging models of consent for the unique endeavor of genomics and biobanking. A series of recommendations are made based on ethical principles that should be considered when ensuring informed consent as it relates to biobanking.