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Mitochondrial replacement therapy (MRT), also called nuclear genome transfer and mitochondrial donation, is a new technique that can be used to prevent the transmission of mitochondrial DNA diseases. Apart from the United Kingdom, the first country to approve MRT in 2015, Australia became the second country with a clear regulatory path for the clinical applications of this technique in 2021. The rapidly evolving clinical landscape of MRT makes the elaboration and evaluation of the responsible use of this technology a pressing matter. As jurisdictions with less strict or non-existent reproductive laws are continuing to use MRT in the clinical context, the need to address the underlying ethical issues surrounding MRT’s clinical translation is fundamental.
Graeme Laurie’s notion of reflexive governance, rooted in learning from experiences as issues arise, reminds us that the future is built upon past lessons. This chapter looks to the past better to understand our present and future. It begins with the past, examining the complex interaction of law, ethics and science through the prism of three types of human rights: the rights of children and decisionally vulnerable adults, the right to benefit from scientific advancement, and the rights of future generations. It traces the maturation of each from humble beginnings to playing an increasingly central role in biomedical research policy-making. It then turns to the future, largely uncertain but nevertheless responding to the past and the present. It contends that the future of policy-making is partly in the debates spurred by advances in epigenomics and microbiomics, human heritable genome editing, and the Covid-19 pandemic. Each has put our policy-making legacy to the test, illustrating how new ethical paradigms build upon older ones. It concludes by reflecting on the role that biomedical research policy plays in ensuring that science serves the interests of humanity above all else.
In this paper, we outline the policy implications of mobile health research conducted at the international level. We describe the manner in which such research may have an international dimension and argue that it is not likely to be excluded from conventionally applicable international regulatory tools. We suggest that closer policy attention is needed for this rapidly proliferating approach to health research.
The Human Genome Organisation (HUGO) is an international membership organization (with 965 current members in 50 countries) whose goal is to coordinate and enhance efforts in the Human Genome Project (HGP). Formally established in 1989 by a group of the world's leading scientists in order to promote genome activities internationally, HUGO operates as a global coordinating organization to create the networks and channels through which genome information, initiatives, and ideas can flow and be disseminated.
Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws.
The last few years have witnessed the growth of large-scale, population genomics biobanks, which serve as longitudinal, gene-environment databases for future yet unspecified research. An international consortium, the Public Population Project in Genomics (P3G), builds harmonization tools for such biobanks and has catalogued numerous studies — at least 139 with over 10,000 banked participants and 34 with over 100,000. As their potential use for translational, clinical research draws near, it is opportune to clarify the duties of such biobanks to communicate results to participants. To identify the potential obligations, some demystification of the terminology surrounding the return of results as found in international and national norms on biobanking generally is essential. On the whole, our proposed lexicon is based on a study of norms as found in national and international policies but excludes debates found in the literature.
For many years, physicians at a cancer clinic have been storing biological samples left over after being used for diagnosis in clinical testing. Prior to 2000, no consent for storage or research was obtained. In 2000, the clinic changed its policy and began to systematically request consent for the use and storage of leftover biological samples “for future cancer research.” From that point on, the clinic has been storing samples only when the patient consented. It discards samples when the patient does not consent. Many of the sample donors are still alive (some are still patients at the clinic), while others have died. The clinic now has over 4000 samples, with comprehensive clinical data. Two groups of geneticists would like to use the samples for research, one examining the genetic basis of certain cancers, and the other examining the genetic basis of ethnicity and drug response in a randomized, heterogeneous population study.
What is bio-banking?
Our knowledge of genetics has largely transformed the manner in which biomedical research takes place. From the Human Genome Project and the International HapMap Consortium, we now know the sequence of the human genome, and we have created a haplotype map of the human genome, describing the common patterns of haplotype ancestry.
In the trauma surrounding mass disasters, the need to identify victims accurately and as soon as possible is critical. DNA identification testing is increasingly used to identify human bodies and remains where the deceased cannot be identified by traditional means. This form of testing compares DNA taken from the body of the deceased with DNA taken from their personal items (e.g. hairbrush, toothbrush etc.) or from close biological relatives. DNA identification testing was used to identify the victims of the terrorist attack on the World Trade Center in New York on September 11, 2001, and of the victims of the Tsunami that hit Asia on December 26, 2004. Shortly after the 9/11 attack, police investigators asked the victims' families for personal items belonging to the missing, and for DNA samples from family members themselves. The New York medical examiner's office coordinated the DNA identification testing program; however, some of the identification work was contracted out to private laboratories.
While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, it is in the very nature of international normative instruments to be general, except on specific issues considered to be in the interest of humanity, such as research into human reproductive cloning or access to AIDS drugs.