_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

Biobanks are increasingly being created specifically for research purposes. Concomitantly, we are seeing significant and evolving shifts in research ethics in relation to biobanking. Three discrete shifts are identified in this article. The first extends the ethical focus beyond the protection of human subjects to the promotion of broader community benefits of research utilizing biobanked resources, and an expectation that these benefits will be shared. The second involves the evolution of the traditional consent paradigm for future research uses of biobanks (...) resources that are not in contemplation at the time of donation. The third involves a move away from single project management to more dynamic governance accountability to research participants and the public. These shifts may take different local and institutional forms but share common recognizable elements. (shrink)

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange (...) of biospecimens and data and in monitoring compliance. (shrink)

Genomics is increasingly becoming an integral component of health research and clinical care. The perceived difficulties associated with genetic research involving Aboriginal and Torres Strait Islander people mean that they have largely been excluded as research participants. This limits the applicability of research findings for Aboriginal and Torres Strait Islander patients. Emergent use of genomic technologies and personalised medicine therefore risk contributing to an increase in existing health disparities unless urgent action is taken. To allow the potential benefits of genomics (...) to be more equitably distributed, and minimise potential harms, we recommend five actions: ensure diversity of participants by implementing appropriate protocols at the study design stage; target diseases that disproportionately affect disadvantaged groups; prioritise capacity building to promote Indigenous leadership across research professions; develop resources for consenting patients or participants from different cultural and linguistic backgrounds; and integrate awareness of issues relating to Indigenous people into the governance structures, formal reviews, data collection protocols and analytical pipelines of health services and research projects. (shrink)

The authors of the ELSIcon special issue have advanced the conversation on ethics and genetics. Nevertheless, we have some concerns. Here, we respond specifically to Conley et al. (2023). We choose...

This book is a rich blend of analyses by leading experts from various cultures and disciplines. A compact introduction to a complex field, it illustrates biotechnology's profound impact upon the environment and society. Moreover, it underscores the vital relevance of cultural values. This book empowers readers to more critically assess biotechnology's value and effectiveness within both specific cultural and global contexts.

It is generally recognised that public health problems in the developing world are dire and that the rest of the world has a moral commitment to provide assistance. Yet many of the world’s poor are unable to access essential pharmaceuticals simply because products that are under patent are too expensive and cheaper generics are not available. One of the proposed solutions to this problem is to allow domestic manufacture of generic products in response to public health crises. However, this solution (...) will provide no assistance in countries that lack the capacity to manufacture pharmaceuticals. This article discusses the extensive international negotiations occurring during the last couple of years that seek to provide an appropriate balance between access rights and patent rights. (shrink)