_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)

Contemporary scientific research depends on sharing resources. Norms, cultures and infrastructures enable, incentivize or require sharing in particular ways. Commons are one type of infrastructure, and their key characteristics include the provision and governance of resources. Understanding how resources become part of a commons is critical for implementing arrangements that effectively facilitate scientific research. This article uses commons theory associated with knowledge resources to explore efforts to establish a registry for the Australian stem cell research community where registration is not (...) a current norm. Analyzing the perspectives of stem cell researchers regarding registries, we make two contributions: (1) a conceptual contribution to the commons literature by explicating a more contingent understanding of resources, and (2) an empirical analysis of a relatively under-examined form of governance arrangement (i.e. registries). We emphasize paying close attention to the context-dependent processes through which resources are viewed as common-able and may subsequently become common-ed. (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)

This article examines the role of patient organizations as mediators between patients and researchers in stem cell research in Australia. We conducted semi-structured interviews with stem cell researchers and patient organization representatives as part of a broader project to deepen public understanding and foster more robust scientific practices in stem cell-based research and therapies. We used Habermas’s Theory of Communicative Action as our theoretical framework to explore the relationships between patient organizations and researchers. Using this framework allowed the identification of (...) two different ways of conceptualizing health and illness—one based on patients’ experiences, which we call “the lifeworld,” and another grounded on researchers’, health professionals’, and policymakers’ professional perspectives, which we call “the rational system.” We found that the different conceptualizations identified influenced the interactions between patients and researchers (and other professionals involved in the healthcare system). Patient organizations, then, act as articulators of patients’ viewpoints in this scenario, which can have advantages and disadvantages. We also found that researchers need to develop less transactional forms of communication with these organizations and that policymakers and regulators could benefit from developing guidelines to encourage researchers to use diverse strategies to engage more meaningfully with patients at individual and organizational levels. (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 Global Alliance for Genomics and Health (GA4GH)GA4GH is an international not-for-profit organization dedicated to the development of standards and policies to expand the use of genomic data within a human rights framework, improving health for everyone. The GA4GHGA4GH benefits from the participation of more than 500 leading organizations in healthcare, patient advocacy, research and ethicsEthics, government, life science, and information technology. This chapter charts the key accomplishments of the Regulatory and Ethics Work Stream (REWS) of the GA4GH. The REWS (...) is a founding Work Stream of the GA4GHGA4GH responsible for the landmark Framework for Responsible Sharing of Genomic and Health-Related Data (2014/19). On the organization’s tenth anniversary, the authors highlight what, in their unique perspective as present or former leaders of the REWS, they consider to be its major contributions to interdisciplinary, participative, and international policy developments in genomics. Considerations for future REWS objectives and outputs are presented in closing. (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)