Determining the state of guidance on pediatric biobanking for researchers, HRECS, and families: Regulatory mapping of international guidance.

Biobanking-the storage of human biological samples, including tissue, blood, urine, and genetic data-raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases. Guidance on navigating these legal and ethical difficulties is needed for those involved in pediatric biobanking-including researchers, participants, and families, and those involved in biobank governance. This paper seeks to map the current regulatory framework governing pediatric biobanking to determine what guidance is currently offered. Regulatory mapping of current international and national guidelines on pediatric biobanking addressing the ethical, legal, and social nuances of pediatric biobanking was undertaken. This paper finds that international guidelines around biobanking are mostly for adults, and even when pediatric-specific, documents are non-binding, inconsistent, or only limited guidance is offered on a range of important issues specific to pediatric biobanks.   Conclusion: This paper shows a need for consistent, comprehensive, and clear regulation on pediatric biobanking so that research can more quickly, efficiently, and ethically be translated to useful information and treatment in pediatric care. What is Known: • Pediatric biobanking presents new opportunities to conduct valuable translational research to benefit pediatric populations. However, the storage of pediatric biological samples raises many ethical, legal and social issues-in part because child participants may be considered to lack capacity to consent but can acquire this capacity upon maturity when the research is still ongoing. Pediatric biobanks must grapple with issues of consent, confidentiality and privacy, and long-term participation regarding child participants. What is New: • Regulatory guidance on these ethical, legal, and social issues is needed for researchers, participants, and families and those involved in biobank governance. This paper identifies nationally specific and international guidance on biobanking and summarizes the guidance provided in relation to these pediatric specific issues. It finds that most guidance is non-binding and inconsistent between guidance documents and may offer only limited guidance to stakeholders. A need for consistent, comprehensive, and clear regulation on pediatric biobanking is needed at an international level to enable research.

Online modules to improve health professionals' end-of-life law knowledge and confidence: a pre-post survey study.

BACKGROUND: Health professionals and medical students have knowledge gaps about the law that governs end-of-life decision-making. There is a lack of dedicated training on end-of-life law and corresponding research on the impact of this type of training. OBJECTIVE: To examine the impact of online training modules on key concepts of end-of-life law on Australian health professionals' legal knowledge and their self-reported confidence in applying the law in practice. METHODS: Online pre- and post-training surveys were completed by training participants. The optional surveys collected demographic data, directly assessed legal knowledge and measured self-reported confidence in applying the law in clinical practice, before and after training. RESULTS: Survey response rates were 66% (pre-training) and 12% (post-training). The final sample for analysis (n = 136 participants with matched pre- and post-training surveys), included nurses, doctors, allied health professionals, medical students and a small number of non-health professionals. Following completion of the online training modules, legal knowledge scores significantly increased overall and across each domain of end-of-life law. Participants were also more confident in applying the law in practice after training (median = 3.0, confident) than before training (median = 2.0, not confident). CONCLUSIONS: This study found that completion of online training modules on end-of-life law increased Australian health professionals' legal knowledge and self-reported confidence in applying the law in clinical practice. Participants demonstrated some remaining knowledge gaps after training, suggesting that the training, while effective, should be undertaken as part of ongoing education on end-of-life law. Future research should examine longer term outcomes and impacts of the training.

Supporting the Involvement of Adults with Cognitive Disabilities in Research: The Need for Reform.

This article examines current legal and ethical requirements concerning research about adults with cognitive disabilities. These requirements, the article argues, are complex, difficult to navigate, and inevitably act as a disincentive for research to be conducted. These requirements also do little to encourage active involvement by adults with cognitive disabilities in deciding whether to participate in research. The article argues that reforms are needed for State and Territory laws to require, wherever possible, adults to be supported to make their own decisions about research participation. State and Territory law reform is also required to clarify when, and on what basis, others may be appointed to make research participation decisions on behalf of adults with cognitive disabilities. The article concludes by seeking complementary reform of the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research, which would result in it being more human rights compliant and simpler to apply.

Transitions in decision-making authority at the end of life: a problem of law, ethics and practice in deceased donation.

Where a person is unable to make medical decisions for themselves, law and practice allows others to make decisions on their behalf. This is common at the end of a person's life where decision-making capacity is often lost. A further, and separate, decision that is often considered at the time of death (and often preceding death) is whether the person wanted to act as an organ or tissue donor. However, in some jurisdictions, the lawful decision-maker for the donation decision (the 'donation decision-maker') is different from the person who was granted decision-making authority for medical decisions during the person's life. To date, little attention has been given in the literature to the ethical concerns and practical problems that arise where this shift in legal authority occurs. Such a change in decision-making authority is particularly problematic where premortem measures are suggested to maximise the chances of a successful organ donation. This paper examines this shift in decision-making authority and discusses the legal, ethical and practical implications of such frameworks.

Guiding Genomic Research: Australia's National Statement on Ethical Conduct in Human Research.

With advances in genomic research playing an important role in the development of clinical applications, it is important that ethical guidance for researchers is contemporary and relevant. In this article we analyse the relevant provisions in Australia's National Statement on Ethical Conduct in Human Research (revised in 2018) and consider the guidance it provides for contemporary genomics research. We analyse four key areas: genomic information; biobanking and use of human tissue; consent to participation in genomic research, including specific issues related to participation by children; and return of findings. We conclude that Australia's National Statement is well-placed to provide guidance to Australian researchers on issues relating to genomics, although there is scope for additional guidance on some issues related to consent.

Removal and use of paediatric tissue for research purposes: Legal and ethical issues in Australia.

Tissue samples may be collected from children in the course of their clinical care, or when they participate in research. Those samples may be stored in research biobanks. However, as the removal of tissue from children in Australia is regulated by State and Territory legislation, clinicians and researchers require an understanding of the regulatory framework. Removal of tissue from children for purposes not authorised under legislation can result in offences being committed. In addition, ethical issues arise from the collection and storage of children's tissue for research purposes. Tissue used for genomic research also brings additional risks to participants. This paper describes the current law, discusses its inadequacies and raises some of the key ethical issues that Australian researchers need to know. This paper focuses on the removal and use of paediatric tissue for research purposes only.

Pressure placed on paediatric haematopoietic stem cell donors: Views from health professionals.

AIM: Paediatric haematopoietic stem cell donors undergo non-therapeutic procedures and endure known and unknown physical and psychosocial risks for the benefit of a family member. One ethical concern is the risk that they may be pressured by parents or health professionals to act as a donor. This paper adds to what is known about this topic by presenting the views of health professionals. METHODS: This qualitative study involved semi-structured interviews with 14 health professionals in Australasia experienced in dealing with paediatric donors. Transcripts were analysed using established qualitative methodologies. RESULTS: Health professionals considered that some paediatric donors experience pressure to donate. Situations that were likely to increase the risk of pressure being placed on donors were identified, and views were expressed about the ethical 'appropriateness' of these practices within the family setting. CONCLUSIONS: Children may be subject to pressure from family and health professionals to be tested and act as donors, Therefore, our ethical obligation to these children extends to implementing donor-focused processes - including independent health professionals and the appointment of a donor advocate - to assist in detecting and addressing instances of inappropriate pressure being placed on a child.

Biobanking of blood and bone marrow: emerging challenges for custodians of public resources.

The Australian Bone Marrow Donor Registry (ABMDR) is a publicly funded company that is part of an international network that facilitates unrelated bone marrow transplantation. This role means that the ABMDR has access to a large biospecimen repository therefore making it a highly valuable research resource. Recognising the potential value of these biospecimens for research purposes, the ABMDR is in the process of determining whether, and how, to share its biospecimens with other biobanks. While this would undoubtedly be of value to the scientific community, and ultimately to the wider community, it would also inevitably transform the role of an institution whose primary role is therapeutic, and would compromise the degree of control that a custodian has over donated material. This article describe the challenges confronting the ABMDR, and organisations like it, in balancing their duties to donors, patients, researchers and the general public. These problems have led inevitably to the use of "property" rights language in the discussion of these issues but notions of gift, ownership, trusteeship and transfer might also be considered.

Decision-making About Premortem Interventions for Donation: Navigating Legal and Ethical Complexities.

Premortem interventions (PMIs) for organ donation play a vital role in preserving opportunities for deceased donation or increasing the chances of successful transplantation of donor organs. Although ethical considerations relating to use of particular PMIs have been well explored, the ethical and legal aspects of decision-making about the use of PMIs have received comparatively little attention. In many countries, there is significant uncertainty regarding whether PMIs are lawful or, if they are, who can authorize them. Furthermore, emphasis on consideration of therapeutic goals in substitute decision-making frameworks may discourage consideration of donation goals. In this article, we examine the fundamental questions of who should have the authority to make decisions about the use of PMIs on behalf of a potential donor and how such decisions should be made. We draw on international examples of legal reform that have sought to clarify the legal position in relation to administering PMIs and identify potential elements of an effective regulatory model for PMIs. In doing so, we argue that reforms are needed in many countries to provide legal certainty for clinicians who are responsible for supporting decision-making about PMIs and to ensure that the goals and preferences of potential donors are accorded due consideration in the decision-making process.

"I used to call him a non-decision-maker - I never do that anymore": parental reflections about training to support decision-making of their adult offspring with intellectual disabilities.

PURPOSE: A rights perspective proposes supported decision-making as an alternative to substitute decision-making. However, evidence about supported decision-making practice is limited. Our aim was to build evidence about building the capacity of decision supporters. METHODS: Eighteen parents of people with intellectual disabilities were trained in decision support using the La Trobe Support for Decision-making Practice Framework. Data from repeated semi-structured interviews and mentoring sessions were used to capture parental reflections on the value of training. RESULTS: The training acted as a catalyst for parent self-reflection and the Framework prompted them to adopt a more deliberative approach to supporting decision-making. Some parents perceived increased confidence of their adult offspring in expressing preferences resulting from their own changed approach. CONCLUSIONS: This study demonstrates the efficacy of this Framework and evidence-based training in building the capacity of parental decision supporters to be consistent with the rights paradigm. IMPLICATIONS FOR REHABILITATIONThe La Trobe Support for Decision-making Practice Framework is an evidence-based approach to decision support practice with an accompanying set of free online resources which can be used by individual practitioners or programs to inform their practice and build the capacity of supporters.Parents of adults with intellectual disabilities value training in the La Trobe Support for Decision-making Practice Framework, which they consider helps to develop their decision support skills and self-reflection.Parents also value individual mentoring following training to assist them to apply the principles of the practice framework to the everyday support for decision-making they provide to their adult son or daughter.Training in support practice should be accompanied by individual mentoring or other strategies to assist parents of adults with intellectual disabilities to discuss and solve the difficult issues they confront in providing decision support more aligned to the rights paradigm.

Young children as regenerative tissue donors: considering the need for legal reform in light of divergent ethical approaches.

In Australia, young children who lack decision-making capacity can have regenerative tissue removed to treat another person suffering from a severe or life-threatening disease. While great good can potentially result from this as the recipient's life may be saved, ethical unease remains over the "use" of young children in this way. This article examines the ethical approaches that have featured in the debate over the acceptability and limits of this practice, and how these are reflected in Australia's legal regime governing removal of tissue from young children. This analysis demonstrates a troubling dichotomy within Australia's laws that requires decision-makers to adopt inconsistent ethical approaches depending on where a donor child is situated. It is argued that this inconsistency in approach warrants legal reform of this ethically sensitive issue.

Cosmetic surgery on children - professional and legal obligations in Australia.

BACKGROUND: Public awareness and concern about cosmetic surgery on children is increasing. Nationally and internationally questions have been raised by the media and government bodies about the appropriateness of children undergoing cosmetic surgery. Considering the rates of cosmetic surgery in comparable Western societies, it seems likely that the number of physicians in Australia who will deal with a request for cosmetic surgery for a child will continue to increase. This is a sensitive issue and it is essential that physicians understand the professional and legal obligations that arise when cosmetic surgery is proposed for a child. OBJECTIVE: This article reviews the current professional and legal obligations that physicians have to competent and incompetent children for whom cosmetic surgery has been requested. DISCUSSION: A case study is used to highlight the factors that Australian primary care physicians must consider before referring and conducting cosmetic surgery on children.

A framework for ethics review of applications to store, reuse and share tissue samples.

The practice of biobank networking-where biobanks are linked together, and researchers share human tissue samples-is an increasingly common practice both domestically and internationally. The benefits from networking in this way are well established. However, there is a need for ethical oversight in the sharing of human tissue. Ethics committees will increasingly be called upon to approve the sharing of tissue and data with other researchers, often via biobanks, and little guidance currently exists for such committees. In this paper, we provide a structured approach to the ethical review of on-sharing of data and tissue for research purposes.

Supporting decision-making of adults with cognitive disabilities: The role of Law Reform Agencies - Recommendations, rationales and influence.

Article 12 of the UNCRPD on equal recognition before the law, places an obligation on member states to 'provide access by persons with disabilities to the support they may require in exercising their legal capacity'. This has resulted in an increased focus on the concept and practice of supported decision-making, as opposed to substitute decision-making, for those with cognitive disabilities. To date, translation of this concept into law has been limited. However, Law Reform Agencies, tasked with reviewing legal decision-making schemes are increasingly recommending incorporation of legally recognised supported decision-making measures. This paper identifies the contribution of Law Reform Agencies' reports and recommendations to the evolving body of knowledge in relation to supported decision-making. In particular, it analyses the rationales for recommendations favouring the introduction of forms of legally recognised supported decision-making and the types of legal models of supported decision-making being recommended by Law Reform Agencies.

Commercialisation of regenerative human tissue: regulation and reform in Australia and England, Wales and Northern Ireland.

The commercialisation of therapeutic products containing regenerative human tissue is regulated by the common law, statute and ethical guidelines in Australia and England, Wales and Northern Ireland. This article examines the regulatory regimes in these jurisdictions and considers whether reform is required to both support scientific research and ensure conformity with modern social views on medical research and the use of human tissue. The authors consider the crucial role of informed consent in striking the balance between the interests of researchers and the interests of the public.

Stem cell technologies: regulation, patents and problems.

Human embryonic stem cell research promises to deliver in the future a whole range of therapeutic treatments, but currently governments in different jurisdictions must try to regulate this burgeoning area. Part of the problem has been, and continues to be, polarised community opinion on the use of human embryonic stem cells for research. This article compares the approaches of the Australian, United Kingdom and United States governments in regulating human embryonic stem cell research. To date, these governments have approached the issue through implementing legislation or policy to control research. Similarly, the three jurisdictions have viewed the patentability of human embryonic stem cell technologies in their own ways with different policies being adopted by the three patent offices. This article examines these different approaches and discusses the inevitable concerns that have been raised due to the lack of a universal approach in relation to the regulation of research; the patenting of stem cell technologies; and the effects patents granted are having on further human embryonic stem cell research.

Regulation of human stem cell research in Australia.

Australia is currently well placed to contribute to the global growth of human stem cell research. However, as the science has progressed, authorities have had to deal with the ongoing challenges of regulating such a fast moving field of scientific endeavour. Australia's past and current approach to regulating the use of embryos in human embryonic stem cell research provides an insight into how Australia may continue to adapt to future regulatory challenges presented by human stem cell research. In the broader context, a number of issues have been identified that may impact upon the success of future human stem cell research in Australia.