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  • 1
    Online Resource
    Online Resource
    Clarifying how to deploy the public interest criterion in consent waivers for health data and tissue research
    Springer Science and Business Media LLC ; 2020
    In:  BMC Medical Ethics Vol. 21, No. 1 ( 2020-12)
    Details
    In: BMC Medical Ethics, Springer Science and Business Media LLC, Vol. 21, No. 1 ( 2020-12)
    Abstract: Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards (IRBs) and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. Conclusion The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment.
    Type of Medium: Online Resource
    ISSN: 1472-6939
    URL: Article
    DOI: 10.1186/s12910-020-00467-5
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2041552-7
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  • 2
    Online Resource
    Online Resource
    What is the sufficientarian precautionary principle?
    Wiley ; 2019
    In:  Bioethics Vol. 33, No. 9 ( 2019-11), p. 1083-1084
    Details
    In: Bioethics, Wiley, Vol. 33, No. 9 ( 2019-11), p. 1083-1084
    Type of Medium: Online Resource
    ISSN: 0269-9702 , 1467-8519
    URL: Issue
    URL: Article
    DOI: 10.1111/bioe.v33.9
    DOI: 10.1111/bioe.12666
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 1480658-7
    SSG: 0
    SSG: 12
    SSG: 1
    SSG: 5,1
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  • 3
    Online Resource
    Online Resource
    Funder priority for vaccines: Implications of a weak Lockean claim
    Wiley ; 2022
    In:  Bioethics Vol. 36, No. 9 ( 2022-11), p. 978-988
    Details
    In: Bioethics, Wiley, Vol. 36, No. 9 ( 2022-11), p. 978-988
    Abstract: The development of some COVID‐19 vaccines by private companies like Moderna and Sanofi‐GSK has been substantially funded by various governments. While the Sanofi CEO has previously suggested that countries that fund this development ought to be given some priority, this suggestion has not been taken seriously in the literature. Considerations of nationalism, sustainability, need, and equitability have been more extensively discussed with respect to whether and how much a country is entitled to advance purchase orders of the vaccine under conditions of absolute scarcity. Yet, little attention has been paid to whether prior investment into developing a vaccine entitles a country to some priority with respect to these orders. Moreover, while not a majority view, some survey results show that a significant minority of the populace does endorse some view like this. This article argues that the minority have a point: recognizing funder countries some priority is justified by the weak Lockean claim (WLC). According to the WLC, the fact that someone has contributed to the development of something gives them some entitlement to the resultant product. This article will defend the WLC, and address objections to the argument, including those pertaining to questions of historical injustice and medical need. This argument does not imply an unconstrained entitlement. Rather, contribution to development is one morally relevant factor that must be tempered by and weighed against potentially more substantial claims to priority based on need, equity, and other considerations.
    Type of Medium: Online Resource
    ISSN: 0269-9702 , 1467-8519
    URL: Issue
    URL: Article
    DOI: 10.1111/bioe.v36.9
    DOI: 10.1111/bioe.13075
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 1480658-7
    SSG: 0
    SSG: 12
    SSG: 1
    SSG: 5,1
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  • 4
    Online Resource
    Online Resource
    An ethical framework for global vaccine allocation
    American Association for the Advancement of Science (AAAS) ; 2020
    In:  Science Vol. 369, No. 6509 ( 2020-09-11), p. 1309-1312
    Details
    In: Science, American Association for the Advancement of Science (AAAS), Vol. 369, No. 6509 ( 2020-09-11), p. 1309-1312
    Abstract: Once effective coronavirus disease 2019 (COVID-19) vaccines are developed, they will be scarce. This presents the question of how to distribute them fairly across countries. Vaccine allocation among countries raises complex and controversial issues involving public opinion, diplomacy, economics, public health, and other considerations. Nevertheless, many national leaders, international organizations, and vaccine producers recognize that one central factor in this decision-making is ethics ( 1 , 2 ). Yet little progress has been made toward delineating what constitutes fair international distribution of vaccine. Many have endorsed “equitable distribution of COVID-19…vaccine” without describing a framework or recommendations ( 3 , 4 ). Two substantive proposals for the international allocation of a COVID-19 vaccine have been advanced, but are seriously flawed. We offer a more ethically defensible and practical proposal for the fair distribution of COVID-19 vaccine: the Fair Priority Model.
    Type of Medium: Online Resource
    ISSN: 0036-8075 , 1095-9203
    URL: Article
    DOI: 10.1126/science.abe2803
    RVK:
    TA 1000
    RVK:
    WA 15000
    Language: English
    Publisher: American Association for the Advancement of Science (AAAS)
    Publication Date: 2020
    detail.hit.zdb_id: 128410-1
    detail.hit.zdb_id: 2066996-3
    detail.hit.zdb_id: 2060783-0
    SSG: 11
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  • 5
    Online Resource
    Online Resource
    Public interest in health data research: laying out the conceptual groundwork
    BMJ ; 2020
    In:  Journal of Medical Ethics Vol. 46, No. 9 ( 2020-09), p. 610-616
    Details
    In: Journal of Medical Ethics, BMJ, Vol. 46, No. 9 ( 2020-09), p. 610-616
    Abstract: The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of particular value. However, several different terms are used to refer to this value (including public interest, public benefit, public good and social value), indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided (1) Those projects have social value, broadly defined. (2) Data are de-identified. (3) Data are kept secure. (4) Businesses are not able to access the data for profit.
    Type of Medium: Online Resource
    ISSN: 0306-6800 , 1473-4257
    URL: Article
    DOI: 10.1136/medethics-2020-106152
    RVK:
    XA 54920
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2026397-1
    SSG: 0
    SSG: 1
    SSG: 5,1
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  • 6
    Online Resource
    Online Resource
    An Ethics Framework for Big Data in Health and Research
    Springer Science and Business Media LLC ; 2019
    In:  Asian Bioethics Review Vol. 11, No. 3 ( 2019-09), p. 227-254
    Details
    In: Asian Bioethics Review, Springer Science and Business Media LLC, Vol. 11, No. 3 ( 2019-09), p. 227-254
    Abstract: Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and Policy-relevant Ethics in Singapore (SHAPES) Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data.
    Type of Medium: Online Resource
    ISSN: 1793-8759 , 1793-9453
    URL: Article
    DOI: 10.1007/s41649-019-00099-x
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2019
    detail.hit.zdb_id: 2602378-7
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  • 7
    Online Resource
    Online Resource
    The Perfect Moral Storm: Diverse Ethical Considerations in the COVID-19 Pandemic
    Springer Science and Business Media LLC ; 2020
    In:  Asian Bioethics Review Vol. 12, No. 2 ( 2020-06), p. 65-83
    Details
    In: Asian Bioethics Review, Springer Science and Business Media LLC, Vol. 12, No. 2 ( 2020-06), p. 65-83
    Type of Medium: Online Resource
    ISSN: 1793-8759 , 1793-9453
    URL: Article
    DOI: 10.1007/s41649-020-00125-3
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2602378-7
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  • 8
    Online Resource
    Online Resource
    Vaccination of individuals lacking decision-making capacity during a public health emergency
    Oxford University Press (OUP) ; 2022
    In:  Journal of Law and the Biosciences Vol. 9, No. 2 ( 2022-07-01)
    Details
    In: Journal of Law and the Biosciences, Oxford University Press (OUP), Vol. 9, No. 2 ( 2022-07-01)
    Abstract: This paper explores the ethical challenges in deciding whether to vaccinate individuals lacking the decision-making capacity needed to provide informed consent during a public health emergency like COVID-19. The best interests standard ordinarily governs such decisions, which under the law in jurisdictions like England, Wales and Singapore takes into account the individual’s past wishes and present preferences. However, in a public health emergency, the interests of third parties become more salient: those whom the unvaccinated individual might expose to infection have an interest in the individual’s being vaccinated. While current mental capacity law has not been interpreted to take such public health considerations into account, we argue that such considerations are nevertheless ethically relevant, and can legitimately be weighed up alongside other considerations such as the preferences of the individual and impacts on their health. This is most relevant for individuals lacking decision-making capacity who have previously declined or presently resist vaccination. The public health impact of vaccination may in some instances be enough to outweigh preferences of the individual and justify providing vaccination against their past or present wishes.
    Type of Medium: Online Resource
    ISSN: 2053-9711
    URL: Article
    DOI: 10.1093/jlb/lsac030
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2756090-9
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  • 9
    Online Resource
    Online Resource
    Double trouble: Should double embryo transfer be banned?
    Springer Science and Business Media LLC ; 2015
    In:  Theoretical Medicine and Bioethics Vol. 36, No. 2 ( 2015-4), p. 121-139
    Details
    In: Theoretical Medicine and Bioethics, Springer Science and Business Media LLC, Vol. 36, No. 2 ( 2015-4), p. 121-139
    Type of Medium: Online Resource
    ISSN: 1386-7415 , 1573-1200
    URL: Article
    DOI: 10.1007/s11017-015-9324-x
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2015
    detail.hit.zdb_id: 2010860-6
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  • 10
    Online Resource
    Online Resource
    On the Ethics of Vaccine Nationalism: The Case for the Fair Priority for Residents Framework
    Cambridge University Press (CUP) ; 2021
    In:  Ethics & International Affairs Vol. 35, No. 4 ( 2021), p. 543-562
    Details
    In: Ethics & International Affairs, Cambridge University Press (CUP), Vol. 35, No. 4 ( 2021), p. 543-562
    Abstract: COVID-19 vaccines are likely to be scarce for years to come. Many countries, from India to the U.K., have demonstrated vaccine nationalism. What are the ethical limits to this vaccine nationalism? Neither extreme nationalism nor extreme cosmopolitanism is ethically justifiable. Instead, we propose the fair priority for residents (FPR) framework, in which governments can retain COVID-19 vaccine doses for their residents only to the extent that they are needed to maintain a noncrisis level of mortality while they are implementing reasonable public health interventions. Practically, a noncrisis level of mortality is that experienced during a bad influenza season, which society considers an acceptable background risk. Governments take action to limit mortality from influenza, but there is no emergency that includes severe lockdowns. This “flu-risk standard” is a nonarbitrary and generally accepted heuristic. Mortality above the flu-risk standard justifies greater governmental interventions, including retaining vaccines for a country's own citizens over global need. The precise level of vaccination needed to meet the flu-risk standard will depend upon empirical factors related to the pandemic. This links the ethical principles to the scientific data emerging from the emergency. Thus, the FPR framework recognizes that governments should prioritize procuring vaccines for their country when doing so is necessary to reduce mortality to noncrisis flu-like levels. But after that, a government is obligated to do its part to share vaccines to reduce risks of mortality for people in other countries. We consider and reject objections to the FPR framework based on a country: (1) having developed a vaccine, (2) raising taxes to pay for vaccine research and purchase, (3) wanting to eliminate economic and social burdens, and (4) being ineffective in combating COVID-19 through public health interventions.
    Type of Medium: Online Resource
    ISSN: 0892-6794 , 1747-7093
    URL: Article
    DOI: 10.1017/S0892679421000514
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2095251-X
    SSG: 3,6
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