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Leah Z. Rand [6]Leah Rand [6]
  1.  34
    Public involvement in the governance of population-level biomedical research: unresolved questions and future directions.Sonja Erikainen, Phoebe Friesen, Leah Rand, Karin Jongsma, Michael Dunn, Annie Sorbie, Matthew McCoy, Jessica Bell, Michael Burgess, Haidan Chen, Vicky Chico, Sarah Cunningham-Burley, Julie Darbyshire, Rebecca Dawson, Andrew Evans, Nick Fahy, Teresa Finlay, Lucy Frith, Aaron Goldenberg, Lisa Hinton, Nils Hoppe, Nigel Hughes, Barbara Koenig, Sapfo Lignou, Michelle McGowan, Michael Parker, Barbara Prainsack, Mahsa Shabani, Ciara Staunton, Rachel Thompson, Kinga Varnai, Effy Vayena, Oli Williams, Max Williamson, Sarah Chan & Mark Sheehan - 2021 - Journal of Medical Ethics 47 (7):522-525.
    Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can (...)
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  2.  51
    National Standards for Public Involvement in Research: missing the forest for the trees.Matthew S. McCoy, Karin Rolanda Jongsma, Phoebe Friesen, Michael Dunn, Carolyn Plunkett Neuhaus, Leah Rand & Mark Sheehan - 2018 - Journal of Medical Ethics 44 (12):801-804.
    Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for (...)
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  3.  18
    Patient and public involvement: Two sides of the same coin or different coins altogether?Matthew S. McCoy, Jonathan Warsh, Leah Rand, Michael Parker & Mark Sheehan - 2019 - Bioethics 33 (6):708-715.
    Patient and public involvement (PPI) has gained widespread support in health research and health policy circles, but there is little consensus on the precise meaning or justifications of PPI. We argue that an important step towards clarifying the meaning and justification for PPI is to split apart the familiar acronym and draw a distinction between patient and public involvement. Specifically, we argue that patient involvement should refer to the practice of involving individuals in health research or policy on the basis (...)
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  4.  12
    Limitations on the Capability of the FDA to Advise.Aaron S. Kesselheim & Leah Z. Rand - 2022 - American Journal of Bioethics 22 (10):15-17.
    Svirsky, Howard, and Berman address the U.S. Food and Drug Administration ’s oversight of tobacco products, the newest major area of regulation Congress assigned to the FDA. They discus...
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  5. Prior Authorization as a Potential Support of Patient-Centered Care.Leah Rand & Zackary Berger - 2018 - Patient 4 (11):371-375.
    We discuss the role of prior authorization (PA) in supporting patient-centered care (PCC) by directing health system resources and thus the ability to better meet the needs of individual patients. We begin with an account of PCC as a standard that should be aimed for in patient care. In order to achieve widespread PCC, appropriate resource management is essential in a healthcare system. This brings us to PA, and we present an idealized view of PA in order to argue how (...)
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  6.  9
    Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines.Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow & William B. Feldman - 2023 - Hastings Center Report 53 (S2):60-68.
    The Covid‐19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions. Ensuring that the FDA is itself trustworthy is important for justifying public trust in its actions, like vaccine approvals, thereby promoting public health. We propose five conditions of trustworthiness that the FDA should meet when it reviews vaccines, even during emergencies: consistency with rules, proper expert or political decision‐makers, proper (...)
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  7.  8
    Priority-Setting on the Path to Universal Health Care.Leah Z. Rand - 2023 - Journal of Law, Medicine and Ethics 51 (1):150-152.
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  8.  10
    An International Review of Health Technology Assessment Approaches to Prescription Drugs and Their Ethical Principles.Leah Z. Rand & Aaron S. Kesselheim - 2020 - Journal of Law, Medicine and Ethics 48 (3):583-594.
    In many countries, health technology assessment organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries’ methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in the methodologies HTA organizations use to conduct (...)
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  9.  31
    Are Medicaid Closed Formularies Unethical? Social Values and Limit-Setting.Leah Rand & Govind Persad - 2019 - AMA Journal of Ethics 21 (8):E654-E660.
    State Medicaid programs have proposed closed formularies to limit spending on drugs. Closed formularies can be justified when they enable spending on other socially valuable aims. However, it is still necessary to justify guidelines informing formulary design, which can be done through a process of decision making that includes the public. This article examines criticisms that Medicaid closed formularies limit deliberation about decisions that affect drug access and unfairly disadvantage poor patients. Although unfairness to poor patients is a risk, it (...)
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  10. Resource allocation issues in dementia.Leah Rand & Mark Sheehan - 2014 - In Charles Foster, Jonathan Herring & Israel Doron (eds.), The law and ethics of dementia. Portland, Oregon: Hart Publishing.
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  11.  16
    High-Priced Sickle Cell Gene Therapies Threaten to Exacerbate US Health Disparities and Establish New Pricing Precedents for Molecular Medicine.Frazer A. Tessema, Ameet Sarpatwari, Leah Z. Rand & Aaron S. Kesselheim - 2022 - Journal of Law, Medicine and Ethics 50 (2):380-384.
    Gene therapies to treat sickle cell disease are in development and are expected to have high costs. The large eligible population size — by far, the largest for a gene therapy — poses daunting budget challenges and threatens to exacerbate health disparities for Black patients, who make up the vast majority of American sickle cell patients.
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  12.  5
    Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, and William B. Feldman Reply. [REVIEW]Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow & William B. Feldman - 2024 - Hastings Center Report 54 (2):44-45.
    The authors respond to a letter by Mitchell Berger in the March‐April 2024 issue of the Hastings Center Report concerning their essay “Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines.”.
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