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  1.  57
    How to Write a Systematic Review of Reasons.Daniel Strech & Neema Sofaer - 2012 - Journal of Medical Ethics 38 (2):121-126.
    Systematic reviews, which were developed to improve policy-making and clinical decision-making, answer an empirical question based on a minimally biased appraisal of all the relevant empirical studies. A model is presented here for writing systematic reviews of argument-based literature: literature that uses arguments to address conceptual questions, such as whether abortion is morally permissible or whether research participants should be legally entitled to compensation for sustaining research-related injury. Such reviews aim to improve ethically relevant decisions in healthcare, research or policy. (...)
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  2.  33
    The Diverse Ethics of Translational Research.Neema Sofaer & Nir Eyal - 2010 - American Journal of Bioethics 10 (8):19-30.
    Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research (now called T1 ). Whether or not T1 has these features, translational research beyond approval (...)
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  3.  51
    The Need for Systematic Reviews of Reasons.Neema Sofaer & Daniel Strech - 2012 - Bioethics 26 (6):315-328.
    There are many ethical decisions in the practice of health research and care, and in the creation of policy and guidelines. We argue that those charged with making such decisions need a new genre of review. The new genre is an application of the systematic review, which was developed over decades to inform medical decision-makers about what the totality of studies that investigate links between smoking and cancer, for example, implies about whether smoking causes cancer. We argue that there is (...)
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  4.  25
    Reciprocity‐Based Reasons for Benefiting Research Participants: Most Fail, the Most Plausible is Problematic.Neema Sofaer - 2014 - Bioethics 28 (9):456-471.
    A common reason for giving research participants post-trial access to the trial intervention appeals to reciprocity, the principle, stated most generally, that if one person benefits a second, the second should reciprocate: benefit the first in return. Many authors consider it obvious that reciprocity supports PTA. Yet their reciprocity principles differ, with many authors apparently unaware of alternative versions. This article is the first to gather the range of reciprocity principles. It finds that: most are false. The most plausible principle, (...)
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  5. Care After Research: A Framework for NHS RECs.Neema Sofaer, Penney Lewis & Hugh Davies - 2012 - Health Research Authority.
    Care after research is for participants after they have finished the study. Often it is NHS-provided healthcare for the medical condition that the study addresses. Sometimes it includes the study intervention, whether funded and supplied by the study sponsor, NHS or other party. The NHS has the primary responsibility for care after research. However, researchers are responsible at least for explaining and justifying what will happen to participants once they have finished. RECs are responsible for considering the arrangements. There are (...)
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  6.  24
    Forthcoming Practical Framework for Ethics Committees and Researchers on Post-Trial Access to the Trial Intervention and Healthcare.Neema Sofaer, Penney Lewis & Hugh Davies - 2014 - Journal of Medical Ethics 40 (4):217-218.
    When research concludes, post-trial access to the trial intervention or standard healthcare can be crucial for participants who are ill such as those in resource-poor countries with inadequate healthcare, British participants testing ‘last-chance drugs’ unavailable on the National Health Service and underinsured US participants. Yet, many researchers are unclear about their obligations regarding the post-trial period, and many research ethics committees do not know what to require of researchers. Consequences include participants who reasonably expect but lack PTA to the trial (...)
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  7. Atención después de la investigación: un marco para los comités de ética de investigación del National Health Service (NHS) (borrador versión 8.0).Neema Sofaer, Penny Lewis & Hugh Davies - 2012 - Perspectivas Bioéticas 17 (33):47-70.
    Resumen Ésta es la primera traducción al español de las guías “Atención después de la investigación: un marco para los comités de ética de investigación del National Health Service (NHS) (borrador versión 8.0)”. El documento afirma que existe una fuerte obligación moral de garantizar que los participantes enfermos de un estudio clínico hagan una transición después del estudio hacia una atención de la salud apropiada. Con “atención de la salud apropiada” se hace referencia al acceso para los participantes a la (...)
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  8.  25
    Did We Describe What You Meant? Findings and Methodological Discussion of an Empirical Validation Study for a Systematic Review of Reasons.Marcel Mertz, Neema Sofaer & Daniel Strech - 2014 - BMC Medical Ethics 15 (1):69.
    The systematic review of reasons is a new way to obtain comprehensive information about specific ethical topics. One such review was carried out for the question of why post-trial access to trial drugs should or need not be provided. The objective of this study was to empirically validate this review using an author check method. The article also reports on methodological challenges faced by our study.
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  9. Economic Inequalities and Choice: A Reassessment of Ronald Dworkin's Theory of Distributive Justice.Neema Sofaer - 2004 - Dissertation, Massachusetts Institute of Technology
    This dissertation proposes a new reading and appraisal of an important theory of distributive justice, Ronald Dworkin's "Equality of Resources" . ER is traditional in holding that choices made by rational, ignorant and purely self-interested beings are relevant to distributive justice. ER is novel both in its use of such choices and in incorporating the idea that one's success is largely one's own responsibility into liberal egalitarianism. ;I argue that the tax-and-redistribution scheme Dworkin proposes to make actual distributions just is (...)
     
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  10.  33
    Translational Research Beyond Approval: A Two-Stage Ethics Review.Neema Sofaer & Nir Eyal - 2010 - American Journal of Bioethics 10 (8):W1-W3.
    Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research. Whether or not T1 has these features, translational research beyond approval is unlikely to and, (...)
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