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  1. The ethical anatomy of payment for research participants.Joanna Różyńska - 2022 - Medicine, Health Care and Philosophy 25 (3):449-464.
    In contrast to most publications on the ethics of paying research subjects, which start by identifying and analyzing major ethical concerns raised by the practice (in particular, risks of undue inducement and exploitation) and end with a set of—more or less well-justified—ethical recommendations for using payment schemes immune to these problems, this paper offers a systematic, principle-based ethical analysis of the practice. It argues that researchers have aprima faciemoral obligation to offer payment to research subjects, which stems from the principle (...)
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  • Ethical considerations around volunteer payments in a malaria human infection study in Kenya: an embedded empirical ethics study.Dorcas Kamuya, Vicki Marsh, Melissa Kapulu, Philip Bejon, Irene Jao, Esther Awuor Owino & Primus Che Chi - 2022 - BMC Medical Ethics 23 (1):1-13.
    Human Infection Studies have emerged as an important research approach with the potential to fast track the global development of vaccines and treatments for infectious diseases, including in low resource settings. Given the high level of burdens involved in many HIS, particularly prolonged residency and biological sampling requirements, it can be challenging to identify levels of study payments that provide adequate compensation but avoid ‘undue’ levels of inducement to participate. Through this embedded ethics study, involving 97 healthy volunteers and other (...)
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  • Pandemic Ethics and Status Quo Risk.Richard Yetter Chappell - 2022 - Public Health Ethics 15 (1):64-73.
    Conservative assumptions in medical ethics risk immense harms during a pandemic. Public health institutions and public discourse alike have repeatedly privileged inaction over aggressive medical interventions to address the pandemic, perversely increasing population-wide risks while claiming to be guided by ‘caution’. This puzzling disconnect between rhetoric and reality is suggestive of an underlying philosophical confusion. In this paper, I argue that we have been misled by status quo bias—exaggerating the moral significance of the risks inherent in medical interventions, while systematically (...)
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  • How Payment For Research Participation Can Be Coercive.Joseph Millum & Michael Garnett - 2019 - American Journal of Bioethics 19 (9):21-31.
    The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent-undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, (...)
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  • How Did There Come To Be Two Kinds of Coercion?Scott Anderson - 2008 - In David A. Reidy & Walter J. Riker (eds.), Coercion and the State. Springer Verlag. pp. 17-29.
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  • Against the inalienable right to withdraw from research.Eric Chwang - 2008 - Bioethics 22 (7):370-378.
    In this paper I argue, against the current consensus, that the right to withdraw from research is sometimes alienable. In other words, research subjects are sometimes morally permitted to waive their right to withdraw. The argument proceeds in three major steps. In the first step, I argue that rights typically should be presumed alienable, both because that is not illegitimately coercive and because the general paternalistic motivation for keeping them inalienable is untenable. In the second step of the argument, I (...)
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  • The importance of social, cultural, and economic contexts, and empirical research in examining "undue inducement".Robert Klitzman - 2005 - American Journal of Bioethics 5 (5):19 – 21.
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  • Controlled human infection with SARS-CoV-2 to study COVID-19 vaccines and treatments: bioethics in Utopia.Søren Holm - 2020 - Journal of Medical Ethics 46 (9):569-573.
    A number of papers have appeared recently arguing for the conclusion that it is ethically acceptable to infect healthy volunteers with severe acute respiratory syndrome coronavirus 2 as part of research projects aimed at developing COVID-19 vaccines or treatments. This position has also been endorsed in a statement by a working group for the WHO. The papers generally argue that controlled human infection is ethically acceptable if the risks to participants are low and therefore acceptable, the scientific quality of the (...)
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  • Precommitting to Serve the Underserved.Nir Eyal & Till Bärnighausen - 2012 - American Journal of Bioethics 12 (5):23-34.
    In many countries worldwide, especially in Sub-Saharan Africa, a shortage of physicians limits the provision of lifesaving interventions. One existing strategy to increase the number of physicians in areas of critical shortage is conditioning medical school scholarships on a precommitment to work in medically underserved areas later. Current practice is usually to demand only one year of service for each year of funded studies. We show the effectiveness of scholarships conditional on such precommitment for increasing physician supplies in underserved areas. (...)
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  • Payments to Normal Healthy Volunteers in Phase 1 Trials: Avoiding Undue Influence While Distributing Fairly the Burdens of Research Participation.A. S. Iltis - 2009 - Journal of Medicine and Philosophy 34 (1):68-90.
    Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups (...)
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  • The Exceptional Ethics of the Investigator-Subject Relationship.B. Sachs - 2010 - Journal of Medicine and Philosophy 35 (1):64-80.
    This article concerns the validity of six canonical rules that institutional review boards use to constrain the behavior of investigators. These rules require investigators to design their studies in a scientifically valid way, not pay their subjects to take risks, minimize risks to their subjects, secure for their subjects access to effective interventions post-trial, not pay their subjects too much and allow their subjects to withdraw from the study unconditionally. Enforcement of these rules is problematic because there are other relationships (...)
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  • Risk, Judgment and Fairness in Research Incentives.Benjamin Hale - 2007 - American Journal of Bioethics 7 (2):82-83.
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  • Enhancing autonomy in paid surrogacy.Jennifer Damelio & Kelly Sorensen - 2008 - Bioethics 22 (5):269–277.
    The gestational surrogate – and her economic and educational vulnerability in particular – is the focus of many of the most persistent worries about paid surrogacy. Those who employ her, and those who broker and organize her services, usually have an advantage over her in resources and information. That asymmetry exposes her to the possibility of exploitation and abuse. Accordingly, some argue for banning paid surrogacy. Others defend legal permission on grounds of surrogate autonomy, but often retain concerns about the (...)
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  • The welcome reassessment of research ethics: Is "undue inducement" suspect?Howard Brody - 2005 - American Journal of Bioethics 5 (5):15 – 16.
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  • Promoting Ethical Payment in Human Infection Challenge Studies.Holly Fernandez Lynch, Thomas C. Darton, Jae Levy, Frank McCormick, Ubaka Ogbogu, Ruth O. Payne, Alvin E. Roth, Akilah Jefferson Shah, Thomas Smiley & Emily A. Largent - 2021 - American Journal of Bioethics 21 (3):11-31.
    To prepare for potential human infection challenge studies involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SAR...
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  • Working for the Weekend Is Not Meaningful Work.Charles Weijer & Mackenzie Graham - 2019 - American Journal of Bioethics 19 (9):48-50.
    Volume 19, Issue 9, September 2019, Page 48-50.
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  • A Defense of Kidney Sales.Luke Bascome Semrau - unknown
    Drawing on empirical evidence in medicine, economics, law, and anthropology, I argue that a market is uniquely capable of meeting the demand for transplantable kidneys, and that it may be arranged so as to operate safely. The welfare gains, expected to accrue to both vendors and recipients, are sufficient to justify sales. Having spelled out the considerations recommending a kidney market, I address the most forceful objections facing the proposal. Despite its currency, the claim that incentives will crowd out altruistic (...)
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  • Protecting and respecting the vulnerable: existing regulations or further protections?Stephanie R. Solomon - 2013 - Theoretical Medicine and Bioethics 34 (1):17-28.
    Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory (...)
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  • Which Benefits Can Justify Risks in Research?Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Helga Gardarsdottir, Johannes J. M. van Delden & on Behalf of the Trials@Home Consortium - forthcoming - American Journal of Bioethics:1-11.
    Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...)
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  • Ethics of Buying DNA.Julian J. Koplin, Jack Skeggs & Christopher Gyngell - 2022 - Journal of Bioethical Inquiry 19 (3):395-406.
    DNA databases have significant commercial value. Direct-to-consumer genetic testing companies have built databanks using samples and information voluntarily provided by customers. As the price of genetic analysis falls, there is growing interest in building such databases by paying individuals for their DNA and personal data. This paper maps the ethical issues associated with private companies paying for DNA. We outline the benefits of building better genomic databases and describe possible concerns about crowding out, undue inducement, exploitation, and commodification. While certain (...)
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  • Payment of COVID-19 challenge trials: underpayment is a bigger worry than overpayment.Jennifer Blumenthal-Barby & Peter Ubel - 2021 - Journal of Medical Ethics 47 (8):585-586.
    One way to test vaccines is through human challenge trials in which participants are intentionally infected with a contagious organism to expedite the process of assessing the vaccine’s effectiveness. Some experts believe challenge trials may play an important role in fighting COVID-19, especially if the vaccines under current study do not demonstrate sufficient efficacy, if spread of COVID-19 is controlled to a point that radically slows down traditional trials, or if new vaccines need to be rapidly developed for specific subpopulations.1 (...)
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  • Payment in challenge studies: ethics, attitudes and a new payment for risk model.Olivia Grimwade, Julian Savulescu, Alberto Giubilini, Justin Oakley, Joshua Osowicki, Andrew J. Pollard & Anne-Marie Nussberger - 2020 - Journal of Medical Ethics 46 (12):815-826.
    Controlled Human Infection Model (CHIM) research involves the infection of otherwise healthy participants with disease often for the sake of vaccine development. The COVID-19 pandemic has emphasised the urgency of enhancing CHIM research capability and the importance of having clear ethical guidance for their conduct. The payment of CHIM participants is a controversial issue involving stakeholders across ethics, medicine and policymaking with allegations circulating suggesting exploitation, coercion and other violations of ethical principles. There are multiple approaches to payment: reimbursement, wage (...)
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  • Harmonization of Ethics Policies in Pediatric Research.Valarie Blake, Steve Joffe & Eric Kodish - 2011 - Journal of Law, Medicine and Ethics 39 (1):70-78.
    The Food and Drug Administration and the European Medicines Agency have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use as a (...)
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  • On measuring attitudes about payment for research.Luke Gelinas - 2020 - Journal of Medical Ethics 46 (12):833-834.
    Significant attention has been given both to the ethics of Controlled Human Infection Model research and the ethics of payment for research participation. However, comparatively little attention has been given to the ethics of paying for participation specifically in CHIM research. Grimwade et al should be commended for thoughtfully addressing this topic and especially for the empirical data collection informing their work, which is too often lacking in discussions of payment for research participation. In what follows I will discuss three (...)
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  • Exploitation in Cross-Border Reproductive Care.Angela Ballantyne - 2014 - International Journal of Feminist Approaches to Bioethics 7 (2):75-99.
    Concerns about exploitation pervade the literature on commercial cross-border reproductive care, particularly egg selling and surrogacy. But what constitutes exploitation, and what moral weight does it have? I consider the relationship between vulnerability, limited choice, consent, and mutually advantageous exploitation. To elucidate the difference between limited choice and consent, I draw on an account of relational autonomy. In the absence of a normative principle of fair distribution, it is unclear whether the providers of reproductive goods and services are treated fairly (...)
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  • Evaluation of Research Design by Research Ethics Committees: Misleading Reassurance and the Need for Substantive Reforms.Howard Mann - 2007 - American Journal of Bioethics 7 (2):84-86.
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  • A quartet of criticisms.Harold Y. Vanderpool - 2005 - American Journal of Bioethics 5 (5):16 – 19.
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  • Ethical Issues in the Use of Nudges to Obtain Informed Consent for Biomedical Research.Maxwell J. Mehlman, Eric Kodish & Jessica Berg - 2018 - IRB: Ethics & Human Research 40 (3):1-5.
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  • For love or money? The saga of korean women who provided eggs for embryonic stem cell research.Françoise Baylis - 2009 - Theoretical Medicine and Bioethics 30 (5):385-396.
    In 2004 and 2005, Woo-Suk Hwang achieved international stardom with publications in Science reporting on successful research involving the creation of stem cells from cloned human embryos. The wonder and success all began to unravel, however, when serious ethical concerns were raised about the source of the eggs for this research. When the egg scandal had completely unfolded, it turned out that many of the women who provided eggs for stem cell research had not provided valid consents and that nearly (...)
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  • Oocytes for sale?Lori Gruen - 2007 - Metaphilosophy 38 (2-3):285–308.
    In order to reach its full potential, human embryonic stem cell (hESC) research requires the use of human oocytes. There is currently a shortage of human eggs for research, and this shortage is likely to continue, as many states and countries prohibit their sale for research purposes, while at the same time condoning unregulated markets for oocytes for use in assisted reproduction. In this essay I first explore possible alternative sources of oocytes for hESC research and conclude that, at present, (...)
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  • Undue inducement: The only objection to payment?Ari VanderWalde - 2005 - American Journal of Bioethics 5 (5):25 – 27.
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  • Undue inducements and reasonable risks: Will the dismal science lead to dismal research ethics?Alex John London - 2005 - American Journal of Bioethics 5 (5):29 – 32.
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  • Payments and Direct Benefits in HIV/AIDS Related Research Projects in Uganda.Julius Ecuru, Douglas Wassenaar & Betty Kwagala - 2010 - Ethics and Behavior 20 (2):95-109.
    Paying research participants in developing countries like Uganda raises ethical concerns over potential for undue inducement. This article, based on an exploratory study, reviewed 49 research protocols from a national HIV/AIDS research ethics committee database. Payments mainly adhered to the reimbursement and compensation payment models. Offers made were diverse but basic in order to limit undue inducement. Implications in terms of undue inducement and possible impact on participants and research are discussed. We end by recommending standardization across comparable studies in (...)
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  • “Paid to Produce Data:” Research Participation as the Labor of Generating Valuable Health Data.Robert C. Miller & Marielle S. Gross - 2019 - American Journal of Bioethics 19 (9):50-52.
    Volume 19, Issue 9, September 2019, Page 50-52.
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  • Gather ye shibboleths while ye may.Norman Fost - 2005 - American Journal of Bioethics 5 (5):14 – 15.
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  • Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy.Euzebiusz Jamrozik & Michael J. Selgelid - 2020 - Journal of Medical Ethics 46 (9):601-609.
    Human infection challenge studies (HCS) involve intentionally infecting research participants with pathogens (or other micro-organisms). There have been recent calls for more HCS to be conducted in low-income and middle-income countries (LMICs), where many relevant diseases are endemic. HCS in general, and HCS in LMICs in particular, raise numerous ethical issues. This paper summarises the findings of a project that explored ethical and regulatory issues related to LMIC HCS via (i) a review of relevant literature and (ii) 45 qualitative interviews (...)
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  • Nice work if you can get it.Lynette Reid - 2005 - American Journal of Bioethics 5 (5):27 – 29.
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  • “Undue Inducement' as Coercive Offers.Joan McGregor - 2005 - American Journal of Bioethics 5 (5):24 – 25.
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  • Money Matters.Toby Schonfeld, Bruce Gordon, Jean Amoura & Joseph Spencer Brown - 2007 - American Journal of Bioethics 7 (2):86-88.
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  • Subject Protection and the Risk–Benefit Relationship.Toby L. Schonfeld, Joseph S. Brown & Bruce G. Gordon - 2005 - American Journal of Bioethics 5 (5):22 – 23.
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  • (2 other versions)Providing monetary and non-monetary goods to research participants: perspectives and practices of researchers and Research Ethics Committees in Zambia.Adnan A. Hyder, Joseph Ali & Chris Mweemba - 2020 - Global Bioethics 31 (1):90-103.
    ABSTRACT There are disagreements among ethicists on what comprises an “appropriate” good to offer research participants. Debates often focus on the type, quantity, timing, and ethical appropriateness of such offers, particularly in settings where participants may be socio-economically vulnerable, such as in parts of Zambia. This was a Cross-sectional online survey of researchers and Research Ethics Committees (RECs) designed to understand practices, attitudes and policies associated with provision of goods to research participants. Of 122 responding researchers, 69 met eligibility criteria. (...)
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  • Vulnerability in Research: Individuals with Limited Financial and/or Social Resources.Christine Grady - 2009 - Journal of Law, Medicine and Ethics 37 (1):19-27.
    Vulnerability in research is often understood as a diminished ability to protect one's own interests, manifested by a compromised capacity to give informed or voluntary consent. Certain groups of people are thought to be more vulnerable than others and therefore are at risk of being exploited or mistreated in research. Accordingly, the federal regulations call for additional safeguards to protect vulnerable groups.There remains some ambiguity and contradiction, however, regarding what groups are vulnerable in research and why,3 since the available codes (...)
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  • (2 other versions)Providing monetary and non-monetary goods to research participants: perspectives and practices of researchers and Research Ethics Committees in Zambia.Chris Mweemba, Joseph Ali & Adnan A. Hyder - 2018 - Tandf: Global Bioethics:1-14.
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  • The value of respect in human research ethics: a coneptual analysis and a practical guide.Ian Pieper & Colin J. H. Thomason - 2014 - Monash Bioethics Review 32 (3-4):232-253.
    In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as (...)
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  • Undue inducement: a case study in CAPRISA 008.Kathryn T. Mngadi, Jerome A. Singh, Leila E. Mansoor & Douglas R. Wassenaar - 2017 - Journal of Medical Ethics 43 (12):824-828.
    Participant safety and data integrity, critical in trials of new investigational drugs, are achieved through honest participant report and precision in the conduct of procedures. HIV prevention post-trial access studies in middle-income countries potentially offer participants many benefits including access to proven efficacious but unlicensed technologies, ancillary care that often exceeds local standards-of-care, financial reimbursement for participation and possibly unintended benefits if participants choose to share or sell investigational drugs. This case study examines the possibility that this combination of benefits (...)
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  • Our Life Depends on This Drug: Competence, Inequity, and Voluntary Consent in Clinical Trials on Supervised Injectable Opioid Assisted Treatment.Daniel Steel, Kirsten Marchand & Eugenia Oviedo-Joekes - 2017 - American Journal of Bioethics 17 (12):32-40.
    Supervised injectable opioid assisted treament prescribes injectable opioids to individuals for whom other forms of addiction treatment have been ineffective. In this article, we examine arguments that opioid-dependent people should be assumed incompetent to voluntarily consent to clinical research on siOAT unless proven otherwise. We agree that concerns about competence and voluntary consent deserve careful attention in this context. But we oppose framing the issue solely as a matter of the competence of opioid-dependent people and emphasize that it should be (...)
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  • Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation.Matt Lamkin & Carl Elliott - 2018 - Journal of Law, Medicine and Ethics 46 (1):52-63.
    Lowering compensation to research subjects to protect them from “undue inducement” is a misguided attempt to shoehorn a concern about exploitation into the framework of autonomy. We suggest that oversight bodies should be less concerned about undue influence than about exploitation of subjects. Avoiding exploitation in human subjects research requires not only increasing compensation, but enhancing the dignity of research participation.
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