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  1. Compensation of subjects for participation in biomedical research in resource – limited settings: a discussion of practices in Malawi.Wongani Nyangulu, Randy Mungwira, Nginanche Nampota, Osward Nyirenda, Lufina Tsirizani, Edson Mwinjiwa & Titus Divala - 2019 - BMC Medical Ethics 20 (1):1-5.
    Background Compensating participants of biomedical research is a common practice. However, its proximity with ethical concerns of coercion, undue influence, and exploitation, demand that participant compensation be regulated. The objective of this paper is to discuss the current regulations for compensation of research participants in Malawi and how they can be improved in relation to ethical concerns of coercion, undue influence, and exploitation. Main text In Malawi, national regulations recommend that research subjects be compensated with a stipend of US$10 per (...)
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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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  • Mutual Obligations in Research and Withholding Payment From Deceptive Participants.Holly Fernandez Lynch, Luke Gelinas & Emily A. Largent - 2018 - American Journal of Bioethics 18 (4):85-87.
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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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  • Money, coercion, and undue inducement: attitudes about payments to research participants.E. A. Largent, C. Grady, F. G. Miller & A. Wertheimer - 2012 - IRB: Ethics & Human Research 34 (1):1-8.
    Using payment to recruit research subjects is a common practice, but it raises ethical concerns that coercion or undue inducement could potentially compromise participants’ informed consent. This is the first national study to explore the attitudes of IRB members and other human subjects protection professionals concerning whether payment of research participants constitutes coercion or undue influence, and if so, why. The majority of respondents expressed concern that payment of any amount might influence a participant’s decisions or behaviors regarding research participation. (...)
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  • Reassessing the Role of the Biomedical Research Ethics Committee.Merryn Ekberg - 2012 - Journal of Academic Ethics 10 (4):335-352.
    The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed (...)
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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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  • Clinical research with economically disadvantaged populations.C. C. Denny & C. Grady - 2007 - Journal of Medical Ethics 33 (7):382-385.
    Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as “venerable” to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or logically untenable, while others (...)
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  • 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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  • Benefit Sharing – From Biodiversity to Human Genetics.Doris Schroeder & Julie Cook Lucas (eds.) - 2013 - Dordrecht, Netherlands: Springer.
    Biomedical research is increasingly carried out in low- and middle-income countries. International consensus has largely been achieved around the importance of valid consent and protecting research participants from harm. But what are the responsibilities of researchers and funders to share the benefits of their research with research participants and their communities? After setting out the legal, ethical and conceptual frameworks for benefit sharing, this collection analyses seven historical cases to identify the ethical and policy challenges that arise in relation to (...)
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  • Researching Domestic Violence in Bangladesh: Critical Reflections.Rituparna Bhattacharyya, Tulshi Kumar Das, Md Fakhrul Alam & Amina Pervin - 2018 - Ethics and Social Welfare 12 (4):314-329.
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  • Best to Exclude but Pay.Marion Danis, Sam Doernberg, Matthew Memoli & Joseph Millum - 2018 - American Journal of Bioethics 18 (4):87-88.
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  • Patient perspectives on compensation for biospecimen donation.Samuel C. Allen, Minisha Lohani, Kristopher A. Hendershot, Travis R. Deal, Taylor White, Margie D. Dixon & Rebecca D. Pentz - 2018 - AJOB Empirical Bioethics 9 (2):77-81.
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  • Forms of benefit sharing in global health research undertaken in resource poor settings: a qualitative study of stakeholders' views in Kenya.Geoffrey Lairumbi, Michael Parker, Raymond Fitzpatrick & Michael English - 2012 - Philosophy, Ethics, and Humanities in Medicine 7:7.
    Background Increase in global health research undertaken in resource poor settings in the last decade though a positive development has raised ethical concerns relating to potential for exploitation. Some of the suggested strategies to address these concerns include calls for providing universal standards of care, reasonable availability of proven interventions and more recently, promoting the overall social value of research especially in clinical research. Promoting the social value of research has been closely associated with providing fair benefits to various stakeholders (...)
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  • Strategies to Minimize Risks and Exploitation in Phase One Trials on Healthy Subjects.Adil E. Shamoo - 2006 - American Journal of Bioethics 6 (3):1-13.
    Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by (...)
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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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  • (1 other version)'Who is going to put their life on the line for a dollar? Thats crazy: community perspectives of financial compensation in clinical research.Amie Devlin, Kirsten Brownstein, Jennifer Goodwin, Emily Gibeau, Mariana Pardes, Heidi Grunwald & Susan Fisher - 2022 - Journal of Medical Ethics Recent Issues 48 (4):261-265.
    Background Financial compensation of research participants has been standard practice for centuries, however, there is an ongoing debate among researchers and ethicists regarding the ethical nature of this practice. While these debates develop ethical arguments and theories, they fail to incorporate input from those most affected by financial compensation: potential research participants. Methods To identify attitudes surrounding clinical research, participants of a long-standing cohort completed a one-time interview. Open-ended questions stimulated a participant-driven discussion surrounding medical research. Following a grounded theory (...)
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  • Some limits of decision-theory in bioethics: Rights, ends, and thick concepts.Stephen R. Latham - 2006 - American Journal of Bioethics 6 (3):56 – 58.
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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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  • Strategies to Minimize Risks and Exploitation in Phase One Trials on Healthy Subjects.Adil E. Shamoo & David B. Resnik - 2006 - American Journal of Bioethics 6 (3):W1-W13.
    Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by (...)
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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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  • Factors Influencing Perceived Helpfulness and Participation in Innovative Research:A Pilot Study of Individuals with and without Mood Symptoms.Jane Paik Kim, Tenzin Tsungmey, Maryam Rostami, Sangeeta Mondal, Max Kasun & Laura Weiss Roberts - 2022 - Ethics and Behavior 32 (7):601-617.
    Little is known about how individuals with and without mood disorders perceive the inherent risks and helpfulness of participating in innovative psychiatric research, or about the factors that influence their willingness to participate. We conducted an online survey with 80 individuals (self-reported mood disorder [n = 25], self-reported good health [n = 55]) recruited via MTurk. We assessed respondents’ perceptions of risk and helpfulness in study vignettes associated with two innovative research projects (intravenous ketamine therapy and wearable devices), as well (...)
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  • (1 other version)‘Who is going to put their life on the line for a dollar? That’s crazy’: community perspectives of financial compensation in clinical research.Amie Devlin, Kirsten Brownstein, Jennifer Goodwin, Emily Gibeau, Mariana Pardes, Heidi Grunwald & Susan Fisher - 2022 - Journal of Medical Ethics 48 (4):261-265.
    BackgroundFinancial compensation of research participants has been standard practice for centuries, however, there is an ongoing debate among researchers and ethicists regarding the ethical nature of this practice. While these debates develop ethical arguments and theories, they fail to incorporate input from those most affected by financial compensation: potential research participants.MethodsTo identify attitudes surrounding clinical research, participants of a long-standing cohort completed a one-time interview. Open-ended questions stimulated a participant-driven discussion surrounding medical research. Following a grounded theory methodology, 58 semistructured (...)
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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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  • A Living Wage for Research Subjects.Trisha B. Phillips - 2011 - Journal of Law, Medicine and Ethics 39 (2):243-253.
    Offering cash payments to research subjects is a common recruiting method, but this practice continues to be controversial because of its potential to compromise the protection of human subjects. Some critics question whether researchers should be allowed to offer money at all, citing concerns about commodification of the research subject, invalidation of study results, and increased risks to subjects. Other critics are comfortable with the idea of monetary payments but question how much researchers can pay their subjects, citing concerns about (...)
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  • Reporting of ethics-related methods in epidemiological research.K. H. Jacobsen - 2009 - Journal of Medical Ethics 35 (4):262-267.
    Objective: This paper describes the variety of ways that information about ethics-related methods are included or not included in public health research articles. Methods: Information about the ethics-related content of all articles published in nine highly-respected public health journals in 2006 was extracted. Results: Of 989 primary analyses, 73% of the articles commented on ethics committee approval or exemption, 63% mentioned participant consent and 9% indicated whether or not inducement or compensation was given. 84% of articles mentioned a funding source, (...)
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  • Money, Advertising and Seduction in Human Subjects Research.Trisha B. Phillips - 2007 - American Journal of Bioethics 7 (2):88-90.
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  • Could providing financial incentives to research participants be ultimately self-defeating?T. L. Zutlevics - 2016 - Research Ethics 12 (3):137-148.
    Controversy over providing financial incentives to research participants has a long history and remains an issue of contention in both current discussions about research ethics and for institutional review bodies/human research ethics committees which are charged with the responsibility of deciding whether such incentives fall within ethical guidelines. The arguments both for and against financial incentives have been well aired in the literature. A point of agreement for many is that inducement in the form of financial incentive is permissible when (...)
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  • Benefits to research subjects in international trials: Do they reduce exploitation or increase undue inducement?Angela Ballantyne - 2006 - Developing World Bioethics 8 (3):178-191.
    There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and (...)
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  • The Need to Track Payment Incentives to Participate in HIV Research.Brandon Brown, Jerome T. Galea, Karine Dubé, Peter Davidson, Kaveh Khoshnood, Lisa Holtzman, Logan Marg & Jeff Taylor - 2018 - IRB: Ethics & Human Research 40 (4):8-12.
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  • What do patients value as incentives for participation in clinical trials? A pilot discrete choice experiment.Akke Vellinga, Colum Devine, Min Yun Ho, Colin Clarke, Patrick Leahy, Jane Bourke, Declan Devane, Sinead Duane & Patricia Kearney - 2020 - Research Ethics 16 (1-2):1-12.
    Incentivising has shown to improve participation in clinical trials. However, ethical concerns suggest that incentives may be coercive, obscure trial risks and encourage individuals to enrol in cli...
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  • Motivations of Patients With Diabetes to Participate in Research.Cynthia Geppert, Philip Candilis, Stephen Baker, Charles Lidz, Paul Appelbaum & Kenneth Fletcher - 2014 - AJOB Empirical Bioethics 5 (4):14-21.
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  • Heterogeneity in IRB Policies with Regard to Disclosures about Payment for Participation in Recruitment Materials.Megan S. Wright & Christopher T. Robertson - 2014 - Journal of Law, Medicine and Ethics 42 (3):375-382.
    The payment of human subjects is an area where Institutional Review Boards have wide discretion. Although the “Common Rule” requires the provision of full information to human research participants to secure valid consent, the Rule is silent on the issue of payment. Still, some federal agencies offer guidance on the matter. For example, the National Science Foundation cautions that high payments for risky research “may induce a needy participant to take a risk that they normally would prefer not to take.” (...)
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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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  • Increasing the amount of payment to research subjects.D. B. Resnick - 2008 - Journal of Medical Ethics 34 (9):e14-e14.
    This article discusses some ethical issues that can arise when researchers decide to increase the amount of payment offered to research subjects to boost enrollment. Would increasing the amount of payment be unfair to subjects who have already consented to participate in the study? This article considers how five different models of payment—the free market model, the wage payment model, the reimbursement model, the appreciation model, and the fair benefits model—would approach this issue. The article also considers several practical problems (...)
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  • Should research ethics committees be told how to think?G. M. Sayers - 2007 - Journal of Medical Ethics 33 (1):39-42.
    Research ethics committees are charged with providing an opinion on whether research proposals are ethical. These committees are overseen by a central office that acts for the Department of Health and hence the State. An advisory group has recently reported back to the Department of Health, recommending that it should deal with inconsistency in the decisions made by different RECs. This article questions the desirability and feasibility of questing for consistent ethical decisions.
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  • “Money Helps”: People who inject drugs and their perceptions of financial compensation and its ethical implications.Roberto Abadie, Brandon Brown & Celia B. Fisher - 2019 - Ethics and Behavior 29 (8):607-620.
    This study documents how people who inject drugs in rural Puerto Rico perceive payments for participating in HIV epidemiological studies. In-depth interviews were conducted among a subset of active PWID older than 18 years of age who had been previously enrolled in a much larger study. Findings suggest that financial compensation was the main motivation for initially enrolling in the parent study. Then, as trust in the researchers developed, participants came to perceive compensation as part of a reciprocal exchange in (...)
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  • Participants’ awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.Gerardo González-Saldivar, René Rodríguez-Gutiérrez, Jose Luis Viramontes-Madrid, Alejandro Salcido-Montenegro, Neri Alejandro Álvarez-Villalobos, Victoria González-Nava & José Gerardo González-González - 2019 - BMC Medical Ethics 20 (1):2.
    The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials on ethical, safety, and protection topics. A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT as well as non-participants with (...)
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  • Decisions devoid of data?Scott D. Halpern - 2006 - American Journal of Bioethics 6 (3):55 – 56.
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  • Payment of research participants: current practice and policies of Irish research ethics committees.Eric Roche, Romaine King, Helen M. Mohan, Blanaid Gavin & Fiona McNicholas - 2013 - Journal of Medical Ethics 39 (9):591-593.
    Background Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Aim Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Method Postal survey of all RECs in Ireland. Results Response rate was 62.5% (n=50). 80% of RECs (...)
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  • Should Women Be Paid for Donating Their Eggs for Human Embryo Research?Loane Skene - 2009 - Monash Bioethics Review 28 (4):1-8.
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  • Remuneration in the United States and Mexico: Assessing the level of influence on potential clinical research participants about their decision to participate in a clinical trial and the risk of fraud.Jose Flores-Figueroa, Ingrid Badillo, Gilberto Botello, Ursus Pacheco, Mercedes Paredes-Paredes & Suzan McGovern - 2018 - Clinical Ethics 13 (2):98-105.
    Monetary compensation given to study subjects in a clinical trial is an effective tool to increase overall study enrolment, nonetheless it may stimulate some participants to commit fraud and lie about their medical history.A survey-study in 684 Hispanic prospective subjects in Mexico and USA was conducted to evaluate if a high monetary compensation would encourage them to lie about their medical history. Almost half of the subjects considered participating in a clinical trial with no compensation. Younger male individuals were more (...)
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