For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.Despite their long history and pervasiveness, charges of undue inducement (...) in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges. (shrink)

Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with (...) the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions. (shrink)

For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.Despite their long history and pervasiveness, charges of undue inducement (...) in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges. (shrink)

Objectives: To determine the effects of risk and payment on subjects’ willingness to participate, and to examine how payment influences subjects’ potential behaviours and risk evaluations.Methods: A 3 × 3 , between subjects, completely randomised factorial design was used. Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study, and completed a questionnaire. Risk level was manipulated using recruitment notices and informed consent documents from hypothetical biomedical research projects. Payment (...) levels were determined using the payment models evaluated by Dickert and Grady as a guide. Five dependent variables were assessed in the questionnaire: willingness to participate, willingness to participate with no payment, propensity to neglect to tell about restricted activities, propensity to neglect to tell about negative effects, and risk rating.Results: Monetary payment had positive effects on respondents’ willingness to participate in research, regardless of the level of risk. However, higher monetary payments did not appear to blind respondents to the risks of a study. Payment had some influence on respondents’ potential behaviours regarding concealing information about restricted activities. However, payment did not appear to have a significant effect on respondents’ propensity to neglect to tell researchers about negative effects.Conclusions: Monetary payments appear to do what they are intended to do: make subjects more willing to participate in research. Concerns about payments blinding subjects to risks could not be substantiated in the present study. However, the findings do raise other concerns—notably the potential for payments to diminish the integrity of a study’s findings. Future research is critical to make sound decisions about the payment of research subjects. (shrink)

This book focuses on experimentation that is carried out on human beings, including medical research, drug research and research undertaken in the social sciences. It discusses the ethics of such experimentation and asks the question: who defends the interests of these human subjects and ensures that they are not harmed? The author finds that ethical research depends on the adequacy of review by committee. Indeed most countries now rely on research ethics committees for the protection of the interests of the (...) human participants in research. Dr McNeill analyses how successful these committees are in balancing the interests of science with the interests of human subjects. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits (...) of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

The current system of organ procurement which relies on donation is inadequate to the current and future need for transplantable kidneys. The growing disparity between demand and supply is accompanied by a steep human cost. I argue that a regulated market in organs from living vendors is the only plausible solution, and that objections common to opponents of organ markets are defeasible. I argue that a morally defensible market in kidneys from living vendors includes four characteristics: (1) the priority of (...) safety for both vendors and recipients, (2) transparency regarding the risks to vendors and recipients, (3) institutional integrity regarding guidelines for cooperating with kidney vendors, and (4) operation under a rule of law. I conclude with some remarks on remaining problems with this account, and offer some suggestions as to how these problems might be addressed. (shrink)

Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting about money as opposed to (...) a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make. (shrink)

Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, (...) and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature. (shrink)

This paper defends an in principle understanding of the authority of persons over themselves and, in consequence, argues for significant limits on morally permissible state authority. It also defends an account of the limits of permissible state action that distinguishes between the ability of persons to convey authority to common projects and what may be judged virtuous, good, safe, or proper to do. In terms of organ transplantation policy, it concludes that it is morally acceptable, and should be legally permissible, (...) for individuals to sell one of their kidneys while living, pocketing the cash to use as that person sees fit to advance their own understanding of their own best interests. Morally objectionable policy proposals, I argue, are not those that encourage individuals to sell a redundant kidney while living or families to sell the organs of a recently deceased loved one, but those that seek coercively to confiscate the organs of the recently deceased. Recognizing the authority of persons over themselves, and their ability to convey moral authority to common projects, including the sale of human organs for transplantation, would shed light on the medical marketplace and clarify public policy, while increasing the efficiency and effectiveness of procuring human organs for transplantation. (shrink)

Relatively subtle forms of exploitation of human subjects may arise from the inefficiency or incompetence of a researcher, from the existence of a power imbalance between principal and subject, or from the uneven distribution of research risks among various segments of the population. A powerful and knowledgeable person (or institution) may perpetrate the exploitation of an unempowered and ignorant individual even without intending to. There is an ethical burden on the former to protect the interests of the vulnerable. Excessive or (...) insufficient compensation may be exploitative. However, genuine economic imperatives motivating needy volunteers have to be considered. These forms of exploitation should be appreciated in the context of social and cultural factors suggesting that the relationship between researcher and subject cannot properly be appraised as a contractual undertaking. While compliance with pertinent codes and regulations minimises the exploitative potential, they cannot be enforced in a way that does not recognise a society's peculiar characteristics. The experience with some Filipino cultural traits illustrates this point. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

This paper argues against paying people to participate in research. Volunteering to participate as a subject in a research program is not like taking a job. The main difference is to do with the risks inherent in research. Experimentation on human beings is, by definition, trying out something with an unknown consequence and exposes people to risks of harm which cannot be known in advance. This is the main reason for independent review by committee of research programs. It is based (...) on a recognition that researchers are not always capable of putting the interests of their subjects ahead of their research objectives. It is not simply a matter of individual autonomy. Society has an obligation, prior to the protection of individual freedom and autonomy, to establish basic safeguards that are equitable in their operation. Any inducement for participating in research would add to the difficulty subjects have in adequately assessing the risks of participating in research. An acceptance of inducement to participate in research would further increase the inequity of research conducted on the impecunious for the benefit of the well‐off. (shrink)

Physician‐investigators face the daunting task of enrolling desperate patients into Phase I cancer trials that are not meant to be therapeutic. Patients doggedly regard the trials as therapeutic, and researchers tend to collaborate in their confusion by glossing the trials’ true purposes and noting the occasional benefit that subjects accidentally receive. The disparity between hope and fact must be redressed by degrees, from many angles at once.

As the ethical framework of the Catholic Church becomes incapable of accommodating the cultural diversity in Ireland, the search for a new moral discourse takes on a greater urgency. In its absence, litigation in Ireland is on the increase.

1. The opinions expressed are the author's own. They do not reflect any position or policy of the National Institutes of Health, Public Health Service, Department of Health and Human Services, or any of the authors affiliated organizations.

(2001). Justice and Healthcare: The Right to a Decent Minimum, Not Equality of Opportunity. The American Journal of Bioethics: Vol. 1, No. 2, pp. 1a-3a.

(2001). The Fiction of 'Undue Inducement': Why Researchers Should Be Allowed to Pay Participants Any Amount of Money for Any Reasonable Research Project. The American Journal of Bioethics: Vol. 1, No. 2, pp. 1g-3g.

This discussion paper continues the debate over risk‐related standards of mental competence which appears in Bioethics 5. Dan Brock there defends an approach to mental competence in patients which defines it as being relative to differing standards, more or less rigorous depending on the degree of risk involved in proposed treatments. But Mark Wicclair raises a problem for this approach: if significantly different levels of risk attach, respectively, to accepting and refusing the same treatment, then it is possible, on this (...) account, for a patient to be considered competent to accept, but not refuse, the treatment, or vice versa. I argue that this puzzle does not constitute a genuine problem for a risk‐related standard. To this end I focus on the situation where, of two mutually exclusive options, one is riskier, but offering more pronounced benefit, while the other is safer, but offering less benefit. I argue for this proposition: it can take far less insight to know that the safe option is good than to know that the risky option is better. Now say one is actually informed enough to know that the safe option is good, but not enough to know whether the risky option is better; in such a case one is competent to say yes to that first option (the safe one), but not to say yes to the other. (I argue in passing that Pascal's Wager can be interpreted as having precisely this deliberative structure.) I thus conclude that cases do indeed exist where one can be competent to say yes but not no, or vice versa; and that it is thus not an anomaly in the risk‐related standard that it entails the existence of such cases. (shrink)

Opposition to inducement payments for research subjects is an international orthodoxy amongst writers of ethics committee guidelines. We offer an argument in favour of these payments. We also critically evaluate the best arguments we can find or devise against such payments, and except in one very limited range of circumstances, we find these unconvincing.

This paper argues against paying people to participate in research. Volunteering to participate as a subject in a research program is not like taking a job. The main difference is to do with the risks inherent in research. Experimentation on human beings is, by definition, trying out something with an unknown consequence and exposes people to risks of harm which cannot be known in advance. This is the main reason for independent review by committee of research programs. It is based (...) on a recognition that researchers are not always capable of putting the interests of their subjects ahead of their research objectives. It is not simply a matter of individual autonomy. Society has an obligation, prior to the protection of individual freedom and autonomy, to establish basic safeguards that are equitable in their operation. Any inducement for participating in research would add to the difficulty subjects have in adequately assessing the risks of participating in research. An acceptance of inducement to participate in research would further increase the inequity of research conducted on the impecunious for the benefit of the well‐off. (shrink)

Objective—To explore the opinions of unpaid healthy volunteers on the payment of research subjects.Design—Prospective cohort.Setting—Southern Alberta, Canada.Participants—Medically eligible persons responding to recruiting advertisements for a randomised vaccine trial were invited to take part in a study of informed consent at the point at which they formally consented or refused trial participation. Of 72 invited, 67 returned questionnaires at baseline and 54 at follow-up.Outcome measures—Proportions of persons who agreed or disagreed with three close-ended statements on the payment of research subjects; themes (...) and categories identified by content analysis of responses to an open-ended question.Results—A minority agreed with paying either patient or healthy volunteer participants. Opinions did not change over time. Participants' comments addressed: benefits and drawbacks to research participation; benefits and drawbacks to paying research participants; conditions under which payment of research subjects would be acceptable, and the nature of acceptable recognition. Acceptable conditions were to improve problematic recruitment, to reimburse costs, and to recognise participants, particularly for their time investment. Both non-monetary and monetary recognition of volunteers were thought to be appropriate.Conclusions—Most unpaid volunteers disagreed with paying research participants. The themes arising from their comments are similar to those that have been raised by ethicists and suggest that recognising the time and effort of participants should receive greater emphasis than presently occurs. (shrink)

(2001). Is Informed Consent Enough? Monetary Incentives for Research Participation and the Integrity of Biomedicine. The American Journal of Bioethics: Vol. 1, No. 2, pp. 49-51.

ABSTRACT Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information provided. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There (...) has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk. (shrink)

Relatively subtle forms of exploitation of human subjects may arise from the inefficiency or incompetence of a researcher, from the existence of a power imbalance between principal and subject, or from the uneven distribution of research risks among various segments of the population. A powerful and knowledgeable person (or institution) may perpetrate the exploitation of an unempowered and ignorant individual even without intending to. There is an ethical burden on the former to protect the interests of the vulnerable. Excessive or (...) insufficient compensation may be exploitative. However, genuine economic imperatives motivating needy volunteers have to be considered. These forms of exploitation should be appreciated in the context of social and cultural factors suggesting that the relationship between researcher and subject cannot properly be appraised as a contractual undertaking. While compliance with pertinent codes and regulations minimises the exploitative potential, they cannot be enforced in a way that does not recognise a society's peculiar characteristics. The experience with some Filipino cultural traits illustrates this point. (shrink)

This discussion paper addresses Ian Wilks’ defence of the risk‐related standard of competence that appears in Bioethics 11. Wilks there argues that the puzzle posed by Mark Wicclair in Bioethics 5 against Dan Brock's argument in favour of a risk‐related standard of competence — namely that Brock’s argument allows for situations of asymmetrical competence — is not a genuine problem for a risk‐related standard of competence. To show this, Wilks presents what he believes to be two examples of real situations (...) in which asymmetrical competence arises. I argue that insofar as Wilks equivocates two senses of competence in his examples — namely, competence to perform a task and competence in performing a task — Wilks is unable to illustrate the existence of real situations of asymmetrical competence. By examining the way in which Wilks equivocates two senses of competence in his examples, and by applying the results of this examination to the problem of patient competency within the medical field, I argue that not only does Wilks fail to show that situations of asymmetrical competence exist, but he is also unable to provide a foundation for understating how the risk‐related standard of competence can strike a balance between an individual’s autonomy and benevolent intervention. I thus conclude that insofar as Wilks fails to answer the objections raised by Wicclair and others against the risk‐related standard of competence, the risk‐related standard of competence continues to be undermined by the problem of asymmetrical competence. (shrink)

: Free-market libertarians have long supported incentives to increase organ procurement, but those oriented to justice traditionally have opposed them. This paper presents the reasons why those worried about justice should reconsider financial incentives and tolerate them as a lesser moral evil. After considering concerns about discrimination and coercion and setting them aside, it is suggested that the real moral concern should be manipulation of the neediest. The one offering the incentive (the government) has the resources to eliminate the basic (...) needs that pressure the poor into a willingness to sell. It is unethically manipulative to withhold those resources and then offer payment for organs. Nevertheless, the poor have been left without basic necessities for 20 years since the passage of the prohibition on incentives. As long as the government continues to withhold a decent minimum of welfare, liberals should, with shame, cease opposing financial incentives for organ procurement. (shrink)

: The March 2003 issue of the Kennedy Institute of Ethics Journal was devoted to cadaveric organ procurement. All the discussed proposals for solving the severe organ shortage place a higher value on respecting individual and/or family autonomy than on maximizing recovery of organs. Because of this emphasis on autonomy and historically high refusal rates, I believe that none of the proposals is likely to achieve the goal of ensuring an adequate supply of transplantable organs. An alternative approach, conscription of (...) cadaveric organs for transplantation, reverses the rank order of these priorities by placing greater value on maximizing recovery of organs than on respect for autonomy. Although conscription of organs initially may appear to be a radical and even ridiculous proposal, careful consideration reveals that it might well solve the organ shortage in an ethically acceptable way. (shrink)