The issue of aftercare for participants in clinical research was explored in the context of an asthma drug trial. Although there may be financial constraints and practical difficulties with implementation, the results show that it may be feasible for clinical investigators and commercial sponsors to take on some limited responsibility for the medical care of research subjects after clinical trials. However, the ethical implications for this practice remain unclear. On the one hand, society may have a moral obligation to compensate (...) and reward some of its members who assume the risk of research subjects for the benefit of society as a whole. On the other hand, the promise of aftercare may provide an inducement to volunteers which, under certain conditions may be considered morally wrong and scientifically unsound. (shrink)

Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UK for injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there is insufficient provision in the current (...) patient guidelines of the Association of the British Pharmaceutical Industry, since they make "no legal commitment" to paying compensation for injury to patient subjects. There is a need for the provision of both adequate insurance and contractual arrangements for making payments. The solution is for Local Research Ethics Committees (LRECs) to make use of their power to withhold approval of medical research where compensation is not legally enforceable. (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)

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.

The practice of paying research subjects for participating inclinical trials has yet to receive an adequate moral analysis.Dickert and Grady argue for a wage payment model in whichresearch subjects are paid an hourly wage based on that ofunskilled laborers. If we accept this approach, what follows?Norms for just working conditions emerge from workplacelegislation and political theory. All workers, includingpaid research subjects under Dickert and Grady''s analysis,have a right to at least minimum wage, a standard work week,extra pay for overtime hours, (...) a safe workplace, no faultcompensation for work-related injury, and union organization.If we accept that paid research subjects are wage earners likeany other, then the implications for changes to current practiceare substantial. (shrink)

In his essay, Philosophical Reflections on Experimenting with Human Subjects, Hans Jonas contends that except in cases of widespread medical emergencies, people do not have a moral or social obligation to volunteer to be subjects in medical experiments. He further argues that any appeal for volunteer subjects in medical experiments should whenever possible give priority to those who can identify with the project and offer a strong sense of commitment to its goals. The first of these claims is given support (...) against some recent criticisms, but argument is offered to show that the second claim not only does little to enhance the stature of the standard requirement of free and informed consent but may even weaken the moral validity of the consent. (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)

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)

The problem of 'no fault' compensation for patients who suffer adverse effects as a result of their participation in clinical trials is discussed in the light of the guidelines issued by the Association of the British Pharmaceutical Industry (ABPI) and our recent experiences in reviewing protocols submitted to the local ethics of surgical research sub-committee. We have found a variety of qualifications being applied by pharmaceutical firms which are not in the spirit of the guidelines, let alone the interests of (...) the patient, and we suggest a means whereby the patients can be assured of fair treatment in the event of 'no fault' injury. (shrink)

The paper defends the permissibility of paying inducements to research subjects against objections not covered in an earlier paper in Bioethics. The objections are that inducements would cause inequity, crowd out research, and undesirably commercialize the researcher‐subject relationship. The paper shows how these objections presuppose implausible factual and/or normative claims. The final position reached is a qualified defence of freedom of contract which not only supports the permissibility of inducements but also offers guidance to ethics committees in dealing with practical (...) problems that might arise if inducements are offered. (shrink)

Calls for the inclusion of women in clinical trials raise the obvious question: why have sponsors excluded them? The answer most often given is one tragically evocative word: Thalidomide. The tragedies of the children born with seal limbs because their mothers took this over-the-counter sleeping pill and cure for morning sickness showed that, contrary to previous perceptions, the placenta could not be depended upon to filter out toxins before they reached the fetus. The specter of birth defects spawned sponsors’ fears (...) of a variety of catastrophes which contributed to closing the doors of clinical trials for women.This paper will not argue that the possibility of birth defects arising from the ingestion of an experimental drug does not exist. Sadly, scientists do not yet have the ability to predict which drugs will cause birth defects. Rather, it will argue that case law does not provide a basis for sponsor liability when a woman gives informed consent and the regulations governing clinical trials are followed. (shrink)

Calls for the inclusion of women in clinical trials raise the obvious question: why have sponsors excluded them? The answer most often given is one tragically evocative word: Thalidomide. The tragedies of the children born with seal limbs because their mothers took this over-the-counter sleeping pill and cure for morning sickness showed that, contrary to previous perceptions, the placenta could not be depended upon to filter out toxins before they reached the fetus. The specter of birth defects spawned sponsors’ fears (...) of a variety of catastrophes which contributed to closing the doors of clinical trials for women.This paper will not argue that the possibility of birth defects arising from the ingestion of an experimental drug does not exist. Sadly, scientists do not yet have the ability to predict which drugs will cause birth defects. Rather, it will argue that case law does not provide a basis for sponsor liability when a woman gives informed consent and the regulations governing clinical trials are followed. (shrink)

This essay develops a framework for thinking about the moral basis for the commodification of human reproductive materials. It argues that selling and buying gametes and genes is morally acceptable although there should not be a market for zygotes, embryos, or genomes. Also a market in gametes and genes should be regulated in order to address concerns about the adverse social consequences of commodification.

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)

: Bioethicists have failed to understand the pervasively paternalistic character of research ethics. Not only is the overall structure of research review and regulation paternalistic in some sense; even the way informed consent is sought may imply paternalism. Paternalism has limits, however. Getting clear on the paternalism of research ethics may mean some kinds of prohibited research should be reassessed.

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)

In this article, I present a contractualist conception of human-participant research ethics, arguing that the most appropriate source of the rights and responsibilities of researcher and participant is the contractual understanding between them. This conception appears to explain many of the more fundamental ethical incidents of human-participant research. I argue that a system of contractual rights and responsibilities would allow a great deal of research that has often been felt to be ethically problematic, such as research involving deception, concealed research, (...) and research on dependent populations. However, in defining the conditions under which such research should be permissible, my contractualist theory also makes it clear that there are limits-and explains what those limits are-to the propriety of such research. (shrink)