To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of (...) potential participants' informed consent. An analysis of individuals' interests suggests that potential participants need to understand three additional facts to understand that they are being invited to participate in research: 1) research contribution: those who enroll in the study will be contributing to a project designed to gather generalizable knowledge to benefit others in the future; 2) research relationship: the investigators will rely on participants' efforts to gather the generalizable knowledge to benefit others; and 3) research impact: the extent to which participating in the study will alter what participants do and what happens to them. (shrink)

This articles considers the larger, external and the micro, internal forces that impinge on the nature and impact of contemporary research-ethics codes. The larger forces that shape the impact of codes involve the increase in public and governmental concern with privacy protection, changes within disciplines, and the rise of research entrepreneurship. In terms of micro-level forces, the article explores the continuing problems associated with the bio-medical approach to research-ethics, on-going instability for some types of social research, slippages between REBs and (...) researchers, and variability of local interpretations of ethics codes. A number of ethics-review fads also produce instability in the ethics regime. (shrink)

Whereas in the 1970s early bioethicists believed that bioethics is an arena for the application of philosophical theories of utilitarianism, deontology, and natural law thinking, contemporary policy-oriented bioethicists seem rather to be keen on framing ethical issues through political ideologies. Bioethicists today are often labeled “liberal” or “communitarian,” referring to their different understandings of the relationship between the individual and society. Liberal individualism, with its conceptual base of autonomy, dignity, and privacy, enjoyed a long period of dominance in bioethics, but (...) it has increasingly come under attack from ideologies promoting a more salient role for concepts of solidarity, community, and public interest. (shrink)

In this paper the authors argue that research ethics committees should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: competent individuals are epistemologically (...) and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the “normal” constraints on people taking risks with themselves; RECs do not judge individual competence ; individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, the moral and political authority of RECs has not been established in this respect. (shrink)

The global development of human embryonic stem cell science and its therapeutic applications are dependent on the nature of its engagement at national and international levels with key cultural values and beliefs concerning the moral status of the early human embryo. This article argues that the political need to reconcile the promise of new health technologies with the cultural costs of scientific advance, dependent in this case on the use of the human embryo, has been met by the evolution of (...) bioethics as a political community, transnational network, and bureaucratic device. Bioethics has become the political means for the creation of a global moral economy where the trading and exchange of values is normalized and legitimated. As a result of such trading, value compromises are produced capable of legitimizing the regulatory policies necessary for maintaining public trust in the new science. (shrink)

There is near universal recognition that human participant protection is both morally and practically essential for all forms of research involving humans. Yet most of the discourse around human participant protection has focussed on norms—rules, regulations and governance arrangements—rather than on the actual effectiveness of these norms in achieving their ends—protecting participants from undue risk and ensuring respectful treatment as well as advancing the generation of useful knowledge. In recent years there has been increasing advocacy for evidence-based human participant protection (...) that would be grounded on the careful investigation of the effects of research on human participants. We offer an analysis of evidence-based protection and then focus on Canadian examples of research on evidence-based protection. We consider the prospects for such research being put into practice in Canada. Finally we connect our remarks to the theme of “the changing landscape of human participant protection.”. (shrink)

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain different levels (...) of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (shrink)

A report by the Nuffield Council on Bioethics, contrary to the Declaration of Helsinki, permits most important research initiatives in developing countries.The Ethics of Research Related to Health Care in Developing Countries by the Nuffield Council on Bioethics makes a number of innovative recommendations that depart from codes such as the Declaration of Helsinki. It recommends that standards of care might be relativised to the standard of that nation. It recommends that very good reasons need to be given for not (...) giving post-trial access to medications but recognises that there may be justifiable instances of this. It is the view of the authors that these and other recommendations of the report are sensible pieces of advice given the complexities of the developing world. (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)

Paul Feyerabend's globally acclaimed work, which sparked and continues to stimulate fierce debate, examines the deficiencies of many widespread ideas about scientific progress and the nature of knowledge. Feyerabend argues that scientific advances can only be understood in a historical context. He looks at the way the philosophy of science has consistently overemphasized practice over method, and considers the possibility that anarchism could replace rationalism in the theory of knowledge. -- Amazon.com.

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute ‘right’ of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw.This does not imply (...) that that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self‐defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to ‘push’ participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to ‘screen out’ people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on‐going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account. (shrink)

ABSTRACT Many people argue that disagreements and inconsistencies between Research Ethics Committees are morally problematic and there has been much effort to ‘harmonise’ their judgements. Some inconsistencies are bad because they are due to irrationality, or carelessness, or the operation of conflicting interests, and so should be reduced or removed. Other inconsistencies, we argue, are not bad and should be left or even encouraged. In this paper we examine three arguments to reject the view that we should strive for complete (...) consistency between committees. The first argument is that differences in judgement are not necessarily incompatible with ideas of justice for patients who are potential participants of research reviewed by different committees. We call this ‘the justice argument.’ The second argument is that such committees do not have access to a single moral truth, to which their judgement is supposed to correspond. We call this the ‘moral pluralism argument.’ The third argument is that the process of ethics committee review is also morally relevant and not solely the outcome. We call this the ‘due process argument.’ While we fall short of establishing exactly how much variation and on what substantive issues would be ethically permissible, we show that it is largely inevitable and that a certain amount of variation could be seen as a desirable part of the institution of medical research. (shrink)

Is bioethics consultation a profession? Withfew exceptions, the arguments andcounterarguments about whether healthcareethics consultation is a profession haveignored the historical and cultural developmentof professions in the United States, the wayssocial changes have altered the work andboundaries of all professions, and theprofessionalization theories that explain howmodern societies institutionalize expertise inprofessions. This interdisciplinary analysisbegins to fill this gap by framing the debatewithin a larger theoretical context heretoforemissing from the bioethics literature. Specifically, the question of whether ethicsconsultation is a profession is examined fromthe (...) perspectives of trait theory, Wilensky''sfive-stage process of professionalization,Abbott''s interdependent system of professions,and Haug''s deprofessionalization thesis. Whilehealthcare ethics consultation does not meetthe criteria to claim professional status,neither could most professions pass these idealtheoretical standards. Instead of a yes or nodichotomous response to the question, it ismore helpful to envision a professionalizationcontinuum with sales clerks or carpenters atone end and medicine or law at the other. During the past decade healthcare ethicsconsultation has been moving along thiscontinuum toward greater professional status. (shrink)

There is an international consensus that medical research involving humans should only be undertaken in accordance with ethical principles. Paradoxically though, there is no consensus over the kinds of activities that constitute research and should be subject to review. In the UK and elsewhere, research requiring review is distinguished from clinical audit. Unfortunately the two activities are not always easy to differentiate from one another. Moreover, as the volume of audit increases and becomes more formal in response to the demand (...) for evidence-based practice in medicine, the overlap between research and audit grows more acute. Arguably, similar ethical standards and systems for ensuring that those standards are met should be applied regardless of whether or not a project is classified as research or audit. At a time when the research ethics review system in the UK is undergoing significant reform it is important that the opportunity is not missed to address the longstanding research-audit problem. We discuss suggestions for further reform that addresses this issue. (shrink)

The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.

(2002). Clarifying the Ethics of Clinical Research: A Path toward Avoiding the Therapeutic Misconception. The American Journal of Bioethics: Vol. 2, No. 2, pp. 22-23.

ABSTRACTThe objective of this module is to familiarise you with the concept of informed consent, its ethical basis, its elements, and typical problems that are encountered even by the most well intentioned researchers when trying to achieve genuine informed consent.

It has become almost a truism to describe the interaction between research ethics committees and researchers as being marred by distrust and conflict. The ethical conduct of researchers is increasingly a matter of institutional concern because of the degree to which non-compliance with national standards can expose the entire institution to risk. This has transformed research ethics into what some have described as a research ethics industry. In an operational sense, there is considerable focus on modifying research behaviour through a (...) combination of education and sanctions. The assessment of whether a researcher is ethical is too often based on whether they submit their work for review by an ethics committee. However, is such an approach making a useful contribution to the actual ethical conduct of research and the protection of the interests of participants? Does a focus on ethical review minimise institutional risk? Instead it has been suggested that ethics committees may be distorting or frustrating useful research and are promoting a culture of either mindless rule following or frustrated resistance. An alternative governance approach is required. There is a need for a strong institutional focus on promoting and supporting the reflective practice of researchers through every stage of their work. By situating research ethics within the broader framework of institutional governance, this paper suggests it is possible to establish arrangements that actually facilitate excellent and ethical research. (shrink)

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

This rich collection, popular among teachers and students alike, provides an in-depth look at major cases that have shaped the field of medical ethics. The book presents each famous (or infamous) case using extensive historical and contextual background, and then proceeds to illuminate it by careful discussion of pertinent philosophical theories and legal and ethical issues.