Empirical research on research ethics

Ethics is normative; ethics indicates, in broad terms, what researchers should do. For example, researchers should respect human participants. Empirical study tells us what actually happens. Empirical research is often needed to fine-tune the best ways to achieve normative objectives, for example, to discover how best to achieve the dual aims of gaining important knowledge and respecting participants. Ethical decision making by scientists and institutional review boards should not be based on hunches and anecdotes (e.g., about such matters as what information potential research participants would want to know and what they understand, or what they consider to be acceptable risks). These questions should be answered through empirical research. Some of the preceding articles in this special issue illustrate uses of empirical research on research ethics. This article places empirical research on research ethics into broader perspective and challenges investigators to use the tools of their disciplines to proactively solve ethical problems for which there currently exist no empirically proven solutions.     

Rethinking research ethics

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.     

Rethinking research ethics

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.     

Christian ethics and empirical research

What significance might empirical research have for a constructive theory of Christian ethics? This article discusses this question by bringing results from a concrete empirical study of aspects of Christian ethics into conversation with two theories of the same phenomenon: those of William Schweiker and Stanley Hauerwas/Samuel Wells. After mapping the results of the empirical study to the views offered by the two constructive accounts, I discuss more generally whether empirical studies of this kind can have significance for constructive ethical theory. I discuss three possible objections against such a position: that introducing empirical research to constructive theory of Christian ethics undermines normativity, that it blocks criticism, and that its contributions are likely to be divergent, incoherent and unsystematic, thus adding little of significance to constructive theory. I argue that none of these objections can definitively exclude empirical research from constructive theory. But they certainly have implications concerning not only how empirical research might have significance, but also regarding criteria it must meet in order to legitimately claim constructive relevance. Some concrete suggestions to this effect are launched in a final argumentative move.     

Statistics and ethics in medical research

Ethical conduct is an essential component in research, especially in medical research. Statistical methods for design and analysis are powerful research tools if used properly. Abuse of these principles and methods are just as unethical as other laboratory or clinical misconduct. Inadequate research design can produce worthless results and thus wastes effort and valuable resources. For clinical research, patient resources are wasted. Inappropriate analysis of data can also produce misleading results and conclusions. For clinical research, inferior therapy might be given to patients as a consequence. These ethical concerns can have implications for and affect the individuals responsible for the statistical design and analysis. Examples are provided which illustrate some possible abuses and inappropriate pressures.     

An introduction to research ethics

Practical issues throughout scientific research can be found to have an ethical aspect. There is a gray area in which scientific error (“honest error”) may be difficult to distinguish from unacceptably poor research practice or an unethical failure to follow scientific norms. Further, there is no clear margin between deceptive practices which are widely accepted and those which must be considered fraudulent. Practical problems arise in matters of data management and presentation, authorship, publication practices, “grantsmanship”, and rights of research trainees, as well as the well-recognized areas of human and animal experimentation. Beyond the gray areas, the legal definition of research misconduct is discussed in relation to research fraud, and the latest proposed definition of the Commission on Research Integrity is briefly reviewed. It is noted that the standards of ethical research are changing. Finally, there is a comment on the idea of institutional integrity in research, and the critical role of the mentor in transmitting research standards to the next generation.     

The ethos and ethics of translational research

Calls for the "translation" of research from bench to bedside are increasingly demanding. What is translation, and why does it matter? We sketch the recent history of outcome-oriented translational research in the United States, with a particular focus on the Roadmap Initiative of the National Institutes of Health (Bethesda, MD). Our main example of contemporary translational research is stem cell research, which has superseded genomics as the translational object of choice. We explore the nature of and obstacles to translational research and assess the ethical and biomedical challenges of embracing a translational ethos.     

The ethics of social science research

ABSTRACT Ethical thinking about social science research is dominated by a biomedical model whose salient features are the assumption that only potential harms to subjects of research are relevant in the ethical evaluation of that research, and in the emphasis on securing informed consent in order to establish ethical probity. A number of counter-examples are considered to the assumption, a number of defences against these counter-examples are examined, and an alternative model is proposed for the ethical evaluation of social science research: a model which can cope with the systemic harms (harms other than those to participants as participants) which have been identified. This model is based on John Rawls's idea of original position reasoning and treats social science research as an institutional feature of the basic structure of society.     

A model for teaching research ethics

A model is described for implementing a program in research ethics education in the face of federal and institutional mandates and current resource, disciplinary, and infrastructure limitations. Also discussed are the historical background, content and evaluation process of the workshop at the heart of the program, which reaches a diverse group of over 250 students per year—from first-year graduate students in basic research labs to clinical fellows. The workshop addresses central issues in both everyday laboratory ethics and in larger societal questions. Goals include improving overall awareness of ethics guidelines and philosophy and enhancing skills in identifying and then analyzing the ethical components of situations. Pedagogies used and their effectiveness and that of the overall workshop and extended program are addressed. Programs like these have initiated a shift in the culture of basic research, which is a critical need given the current atmosphere.     

On the ethics of psychological research

Three philosophical positions on the nature of ethics were examined and contrasted within the context of psychological research: (a) teleology, which involves the balancing of the costs and benefits associated with an action as a means of developing general ethical rules; (b) deontology, which involves the rational adherence to rigid, universal rules that hold irrespective of the situation or consequences; and (c) skepticism, which involves denying the ability to apply universal rules and asserting the individuality of moral codes. Two experiments investigated the degree to which judgments of the ethicality of psychological research are affected by the consequences of the research and judge's ethical ideology. Subjects judged experiments that investigated obedience to an authority as generally less moral and more threatening to the participants' dignity and welfare when the proportion of total obedience was high rather than low. The proportion of participants (10 vs 40%) who were described as “psychologically upset” by the research did not affect moral judgments. These results were obtained across two different obedience situations (Milgram's study and a Watergate study) and different subject populations (high school and college students, males and females). As suggested by philosophers, a judge's ethical ideology determined how the perceived benefits and costs of the research were correlated with moral judgments. Teleologists weighed scientific benefits heavily, deontologists weighed participants' costs heavily, and skeptics weighed both heavily.     

A model for teaching research ethics

A model is described for implementing a program in research ethics education in the face of federal and institutional mandates and current resource, disciplinary, and infrastructure limitations. Also discussed are the historical background, content and evaluation process of the workshop at the heart of the program, which reaches a diverse group of over 250 students per year—from first-year graduate students in basic research labs to clinical fellows. The workshop addresses central issues in both everyday laboratory ethics and in larger societal questions. Goals include improving overall awareness of ethics guidelines and philosophy and enhancing skills in identifying and then analyzing the ethical components of situations. Pedagogies used and their effectiveness and that of the overall workshop and extended program are addressed. Programs like these have initiated a shift in the culture of basic research, which is a critical need given the current atmosphere.