Research Ethics Policies Research Articles

The “Ethics Rupture” Summit, Fredericton, New Brunswick, Canada, October 25–28, 2012

This report explains the background of the "Ethics Rupture" Summit held in New Brunswick, Canada, October 2012, focusing on the disconnect between research-ethics policies and the nature and purpose of social-science research-an unintended "rupture" in ethics governance. Ethics is about human relationships, and the governance of ethics must reflect that fact rather than function as a bureaucratic, self-legitimating system of control. The themes that emerged from the Summit point to: structural problems with the current system; an undermining of the original, historical mission of some social-science disciplines; a discomfort with new methodologies; ethics committees and the well-being and education of social-science students; the possibilities of reform and renewal; and the next steps. Finally, the report refers in broad outlines to a "New Brunswick Declaration," which is currently being considered by participants of the Summit.

Protecting and respecting the vulnerable: existing regulations or further protections?

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 protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research.

Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines

Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation arena.

Ethical Issues in the Translation of Social Neuroscience: A Policy Analysis of Current Guidelines for Public Dialogue in Human Research

Social neuroscience and its potential implications create an interesting case study for examining human research ethics policies on the topic of public communication of research. We reviewed mainstream national and international human research ethics guidelines and policies on issues of public communication of research. Our analysis relied on five thematic nets to capture the interactions between research and the public: public understanding, knowledge translation, public participation, social outcomes, and dual use. Coverage of these topics is sparse and inconsistent in mainstream policies and guidelines. We identify three options to address these gaps and analyze their strengths and weaknesses.

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.

Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems

Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines whether the principle of clinical equipoise can be used as a standard for assessing the ratio of risk to direct-benefit presented by drugs administered in one category of Phase 1 study--first-in-human trials involving patients. On the basis of the supporting evidence for, and architecture of, Phase 1 studies, the articles offers two provisional conclusions: (1) the risks of drug administration in such trials cannot generally be justified on therapeutic grounds but by appeal to the social value of the research; and (2) a framework for adjudicating the ratio of risk/social-value must be developed.

Stem cell research policy and iPS cells.

The field of induced pluripotent stem cells (iPSCs) will be subject to a wide range of laws and research ethics policies, many of which exist as a result of the controversies associated with research on human embryonic stem cells. Understanding this potentially complex regulatory environment will help iPSC research move forward and will inform future policy.

When Does Decisional Impairment Become Decisional Incompetence? Ethical and Methodological Issues in Capacity Research in Schizophrenia

Most decision-making capacity (DMC) research has focused on measuring the decision-making abilities of patients, rather than on how such persons may be categorized as competent or incompetent. However, research ethics policies and practices either assume that we can differentiate or attempt to guide the differentiation of the competent from the incompetent. Thus there is a need to build on the recent advances in capacity research by conceptualizing and studying DMC as a categorical concept. This review discusses why there is a need for such research and addresses challenges and obstacles, both practical and theoretical. After a discussion of the potential obstacles and suggesting ways to overcome them, it discusses why clinicians with expertise in capacity assessments may be the best source of a provisional "gold standard" for criterion validation of categorical capacity status. The review provides discussions of selected key methodological issues in conducting research that treats DMC as a categorical concept, such as the issue of the optimal number of expert judges needed to generate a criterion standard and the kinds of information presented to the experts in obtaining their judgments. Future research needs are outlined.

Is Psychiatric Research Stigmatized? An Experimental Survey of the Public

Although decisional incapacity can be caused by various medical conditions, incapacity due to mental illness is often singled out for scrutiny in research ethics policy debates. We assessed whether there is a general discriminatory perception of mental illness research and, if so, aimed to characterize the nature of that perception. We conducted an experimental, randomized Internet survey of the general public. We recruited 3140 adults through a web-research survey panel, with oversampling of racial and ethnic minorities and the elderly. Willingness to allow medical versus mental illness research was compared by randomly assigning the respondents to 1 of 7 web-based experimental scenarios depicting a subject being considered for research participation. Respondents were more willing to allow research with medically ill than the mentally ill subjects, even when ethically relevant factors were equal. This difference was mediated through the respondents' tendency to view mentally ill subjects as more decisionally incapable than medically ill subjects, even when they were told that the subjects portrayed were in fact competent. Discriminatory perception of mental illness research exists and is mediated by an outdated view of mental illness and decisional capacity. Policymakers and institutional review board members may need to guard against its influence in their deliberations.

Rethinking Research Ethics

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.