Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

Human clinical research has become a huge economic enterprise (Morin et al. 2002; Noah 2002). Because the human subject at the center can be so easily marginalized, many commentators recommend spec...

Biomedical research is an increasingly multidisciplinary activity bringing together a range of different academic fields and forms of expertise to investigate diseases that are increasingly understood to be complex and multifactorial. Recently the discipline of ethics has been starting to find a place in large-scale biomedical collaborations. In this article we draw from our experience of working with the Malaria Genomic Epidemiology Network and other research projects to reflect upon the integration of ethics into biomedical research. We examine the way (...) in which ethics input may be valuable to research, the forms it tends to take, and also the problems and limitations of such collaborations. (shrink)

Trust in the nurse—patient relationship is maintained not by how professionals perceive their actions but rather by how the public perceives them. However, little is known about the public's view of nurses and other health care professionals who participate in pharmaceutical marketing. Our study describes public perceptions of health care providers' role in pharmaceutical marketing and compares their responses with those of a random sample of licensed family nurse practitioners. The family nurse practitioners perceived their participation in marketing activities as (...) significantly more ethically appropriate than did the public responders. Further research is warranted before conclusions can be drawn, but these early findings suggest that nurse practitioners should consider a conservative approach to participating in pharmaceutical marketing. (shrink)

Academic-industry collaborations and the conflicts of interest (COI) arising out of them are not new. However, as industry funding for research in the life and health sciences has increased and scandals involving financial COI are brought to the public’s attention, demands for disclosure have grown. In a March 2008 American Council on Science and Health report by Ronald Bailey, he argues that the focus on COI—especially financial COI—is obsessive and likely to be more detrimental to scientific progress and public health (...) than COI themselves. In response, we argue that downplaying the potential negative impact of COI arising out of academic-industry relationships is no less harmful than overreacting to it. (shrink)

Bioethicists function in an environment in which their peers - healthcare executives, lawyers, nurses, physicians - assert the integrity of their fields through codes of professional ethics. Is it time for bioethics to assert its integrity by developing a code of ethics? Answering in the affirmative, this paper lays out a case by reviewing the historical nature and function of professional codes of ethics. Arguing that professional codes are aggregative enterprises growing in response to a field's historical experiences, it asserts (...) that bioethics now needs to assert its integrity and independence and has already developed a body of formal statements that could be aggregated to create a comprehensive code of ethics for bioethics. A Draft Model Aggregated Code of Ethics for Bioethicists is offered in the hope that analysis and criticism of this draft code will promote further discussion of the nature and content of a code of ethics for bioethicists. (shrink)

Conflicts of interest are receiving increased attention in medical research, clinical practice and education. Criticism of, and penalties for, conflicts of interest have been insufficiently discussed and have been applied without adequate conceptual backing. Genuine conflicts of interest are situations in which alternative courses of action are ethically equivalent, decision-making being less a matter of moral deliberation than of personal weighing of interest. In contrast, situations usually thought of as conflicts of interest are mostly temptations to follow an attractive but (...) undue option that causes harm by failing to uphold well-entrenched ethical standards. Examples of moral quandaries that pose as ethically neutral conflicts of interest are healthcare providers enticed to favour certain products; patients being referred to non-therapeutic trials entailing risks and non-optimal healthcare; industry-supported scientists failing to deliver unbiased research results and reports or participating in ghost-writing; and sponsored educators who praise their supporters beyond objective evidence. All these are moral blemishes, where integrity gives way to material incentives at the cost of provoking risky and harm-producing situations, thus constituting false conflicts of interest when they are in fact ethical misdemeanours. Disclosure has been the most widely recommended response to avoid the concealment of conflicting and ethically suspect interests. Regulations regarding disclosure reveal a utilitarian stance that shows more concern for the magnitude of support or sponsorship than for the underlying ethical transgression. Education and oversight should directly address and help correct the moral attitude towards undue influence of inducements and marketing strategies falsely posing as conflicts of interest. (shrink)

Ethicists have investigated ethical problems in other disciplines, but there has not been much discussion of the ethics of their own activities. Research in ethics has many ethical problems in common with other areas of research, and it also has problems of its own. The researcher’s integrity is more precarious than in most other disciplines, and therefore even stronger procedural checks are needed to protect it. The promotion of some standpoints in ethical issues may be socially harmful, and even our (...) decisions as to which issues we label as “ethical” may have unintended and potentially harmful social consequences. It can be argued that ethicists have an obligation to make positive contributions to society, but the practical implications of such an obligation are not easily identified. This article provides an overview of ethical issues that arise in research into ethics and in the application of such research. It ends with a list of ten practical proposals for how these issues should be dealt with. (shrink)

Bioethics, once a four-letter word in the private sector, is now an integral part of the decisionmaking process of biotechnology and pharmaceutical companies. And bioethicists, once confined to the classroom and limited to abstract, philosophical discussions about what is right and wrong in medicine and medical research, now play an important role in the practical implementation of ethical boundaries. Bioethicists increasingly are hired by biomedical companies as consultants to highlight and help resolve complex ethical issues that arise in the companies’ (...) normal business practices. Whether motivated by profit, reputation, or a genuine desire to act morally, these companies are willing to pay bioethicists substantial consultation fees for their “expert” opinions. This fairly recent phenomenon has caused some to be concerned about the potential for bioethicists to encounter conflicts of interests. Specifically, many critics of this new relationship between bioethicists and the private sector “are concerned about the appropriateness of ethicists who should have broader interests, such as concerns about social justice, serving clients whose primary interest is profit-maximizing.”. (shrink)

Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of ‘big data’. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The (...) main purpose of the register was to enable future research into the consequences of ritual circumcision. This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent – Meta consent – aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised. (shrink)

Growing ties to private industry have prompted many to question the impartiality of academic bioethicists who receive financial support from for-profit corporations in exchange for ethics-related services and research. To the extent that corporate sponsors may view bioethics as little more than a way to strengthen public relations or avoid potential controversy, close ties to industry may pose serious threats to professional independence. New sources of support from private industry may also divert bioethicists from pursuing topics of greater social importance, (...) such as the needs of medically underserved communities. To inform ongoing debates about the financing of bioethics and its transparency to those concerned about potential sources of bias, we examined funding disclosures appearing in original research reports in major bioethics journals. Reviewing research published over a 15-year period, we found little evidence that for-profit corporations are influencing bioethics research directly. Instead, we found evidence that a great number of organizations, both public and private, support bioethics research. These findings suggest that worries about the cooption of bioethics research by a few interested stakeholders are greatly overstated and undersupported by available data. (shrink)