The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually exclusive sets of activities and interventions. This (...) model is still the standard in federal regulations today. However, the Commission’s deliberations and conclusions about the boundaries are more complicated, nuanced, and instructive than has generally been appreciated. The National Commission did not conclude that practice needs no oversight comparable to the regulation of research. It debated the matter and inclined to the view that the oversight of practice needed to be upgraded, though the Commission stopped short of proposing new regulations for its oversight, largely for prudential political reasons. (shrink)

In the past twenty years, the field of science and technology studies (S&TS) has made considerable progress toward illuminating the relationship between scientific knowledge and political power. These insights have not yet been synthesized or presented in a form that systematically highlights the connections between S&TS and other social sciences. This timely collection of essays by some of the leading scholars in the field attempts to fill that gap. The book develops the theme of "co-production", showing how scientific knowledge both (...) embeds and is embedded in social identities, institutions, representations and discourses. Accordingly, the authors argue, ways of knowing the world are inseparably linked to the ways in which people seek to organize and control it. Through studies of emerging knowledges, research practices and political institutions, the authors demonstrate that the idiom of co-production importantly extends the vocabulary of the traditional social sciences, offering fresh analytic perspectiveson the nexus of science, power and culture. (shrink)

As Internet resources are usedmore frequently for research on social andpsychological behavior, concerns grow aboutwhether characteristics of such research affecthuman subjects protections. Early efforts toaddress such concerns have done more toidentify potential problems than to evaluatethem or to seek solutions, leaving bodiescharged with human subjects oversight in aquagmire. This article critiques some of theseissues in light of the US Code of FederalRegulations' policies for the Protection ofHuman Subjects, and argues that some of theissues have no pertinence when examined in thecontext (...) of common methodological approachesthat previous commentators failed to consider. By separating applicable contexts from thosethat are not, and by identifying cases wheresubjects' characteristics are irrelevant and/orimpossible to provide, oversight committees maybe able to consider research applications moreappropriately, and investigators may be lessethically bound to ascertain and demonstratethose characteristics. (shrink)

A tension between the professions' pursuit of autonomy and the public's demand for accountability has led to the development of codes of ethics as both a foundation and guide for professional conduct in the face of morally ambiguous situations. The profession as an institution serves as a normative reference group for individual practitioners and through a code of ethics clarifies, for both its members and outsiders, the norms that ought to govern professional behavior. Three types of codes can be identified (...) — aspirational, educational and regulatory. All codes serve multiple interests and, as a consequence, perform many functions, eight of which are discussed. The process of developing a code of ethics is assessed because of the role it plays in gaining consensus on professional values and ethical norms. After discussing some of the weaknesses in current approaches to professional self-regulation, several new private and public initiatives are proposed. (shrink)

This article examines how the availability of Big Data, coupled with new data analytics, challenges established epistemologies across the sciences, social sciences and humanities, and assesses the extent to which they are engendering paradigm shifts across multiple disciplines. In particular, it critically explores new forms of empiricism that declare ‘the end of theory’, the creation of data-driven rather than knowledge-driven science, and the development of digital humanities and computational social sciences that propose radically different ways to make sense of culture, (...) history, economy and society. It is argued that: Big Data and new data analytics are disruptive innovations which are reconfiguring in many instances how research is conducted; and there is an urgent need for wider critical reflection within the academy on the epistemological implications of the unfolding data revolution, a task that has barely begun to be tackled despite the rapid changes in research practices presently taking place. After critically reviewing emerging epistemological positions, it is contended that a potentially fruitful approach would be the development of a situated, reflexive and contextually nuanced epistemology. (shrink)

The speed of development in Big Data and associated phenomena, such as social media, has surpassed the capacity of the average consumer to understand his or her actions and their knock-on effects. We are moving towards changes in how ethics has to be perceived: away from individual decisions with specific and knowable outcomes, towards actions by many unaware that they may have taken actions with unintended consequences for anyone. Responses will require a rethinking of ethical choices, the lack thereof and (...) how this will guide scientists, governments, and corporate agencies in handling Big Data. This essay elaborates on the ways Big Data impacts on ethical conceptions. (shrink)

In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.

(2013). Informed Consent, Big Data, and the Oxymoron of Research That Is Not Research. The American Journal of Bioethics: Vol. 13, No. 4, pp. 40-42. doi: 10.1080/15265161.2013.768864.

Following the example of the many organizations in the United States which have a code of ethics, an increasing interest on the part of companies, trade organizations, (semi-)governmental organizations and professions in the Netherlands to develop codes of ethics can be witnessed. We have been able to escort a variety of organizations in this process. The process that organizations must go through in order to attain a code involves a variety of difficult decisions. In this article we will, based on (...) our experiences, describe twelve dilemmas which will have to be solved during the development of such a code. When one or more of these dilemmas is ignored or an ungrounded choice is made, the effectiveness of the code will be negatively affected. Furthermore, the twelve dilemmas could be used as twelve dimensions to exemplify organizational codes of ethics. In this article we will also discuss a method to organize ethics within the organization. This will serve as a guide as to how, with respect to the dilemmas described, adequate considerations can be made. The article will be concluded with a description of our experiences at the Dutch Schiphol Airport. This case demonstrates how the aforementioned reasoning can be applied in practice. (shrink)

This paper reports an analysis of the content of the codes of ethics of 15 professional business organizations in the United States, representing the broad range of disciplines found in business. The analysis was conducted to identify common ethical issues faced by business professionals. It was also structured to highlight ethical issues that are either unique to or of particular importance for business professionals. No attempt is made to make value judgments about either the codes of ethics studied or of (...) their content. General ethical values identified include honesty and integrity, general legal compliance, discreditable or harmful acts, and obligations related to social values. More business-specific issues include confidentiality, responsibilities to employers/clients, obligations to the profession, independence and objectivity, and business-specific legal and technical compliance issues. (shrink)