Inmaculada de Melo-Martín

The role of ethics in shale gas policies

The United States has experienced a boom in natural gas production due to recent technological innovations that have enabled natural gas to be produced from unconventional sources, such as shale. There has been much discussion about the costs and benefits of developing shale gas among scientists, policy makers, and the general public. The debate has typically revolved around potential gains in economics, employment, energy independence, and national security as well as potential harms to the environment, the climate, and public health. In the face of scientific uncertainty, national and international governments must make decisions on how to proceed. So far, the results have been varied, with some governments banning the process, others enacting moratoria until it is better understood, and others explicitly sanctioning shale gas development. These policies reflect legislatures preferences to avoid false negative errors or false positive ones. Here we argue that policy makers have a prima facie duty to minimize false negatives based on three considerations: (1) protection from serious harm generally takes precedence over the enhancement of welfare; (2) minimizing false negatives in this case is more respectful to peoples autonomy; and (3) alternative solutions exist that may provide many of the same benefits while minimizing many of the harms.

Clinical and Translational Science Awards: can they increase the efficiency and speed of clinical and translational research?

Most agree that the recent decades-long boom in biomedical research discoveries has not had a sufficient effect on the publics health. To overcome some of the barriers to speeding clinical and translational (C/T) research, the National Institutes of Health has established the Institutional Clinical and Translational Science Award (CTSA). To explore whether the CTSA proposal addresses major C/T barriers and whether funded institutions offer adequate solutions, the authors reviewed the obstacles to C/T research described in the literature and examined the completeness of the solutions offered by the 12 initial CTSA awardees. Through an analysis of the literature, the authors categorized C/T barriers into three categories (research workforce, research operations, and organizational silos). They then analyzed each CTSA proposal regarding the types of programs offered to address these barriers. They found that, in general, institutions developed detailed programs to address research workforce and research operations barriers but had limited to no solutions for organizational silos. The authors suggest that differences in how barriers are addressed are consistent with the degree of control that CTSA centers have over these obstacles and solutions. They argue that although CTSA centers might have an important role in successfully addressing some of the barriers to C/T research, CTSA centers might ultimately have difficulties achieving their purported goal of facilitating and increasing the efficiency and speed of C/T research because of a lack of control over solutions to some important obstacles facing such research.

Viewpoint: Developing a Research Ethics Consultation Service to Foster Responsive and Responsible Clinical Research

Although clinical ethics has become a central, and welcome, component of the health care landscape, research ethics consultation services are still uncommon. Indeed, the usual approach to ethical concerns in research with human subjects has been primarily a regulatory one. Nonetheless, ethical problems also arise in the context of research and thus collaborations between investigators and research ethicists are as essential as those between physicians and clinical ethicists. The authors argue that the use of research ethics consultation services can be of benefit to clinical scientists, bioethicists, research institutions, and research subjects. Such services can increase sensitivity among researchers to the ethical implications of their work, result in better institutional research policies, and facilitate the development of an organizational culture that is receptive to the identification and resolution of ethical conflicts. The authors conclude by describing the process of development and implementation of such a research ethics consultation service at Weill Medical College of Cornell University.

Beyond risk. A more realistic risk–benefit analysis of agricultural biotechnologies

Like any technology, agricultural biotechnologies that use genetically modified organisms (GMOs) have their opponents and supporters. For their proponents, the significant benefits of GMOs for humans, animals and the environment clearly outweigh any risks that are inherent with new technologies (Jauhar, 2006; Reis et al , 2006). For example, crops could be genetically engineered to grow more quickly and more densely to use less land, feed the increasing world population and slow environmental degradation. These new crops could also be engineered to reduce the need for pesticides and herbicides, thus decreasing the contamination of soil and water. Similarly, animals could be engineered, for example, to lack the traits that account for their suffering in large‐scale, intensive animal farming environments. > …ethical concerns are reduced to technical questions and, of course, technical questions beg for technical answers Critics of GMOs and other agricultural biotechnologies do not find such claims compelling, and see the balance between risk and benefit as less clear‐cut (Margulis, 2006; Seralini et al , 2007). They contend that GM plants might have an allergenic potential that would render them unsafe for human consumption, that their nutritional value could be altered for the worse and that they could contribute to the spread of antibiotic resistance. Opponents also question the potential benefits of GMOs for the environment and animals. They worry that genetically altered plants could transfer recombinant DNA to other plants—thus threatening biodiversity—or that they might create superweeds or kill unintended organisms. Detractors also point out that GMO crops alone could not feed the worlds population without serious social, economic and political changes. These concerns about GMOs—although not a complete list—also indicate that previous and current discussions about the ethics of developing and using agricultural biotechnologies have focused solely, or at least primarily, on narrow assessments of risks and possible …

How do disclosure policies fail? Let us count the ways

The disclosure policies of scientific journals now require that investigators provide information about financial interests relevant to their research. The main goals of these policies are to prevent bias from occurring, to help identify bias when it occurs, and to avoid the appearance of bias. We argue here that such policies do little to help achieve these goals, and we suggest more effective alternatives.—De Melo‐Martin, I., Intemann, K. How do disclosure policies fail? Let us count the ways. FASEB J. 23, 1638–1642 (2009)

A Duty to Participate in Research: Does Social Context Matter?

Because of the important benefits that biomedical research offers to humans, some have argued that people have a general moral obligation to participate in research. Although the defense of such a putative moral duty has raised controversy, few scholars, on either side of the debate, have attended to the social context in which research takes place and where such an obligation will be discharged. By reflecting on the social context in which a presumed duty to participate in research will obtain, this article shows that decontextualized discussions of this putative moral obligation are problematic.Because of the important benefits that biomedical research offers to humans, some have argued that people have a general moral obligation to participate in research. Although the defense of such a putative moral duty has raised controversy, few scholars, on either side of the debate, have attended to the social context in which research takes place and where such an obligation will be discharged. By reflecting on the social context in which a presumed duty to participate in research will obtain, this article shows that decontextualized discussions of this putative moral obligation are problematic.

Interpreting Evidence: why values can matter as much as science

Despite increasing awareness of the ways in which non-epistemic values play roles in science, many scientists remain reluctant to acknowledge values at stake in their own work. Even when research clearly relates to risk assessment and establishing public policy, contexts in which the presence of values is less likely to be contentious, scientists tend to present such research as merely involving empirical questions about what the evidence is. As a result, debates over policy-related science tend to be framed as purely epistemic debates over the state of the evidence. We argue that this neglects the important ways that ethical and social values play legitimate roles in judgments about what we take to be evidence for a particular policy. Using the case of recent disputes about the relative safety of home birth, we argue that although the debate has been framed as a purely scientific one about the empirical evidence for home birth, it actually involves disagreements about underlying value assumptions. If our claims are correct, then in order to move the debate forward, scientists will need to engage in a critical discussion about the values at stake.

Moral Bioenhancement: Much Ado About Nothing?

Recently, some have proposed moral bioenhancement as a solution to the serious moral evils that humans face. Seemingly disillusioned with traditional methods of moral education, proponents of bioenhancement believe that we should pursue and apply biotechnological means to morally enhance human beings. Such proposal has generated a lively debate about the permissibility of moral bioenhancement. We argue here that such debate is specious. The claim that moral bioenhancement is a solution - whether permissible or not - to the serious moral problems that affect human beings is based on several problematic framing assumptions. We evaluate here three of such assumptions: the first rests on a contested understanding of morality, the second consist in a mistaken conception of human moral problems, and the third relates to problematic presuppositions grounding the interpretation of existent scientific evidence presented to defend moral bioenhancement. Once these framing assumptions are identified and critically evaluated, it becomes clear that the moral bioenhancement debate is misguided.

Can ethical reasoning contribute to better epidemiology? A case study in research on racial health disparities

A common belief among epidemiologists and other scientists is that they ought not engage in ethical evaluation or endorse any particular ethical, political, or social values while involved in scientific reasoning. Such values are irrelevant to collecting and interpreting data and can only lead to bias. This view is also reflected in scientists’ education. The authors argue that ethical values are crucial to conducting much epidemiological research. Focusing on epidemiological research on racial health disparities, they show that value judgments are inescapable when performing such research. Values are implicit in the framing of research questions, the identification of the problem, and the choices of design and methodology. By making value judgments explicit, scientists will be more likely to pay attention to them and thus assess them in critical ways. Finally, the implications that this has for scientific training are discussed. Scientific training should prepare scientists to engage in ethical reasoning not only because it will make them more responsible human beings, but also because it will make them better scientists.

The U.S. Food and Drug Administration's evaluation of the safety of animal clones: a failure to recognize the normativity of risk assessment projects.

The U.S. Food and Drug Administration (FDA) announced recently that food products derived from some animal clones and their offspring are safe for human consumption. In response to criticism that it had failed to engage with ethical, social, and economic concerns raised by livestock cloning, the FDA argued that addressing normative issues prior to issuing a final ruling on animal cloning is not part of its mission. In this article, the authors reject the FDAs claim that its mission to protect and advance public health can be accomplished without considering ethical issues or without making value judgments. The authors offer two arguments in support of their position. First, the agencys mission statement presupposes significant normative commitments and judgments. Second, the FDAs risk assessment of food products from cloned animals and their offspring is itself clearly shaped by a variety of normative commitments.