Research on the socio-ethical impact of biomarker use and the communication processes in ECNIS NoE and NewGeneris IP

Current research projects using human biomarkers in their search for better knowledge on the interaction between environment and human health are facing sensitive ethical issues. Researchers may be put in situations in which it is unclear how to act in accordance with all necessary legal requirements on ethical aspects of research. As a consequence, scientific opportunities and important developments of which many individuals will benefit, may be missed. Sound scientific research in the field of environment and health may benefit from a "rethinking" of current theoretical frameworks and procedures issuing from clinical medicine, putting emphasis on decisional autonomy and the protection of the individual and to a much lesser degree taking into account the concept of "public interest". The protection of individuals participating in studies in the field of environmental health calls, e.g., new communication strategies from recruitment to debriefing, at individual as well as at societal levels. Research on the socio ethical aspects on HBM within ECNIS and Newgeneris is situated at the interface of science, ethics and law and should be considered in the context of one final goal: contributing to guidelines for a harmonized socio-ethical and legal approach of human biomonitoring activities in the EU, including procedures for effective and appropriate communication both a the individual and at the collective level, resulting in a European research atmosphere in which scientific research related to development and use of human biomarkers is promoted, and in which a simultaneous protection of the rights and dignity of the study subjects is guaranteed. A harmonized socio-ethical and legal approach not only increases the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of each citizen of the European Union.     

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.     

Scientific research on human subjects and ethics procedures at the Istituto Superiore di Sanità: a survey of the articles issued in 2001

Principles promoting the protection of subjects involved in biomedical research are interpreted differently within the scientific community. The purpose of this paper is to describe the attitudes of researchers working at the Istituto Superiore di Sanità (ISS) regarding the ethical implications of studies involving human beings, with particular emphasis on aspects concerning informed consent (IC) and ethics committee (EC) review. In 2001, ISS researchers published a total of 733 articles, 93 (12.7%) of which were studies involving human beings. Nearly 2/3 (60/93) were epidemiological, while the remaining 35.5% were based on laboratory data. Half (47/93) reported physical or psychological interventions or treatments on study subjects. 40.9% of articles mentioned that informed consent had been obtained and only 12.9% that approval had been given by an ethics committee. The low proportion of articles on which a protocol had been submitted the EC was due in part to the type of studies, but also to the absence of an institutional EC prior to 2001. Ethical procedures were more present in laboratory than in epidemiologic studies (IC: 69.7% vs 25.0%, p < 0.001) (EC: 27.3% vs 5.0% p = 0.004). Those differences were more likely due to the less interventionist nature of the epidemiologic studies rather than in poor ethical awareness on the part of epidemiologists. Further efforts are needed to develop and enforce clear institutional policies regarding ethical procedures.     

Ethics in epidemiological research

This text focus, on a series of author's opinions, on the difficulties that the current system of regulation of ethics in research represents for the practice of the epidemiological research, in the Country. It introduces a few understandings concerning the present subject in the international literature, pointing out some of the most relevant themes and problems. It also examines part of the difficulties faced by Brazilian epidemiologists. The main topic developed in the article is the specificity of the science's reasoning that guides acting of the public health and epidemiology with repercussions for the practice of scientific research in this field, plenty different from the science's reasoning that preside medical practice and biomedical research. Hence the inadequacy of the ethical recommendations in force, all of them based on biomedical research, particularly at that with experimental design. It concludes with the indication that procedures adopted by the system of the ethics in research should be reviewed, adapting such procedures to the characteristics of different kinds of research.     

Blurring nature at its boundaries. Vague phenomena in current stem cell debate

This paper illuminates the explanatory role of vagueness und species membership against the background of scientific developments in recent stem cell research. With the help of the Neo-Aristotelian concept of “life form naturalism” ontologically vague entities such as stem cells, all above induced pluripotent stem cells (iPS), could be described as necessary constituents for the correct sorting and naming of natural processes and its bearers. Furthermore this specific assessment allows drawing some important ontological and ethical consequences.     

Ethical review: Standardizing procedures and local shaping of ethical review practices

Since ethical review practice has developed in relation to specific regulatory regimes and local contexts, it cannot be understood without paying attention to the institutional context of ethical review practices. We believe the tendency towards strong central governance and standardization in ethical review implies a lack of understanding of how specific local institutional contexts actually affect ethical review practices. Our question is: “How do local institutional contexts relate to the way REC's shape their formal mandate, and what are the implications for research governance?” To get in-depth insights in how REC's shape their formal mandates in every-day practice, we did a qualitative ethnographic-sociological study of three Dutch REC's in different contexts: an academic context, a care context and a commercial context. In analyzing these three REC's we paid attention to the procedures operative in REC practices, the cultures and everyday experiences of REC members, the scientific, social and financial resources that are available to REC's, and the evaluative perspective REC's employ. We conclude that specific local, institutional contexts offer valuable resources for ethical review. To track this, insight into the institutional configuration as a whole is necessary. Variations in the ways REC's shape their formal mandate should not be regarded problematic, but rather as fruitful opportunities for public learning.     

Ethics in international health research: a perspective from the developing world

Health research plays a pivotal role in addressing inequities in health and human development, but to achieve these objectives the research must be based on sound scientific and ethical principles. Although it is accepted that ethics play a central role in health research in developing countries, much of the recent debate has focused on controversies surrounding internationally sponsored research and has taken place largely without adequate participation of the developing countries. The relationship between ethical guidelines and regulations, and indigenously sponsored and public health research has not been adequately explored. For example, while the fundamental principles of ethical health research, such as community participation, informed consent, and shared benefits and burdens, remain sacrosanct other issues, such as standards of care and prior agreements, merit greater public debate within developing countries. In particular, the relationship of existing ethical guidelines to epidemiological and public health research merits further exploration. In order to support health research in developing countries that is both relevant and meaningful, the focus must be on developing health research that promotes equity and on developing local capacity in bioethics. Only through such proactive measures can we address the emerging ethical dilemmas and challenges that globalization and the genomics revolution will bring in their wake.     

Neuroscientists’ everyday experiences of ethics: the interplay of regulatory,professional, personal and tangible ethical spheres

The ethical issues neuroscience raises are subject to increasing attention, exemplified in the emergence of the discipline neuroethics. While the moral implications of neurotechnological developments are often discussed, less is known about how ethics intersects with everyday work in neuroscience and how scientists themselves perceive the ethics of their research. Drawing on observation and interviews with members of one UK group conducting neuroscience research at both the laboratory bench and in the clinic, this article examines what ethics meant to these researchers and delineates four specific types of ethics that shaped their day‐to‐day work: regulatory, professional, personal and tangible. While the first three categories are similar to those identified elsewhere in sociological work on scientific and clinical ethics, the notion of ‘tangible ethics’ emerged by attending to everyday practice, in which these scientists’ discursive distinctions between right and wrong were sometimes challenged. The findings shed light on how ethical positions produce and are, in turn, produced by scientific practice. Informing sociological understandings of neuroscience, they also throw the category of neuroscience and its ethical specificity into question, given that members of this group did not experience their work as raising issues that were distinctly neuro‐ethical.     

Analysis of the ethical issues raised by a ten-year epidemiology program in French Guiana: limitations of the current legal framework and solutions adopted

BACKGROUND: This paper discusses the ethical aspects of a large research program in virology, conducted since 1994 and which has evolved in parallel with the elaboration of bioethics laws in France. This research, which involved the collection of a considerable amount of epidemiological data in the field, focused on epidemiological determinants (mother to child transmission, genetic susceptibility/resistance) of the human oncogenic retrovirus human T cell lymphotropic virus type 1 (HTLV-1). Data were collected from a specific population (Noirs Marrons) living in remote areas in French Guiana (South America). This ethnic group of African descent is highly endemic for HTLV-1 and associated adult T cell leukemia/lymphoma. The population has lived for two centuries on either side of the Maroni river, which constitutes the frontier between French Guiana and Surinam. The low socioeconomic and education levels of a large part of this population are mainly explained by a recent housing/residence fixation on the French side of the Maroni river. It is also linked to significant immigration from Surinam due to the civil war, which lasted for five years in the late 1990s, in this country. Conducting epidemiological surveys in this peculiar context illustrates the limitations of the available current legal framework in France for such studies. Indeed, several important ethical issues arose concerning not only individual and population benefits, but also specificities of the given information and of the informed consent. Another question concerns individual information feed-back in such a context of persistent viral infection, with a very low disease incidence, in a population with a relatively low education level. The goal of this work was mainly to report several of the ethical issues encountered and to discuss possible ways of achieving better information deliver and consent procedures in such a context. Indeed, these procedures should include new ideas and regulations promoting a real partnership, in order to conduct long-term epidemiological studies in populations with a low education level.     

Misconduct by researchers and authors

Most scientific research is conducted properly and reported honestly but a few authors invent or manipulate data to reach fraudulent conclusions. Other types of misconduct include deliberately providing incomplete or improperly processed data, failure to follow ethical procedures, failure to obtain informed consent, breach of patient confidentiality, improper award or denial of authorship, failure to declare competing interests, duplicate submission and plagiarism. Editors, peer reviewers and publishers may also act wrongly. Good practice guidelines are available from the International Committee of Medical Journal Editors (The Vancouver Group) and the Council of Science Editors, amongst others. The Committee on Publication Ethics provides flowcharts to assist editors deal with authorial misconduct. Examples are provided of cases involving epidemiological or public health research, reported to COPE over the last 9 years. Suggestions are offered as to how misconduct might be handled in future.     

Points of view in comparison on the 5ht revision of the Declaration of Helsinki

The horror for the scientific crimes of the nazi period led the World Medical Association (WMA), in 1964, to settle by the Helsinki declaration, an ethical code for the medical research on human beings. The code was successively modified in order to account for the developments of the medical science in the past decades. In October 2000, the last revision, the 5th one, has been approved in Edinburgh. Its preparation lasted three years and entailed a passionate, but also profitable dispute between who believes that ethical principles must be followed even though they can hamper the scientific progress, and who thinks that more articulate evaluations should prevail. The initial victory of the more intransigent party resulted in the maintenance of the norm which entails the greatest restriction in using placebo, but, after one year and half, it was partially reshaped by a more permissive interpretation of the same WMA, while waiting for a new revision that is scheduled for this year.     

Recherche et non-recherche. Les valeurs à l’oeuvre dans l’évaluation des protocoles épidémiologiques

BackgroundEvaluation and ethical review of epidemiological research projects raises the problem of the limits between research and non-research. This ambiguous boundary reflects the status of this discipline at the crossroads between research and practical action. The question then is: in the field of health research, what gives data collection and analysis its quality of scientific activity?MethodsA conceptual and empirical study has been conducted about the practices of epidemiological research evaluation, centred on the case of the French Consultative Committee for the data processing in health research (CCTIRS), which is a consultative board that permits the National commission for the personal data protection (CNIL) to take decision about health research protocols that process personal data. The study was realized from 2003 to 2006.ResultsIt is shown that the evaluation of such research protocols processing personal data articulates intimately two kinds of criteria: methodology and relevance. By studying and characterizing the different kinds of protocols that are judged not to be “scientific research” (poor science, pseudo-science and non-science), it becomes possible to understand the motives that lead to distinguish between what is and what is not research in epidemiology. A special attention is given to two kinds of problematic cases: firstly, the case of conflict of interests into the protocols themselves (i.e. seeding trials or surveys); secondly, the problem of epidemiological registers and other databases which are not hypothesis-oriented. This last case leads to relate the conceptual frame of the committee with historical circumstances (the way which this discipline was introduced in France) and also mere epistemological considerations (the question of induction and generalizability).ConclusionThe activity of this committee illustrates a differentiated conception of what is research in epidemiology, influenced by explanatory analytical research paradigms. Finally, the field of epidemiological research appears to be structured by some values that appear through the elaboration and the application of the ethical and regulatory texts.     

Research Ethics Committees: can they contribute to the improvement of clinical research in Europe?

There is an increasing crisis of credibility in the world of clinical and epidemiological research because of lack of transparency in the identification of research priorities, increasing dominance of commercial interests over patients' problems, limited funds for independent research, and lack of awareness that clinical research is integral to the duties of clinicians as patients' agents. Research Ethics Committees (RECs) are an important component of the research world and since their institution there are expectations at their ability to protect patients and improve clinico-epidemiological research. To many people, however, the task of RECs is still essentially that of safeguarding the ethical/informed consent issues related to research protocols without a role in the core content (scientific and clinical) of the research projects themselves. Others argue that the duties of RECs should be broader because scientifically invalid research is in itself unethical. The remits of RECs, therefore, should embrace a full range of issues, from assessment of the core content of research (objectives, nonredundancy, clinical relevance, and likelihood of reaching the stated goals) to the protection of publication and dissemination rights of researchers from the intrusiveness of commercial sponsors. This debate is further complicated by current arrangements in countries where RECs' decentralization has made their operation less homogeneous and reproducible, with a diffuse discontent about the end results of their activities. In the first part of the article I discuss the evolution of the concept of the ethics of clinical research and the main differences in the arrangements of RECs across Europe. In the second part, after a brief discussion of the new European Directive on Clinical Trials and its potential problematic impact on publicly-funded trials, I propose a series of actions that should be taken to improve the functioning of RECs and outline the cultural changes needed for research of better methodological quality and of greater relevance to patients.     

Screening for postpartum depression with the Edinburgh Postnatal Depression Scale (EPDS): an ethical analysis

AIMS: To assess the Edinburgh Postnatal Depression Scale (EPDS), a self-administered questionnaire created to screen for symptoms of postpartum depression in the community, from an epidemiological and ethical perspective. Screening, as the practice of investigating apparently healthy individuals to detect unrecognised disease or its precursors, has interpretation problems and is complicated by deliberations on probabilities for something to occur, on which the scientific community is unanimous. METHODS: Our ethical analysis is made using a framework with two different dimensions, the ethical principles autonomy and beneficence and the affected persons. To balance the ethical costs and the ethical benefits of EPDS an analogy with the assessment of pharmaceutics is used. RESULTS: In this article we argue that routine EPDS screening of Swedish postpartum women would lead to considerable ethical problems due to the weak scientific foundation of the screening instrument. Despite a multitude of published studies, the side-effects in terms of misclassifications have not been considered carefully. The EPDS does not function very well as a routine screening instrument. The dualism created is too reductive and fails to recognize the plurality of difference that exists in the social word. CONCLUSIONS: Public health authorities should not advocate screening of unproved value. Screening is not just a medical issue but also an ethical one.     

STrengthening the Reporting of OBservational studies in Epidemiology--Molecular Epidemiology STROBE-ME: an extension of the STROBE statement

Advances in laboratory techniques have led to a rapidly increasing use of biomarkers in epidemiological studies. Biomarkers of internal dose, early biological change susceptibility and clinical outcomes are used as proxies for investigating the interactions between external and/or endogenous agents and body components or processes. The need for improved reporting of scientific research led to influential statements of recommendations such as the STrengthening Reporting of OBservational studies in Epidemiology (STROBE) statement. The STROBE initiative established in 2004 aimed to provide guidance on how to report observational research. Its guidelines provide a user-friendly checklist of 22 items to be reported in epidemiological studies, with items specific to the three main study designs: cohort studies, case-control studies and cross-sectional studies. The present STrengthening the Reporting of OBservational studies in Epidemiology -Molecular Epidemiology (STROBE-ME) initiative builds on the STROBE statement implementing 9 existing items of STROBE and providing 17 additional items to the 22 items of STROBE checklist. The additions relate to the use of biomarkers in epidemiological studies, concerning collection, handling and storage of biological samples; laboratory methods, validity and reliability of biomarkers; specificities of study design; and ethical considerations. The STROBE-ME recommendations are intended to complement the STROBE recommendations.     

Governance of dual-use research: an ethical dilemma

Scenarios where the results of well-intentioned scientific research can be used for both good and harmful purposes give rise to what is now widely known as the “dual-use dilemma”. There has been growing debate about the dual-use nature of life science research with implications for making biological weapons. This paper reviews several controversial publications that have been the focus of debates about dual-use life science research and critically examines relevant policy developments, particularly in the United States of America. Though the dual-use dilemma is inherently ethical in nature, the majority of debates about dual-use research have primarily involved science and security experts rather than ethicists. It is important that there is more ethical input into debates about the governance of dual-use research.     

Coupled Ethical–Epistemic Analysis of Public Health Research and Practice: Categorizing Variables to Improve Population Health and Equity

The categorization of variables can stigmatize populations, which is ethically problematic and threatens the central purpose of public health: to improve population health and reduce health inequities. How social variables (e.g., behavioral risks for HIV) are categorized can reinforce stigma and cause unintended harms to the populations practitioners and researchers strive to serve.Although debates about the validity or ethical consequences of epidemiological variables are familiar for specific variables (e.g., ethnicity), these issues apply more widely.We argue that these tensions and debates regarding epidemiological variables should be analyzed simultaneously as ethical and epistemic challenges. We describe a framework derived from the philosophy of science that may be usefully applied to public health, and we illustrate its application.How epidemiological variables are categorized may result in real-world effects that reinforce stigma and cause unintended harms to the populations that public health professionals strive to serve. Debates about the validity or ethical consequences of variable choice are relatively familiar in the literature on ethnicity and race, but we suggest these problems apply more widely. We contend that stigmatizing vulnerable populations is ethically problematic, as has been previously established, and it more fundamentally undermines the purpose of public health research and practice: to improve population health and reduce health inequities.1 We outline some tensions that researchers face when categorizing variables and argue that these issues benefit from being approached as problems that are analyzed simultaneously as ethical challenges and as epistemic or evidentiary challenges. We present a framework, derived from the philosophy of science, as an approach that could be usefully applied to public health. We apply this framework to 2 examples: the use of men who have sex with men (MSM) as a variable in US blood bank policies and the use of the Scottish Index of Multiple Deprivation (SIMD) in health disparities policy.     

STrengthening the Reporting of OBservational studies in Epidemiology: Molecular Epidemiology STROBE-ME. An extension of the STROBE statement

Advances in laboratory techniques have led to a rapidly increasing use of biomarkers in epidemiological studies. Biomarkers of internal dose, early biological change, susceptibility, and clinical outcomes are used as proxies for investigating the interactions between external and/or endogenous agents and the body components or processes. The need for improved reporting of scientific research led to influential statements of recommendations such as STrengthening Reporting of Observational studies in Epidemiology (STROBE) statement. The STROBE initiative established in 2004 aimed to provide guidance on how to report observational research. Its guidelines provide a user-friendly checklist of 22 items to be reported in epidemiological studies, with items specific to the three main study designs: cohort studies, case-control studies and cross-sectional studies. The present STrengthening the Reporting of OBservational studies in Epidemiology - Molecular Epidemiology (STROBE-ME) initiative builds on the STROBE Statement implementing 9 existing items of STROBE and providing 17 additional items to the 22 items of STROBE checklist. The additions relate to the use of biomarkers in epidemiological studies, concerning collection, handling and storage of biological samples; laboratory methods, validity and reliability of biomarkers; specificities of study design; and ethical considerations. The STROBE-ME recommendations are intended to complement the STROBE recommendations.