Dans le cadre de la collecte des corpus oraux et multimodaux en Sciences Humaines et Sociales (SHS), le respect de l’application du nouveau Règlement Général sur la Protection des Données à caractère personnel provoque un profond bouleversement dans l’organisation et les méthodes de travail des chercheurs. C’est aussi le cas de la Loi Jardé, relative aux recherches impliquant la personne humaine, qui a étendu la notion de protection des personnes au-delà du champ de la recherche biomédicale. Ces deux importants (...) changements de cadre législatif obligent aujourd’hui la communauté scientifique à s’interroger à la fois sur la protection de la personne et sur la protection des données à caractère personnel.En définitive, avant d’initier un travail de recherche, un important travail de réflexion et d’actions est à mettre en place pour collecter des données dans le respect de la réglementation de protection des données et du cadre législatif de protection de la personne humaine. Identifier les difficultés pour envisager les solutions les plus adaptées est la mission que s’est fixée le groupe de réflexion constitué autour de la question « éthique » au Laboratoire Parole et Langage (LPL 2020). Nous proposerons dans cet article les réflexions argumentées de notre groupe sur l’impact de ces nouvelles réglementations sur les recherches en linguistique. (shrink)

The aim of the article is to explain the relationship between the ethical evaluation of scientific research involving personal data and the assessment of compliance with data protection law. The article presents the mutual relationship between the protection of personal data and scientific activity from a dogmatic perspective, the legal regulation of the processing of personal data in scientific research, and the so-called research exceptions that apply when data are processed for scientific (...) class='Hi'>research. It also covers the importance of meeting the ethical requirements of scientific research in order to profit from the indicated exceptions. Finally, it provides a comparison between the ethical and the legal systems of personal data protection in research (objectives, criteria, authorities, and procedures). (shrink)

This chapter contains sections titled: Introduction Fundamental Ethical Principles for Research Respect for Persons: Informed Consent Beneficence Justice Vulnerability and Exploitation Research Ethics Committees Conclusion Acknowledgments References.

Introduction The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. Objective The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Methods Curricula and teaching projects of 175 Brazilian medical schools were analyzed using (...) a retrospective historical and descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Results Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1 – ethics in research (26); 2 – ethical procedures and advanced technology (46); 3 – ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. Conclusion The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical education, these findings are significant for curriculum change and modification plans in the future of Brazilian medical education. (shrink)

Background Regulations on research ethics in France have evolved considerably over the past four years: the implementation of the Jardé law and of the General Data Protection Regulations have changed the landscape of research ethics for research involving or not involving human persons. In a context of creation of an Institutional Review Board at the University of Bordeaux, France, we sought to explore research ethics practices and perceptions in the medical community of (...) our University Hospital. Methods A short questionnaire was sent to all physicians of the University Hospital of Bordeaux. The questionnaire included closed questions and main topics were: physicians’ education in research ethics, ethics practices concerning researches non implying human persons, and physicians’ perceptions about current regulations. Results 86 questionnaires were sent back. If a majority of physicians have validated Good Clinical Practices trainings, there was a low rate of specific training on fundamental references in research ethics and a high proportion of responders do not consider themselves as educated in research ethics after completion of GCPs. Regulations on research ethics have many implications on medical research, especially by inducing changes in protocols in order to alleviate ethical requirements. Malpractices were acknowledged like false mention of positive opinion from an ethics committee. If If a majority of responders considers regulations as a positive answer to research ethics, a large majority considers it as a constraint and a complexification of research process. For 58%, regulations in research ethics are perceived as a hindrance for research initiatives. Conclusion Because of their impact on research process, regulations seem to constitute a scarecrow for physicians. Lack of training, bad representations and questionable practices highlight the need to improve education and to propose concrete guidance for medical researchers. (shrink)

The study of social, ethical, and political issues from a naturalistic perspective has been pervasive in social sciences and the humanities in the last decades. This articulation of empirical research with philosophical and normative reflection is increasingly getting attention in academic circles and the public spheres, given the prevalence of urgent needs and challenges that society is facing on a global scale. The contemporary world is full of challenges or what some philosophers have called ‘existential risks’ to humanity. Nuclear (...) wars, natural and/or engineered pandemics, climate change, global totalitarianism, and emergent technologies, are some of the challenges mentioned by many authors devoted to the study of long-term potential risks for the survival of the human species. However, while there are many reasons to be a pessimist about the future of humanity, there is also a lot of ink wasted in showing that the world today is far better than we had in the past and also that there have been many instances of social and moral progress in the last centuries. Some authors have even claimed that “we have made more progress over the last 100 years than in the first 100,000”. According to ‘our world in data’, some of the most relevant advances of humanity in the last centuries have to do with the reduction of poverty and/or inequality, better health and security, the decline of violence and war, and the development of democracy and institutional mechanisms to guarantee individual freedom and rights. Yet, there is a more concrete concern that our world faces nowadays, and requires a particularly detailed analysis. In a few words, the advance in information and communication technologies, the huge volume of people migration because of prevalent instances of global inequality, and the reality of an interconnected world that just mirrors an extensive history of massive human intergroup relations open the question about the feasibility of social and moral progress in the contexts of diverse, multicultural, and unequal societies. This makes it crucial to reflect not only on whether human societies may keep advancing on a path of social progress, but how this can be achieved by addressing the challenges of inequality and potential intergroup conflict. This concern closely relates to the further consolidation of democratic values and the achievement of a more generalized consideration of the equal moral value of human individuals far from group, ethnic, or collective distinctions. This vision of progress follows the moral convictions that have been considered right and worthy to be pursued by most ethical theories explored by philosophers and social scientists so far. This work aims to contribute to the study of the mechanisms and feasibility of social and moral progress grounded on the precept of human equality and is guided by the idea that social and moral progress in a plural world requires the accomplishment of a more democratic and tolerant society. These forms of progress have already been defined by philosophers Allen Buchanan and Russel Powell as inclusivist forms of moral progress. According to these authors, inclusivist moral progress is featured by the transformation of moral judgments, motivations, and norms guided by the rejection of “group-based restrictions on moral standing and moral status” (2018). The work of Buchanan and Powell is fundamental for the argumentation developed in this work since they have pioneered a more complex debate in the field of evolutionary social sciences and philosophical anthropology. In brief, these authors have inquired how human nature, conceptualized by the advances in evolutionary thinking and the empirical sciences, is related to our moral convictions and the possibilities that we have to establish certain forms of social and moral progress. The work of Buchanan and Powell contributes to the debate on moral progress by incorporating empirically-informed concepts and arguments. With this objective in mind, they develop their discussion around a generalized tension between exclusivist and inclusivist forms of moral progress. This tension revolves around the question of whether and to what extent human moral concerns, motivations, and norms, are limited or bounded by social identities, group thinking, or collective values. This question is at the center of this work. In other words, I aim to answer whether and to what extent the nature of our social and moral cognition hinders or enables the development of inclusivist forms of morality and moral progress. As I mentioned so far, the distinction between exclusivist and inclusivist forms of morality has a practical implication and facilitates the reflection on the mechanisms and feasibility of concrete forms of progress based on the precept of human equality, which is the road to progress that we should follow according to most ethical theories. The distinction between exclusivist and inclusivist morality is not used here as a form of summarizing highly divergent descriptive approaches to morality, but as a way to address the practical implications of morality research, particularly around the question of the feasibility of social forms of progress based on the precept of equality and tolerance. My objective then has less to do with offering a conceptualization of human morality or with the proposition of a new ethical perspective. Instead, I aim to identify, from an empirically informed perspective, what enables the achievement of egalitarian forms of social progress, to subsequently offer a normative reflection about what we should do if we want to accomplish such inclusivist forms of progress. This task is of great relevance, having in mind that some theoretical proposals on the matter have claimed that human prosocial behavior and morality are constrained by exclusivist fixed tendencies as a product of our evolutionary history. According to these views, human morality is a group-centered cognitive and behavioral expression that has severe limits in its scope and extent, which hinders in the end the emergence of inclusivist forms of moral concerns and behaviors. These claims align with the philosophical intuition about the ‘dissociation of empathy’, or the fact that human individuals tend to express empathy and sympathy preferably for members of their group whereas their empathic and moral concern and recognition for outgroup individuals tend to be reduced or eliminated in real-life social interactions. Multiple theorists have expressed, however, that these assumptions are wrong for empirical and philosophical reasons, which results in a serious challenge to the conception of human morality as exclusivist by nature. Furthermore, simple intuition and practical experience constantly show us that human individuals can develop and endorse a broad spectrum of moral considerations and adopt an arguably inclusivist stance concerning the kind of persons or agents that deserve moral concern. Moreover, and adopting a historical perspective, the expansion of cultural and commercial exchanges, the consolidation of democracy, the development of welfare states, or the emergence of institutions based on the concept of universal human rights, have partially driven human progress based on the impartial concern for the well-being of persons. These historical instances of cultural evolution and institutional design have shown that it is feasible to promote behaviors and attitudes grounded in impersonal prosocial and inclusivist principles. This optimistic perspective, however, still begs the question of the exact relationship between social, cultural, and historical contexts, and the emergence of certain behavioral expressions of inclusivist morality. This is crucial since a great number of human individuals around the world still do not make part of these instances of social progress, and some authors have suggested that such instances of social and moral progress are particularly favored by the contexts of the WEIRD world, that is the world of Western, Educated, Industrialized, Rich, and Democratic societies. Some of these approaches consider moral inclusivity a ‘luxury good’ and follow the ‘dependency thesis’ according to which the expression of moral inclusivity depends on the presence of very concrete material conditions that trigger inclusivist and impersonal prosocial tendencies that human beings are not able to express in threatening contexts without physical security. This thesis is problematic for various reasons and has led to incomplete explanations about the enabling and causal factors of inclusivist moral progress, as well as unsatisfactory suggestions about what we should do to foster the accomplishment of more generalized instances of progress based on inclusivist concerns. In an attempt to contribute to this debate, the main objective of this thesis is to offer an alternative proposal about the nature of human morality and a more detailed reflection on what we should do if we want to further accomplish such instances of progress. More precisely, this work adopts a particular developmental and constructivist vision of human morality to answer the question of how feasible it is to reach generalized forms of social progress based on the precepts of moral inclusivity. Furthermore, it offers some ideas about what are the most adequate and favorable conditions to foster such progress both at the individual and the collective level. At this point, a preliminary clarification of some starting points is necessary. In the first place, and contrary to what other authors have proposed when debating moral progress from an empirically-based approach, my perspective adopts a radical developmental and constructivist perspective, following particularly the conceptual and empirical ideas of the social-domain theory in moral psychology. From this perspective, morality is a domain of normative and social knowledge that develops and emerges in human interactions. Moral concerns, judgments, and norms are not only the result of the expression of innate adaptive intuitions, nor the product of social conformity and a simple process of mirroring the normativity that communities have established to organize their social life. Human individuals, instead, construct moral concerns and judgments during their situated interactions. More specifically, the constructivist tradition claims that we need to research how moral concerns, judgments, and reasons emerge in social interactions and how human beings construct the content of their moral knowledge in the first place. Based on these ideas, morality is defined here as the result of a constructive process through which human individuals, by the means of constant interactions on a background of mutual respect and recognition, develop evaluative concerns about how we ought to treat others, and how to ‘care’ and ‘respect’ others’ well-being, needs, and vulnerabilities. This developmental-constructivist theory of human psychology contributes to an alternative understanding of the origins of moral variability and informs a very particular normative stance about the most desirable contexts needed for the urgent accomplishment of inclusivist forms of morality in contemporary societies. This is so given that the very same definition of morality adopted presupposes the feature of inclusivity. The main objective of this work is then to argue, based on a developmental perspective, what are the most favorable conditions to foster the development of moral inclusivity and what we should do to accomplish concrete instances of moral progress that truly help us to overcome our most urgent moral challenges. The whole thesis is organized as follows. In part I, I show how received visions about human social evolution have informed conceptions of morality as an adaptive function evolved to solve the challenges of cooperative life. Based on these assumptions, some theories argue that human morality is limited by the boundaries of group thinking, and always obeys the mandates of collective interests and the will of the majority. However, this conception has problematic implications from a normative and ethical perspective. The aim of Chapter 1 is to present this introductory debate in detail. In chapter 2, I consider a relevant amount of scientific evidence that helps to consolidate a more optimistic and inclusivist perspective about the starting conditions of human prosocial behavior. Later, I will summarize some ideas offered to explain the possible evolutionary mechanisms that led to the consolidation of these inclusivist capacities. However, I will also show how evolutionary theories that share the same adaptationist foundations but initially seem relevant to explain the feasibility of moral inclusivity, result incomplete when considering the complexity of moral behavior and its ethical implications. Part II is devoted to presenting a developmental alternative to the adaptationist versions around the starting conditions of morality. In this section, I first summarize the epistemological, conceptual, and empirical basis of a constructivist perspective already proposed by several authors in the last decades. This is the goal of chapter 3. More precisely, I adopt the conceptualization of morality established by the social-domain theory school and clarify its conception of the situated development of moral concerns, motivations, and norms. All these ideas are essential for my argumentation on the feasibility of inclusivist moral progress offered later. Chapter 4 provides a more detailed idea of constructivist thinking about moral development, by analyzing one particular dimension: the development of moral concerns for fairness and the sense of justice in distributive dilemmas. In Part III, I assume a constructivist perspective on morality to contribute to the philosophy of moral progress. In particular, I discuss the implications of such a perspective for the conceptualization of human moral nature and discuss what are the most favorable conditions for moral inclusivity to emerge. Answering that question is of enormous relevance since favoring the transition of human societies towards more inclusivist forms of moral concern and behavior supposes a more generalized accomplishment of our most urgent moral convictions. Previous developmental or culturally-sensible attempts to explore this issue are already on the market. As mentioned before, most authors have approached the topic by situating the cultural evolution and development of (inclusivist) moral progress in the WEIRD world. For instance, some of these authors claim that very concrete material conditions (mostly present in the Western World) have been necessary for triggering inclusivist and impersonal prosocial tendencies that human beings are not able to express in threatening contexts without physical security. Despite their interest in explaining inclusivist morality and the feasibility of inclusivist forms of progress following a naturalistic and culturally situated approach, these theories are problematic for two main reasons. In the first place, most of the authors that explain moral progress tend to focus exclusively on the consolidation of liberal values in the Western world and the underlying adoption of laws, social-epistemic practices, and public narratives about tolerance and inclusivity, as unequivocal signs of inclusivist morality. Nevertheless, there is an enormous distance between the institutional and public support of inclusivist moral values or the construction of public images of tolerance and inclusivity, and the real materialization of impersonal moralities in situated social interactions. Secondly, the variability of human moral behavior is far bigger than most of the theories in moral psychology and moral progress tend to assume. Accordingly, inclusivist and exclusivist forms of morality may develop simultaneously in similar or divergent geographical and socio-ecological environments, including those with harsh conditions such as competition for scarce resources, potential intergroup conflict, and risks of disease transmission. In addition, harsh environmental conditions are usually present in almost all societies around the globe, and the presence of socio-ecological conditions such as physical security and prosperity, predominant in highly resourced populations, do not prevent the existence of exclusivist moral tendencies. My model explores a different perspective on the relationships between cultural, institutional, and historical factors, and the situated development of human morality. This supposes a clear distinction from previous approaches to the matter since it offers a different view on what we should do to pursue further instances of inclusivist social progress. In the fifth chapter, I first analyze the proposals of some defenders of the ‘dependency’ theory. The attention is focused on the ‘Evolutionary Developmental Model’ proposed by Buchanan and Powell (2018). Based on a critique of this approach, I will argue that to explain the evolution and development of human morality in its multiple manifestations, it is essential to put focus on social interactions. This also involves a different perspective on human-environment relations that in line with a constructivist worldview makes an innovative contribution to the philosophy of moral behavior and moral progress. Later, in the sixth chapter, I will define my alternative relational view of inclusivist morality and I will offer my view on how to establish favorable conditions that make inclusivist morality possible. Complementing the constructivist approach, my conception is based on the essential role of equality and individuality and on how moral inclusivity is favored if moral concerns do not develop driven by the accomplishment of group-centered, binding, and communitarian concerns and values. In brief, my relational model suggests that the accomplishment of moral inclusivity not only depends on the overall achievement of certain levels of physical security or economic prosperity. Instead, its development is favored by transforming the interactional contexts in which moral concerns towards autonomy and individuality emerge. In arguing so, I will need to start with a critique of contemporary situated and embodied approaches in ethics. Then, I will show how societies guided by the accomplishment of group-centered values of power, dominance, and relational inequality tend to express exclusivist moral behaviors, while individualistic societies tend to be more inclusivist. Starting from this diagnosis, my final attempt is then to reflect on which are the best conditions for the moral valuation of individuality to emerge and what we should do to promote the accomplishment of moral inclusivity at the societal level. (shrink)

As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for future research, which contain extremely important personal information and health data of the participants involved. Given the vast amount of samples and data accumulated by biobanks, they can be considered as reservoirs (...) of precious biomedical big data. It is therefore imperative for biobanks to have in place regulatory measures to ensure ethical use of the biomedical big data. Malaysia has yet to introduce specific legislation for the field of biobanking. However, it can be argued that its existing Personal Data Protection Act 2010 has laid down legal principles that can be enforced to protect biomedical big data generated by the biobanks. Consent is a mechanism to enable data subjects to exercise their autonomy by determining how their data can be used and ensure compliance with legal principles. However, there are two main concerns surrounding the current practice of consent in biomedical big data in Malaysia. First, it is uncertain that the current practice would be able to respect the underlying notion of autonomy, and second, it is not in accordance with the legal principles of the PDPA. Scholars have deliberated on different strategies of informed consent, and a more interactive approach has recently been introduced: dynamic consent. It is argued that a dynamic consent approach would be able to address these concerns. (shrink)

In Switzerland, research with identifiable human tissue samples, and/or its accompanying data, must be approved by a research ethics committee before it can be allowed to take place. However, as the demand for such tissue has rapidly increased in recent years, and biobanks have been created to meet these needs, committees have had to deal with a growing number of such demands. Detailed instructions for evaluating every kind of tissue request are scarce. Committees charged with evaluating (...) class='Hi'>research protocols therefore sometimes face uncertainty in their decision-making. We examine how a pool of Swiss REC members deal with a number of cases involving human tissue, in order to determine the standards they adhere to, and their understanding and implementation of existing laws and guidelines. There is considerable divergence in the approaches and decisions of Swiss REC members regarding human tissue sample requests, particularly concerning the issue of informed consent. Despite recent trends towards less strict consent requirements for biosample research, many of our respondents continue to employ demanding standards for researchers. The question of informed consent, and the circumstances in which it is required, continues to result in differences of opinion. While room for local and cultural interpretation is essential to the workings of an REC, misunderstanding of existing guidelines, or an absence of regulation in sensitive areas, will only lead to suboptimal functioning of the REC itself. Our data suggests that there is uncertainty and disagreement on the question of consent for human tissue sample, which existing laws and guidelines may not fully clarify. Methods to address these uncertainties should be implemented in order to ensure efficient and harmonious review of research protocols. (shrink)

This paper explores the legal and ethical concept of human subject research in order to determine whether genetic research with already available biosamples and data falls within this concept. Although the ethical concept seems to have evolved to recognize research based on data as human research, from a supranational legal perspective this form of research is not considered human subject research. Thus human subject research regulations do not apply and (...) therefore do not invoke the requirement of obtaining consent prior to using an individual’s biosample or genetic data in research. Furthermore, it remains ambiguous in both the legal and ethical realm whether the use of biosamples or genetic data without additional links to the individual would invoke the same safeguards as research involving additional or specific identifiers. Seeing that research based on already available biosamples and genetic data is not governed by rules concerning human subject research, the second part of the paper analyses whether any consent requirements apply for the further use of already available bio‐samples or genetic data in research. Whereas further use of biosamples is subject to considerably lax consent requirements under Article 22 of the Oviedo Convention, under the General Data Protection Regulation further use of genetic data might not be subject to a prior consent requirement at all, unless it is stipulated in national laws. When it comes to clinical trials, however, sponsors will have the possibility under Article 28(2) of Regulation 536/2014 to obtain open consent for further use of data in any kind of future research. (shrink)

Information communication technology is spreading fast and wide. Driven by convenience, it enables people to undertake personal tasks and make decisions more easily and efficiently. Convenience enjoys an air of liberation as well as self-expression affecting all areas of life. The industry for children's toys is a major economic market becoming ever more tech-related and drawn into the battle for convenience. Like any other tech-related industry, this battle is about industry dominance and, currently, that involves networked toys. Networked toys (...) aim to enhance convenience for children and parents alike. Increasingly difficult to resist, these convenient networked devices are also a societal game changer. Neatly nestled in a lacuna juris and surrounded by a lack of clinical evidence, networked toys raise complex ethical issues concerning human development. This article lays bare the regulatory nexus for networked toys and invites ethical thinking to fill the gap to ensure sufficient protection for all human developmental stages. Networked toys not only affect but also might interfere with child development. Therefore, the article initially summarises the four key psychological stages through which the neurological development of the human brain processes. Each of these stages involves vital windows for human development in cognitive, emotional and social dimensions. Missing any of these developmental windows changes an individual human for life. The article then takes a look at the two main legal frameworks protecting the stages of human development which are applicable to networked toys: First, the examination of the human rights framework with its major segments emanating from the fundamental rights to privacy for family and home, to a child's education as well as to personal data reveals the use of current networked toys as a shielded part of parenting which tends to be at odds with privacy and data protection requirements. Second, the product liability framework for toy manufacturers requires evidence-based causality for putting a child's safety at risk. Unfortunately, these legal frameworks fail to offer sufficient protection of the human developmental stages. There is a lacuna juris. Although networked toys involve the risk of negatively impacting human development in every dimension, clinical psychological studies are impossible to acquire as court evidence for product liability because they take too long to provide reliable data while exposing several generations of children to the examined risk in the process. Meanwhile the temptation of convenience continues to drive the industry and consumers of networked toys and devices, which are already impacting children of all age groups. Accepting this phenomenon as an element of cognitive dissonance in society and in science falls far short of an appropriate ethical balance. The need for creating such an ethical balance concerning networked toys is all the more imperative because even if the networked toy industry managed to eliminate all psychological risks for human development and every legal conflict with privacy and security, significant ethical and societal risks of networked toys remain due to inevitable technological bias. Against these mounting changes, it is suggested that only an ethical approach of interdisciplinary research and learning seems most promising to develop an appropriate equilibrium between the complex challenges posed by networked toys and the societal values at stake. (shrink)

The application of the latest technologies in biology and medicine has brought them to a qualitatively new level of possibilities. Worldwide, biobanking is actively developing through the creation of biobanks of various types and purposes, whose resources are used to solve therapeutic or scientific problems. Legal science remains an open question concerning the boundary that runs between the right to data protection and the scope of disclosure of data needed for medical purposes. In this article, the author considers peculiarities of (...) data processing in the context of biobanking activity on the example of Austria and its national legislation. In addition, the article reveals features of the approaches of the European Court of Human Rights (ECtHR) and the Council of Europe to the issue of biobanking in general, its characteristics in the context of data, and legal regulation of this phenomenon in the national law of states. The author devoted an important part of the study to the role of Austria’s experience in the context of data processing for scientific purposes and the development of biobanking for a number of other European states. The aim of the article is to analyze the Austrian legislation on data processing for scientific research and biobanking, the attitude of the Council of Europe to this phenomenon, and the practice of the ECtHR, as well as to consider the impact of the current world situation on these activities. The leading method of research used in the article is the formal-legal method. The article analyzes the Austrian law in the context of data processing in medical research, the relationship of the specifics of personal data protection, and the need to disclose them for scientific purposes. The author pays special attention to the influence of Austrian law on the legislation of other countries, which is reflected in the conclusions to the article. In addition, based on an analysis of the application of the Austrian experience to the legislation of Poland and Ukraine, the author points out the necessary changes that should be made in the laws of these countries. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December (...) 1948;Bearing in mind the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)

Purpose. The article highlights the demand for critical thinking in everyday life at the present stage of development of globalized culture and emphasizes the role of philosophy as a source of rationality. Philosophizing, which is determined by the psychosociocultural matrix, sets the toposes, vocabulary and rhythms of meaning making, their preservation and transformation. The purpose of the article is to concretize the practices of socio-cultural communication, primarily through the social institute of education, where individuals interact with the psychosociocultural matrix of (...) philosophizing, which mediate the general and individual level in philosophical culture. Theoretical basis of the study are cultural anthropology and phenomenological methods. Originality of the study: based on the philosophy of intersubjectivity, we actualized the rational grounds for formation of adequate judgments in modern culture at the level of everyday life. This justifies the inevitability of the spread of various forms and types of philosophical education, philosophical thinking, ideas and values developed in philosophical communities beyond the narrow circle of professional philosophers. This implies the systemic involvement of philosophers as professionals of meaning-making in solving problems in various non-academic fields – politics, economics, law, etc. The formation of skills of philosophical critical thinking in the process of preparing young people for active civil life is no less important aspect of this. Conclusions lead to an understanding of the existential importance of philosophy and philosophizing and the need for organized forms of knowledge transfer such as the Faculty of Philosophy of the Classical University. There is a mutual interest and interaction of the general culture of society and philosophy as a special kind of culture. Because philosophy actively configures other forms of culture, contributes to the creation of sociocultural identities precisely because of its ability to conceptually reproduce the core of the psychosociocultural matrix that underlies the existence of all these different forms within one society. The sociocultural macro level of philosophical spiritual practices is formed by the psychosociocultural matrix of the philosophical tradition, which retains its longevity from the emergence of philosophy and goes through its history, demonstrating the features of the national reception of philosophy as a national-specific embodiment of sociocultural macro level of the psychosociocultural matrix. (shrink)

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social–psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices :168–175, 2001). Institutions such as Institutional Review (...) Boards and Ethics Committees oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki. Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants. The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2 years ago we launched a pilot ethics committee at our technical university and began soliciting our colleagues to submit their studies for review. In the past year, we have become officially recognized as a human subjects ethics committee for our university and we are beginning the process of requiring all studies using human subjects to apply for our approval. In this article, we consider some of the special problems relating to protecting human participants in a technology context, and discuss some of our experiences and insights about reviewing human subjects research at a technical university, concluding: that not less than in medical studies, human participants used in technology research benefit from ethical committees’ reviews, practical requirements for publications, grants, and avoiding legal liability are also served by such committees, and ethics committees in such contexts have many similarities to, but certain other special foci than medical ethics committees. We believe that this experience, and these observations, are helpful for those seeking to establish such committees in technology research contexts, and for framing the particular issues that may arise in such contexts for the benefit of researchers, and nascent committees seeking to establish their own procedures. (shrink)

Dignity is a value inherent to all human beings, guaranteed to every individual from birth, and influenced by culture and society. It is protected by various laws and declarations, and represents one of the fundamental human rights. Preserving human dignity is an essential aspect of nursing practice and a central element of care. Dignity is a highly subjective and personal concept; there may be variations in the way that patients perceive it and in the ways (...) that nurses can guarantee it. A systematic review of the qualitative literature was conducted to obtain a comprehensive understanding of adult patients’ perceptions of dignity in a hospital setting. This review adhered to the PRISMA Statement for reporting systematic reviews, and the results were reported in accordance with the Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) guidelines. Major databases (PubMed, CINAHL, Scopus, and PsycINFO) were consulted and resulted in the inclusion of 21 studies. Methodological quality was assessed using the Critical Appraisal Skills Program (CASP) Checklist for Qualitative Studies. Six main themes emerged from the data analysis: (1) The concept of dignity and its various dimensions; (2) The significance of maintaining one’s own privacy and confidentiality; (3) The hospital environment’s influence on patients’ dignity; (4) Healthcare professionals’ characteristics and behaviours that affect dignity; (5) The role of communication and the relationship with healthcare providers; and (6) The patient’s ability to make choices and be involved actively in their care. These findings underscore the importance of understanding caregivers’ perspectives on dignity to ensure that they provide respectful and dignified care and treatment that prioritizes the patient’s mental and physical needs. (shrink)

The acknowledgement of basic human vulnerability in relationships between mental health service users and professionals working in community-based mental health services (in Norway) was a starting point. The purpose was to explore how users of these services describe and make sense of their meetings with other people. The research is collaborative, with researcher and person with experienced-based knowledge cooperating through the research process. Data is derived from 19 interviews with 11 people who depend on mental health services (...) for assistance at least three times a week. Data is analysed according to the Interpretative Phenomenological Analysis (IPA). Results confirm that reciprocity is fundamental for relationships, and that recognizing the individual entails personal involvement. The participants describe a struggle, and recognizing this struggle may help the professional to achieve a deeper understanding of the individual. (shrink)

This article argues that teenagers become fully capable of consenting to participation in most IRB-approved research involving human subjects at age 14, four years earlier than they are allowed to consent under virtually all states' laws, and, consequently, four years younger than they are able to consent under currently applicable federal regulations. In determining the age at which person is old enough to have decision-making authority, legal institutions look at the intellectual and emotional maturity of someone of (...) the age of the decision-maker, the risks and benefits of allowing the decision to be made by someone of that age, and the risks and benefits of denying a person of that age the authority to make the decision. Given the high level of safety of participating in IRB approved research, the value of doing so for both the society and the teenage subject, and the psychological and neuropsychological research on the specific nature of emotional and intellectual development during the teen years, the balance comes out in favor of allowing younger teens, by the age of 14, authority to consent to participate as subjects in IRB approved research. The current process requiring both teen assent and parental permission should give way to a process that requires only a teen's consent. (shrink)

Human dignity is the supreme criterion for protecting research participants, and likewise for numerous ethical matters of ultimate importance. But what is meant by “human dignity”? Isn’t this some vague criterion, some sort of lip service of questionable relevance and application? We shall see that it is nothing of the sort, that to the contrary, it is a very definite and very accessible criterion. However, how is this criterion applied in protecting research participants? These are the (...) matters that we will examine now. My presentation is divided into four parts. 1/Recognizing Human Dignity; 2/Practical Definition of Human Dignity; 3/The Human Being in a Weakened State; 4/ Conclusion. (shrink)

This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this (...) reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent – in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context – exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of ‘data’. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly. (shrink)

Meeting appropriate ethical standards for research involving human participants, mean ensuring confidentiality. It is assumed that the research participant will accept the safeguarding protocols necessary to ensure confidentiality. This assumption however oversimplifies the variation of motivations that goes into participants’ decisions to participate in research. Drawing on reflections from my fieldwork experience in Ghana, I answer the questions: Why do research participants reject confidentiality? What ethical position can one take when the researcher and the (...) researched have conflicting perspectives about confidentiality? I contend that participants with personal stake refuse confidentiality when they want to be acknowledged for their data. Rejecting confidentiality is however, embedded in the individual perspective, cultural, and political context of the study area. The ethical concerns of such refusal can be ameliorated if confidentiality is nuanced to include six categorically distinct but mutually non-exclusive stages: research-planning, ongoing-information, writing-up, reality-after-research, differential-disseminations, and no-confidentiality-clause. The paper further argues that whilst maintaining institutional allegiance in this matter is crucial, employing confidentiality should lie at the intersection of participants’ motivation for taking part in the research, the socio-cultural-specific-context of the study location and the nature of the topic being explored. (shrink)

Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim (...) to research a range of factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years. (shrink)

Drawing on Lennart Nordenfelt’s distinction between the four distinct senses of dignity, I elucidate the meaning of dignity in the context of research involving human subjects. I acknowledge that different interpretations of the personal senses of dignity may be acceptable in human subject research, but that inherent dignity (Menschenwürde) is not open to interpretation in the same way. In order to map out the grounds for interpreting dignity, I examine the unique application of the (...) principle of respect for dignity in Canada’s research ethics guidelines. These guidelines are unique because they consider dignity to be a foundational concept and the protection of the dignity of research subjects is regarded as a measure that prevents “the impoverishment of humanity as a whole”. While the conception of humanity invoked here is incomplete, Canada’s research ethics guidelines nevertheless represent a more European approach to biomedical policy. Finally, in order to correct a pervasive blind spot in contemporary policy on research involving human subjects, I sketch a functional model for attributing inherent dignity that avoids the untenable connotations of speciesism. (shrink)

In this paper, we discuss several problems with current Big data practices which, we claim, seriously erode the role of informed consent as it pertains to the use of personal information. To illustrate these problems, we consider how the notion of informed consent has been understood and operationalised in the ethical regulation of biomedical research (and medical practices, more broadly) and compare this with current Big data practices. We do so by first discussing three types of problems that (...) can impede informed consent with respect to Big data use. First, we discuss the transparency (or explanation) problem. Second, we discuss the re-repurposed data problem. Third, we discuss the meaningful alternatives problem. In the final section of the paper, we suggest some solutions to these problems. In particular, we propose that the use of personal data for commercial and administrative objectives could be subject to a ‘soft governance’ ethical regulation, akin to the way that all projects involving human participants (e.g., social science projects, human medical data and tissue use) are regulated in Australia through the Human Research Ethics Committees (HRECs). We also consider alternatives to the standard consent forms, and privacy policies, that could make use of some of the latest research focussed on the usability of pictorial legal contracts. (shrink)

Being in the bodily presence of others facilitates important perceptual, social, and informational advantages. For example, it enables direct access to other subjects’ embodied perspectives, motivates intersubjective engagements, and is involved in the construction of shared experiences and joint actions. These advantages are based on and gained through attending to and with others, i.e. they rely on social attention. It is no surprise, therefore, that a growing body of empirical data indicates that social attention is a special attentional state that (...) involves specific behavioral and neural-cognitive properties. Another important feature of the human capacity for social attention, which is highlighted in this article is that in everyday environments social attention considerably extends and enriches the subject’s attentional field. This idea draws on phenomenological considerations and on findings from cognitive science research that suggest that subjects can attend to more than in the center of their attention and that under normal conditions we can gain more features and more situations when attending to the movements, gestures, and facial expressions of others. The influence of others on the structure of our attentional field is evident from situations where others are absent from our daily surroundings. In these circumstances our attentional field narrows and the world transforms into an unfamiliar and sometimes uncanny place. Intriguingly, the same most likely occurs in social pathologies such as BPD and SAD, in which the bodily presence of others does not generate the emotional response we see in healthy humans even though the subject’s basic capacity for social attention is intact. (shrink)

Restricting a person’s liberty presents society with many inherent ethical challenges. The historical purposes of confinement have included punishment, penitence, containment, rehabilitation, and habilitation. While the purposes are indeed complex, multifaceted, and at times ambiguous or contradictory, the fact of incarceration intrinsically creates many ethical challenges for psychiatrists working in correctional settings. Role definition of a psychiatrist may be ambiguous, with potential tensions between forensic and therapeutic demands. Privacy may be limited or absent and confidentiality may be compromised. Patient autonomy (...) may be threatened to address real or perceived security concerns. Care delivery may actually have harmful consequences in court cases for pretrial detainees or lethal consequences for those under a death sentence. An absence of data and targeted research hampers the development of evidence-based care delivery for the disenfranchised, understudied, and disproportionately ill prisoner population. In this review paper, I discuss a few of the challenges and dilemmas routinely faced and present a series of questions. Where feasible, proposed resolutions are offered. (shrink)

Property rights of personal data have been advocated for some time. From the perspective of economics of law some argued that they could lower transaction costs for contracts involving personal data. This may be the case, but new transaction costs are introduced by propertization and the issue has not been settled. In this paper, I focus on a different and potentially more important aspect. In the actual situation, data collectors externalize costs and internalize benefits. An ownership regime (...) that enables every citizen to hold a personal data account, like a bank account, and that gives people ownership rights over secondary use of personal data could correct these misallocations. I hope to shed new light on the normative implications of the issue by offering normative justifications for property rights of personal data (Sections 2–4). Secondly, I present fundamental goals and building blocks of a property regime of personal data (Section 5) and, thirdly, I illustrate how income from personal data ownership could for instance contribute to financing pensions under proper regulation (Section 6). (shrink)

Property rights of personal data have been advocated for some time. From the perspective of economics of law some argued that they could lower transaction costs for contracts involving personal data. This may be the case, but new transaction costs are introduced by propertization and the issue has not been settled. In this paper, I focus on a different and potentially more important aspect. In the actual situation, data collectors externalize costs and internalize benefits. An ownership regime (...) that enables every citizen to hold a personal data account, like a bank account, and that gives people ownership rights over secondary use of personal data could correct these misallocations. I hope to shed new light on the normative implications of the issue by offering normative justifications for property rights of personal data (Sections 2–4). Secondly, I present fundamental goals and building blocks of a property regime of personal data (Section 5) and, thirdly, I illustrate how income from personal data ownership could for instance contribute to financing pensions under proper regulation (Section 6). (shrink)

Bioethicists have for quite some time discussed the right to know and the right not to know personal health information, such as genetic information acquired in health care and incidental health-related findings in research. Several international ethical guidelines explicitly defend these rights.My own interest in these matters stems from my participation in ethics-related research tied to a longitudinal screening study on Type I diabetes involving young children. A few of the participating parents did not want to (...) be informed if the study revealed their child had a high risk of developing diabetes. This response was troublesome, not least since the information would concern the child's and not the parents’ health. Our inclination was that there cannot be a right not to know that should be granted without qualifications. Furthermore, other contextual factors, e.g., that parents experienced pressure to participate and felt concern about some of the personal data handled in the study, gave reason to question whether autonomous decisions were made regarding participation. The autonomy of their expressed desire not to know was therefore questionable. (shrink)

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: the data protection regime which follows the application of the European Union General Data Protection Regulation, and the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given (...) and revocable and therefore has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Chair’s Perspective on the Work of the Advisory Committee on Human Radiation ExperimentsRuth Faden (bio)On January 15, 1994, President Clinton created the Advisory Committee on Human Radiation Experiments in response to his concern about the increasing number of reports describing alleged unethical conduct of the U.S. Government, and institutions funded by the government, in the use of, or exposure to, ionizing radiation in human beings (...) at the height of the Cold War. He directed the Committee: (1) to uncover the history of human radiation experiments and intentional environmental releases of radiation; (2) to identify the ethical and scientific standards for evaluating these events; and (3) to make recommendations to ensure that whatever wrongdoing may have occurred in the past will not be repeated.The Committee was composed of 14 members: a citizen representative and 13 experts in bioethics, radiation oncology and biology, epidemiology and statistics, public health, history of science and medicine, nuclear medicine, and law. We reported to a cabinet-level group (the Human Radiation Interagency Working Group) convened by the president, which includes the secretaries of defense, energy, health and human services, and veterans affairs; the attorney general; the administrator of the National Aeronautics and Space Administration; the director of the Central Intelligence Agency; and the director of the Office of Management and Budget.On April 21, 1994, at the end of the first day of our first meeting, President Clinton invited us to the White House to personally communicate his commitment to the process we were about to undertake. He urged us to be fair, thorough, and unafraid to shine the light of truth on this hidden and poorly understood aspect of our nation’s past. Our most important task, he said, was to tell the full story to the American public. [End Page 215] At the same time, we were to examine the present, to determine how the conduct of human research today compares with that of the past, and to assess whether, in light of this inquiry, changes need to be made in the policies of the federal government. Eighteen months later, the Committee’s attempt to tell the story of the past and to report on our inquiry into the present was delivered to the president in a 900-page Final Report (ACHRE 1995) and several supplemental volumes.The Committee’s charge was enormous. We were asked to conduct a massive investigation into events that occurred as much as 50 years ago and that involved the highest reaches of the defense establishment and the medical community. This investigation necessitated an examination of the conduct and policies of six federal agencies and countless agents in the private sector, as well as the location and interpretation of hundreds of thousands of documents, many of which were buried in obscure locations or were still classified.In addition, the Committee was instructed to establish standards for judging, in moral terms, the events that it uncovered. This charge necessitated the confrontation of contentious debates in moral thought and theory about history, relativism, and the significance of context in moral judgment. But our purpose was not to engage in these debates in the abstract. Although the Committee was not expressly charged with considering issues relating to remedies, including financial compensation, we felt obliged to address the type of remedies that we believed the government, as an ethical matter, should provide to subjects of experiments where the circumstances warranted such a response. Thus our deliberations about relativism and moral judgment were tied to concrete recommendations for public policy and were conducted in a public context that included participants from numerous adversarial legal proceedings.In tandem with our reconstruction of the past, we undertook three projects to examine the current state of human radiation experiments. First, we studied how each federal agency that currently conducts or funds research involving human subjects regulates and oversees its research activity. Second, from among the very large number of federally-supported research projects involving human subjects, we randomly selected 125 projects for closer scrutiny. We reviewed all available relevant documentation for each project in order to assess how well it appeared to protect the rights and interests of the participating subjects. Third... (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently (...) or are not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently (...) or are not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Re-examining Empirical Data on Conflicts of Interest Through the Lens of Personal NarrativesEmily E. Anderson and Elena M. KrausIntroductionThe personal stories submitted by physicians and researchers for this symposium add much–needed dimension to conversations on conflicts of interest in medicine and research. Narratives from individuals living with conflicts of interest can serve as a unique lens through which to consider psychological and economic theories and survey (...) data on physician and patient views. In our reading of these personal narratives, we identified four primary themes that will serve as springboards for our commentary. We aim to triangulate clusters of meaning drawn from the narratives with relevant data from published empirical studies and identify gaps in knowledge where more research is needed. These themes are: the unique environments of medicine and research; weighing the potential benefits of conflicts of interest against the risks; conflict of interest management; and the roles and responsibilities of diverse stakeholder groups.The Unique Challenges of the Medical and Research EnvironmentsThe reflections of the narrative authors draw attention to many of the unique environmental aspects of medicine and medical research that make physicians and researchers especially vulnerable to conflicts of interest. Conflicts of interest may be more ubiquitous in medicine than in any other industry (Kassirer, 2006). As the narratives demonstrate, conflicts of interest emerge across a range of health care delivery and research activities. Surveys have shown that 94 percent of physicians have some kind of relationship with industry (Campbell, Gruen, Mountford, et al., 2007). There is also evidence that physician interactions with medical industry begin early and are a regular part of a physician’s professional practice along the career continuum (Wazana, 2000).Medicine as a profession is distinct from banking or law. It is often said that medicine is an art; in treating patients, creative individualized solutions and gut instinct are as (if not more) important than the application of scientific knowledge. Uncertainty surrounds medical decision making. There is limited precision with respect to diagnoses and prognoses, limited data regarding the effectiveness of many treatments, and a range of patient values and preferences. Because of this uncertainty, rules about practice standards, especially with respect to avoidance and management of conflicts of interest, cannot be as explicit as they are in law or business. As demonstrated by the story presented by Sal Cruz–Flores, research and practice often intersect. And, there is no system in greater need of reform—and no system about which there are more divergent opinions as to what shape that reform should take—than the United States health care [End Page 91] system. The narratives of Tony Mikulec, Govind Nagaldinne, and David M. Zientek demonstrate how various aspects of the structure of healthcare service provision and third–party payer arrangements have the potential to harm patients. Conflicts of interest comprise more than relationships with pharmaceutical and medical device manufacturers.The narratives of Laura Jean Bierut and David M. Zientek also discuss examples of conflicts of interest that arise from factors beyond relationships with industry or the direct potential for financial gain. This may be somewhat unique to the medical milieu. Non-financial conflicts such as a desire for the prestige bestowed upon scientists who make key discoveries, a requirement to publish for tenure and promotion, the need to maintain one’s license or other privileges, or simply the pressure of a competitive environment can influence physician and researcher behavior. As noted by Bierut, more research on how to identify and manage non-financial conflicts is needed.The Potential Benefits and Harms of Conflicts of InterestConflicts of interest are usually presented in a negative light, particularly those that involve physician relationships with the pharmaceutical industry. To “have a conflict of interest” is to be in a situation or role where there is potential for personal interests to be prioritized over professional responsibilities. However, in terms of public perception, it seems that conflicts of interest have become almost synonymous with wrongdoing. Perhaps this is due to the barrage of media reports during the last decade on significant harms caused by financial conflicts of interest in business, journalism, and sports as well as in medicine (Steinbrook, 2004). Amidst... (shrink)

This article is the result of an international research between law and ethics scholars from Universities in France and Switzerland, who have been closely collaborating with technical experts on the design and use of information and communication technologies in the fields of human health and security. The interdisciplinary approach is a unique feature and guarantees important new insights in the social, ethical and legal implications of these technologies for the individual and society as a whole. Its aim is (...) to shed light on the tension between secrecy and transparency in the digital era. A special focus is put from the perspectives of psychology, medical ethics and European law on the contradiction between individuals’ motivations for consented processing of personal data and their fears about unknown disclosure, transferal and sharing of personal data via information and communication technologies (named the “privacy paradox”). Potential benefits and harms for the individual and society resulting from the use of computers, mobile phones, the Internet and social media are being discussed. Furthermore, the authors point out the ethical and legal limitations inherent to the processing of personal data in a democratic society governed by the rule of law. Finally, they seek to demonstrate that the impact of information and communication technology use on the individuals’ well-being, the latter being closely correlated with a high level of fundamental rights protection in Europe, is a promising feature of the socalled “e-democracy” as a new way to collectively attribute meaning to large-scale online actions, motivations and ideas. (shrink)

As opposed to a ‘one size fits all’ approach, precision medicine uses relevant biological, medical, behavioural and environmental information about a person to further personalize their healthcare. This could mean better prediction of someone’s disease risk and more effective diagnosis and treatment if they have a condition. Big data allows for far more precision and tailoring than was ever before possible by linking together diverse datasets to reveal hitherto-unknown correlations and causal pathways. But it also raises ethical issues relating to (...) the balancing of interests, viability of anonymization, familial and group implications, as well as genetic discrimination. This article analyses these issues in light of the values of public benefit, justice, harm minimization, transparency, engagement and reflexivity and applies the deliberative balancing approach found in theEthical Framework for Big Data in Health and Research to a case study on clinical genomic data sharing. Please refer to that article for an explanation of how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. Our discussion is meant to be of use to those involved in the practice as well as governance and oversight of precision medicine to address ethical concerns that arise in a coherent and systematic manner. (shrink)

Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals’ exclusion from research as a result of such regulation risks condemning such populations to poor quality (...) care as a result of ‘evidence biased’ medicine. This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs. The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented. (shrink)

Emergency care research sometimes involves incapacitated adults as research participants. The ethical principle of respect for autonomy may not necessarily apply to an incapacitated person unable to act in an autonomous manner, although it can be argued that researchers still have a duty of respect towards such people because they have moral status despite being incapacitated. Sharing some common ground with theories of moral status based on ‘humanness’ and the ability for rational thought is the notion of (...) class='Hi'>human dignity, which features in arguments regarding researcher conduct with incapacitated patients. However, human dignity premised upon the unique ability of humans for rational thought and moral self-regulation is contingent upon these capabilities – a limitation that possibly makes dignity a less useful framework for research conduct in emergency care research. In this article, I will discuss the different conceptions of human dignity – as equality, status and virtue – and then draw on more recent literature that explains human dignity as a social constraint and as a factor influencing the conduct of healthcare professionals and researchers. I will address questions of whether dignity as a principle ought to apply only to those who have the ability to think rationally, or to all humans regardless of their condition or mental status. I will argue that, in relation to offering protection to research participants in emergency conditions, it is immaterial which view is taken. (shrink)

Answering important public health questions often requires collection of sensitive information about individuals. For example, our understanding of how HIV is transmitted and how to prevent it only came about with people's willingness to share information about their sexual and drug-using behaviors. Given the scientific need for sensitive, personal information, researchers have a corresponding ethical and legal obligation to maintain the confidentiality of data they collect and typically promise in consent forms to restrict access to it and not to (...) publish identifying data.The interests of others, however, can threaten researchers' promises of confidentiality when legal demands are made to access research data. In some cases, the subject of the litigation is tightly connected to the research questions, and litigants' interest in the data is not surprising. Researchers conducting studies on tobacco or occupational or other chemical exposures, for example, are relatively frequent targets of subpoenas. (shrink)

Evidence, as viewed through the lens of statistical significance, is not always as it appears! In the investigation of clinical research findings arising from statistical analyses, a fundamental initial step for the emerging fraud detective is to retrieve the source data for cross-examination with the study data. Recognizing that source data are not always forthcoming and that, realistically speaking, the investigator may be uninitiated in fraud detection and investigation, this paper will highlight some key methodological procedures for providing a (...) sounder evidence base for withdrawing from a study on grounds of integrity. The promotion of patient safety is paramount. However, there is a broader rationale for disseminating these ideas. This includes empowering researchers to optimize their personal integrity, make informed choices regarding membership of future research collaborations and successfully voice their concerns to journal editors, particularly where a conflict of interests can render such dialogues particularly difficult. Recommendations will be supported by topical case studies and practical steps involving data exploration, testing of baseline data and application of Benford’s Law. While this paper has a clinical focus, the advice provided is transferrable to a wide range of multidisciplinary research settings outside of Medicine. (shrink)

Although Canada has not yet enacted any biobanking-specific privacy law, guidance and oversight are provided via various federal and provincial health and privacy-related laws as well as via ethics and policy documents. The primary policy document governing health research, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, provides the framework for the strong role of Research Ethics Boards in Canada, and limits research funding from Canada's three main federal funding agencies to those who (...) agree to adhere to its policies. The broad consent model is gaining traction in Canada, although lack of legal and constitutional precedence for the broad consent or opt-out options makes this an evolving issue. In general, data is required to be coded; more specific security measures are outlined in guidelines that may be implemented by local policy. International sharing is allowed, and Canada meets the European Union's standards for receipt of data and samples. (shrink)

BackgroundEgg donor agencies are increasingly being used as part of IVF in the US, but are essentially unregulated, posing critical ethical and policy questions concerning how providers view and use them, and what the implications might be.MethodsThirty-seven in-depth interviews of approximately 1 h were conducted – with 27 IVF providers and 10 patients.ResultsClinicians vary in their views and interactions concerning egg donor agencies, ranging widely in whether and how often they use agencies. Agencies may offer egg recipients increased choices, but (...) raise ethical and other concerns regarding respect for donors as individuals, potential harms, justice, and donors constituting a vulnerable group. The quality of agencies appears to vary considerably, from acceptable to problematic. Agencies’ medical and psychological screenings of donors can range, and be minimal. Not all agencies adequately track donors’ prior numbers of donations, or share the relevant records with clinics. Clinics may find that potential donors have genetic mutations and medical problems about which they were unaware. Yet agencies and clinics do not provide care for such donors, generating stress. Dissemination of donors’ personal data can potentially threaten confidentiality. Questions emerge of whether increased monitoring/oversight of agencies may be beneficial.ConclusionsThese data, the first to examine providers’ views and interactions regarding egg donor agencies, suggest wide variations in quality and use of agencies, and have critical implications for practice, policy, education and research. Given the potential limitations of the current model of self-regulation of agencies, the present data suggest needs to consider stronger professional guidelines or possible governmental regulations to establish, require and enforce higher standards for agencies to follow, regarding advertising to potential donors and recipients, arranging for appropriate informed consent concerning risks and benefits involved, and for quality control. Appropriate informed consent should be obtained from potential egg donors, including the fact that they may learn about mutations or medical problems about which they were unaware, but for which they will not receive treatment as part of this process. Enhancing understanding among the public-at-large about what egg donation entails may also be helpful. (shrink)

One strategy for arguing that it should be legally permissible to create human embryos, or to use of spare human embryos, for scientific research purposes involves the claim that such embryos cannot be persons because they are not human individuals while twinning may yet take place. Being a human individual is considered to be by most people a necessary condition for being a human person. I argue first that such an argument against the personhood (...) of embryos must be rationally conclusive if their destruction in public places such as laboratories is to be countenanced. I base this argument on a popular understanding of the role that the notion of privacy plays in abortion law. I then argue that such arguments against personhood are not rationally conclusive. The claim that the early embryos is not a human individual is not nearly as obvious as some assert. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing (...) Using Random Notification), each school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

Following Alder Hey and the earlier and much more extreme practices at Nuremberg, legislation has been developed governing the practice of medical ethics and research involving human participants more generally. In the medical context, relevant legislation includes GMC guidance, which states that disclosure of identifiable patient information without consent, for research purposes, is not acceptable unless it is justified in the public interest. There is a presumption, in other words, in favour of the view that patient (...) consent ought to be obtained before any piece of research is conducted. The Data Protection Act, furthermore, requires informed consent to be given before any use of identifiable personal data is made for any purpose. Moreover, ensuring that the informed consent of participants is gained is common practice on most research ethics committees. I argue, in this paper, that applying the principle of ‘informed consent’ too mechanistically in the research ethics context risks undermining the very principle it is designed to support – the principle of autonomy. This issue has been much discussed in medical ethics but not so much, so far, in the research ethics context. It will be argued that a more discerning and a less rigid and mechanistic approach, applied by research ethics committees, may help ensure that ethical issues are properly considered. (shrink)

Self-monitoring theory explains the individual differences in using interpersonal adjustment techniques like self-control, self-regulation, and self-presentation. Self-monitoring plays a key role for understanding the social life. Therefore, it has been one of most popular research topics in social psychology. The aim of this study is to find out if there is a meaningful relationship between religious orientation and self-monitoring, and to determine the direction of the relationship if it exists. Besides, examining the effect of religious group membership on self-monitoring (...) is another aim of this study. In accordance with this purpose, Religious Orientation Scale and Revised Self-Monitoring Scale are applied to sample group which consists of 437 female and 369 male participants aged16 to 65+ living in Bursa. The results has revealed that there is a meaningful positive correlation between intrinsic religious orientation and self-monitoring. In addition, no meaningful relationship between religious group membership and self-monitoring has been confirmed.Summary: The adaptation process of the human being as a social creature starts in a mother's womb and becomes more complicated in consequence of coming into the world which is full of stimulus. In the beginning, this process has only a physical aspect, but with the inclusion of emotional, cognitive, and social factors over time turns into developmental tasks that people will struggle throughout their lives. The social development involves the process of becoming of the individual as an organic part of the society. As the individual realizes the existence of the other, he/she develops similar patterns of behavior that can be approved by the other. Because the meaningful relationships that form the backbone of social development constitute an important part of the self. Belonging is one of the main needs, that the individual shapes his emotions, actions, and decisions more or less in line with this need in order not to encounter the possibility of social exclusion. While belonging is a universal need for every healthy individual, there are differences between individuals in terms of directing the course of the relationship, role sharing, and using situational clues. Individual differences in how people construct interpersonal processes led Mark Snyder to systematize and theorize the concept of self-monitoring. Self-monitoring is a concept that expresses individuals' control of self-presentation, expressive behavior, and non-verbal emotional expression and their regulation. Accordingly, individuals with a high tendency to shape their behavior according to the context are classified as high self-monitors and those with low tendency are classified as low self-monitors. It can be said that adherence to religion, which is one of the determinants of social behavior, is related to self-monitoring. In this context, the main subject of this study is the relationship between self-monitoring and religiosity. The study aims to examine the effect of intrinsic-extrinsic religiosity on individuals' self-monitoring levels. Besides, as a form of religiosity, to reveal whether religious group religiosity affects self-monitoring, the study examines also self-monitoring levels of individuals belonging to the religious group and those who are not.The sample of the study was selected by a simple random sampling method and it consists of 806 participants aged 16 to 65+ living in Bursa in 2017. 437 (54.2%) of the participants in the research are women and 369 (45.8%) are men. In this study, a relational screening model was used for determining the presence, direction, and degree of the relationship between the variables. The questionnaire technique was preferred as the method of gathering information. The questionnaire was arranged in a way that does not require asking the participant any other questions apart from the questions on the form. The questionnaire form used in this research consists of 43 items. At the beginning of the questionnaire, there is a 9-item personal information form that includes demographic items consisting of age, gender, educational status, marital status, occupation, place of residence, socio-economic status, levels of subjective religious involvement, and religious group membership. For the measurement of self-monitoring, a 12-item "Self-Monitoring Scale", which was developed by Mark Snyder, revised by Richard Lennox and Raymond Wolfe and adapted by İlknur Özalp Türetgen and Sevim Cesur to Turkish (α =.80) was used. For the measurement of religious orientation, a 22-item “Religious Orientation Scale” developed by Gordon Allport and Michael Ross and adapted to Turkish by Fatma Gül Cirhinlioğlu was used (α =.90). Data collected through scales were processed by One Way Variance Analysis (ANOVA), t-Test, Pearson Correlation Analysis, and Simple Linear Regression Analysis and turned into research findings.According to the results of the simple linear correlation analysis conducted to reveal whether there is a relationship between the self-monitoring scores of the participants and the intrinsic religious orientation scores, there is a positive and significant relationship between the variables (r = 0.102, p = 0.004 0.05). The result of the correlation analysis between self-monitoring and the level of subjective religious involvement shows that no significant relationship is found (r = 0.051, p = 0.146> 0.05).This research expected that there was a negative relationship between self-monitoring and intrinsic religious orientation. However, the analyses has not reported anticipated results as addressed in the previous research. Therefore, this study opens the door for asking new questions about the subject. Religious groups, by their very nature, can refer the individual to self-presentation control, obedience, to act as deemed appropriate by the group, to adapt to the group, to change behavior without attitude change, and therefore, to attitude-behavior inconsistency. It can be argued that not only religious groups but, by their nature, all social groups create harmony-oriented pressure on the individual. Therefore, it can be predicted that belonging to a group, in general, may have a significant effect on the level of self-monitoring. The high self-monitoring scores of the participants, whether religious or non-religious group members of this study may have reduced the observability of the difference between the two groups. Therefore, repeating the study on a different sample may produce different results. (shrink)

BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical (...) oversight. Second, we map these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)

Sabrina Fortin | : La recherche sur les populations permet d’améliorer nos conditions de vie en identifiant les facteurs de risque attribuables aux liens entre l’environnement et certains déterminants socio-sanitaires. Elle nécessite de vastes échantillons qui proviendront souvent de renseignements personnels ou de matériel biologique déjà recueillis. Pour les utiliser, la règle générale veut qu’un consentement individuel soit obtenu. Cependant, dans la pratique, il est souvent impossible d’obtenir un tel consentement sans affecter la qualité et la capacité de généralisation des (...) résultats de recherche. Cette obligation de consentement est fondée sur la primauté de la personne et la dignité humaine, qui ont été intégrées dans le droit des personnes à la fin de la Seconde Guerre mondiale. Ce principe fondamental a également été inséré au coeur de l’encadrement de la recherche scientifique. La philosophie personnaliste en serait à l’origine. Cet article, après avoir établi la provenance philosophique et historique du principe de dignité humaine, tente de rétablir un certain équilibre entre les intérêts individuels et collectifs impliqués dans la recherche populationnelle. | : According to this paper, personalist philosophy could be at the origin of the importance given to consent in an actual research normative framework. The obligation of consent is well established in Canadian law, but when the time comes to apply it to research on populations, which involves large number samples, it causes some impracticabilities. Access to personal data for populational research should be viewed as a common good contributing to improve life conditions. Hence, the collective interests generated by populational research should be better balanced against preferences and personal interests. (shrink)

All scientific activity involves some method of observation and some method of recording what is observed. These activities can be carried out in ways that involve little interaction between subject and object, as is the case when a telescope observes a far-away star. At the other end of the scale are experiments in modern high energy physics in which there is little distinction between the observer and the observed, and the process of observation materially affects the data that are recorded. (...) In this regard, research on human phenomena resembles modern physics more than it does classical astronomy.Research on human phenomena, however, differs from modern physics in the way in which it affects that which is observed. Both the procedures and the findings of research on human phenomena alter the modes of thinking and the self-awareness of the objects of study. (shrink)

Over the past three decades, two separate federal regulatory structures have emerged, each seeking to assure separate aspects of the integrity and ethics of research conducted using federal funding. One set of regulations is described in the Public Health Service Policies on Research Misconduct and relates to research misconduct, defined as consisting of fabrication of data or results, falsification of data and results, or plagiarism, in accordance with the federal‐wide definition adopted by the Office of Science and (...) Technology Policy. The second set of regulations, set forth in the Department of Health and Human Services regulations on the protection of human subjects (known as the “Common Rule”), prescribes a set of ethical and procedural protections for research involving human subjects.These two sets of research regulations are distinguished from each other by having different foci of enforcement, priorities of protection, oversight officials, oversight procedures, seizure of evidence, standards of proof, expectations of privacy, and appeal procedures for researchers who are subject to adverse findings and penalties. These differences are significant and fundamental. They complicate the process of compliance for institutions and researchers, who are expected to adhere to both sets of standards for the same federally funded research activities in research with human subjects. Compliance is especially complicated when suspected violations of both sets of standards must be investigated and resolved concurrently. This document represents an effort to provide institutions and individuals with practical suggestions as they try to comply with both sets of regulations. (shrink)

All scientific activity involves some method of observation and some method of recording what is observed. These activities can be carried out in ways that involve little interaction between subject and object, as is the case when a telescope observes a far-away star. At the other end of the scale are experiments in modern high energy physics in which there is little distinction between the observer and the observed, and the process of observation materially affects the data that are recorded. (...) In this regard, research on human phenomena resembles modern physics more than it does classical astronomy.Research on human phenomena, however, differs from modern physics in the way in which it affects that which is observed. Both the procedures and the findings of research on human phenomena alter the modes of thinking and the self-awareness of the objects of study. (shrink)