Coordination and expertise foster legal textualism.

A cross-cultural survey experiment revealed a dominant tendency to rely on a rule's letter over its spirit when deciding which behaviors violate the rule. This tendency varied markedly across (k = 15) countries, owing to variation in the impact of moral appraisals on judgments of rule violation. Compared with laypeople, legal experts were more inclined to disregard their moral evaluations of the acts altogether and consequently exhibited stronger textualist tendencies. Finally, we evaluated a plausible mechanism for the emergence of textualism: in a two-player coordination game, incentives to coordinate in the absence of communication reinforced participants' adherence to rules' literal meaning. Together, these studies (total n = 5,794) help clarify the origins and allure of textualism, especially in the law. Within heterogeneous communities in which members diverge in their moral appraisals involving a rule's purpose, the rule's literal meaning provides a clear focal point-an identifiable point of agreement enabling coordinated interpretation among citizens, lawmakers, and judges.

Half a century of bioethics and philosophy of medicine: A topic-modeling study.

Topic modeling-a text-mining technique often used to uncover thematic structures in large collections of texts-has been increasingly frequently used in the context of the analysis of scholarly output. In this study, we construct a corpus of 19,488 texts published since 1971 in seven leading journals in the field of bioethics and philosophy of medicine, and we use a machine learning algorithm to identify almost 100 topics representing distinct themes of interest in the field. On the basis of intertopic correlations, we group the content-based topics into eight clusters, thus providing a novel, fine-grained intellectual map of bioethics and philosophy of medicine. Moreover, we conduct a number of diachronic analyses, examining how the "prominence" of different topics has changed across time. In this way, we are able to observe the distinct patterns in which bioethics and philosophy of medicine have evolved and changed their focus over the past half a century.

Are observer memories (accurate) memories? Insights from experimental philosophy.

A striking feature of our memories of the personal past is that they involve different visual perspectives: one sometimes recalls past events from one's original point of view (a field perspective), but one sometimes recalls them from an external point of view (an observer perspective). In philosophy, observer memories are often seen as being less than fully genuine and as being necessarily false or distorted. This paper looks at whether laypeople share the standard philosophical view by applying the methods of experimental philosophy. We report the results of five studies suggesting that, while participants clearly categorize both field and observer memories as memories, they tend to judge that observer memories are slightly less accurate than field memories. Our results suggest, however, that in lay thought, the difference between field and observer memories is not nearly as clear-cut as philosophers have generally taken it to be.

The weirdness of belief in free will.

It has been argued that belief in free will is socially consequential and psychologically universal. In this paper we look at the folk concept of free will and its critical assessment in the context of recent psychological research. Is there a widespread consensus about the conceptual content of free will? We compared English "free will" with its lexical equivalents in Lithuanian, Hindi, Chinese and Mongolian languages and found that unlike Lithuanian, Chinese, Hindi and Mongolian lexical expressions of "free will" do not refer to the same concept free will. What kind people have been studied so far? A review of papers indicate that, overall, 91% of participants in studies on belief in free will were WEIRD. Thus, given that free will has no cross-culturally universal conceptual content and that most of the reviewed studies were based on WEIRD samples, belief in free will is not a psychological universal.

Ethical issues in biomedical research using electronic health records: a systematic review.

Digitization of a health record changes its accessibility. An electronic health record (EHR) can be accessed by multiple authorized users. Health information from EHRs contributes to learning healthcare systems' development. The objective of this systematic review is to answer a question: What are ethical issues concerning research using EHRs in the literature? We searched Medline Ovid, Embase and Scopus for publications concerning ethical issues of research use of EHRs. We employed the constant comparative method to retrieve common ethical themes. We descriptively summarized empirical studies. The study reveals the breadth, depth, and complexity of ethical problems associated with research use of EHRs. The central ethical question that emerges from the review is how to manage access to EHRs. Managing accessibility consists of interconnected and overlapping issues: streamlining research access to EHRs, minimizing risk, engaging and educating patients, as well as ensuring trustworthy governance of EHR data. Most of the ethical problems concerning EHR-based research arise from rapid cultural change. The framing of concepts of privacy, as well as individual and public dimensions of beneficence, are changing. We are currently living in the middle of this transition period. Human emotions and mental habits, as well as laws, are lagging behind technological developments. In the medical tradition, individual patient's health has always been in the center. Transformation of healthcare care, its digitalization, seems to have some impacts on our perspective of health care ethics, research ethics and public health ethics.

Balancing professional obligations and risks to providers in learning healthcare systems.

Clinicians and administrators have a professional obligation to contribute (OTC) to improvement of healthcare quality. At the same time, participation in embedded research poses risks to healthcare institutions. Disclosure of an institution's sensitive information could endanger relationships with patients and undermine its reputation. The existing ethical framework (EF) for learning healthcare systems (LHSs) does not address the conflict between the OTC and institutional interests. Ethical guidance and policy regulation are needed to create a safe environment for embedded research. In this article we analyse the EF for LHSs and the concept of professionalism. We suggest that the EF should be supplemented with an obligation to protect provider's legitimate interests. We define legitimate interests as those that enable providers to discharge their primary duties. We argue that both the OTC and the obligation to protect legitimate interests are grounded in the concept of medical professionalism and can be understood as a matter of contract between a democratic society and medical professionals. The proposed supplemented EF can be implemented into a regulatory system in three different ways: the self-regulating: where providers decide themselves how to balance the ethical claims, the centralised: where a governmental institution decides the right balance between providers' interests and interests of a health system; and the mediating: where medical professionals, the state and patients negotiate their interests. Our article contributes to the discussion on ethical relevance of providers' interests and the regulatory model for weighing opposite interests in LHSs.

Research versus practice: The dilemmas of research ethics in the era of learning health-care systems.

In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health-care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health-care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy-making levels.

Learning to Regulate Learning Healthcare Systems.

It is commonplace to observe that science often outstrips the ability of society to monitor, supervise and regulate it. A recent challenge in this regard concerns Learning Healthcare Systems, an initiative to collect data and test hypotheses across clinical settings, and therefore to a larger degree than before. Some argue that the line between research and clinical practice is becoming blurred, and that existing regulation seems to obstruct low risk research. They propose the creation of a new ethical framework for Learning Healthcare Systems, to speed up research. This paper opposes that view, and argues that Learning Healthcare Systems do not blur or remove the line between research and practice, and will not result in a single set of regulations for all kinds of biomedical research. The authors suggest that a large proportion of Learning Healthcare System activities resemble public health surveillance to a significant extent. Therefore, they propose that these activities should be organized in accordance with the same ethical principles as public health surveillance, specifically that Learning Healthcare Systems should rest on the principles of comprehensiveness, transparency, and public accountability.

Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure.

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups.

What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review.

Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis (constant comparative method) was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs.

Forensic uses of research biobanks: should donors be informed?

Occasional reports in the literature suggest that biological samples collected and stored for scientific research are sometimes accessed and used for a variety of forensic purposes. However, donors are almost never informed about this possibility. In this paper we argue that the possibility of forensic access may constitute a relevant consideration at least to some potential research subjects in deciding whether to participate in research. We make the suggestion that if some type of forensic access to research collections is likely to be perceived by the subjects as a reason against donating their biological materials, there are good ethical reasons to make this type of access impossible or at least severely restricted. We also provide an ethical argument for the claim that, if a total ban on this type of forensic access cannot be achieved, potential research subjects should be informed about the extent to which this type of forensic access is possible.

Non-beneficial pediatric research: individual and social interests.

Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects.

Child's assent in research: age threshold or personalisation?

BACKGROUND: Assent is an important ethical and legal requirement of paediatric research. Unfortunately, there are significant differences between the guidelines on the details of assent. DISCUSSION: What often remains unclear is the scope of the assent, the procedure for acquiring it, and the way in which children's capacity to assent is determined. There is a general growing tendency that suggests that the process of assent should be personalised, that is, tailored to a particular child. This article supports the idea of personalisation. However, we also propose placing limits on personalisation by introducing a suggested requirement of assent starting at a school-age threshold. In some situations RECs/IRBs and researchers could reduce the suggested threshold. SUMMARY: A recommended age threshold is likely to serve the interests of children better than ambiguous and flexible criteria for personalised age determination.

Which kind of sameness? Disambiguating two senses of identity with a novel linguistic task.

When people report that a person's identity has changed, what do they mean by this? Recent research has often assumed that participants are indicating a change in numerical, rather than qualitative, identity. Investigations into this matter have been hampered by the fact that English has no clear way to demarcate one type of identity from the other. To resolve this matter, we develop and test a novel task in Lithuanian, which has lexical markers for numerical and qualitative identity. We apply this task to intuitions about changes in moral capacities, which has previously shown to lead to high ratings in identity change. We discover that, when people say that a morally altered person is dramatically different, they mean the person is qualitatively transformed, but numerically intact. We conclude that this methodology is a valuable tool not only for illuminating the specific phenomenon of the moral self, but for general use in studying folk ascriptions of identity persistence.

Turning residual human biological materials into research collections: playing with consent.

This article focuses on three scenarios in which residual biological materials are turned into research collections during the procedure of procuring these materials for diagnostic, therapeutic or other non-research purposes. These three scenarios differ from each other primarily because they employ different models of consent: (a) precautionary consent, which may be secured during the collecting procedure; (b) the presumed consent model, which may be applied during the collection of materials; and (c) consent for research use of identifiable human biological materials, which may be skipped entirely. These scenarios offer additional sources of biological samples for research purposes and at the same time seem to offer even more flexibility in terms of stringency of consent as compared with the more traditional models of broad consent in prospective research collections and the waiver of consent in retrospective research. Our discussion leads us to think that precautionary consent is preferable to presumed consent and no consent when handling issues of consent in the use of residual human biological materials for research. However, such precautionary consent should not be construed as blanket, unrestricted consent for any future use.