Research ethics consultation is increasingly recognized as a potentially valuable mechanism for addressing the depth and breadth of ethical issues that arise in research related to human health and well-being. However, fundamental questions remain, including: What is “research ethics consultation”? And what is its justification beyond the purposes already served by existing entities? We examine how a research ethics consultation service may differ from or complement the role of an institutional review board by offering a definition of research ethics consultation (...) and by exploring the potential scope of a consultation service in terms of types of clients served, questions addressed, and advice provided at various stages of the research process. We then consider the relationship between research ethics consultation services and IRBs, as well as the issues that may arise between them, including possible conflicts of interest. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...) negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. (shrink)

abstractBackground: Evidence shows both a tendency for research participants to conflate research and clinical care and a limited public understanding of research. Conflation of research and care by participants is often referred to as the therapeutic misconception. Despite this evidence, few studies have explicitly asked participants, and especially minors, to explain what they think research is and how they think it differs from regular medical care. Methods: As part of a longer semistructured interview evaluating assent and parental permission for research, (...) adolescent research participants (n = 177), including adolescents with illnesses and healthy volunteers, and their parents (n = 177) were asked to describe medical research in their own words and say whether and how they thought being in medical research was different from seeing a regular doctor. Qualitative responses were coded and themes were identified through an iterative process. Results: When asked to describe medical research, the majority described research in terms of its goals of helping to advance science, develop treatments and medicines, and help others; fewer described research as having the goal of helping particular research participants, and fewer still in terms of the methods used in research. The majority of teen and parent respondents said being in research is different than seeing a regular doctor and explained this by describing different goals, different or more procedures, differences in the engagement of the doctors/researchers, and differences in logistics. Conclusions: Adolescents participating in clinical research and their parents generally describe medical research in terms of its goals of advancing science and finding new medicines and treatments, sometimes in combination with helping the enrolled individuals. The majority perceive a difference between research and regular medical care and described these differences in various ways. Further exploration is warranted about how such perceived differences matter to participants and how this understanding could be used to enhance informed consent and the overall research experience. (shrink)

Philosophers have hitherto only interpreted the world in various ways; the point is to change it.Karl marx’s distinction between interpreting the world and changing it points by extension to the state of contemporary philosophy and psychiatry. The 1990s resurgence of interdisciplinary work in this area was driven equally by phenomenological scholarship and by initiatives in analytic philosophy. The former reflected the focus in phenomenology on ‘what it is like’ to experience a given mental symptom with the aim of reconstructing the (...) life-worlds of people experiencing mental disorders, while the latter reflected directly or indirectly the influence of J. L. Austin and others from... (shrink)

This chapter introduces the edited volume, The Oxford Handbook of Philosophy and Psychiatry. Published in 2013, the centenary of Karl Jaspers' General Psychopathology, the chapter draws lessons from the last hundred years for the coming century. No predictions are made. Instead, five 'conditions for flourishing' are set out: 1) Particular Problems - the importance of focussing on well-defined particular problems rather than general theory building, 2) Product- orientation - remaining always responsibly product oriented in the specific sense that both sides (...) put in the work necessary to 'go deep' with each other's fields, 3) Partnership - working in partnerships of one kind or another, 4) Process - constant reflection on process based on peer review but leaving scope for the occasional rogue voice to cut innovatively against the grain, and 5) Q - a condition of a different kind, Q is an empirically derived measure of the balance between in-group cohesion and out-group openness required to support creativity. Illustrations are given of how these five conditions for flourishing have underpinned the rapid expansion of philosophy and psychiatry in the closing decades of the twentieth century, and, correspondingly, are also reflected in the Handbook as a whole. Overviews and commentaries on individual contributions to the Handbook are given in extended editorial introductions to each of its eight sections. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Concurrent Contents: Recent and Classic References at the Interface of Philosophy, Psychiatry, and PsychologyArticlesAntonak, R. J., C. R. Fielder, and J. A. Mulick. 1993. A scale of attitudes toward the application of eugenics to the treatment of people with mental retardation. Journal of Intellect Disabilities Research 37:75–83.Arens, K. 1996. Commentary on “Lumps and bumps.” Philosophy, Psychiatry, & Psychology 3:15–16.Bavidge, M. 1996. Commentary on “Minds, memes, and multiples.” Philosophy, Psychiatry, (...) & Psychology 3:29–30.Blashfield, R. K. 1973. Evaluation of the DSM-II classification of schizophrenia as a nomenclature. Journal of Abnormal Psychology 85(2):140–150.Braude, S. E. 1996. Multiple personality and moral responsibility. Philosophy, Psychiatry, & Psychology 3:37–54.Broverman, I. K., S. R. Vogel, D. M. Broverman et al. 1972. Sex-role stereotypes: a current appraisal. Journal of Social Issues 28:59–78.Broverman, I. K., D. M. Broverman, P. E. Clarkson et al. 1975. Sex-role stereotypes and clinical judgments of mental health. Journal of Consulting and Clinical Psychology 34:1–7.Checkland, D., and M. Silberfeld. 1996. Mental competence and the question of beneficient intervention. Theoretical Medicine 17(2):121–134.Clark, S. R. L. 1996. Commentary on “Multiple personality and moral responsibility.” Philosophy, Psychiatry, & Psychology 3:55–57.Clark, S. R. L. 1996. Minds, memes, and multiples. Philosophy, Psychiatry, & Psychology 3:21–28.Dickenson, D., and D. Jones. 1995. True wishes: The philosophy and developmental psychology of children’s informed consent. Philosophy, Psychiatry, & Psychology 2:287–303.Donaldson, T. 1978. Psychoanalyzing the practical inference model. Philosophical Research Archives 4:1215.Eekelaar, J. 1995. Commentary on “True wishes.” Philosophy, Psychiatry, & Psychology 2:305–307.Fisher, S., and R. P. Greenberg. 1993. How sound is the double-blind design for evaluating psychotropic drugs? Journal of Nervous and Mental Disease 181:345–350.Fulwiler, C., and M. F. Folstein. 1995. Commentary on “Chris Walker’s interpretation of Karl Jaspers’ phenomenology.” Philosophy, Psychiatry, & Psychology 2:345–346.Heinze, M. 1995. Commentary on “Moralist or therapist?” Philosophy, Psychiatry, & Psychology 2:31–32.Iturrate, M. 1977. Man’s freedom: Freud’s therapeutic goal. Review of Existential Psychology and Psychiatry 15:32–45.Littlewood, R. 1991. From diseae to illness and back again. Lancet 337:1013–1015.Maddox, J. 1993. New genetics means no new ethics. Nature 364:97.McCormick, S. 1995. Commentary on “True wishes.” Philosophy, Psychiatry, & Psychology 2:309–310.Murray, T. H. 1995. Commentary on “True wishes.” Philosophy, Psychiatry, & Psychology 2:311–312.Muzika, E. G. 1989. Object relations theory, Buddhism, and the self-synthesis of eastern and western approaches. International Philosophical Quarterly 30(1):59–74.Parker, M. 1995. Commentary on “True wishes.” Philosophy, Psychiatry, & Psychology 2:313–314.Phillips, J. 1996. Key concepts: Hermeneutics. Philosophy, Psychiatry, & Psychology 3:61–69.Pole, D. 1970. Self and personality. The Journal of the British Society for Phenomenology 1:30–36.Priebe, S. 1989. On the subjectivity of psychiatric diagnosis. Psychiatric Praxis 16:86–89.Radden, J. 1996. Lumps and bumps: Kantian faculty psychology, phrenology, and twentieth-century psychiatric classification. Philosophy, Psychiatry, & Psychology 3:1–14.Sampson, E. E. 1981. Cognitive psychology as ideology. American Psychologist 36:730–743.Sarbin, T. R. 1976. Contextualism: A worldview for modern psychology. Nebraska Symposium on Motivation 24:1–41.Senft, P. A. 1975. The self-contradictions (antinomies) of psychotherapy: Is a solution in social action possible? The Human Context 7:367–372.Shuman, D. W. 1996. Commentary on “Multiple personality and moral responsibility.” Philosophy, Psychiatry, & Psychology 3:59–60.Sprigge, T. 1996. Commentary on “Minds, memes, and multiples.” Philosophy, Psychiatry, & Psychology 3:31–36.Wallace, K. 1996. Commentary on “Lumps and bumps.” Philosophy, Psychiatry, & Psychology 3:17–20.Wells, L. A. 1995. Commentary on “True wishes.” Philosophy, Psychiatry, & Psychology 2:315–317.Wiggins, O. P., and M. A. Schwartz. 1995. Chris Walker’s interpretation of Karl Jaspers’ phenomenology: a critique. Philosophy, Psychiatry, & Psychology 2:319–343.BooksAmerican Hospital Association. 1994. Values in conflict: Resolving ethical issues in health care. 2nd ed. Chicago: American Hospital Association.American Medical Association. 1992. Code of medical ethics: Annotated current opinions of the council on ethical and judicial affairs. Chicago: American Medical Association.———. 1994. Council on ethical and judicial affairs... (shrink)

This essay introduces a thematic issue focused on the contributions to clinical ethics and the philosophy of medicine by Richard M. Zaner. We consider the apparent divorce of Zaners philosophical roots from his recent narrative immersions into the blooming, buzzing confusions of clinical-moral lifeworlds. Our considerations of the Zanerian context and origins of the clinical encounter introduce the fundamental questions faced by Zaner and his commentators in this issue, questions about the role of ethics consultants, moral authority, and clinical truths.

In lieu of an abstract, here is a brief excerpt of the content:Philosophy, Psychiatry, & Psychology 4.1 (1997) 91-93 Concurrent Contents: Recent and Classic References at the Interface of Philosophy, Psychiatry, and Psychology Articles Allen, J. F., J. Hallperin, and R. Friend. 1985. Removal and diversion tactics and the control of auditory hallucinations. Behavior Research and Therapy 23:601-605.Baker, H. D. 1995. Psychoanalysis and ideology: Bakhtin, Lacan, and Zizek. History of European Ideas 20:499-504.Bernet, R. 1994. Derrida-Husserl-Freud: The trace of transference. Southern (...) Journal of Philosophy 32 suppl.:141-158.Boden, M. A. 1996. Commentary on "Towards a design-based analysis of emotional episodes." Philosophy, Psychiatry, & Psychology 3, no. 2:135-136.Castelfranchi, C., and M. Miceli. 1996. Commentary on "Towards a design-based analysis of emotional episodes." Philosophy, Psychiatry, & Psychology, no. 2:129-133.Fowes, B. J., and F. C. Richardson. 1996. Why is multiculturalism good? American Psychologist 51, no. 6:609-621.Frith, C. 1996. Commentary on "Free will in the light of neuropsychiatry." Philosophy, Psychiatry, & Psychology 3, no. 2:91-93.Forde, R. 1996. Inclusion of psychosocial conditions in clinical practice and the problem of medicalization. Theoretical Medicine 17, no. 2:151-161.Gaylin, W., and D. Doukas. 1995. The second-hand suicide threat. Hastings Center Report 25:20-22.Gillet, G. 1995. Consciousness, thought, and neurological integrity. Journal of Mind and Behavior 16, no. 3:215-233.Haskell, R. E. 1993. Realpolitik in the addictions field: Treatment-professional, popular-culture ideology, and scientific research. Journal of Mind and Behavior 14, no. 3:257-276.Kuys, T. 1995. The tally argument again. Methodological Science 28, nos. 2-3:43-55.Lear, J. 1995. The heterogeneity of the mental: Sebastian Gardner's irrationality and the philosophy of psychoanalysis. Mind: A Quarterly Review of Psychology and Philosophy 104:863-879.Libet, B. 1996. Commentary on "Free will in the light of neuropsychiatry." Philosophy, Psychiatry, & Psychology 2, no. 3:95-96.Lloyd, D. 1996. Commentary on "Toward a design-based analysis of emotional episodes." Philosophy, Psychiatry, & Psychology 3, no. 2:127-128.Pepper-Smith, R., W. R. C. Harvey, and M. Silberfeld. 1996. Competency and practical judgment. Theoretical Medicine 17, no. 2:135-150. [End Page 91]Spence, S. A. 1996a. Free will in the light of neuropsychiatry. Philosophy, Psychiatry, & Psychology 3, no. 2:75-90.------. 1996b. Response to the commentaries. Philosophy, Psychiatry, & Psychology 3, no. 2:99-100.Stein, D. J. 1996. The philosophy of psychopathy. Perspectives in Biology and Medicine 39:569-580.Stephens, G. L. 1996. Commentary on "Free will in the light of neuropsychiatry." Philosophy, Psychiatry, & Psychology 3, no. 2:97-98.Varela, C. R. 1995. Ethnogenic theory and psychoanalysis: The unconscious as a social construction and a failed explanatory concept. Journal for the Theory of Social Behavior 25:4.Weisberger, A. M. 1995. The ethics of the broader usage of Prozac: Social choice or social bias? International Journal of Applied Philosophy 10, no. 1:69-74.Wright, I., A. Sloman, and L. Beaudoin. 1996a. Response to the commentaries. Philosophy, Psychiatry, & Psychology 3, no. 2:137.------. 1996b. Towards a design-based analysis of emotional episodes. Philosophy, Psychiatry, & Psychology 3, no. 2:101-126. Books American Psychiatric Association. Task Force on Consent to Voluntary Hospitalization. 1993. Consent to voluntary hospitalization. Washington, DC: American Psychiatric Association.Christiansen, H. D. 1972. Ethics in counseling: Problem situations. Tucson: University of Arizona Press.Clark, P., and C. Wright, eds. 1988. Mind, psychoanalysis and science. New York: Blackwell.Comerchero, V., ed. 1970. Values in conflict: Christianity, marxism, psychoanalysis, existentialism. New York: Appleton-Century-Crofts.Epstein, R. S. 1994. Keeping boundaries: Maintaining safety and integrity in the psychotherapeutic process. Washington, DC: American Psychiatric Press.Fairbairn, G. J. 1995. Contemplating suicide: The language and ethics of self harm. New York: Routledge.Grubb, A., ed. 1991. Decision-making and problems of incompetence. New York: John Wiley & Sons.Haas, L. J., and J. L. Malouf. 1995. Keeping up the good work: A practitioner's guide to mental health ethics. 2nd ed. Sarasota: Professional Resource Exchange.Hacking, I. 1995. Rewriting the soul: Multiple personality and the sciences of memory. Princeton: Princeton University... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Crushing Pressures and Radical IdeasJohn Z. Sadler, MD (bio)Back in 2011, I wrote a paper for the Journal of Bioethical Inquiry, an Australian journal, for a special issue dedicated to ethical issues associated with psychiatric genetics research. The editor was particularly excited by the recent findings of the 5-HTT allele in psychiatric illness. I had different ideas about what I wanted to write about, and the editor, Michael (...) Robertson, graciously considered them and ultimately published the paper. At the time I was interested in the colossal investment of National Institutes of Mental Health (NIMH) research dollars in psychiatric genetic research; at the time I was troubled at the lack of on-the-ground clinical implications of this research investment, and figured an Australian journal and referees would be more generous to a critical paper on U.S. funding priorities. I dug into the National Institutes of Health (NIH), NIMH, and National Science Foundation websites and found some crude dollar evidence of respective expenditures for research funding in various disorders and focus areas, and compared these investments to psychiatric genetic research funding commitments. I will not go into details (Sadler, 2011), but the gist was that the psychiatric genetics research enterprise was and had been an extraordinarily expensive enterprise, when other research questions that could be immediately implementable into clinical care improvements remained marginally funded at best. The paper was not read widely and other than a couple of annoyed responses from psychiatric genetic researchers, not much came of it.This concern about funding priorities was one of the reasons why I was pleased to see this paper by Turkheimer and Greer which explores the long term results of the Spit for Science (S4S) initiative, which was launched grandly the same year as my paper’s whisper from down under. I hope this Philosophical Case Conference explores the many dimensions of interest for this paper, which is extraordinarily careful and even handed in its attitude, while at the same time being incisive in its analysis.My focus here is not in the science per se, which is beyond my competence. I’m interested in Turkheimer and Greer’s (T&G) conceptual overview of this research program. More specifically, I focus on T&G’s highlighting of the extraordinary willingness of the S4S authors to interpret prevailingly negative results in the most generous, even misleading, degree possible. I try to provide some possible ways of understanding this kind of research rhetoric exhibited by a cohort of highly respected, very successful scientists.I acknowledge the well-described varieties of interpretive bias that all of us are subject to. First on the list must be confirmation bias, our tendency to interpret situations in terms consistent [End Page 447] with our preconceived notions—in this case, the idea that genetics has something important to do with addictive disorders. Another might be epistemic overconfidence—the tendency to fail at interpretive skepticism in favor of one’s preferred conclusion. Related to this may also be interpretive momentum, the tendency to maintain a conviction about the correctness of one’s expectations and disregard inconsistent findings over the course of a research program—in this case, the multiple S4S studies (O’Sullivan & Schofeld, 2018). However, these kinds of biases tend to “blame” the individual authors’ thinking styles. I opine, though, that other vectors shaping the declaring-success rhetoric are more important.These sources have to do with the state of practice in doing biomedical science research in universities and particularly academic medical centers (AMCs) today. I identify several causal vectors that compel, however subtly, researchers to declare success in the face of failure. I have only picked three, and in no order of importance: 1) funding caps for NIH grants, 2) the overleveraging of university budgets and ballooning dependence on soft money, and 3) the incentivizing of intellectual property development within AMCs.Funding Caps for NIH GrantsIf you are a university or AMC, one way you hold onto your most productive scientists (e.g., grants, publications, discoveries, and status) is by paying them well. Single NIH grants today commonly amount to millions of dollars, and often tens of millions. These bring... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Introduction to the 30th Anniversary Issue of Philosophy, Psychiatry, & PsychologyJohn Z. Sadler (bio)This issue marks the 30th anniversary of Philosophy, Psychiatry, and Psychology (PPP). All of us at the journal are grateful to our authors, readers, editors, and publishers for enabling this landmark. To commemorate this event, I invited our Founding Editor and Chair of the Advisory Board, K.W.M. "Bill" Fulford to write a brief essay, along (...) with our panel of smart and industrious senior editors. Their instructions were simple: 500 words on PPP past, present, and/or future. These essays appear in the pages to follow. As Editor-in-Chief, I write about PPP's early commitments as a scholarly journal, situate these in the history of academic publishing, and muse over our current moment.Bill Fulford briefly discusses the early years of the journal in his essay. My perspective emerges from an editor's perspective. As co-editors in the early years, Bill and I were committed to an international authorship with comparable editorial oversight. We wanted to build a journal that would equally recognize clinical science and practice and philosophy, maintaining the rigor of each field. We saw philosophers and mental health practitioners as equal partners, collaborators, innovators, and educators. More important, PPP was intended to offer up the best criticism of the mental health and related fields.The scattershot history of scholarly editing has identified several functions of the editor over the centuries following Gutenberg's invention of the printing press in the mid-1440s. The earliest editors took liberties with the language of the Bible, trying to make it more accessible to the public; the printing press permitted fast and inexpensive reproduction. Not surprisingly, this popularizing of the Bible led to praise as well as outrage. The printing of other scholarly works followed quickly. In 1470, only about 25 years after the invention of the printing press, Niccolo Perroni called for Pope Paul II to censor Andrea Bussi's edition of Pliny the Elder's Natural History, an anthology of then-ancient writings about the natural world. This marked the first recorded instance of censorship of a more-or-less secular scholarly work (Monfasani, 1988). In the ensuing centuries, "editors" initially were the popularizers, and later the gatekeepers of texts worth (and not worth) reading. In the [End Page 1] ensuing centuries into the present, editors have been venerated both as defenders of good reading and reviled as censors or intellectual selfaggrandizers.The current moment, in my view, represents a crisis in the history of editing and editorship. Digital communications have liberated communications worldwide. However, this liberty has come at the cost of colossal amounts of material not worth reading and an explosion of divisive, destructive discourse. Even worse, internet "trolls" on social media have moved bullying out of the schoolyard and into international cyberspace. Determining what is worth reading has moved away from a cluster of (hopefully) responsible editors to anyone who wants to go to the small effort of silencing others through online harassment and even violent threats. Such cyberbullying does not eliminate elitism, but instead substitutes a toxic online "elite" without principle other than self-promotion and the alienation of others. Our contemporary online culture has yet to figure out how to shape what is, and is not, worth reading.My wish and intent for the future of PPP is to maintain and grow our place of rational, deliberative, and open discourse, even in the face of such disruptive cultural change.John Z. Sadler John Z. Sadler, MD, is the Editor-in-Chief of PPP. He is the Daniel W. Foster, MD, Professor of Medical Ethics at the University of Texas Southwestern Medical Center, as well as a Professor of Psychiatry there. He has been a PPP editor since its inception.ReferenceMonfasani, J. (1988). The first call for press censorship: Niccolo Perotti, Giovanni Andrea Bussi, Antonio Moreto, and the editing of Pliny's Natural History. Renaissance Quarterly, 41, 1–31. Google ScholarCopyright © 2023 Johns Hopkins University Press... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy, Psychiatry, & Psychology 3.2 (1996) 139-142 Concurrent Contents: Recent and Classic References at the Interface of Philosophy, Psychiatry, & Psychology Articles Abramowitz, S., C. Abramowitz, C. Jackson et al. 1973. The politics of clinical judgment. Journal of Consulting and Clinical Psychology 41: 385-391.Audi, R. N. 1972. Psychoanalytic explanation and the concept of rational action. The Monist 56: 444- 464.Barondess, J. A. 1979. Disease and illness--a crucial distinction. American (...) Journal of Medicine 66: 375-376.Barrett, R. J. 1988. Interpretations of schizophrenia. Culture, Medicine and Psychiatry 12: 357-388.Bechtel, W. 1993. The case for connectionism. Philosophical Studies 7: 119-154.Belzen, J. A. 1995. The impact of phenomenology on classical psychiatry: Rümke's position between Jaspers and Kraepelin. History of Psychiatry 6: 349-385.Benda, C. E. 1967. Neuroses of conscience. Journal of Existentialism 7: 425-442.Binns, P. 1995. Commentary on "Contentless consciousness." Philosophy, Psychiatry, & Psychology 2: 61-63.Blankenburg, W. 1980. Phenomenology and psychopathology. Journal of Phenomenological Psychology 11: 50-78.Bloomfield, T. M. 1979. Psychoanalysis: A human science? Journal for the Theory of Social Behavior 9: 271-287.Blumenfeld, D. 1972. Free action and unconscious motivation. The Monist 56: 426-443.Boudreaux, G. 1977. Freud on the nature of unconscious mental processes. Philosophy of the Social Sciences 7: 1-32.Bracken, P. J. 1995. Beyond liberation: Michael Foucault and the notion of a critical psychiatry. Philosophy, Psychiatry, & Psychology 2, no. 1: 1-13.Brazier, M. 1995. Commentary on "Who should be committable?." Philosophy, Psychiatry, & Psychology 2, no. 1: 49-50.Bursztajn, J., and A. Brodsky. 1995. Authenticity and autonomy in the managed-care era: Forensic psychiatric perspectives. Journal of Clinical Ethics 5, no. 3: 237-242.Byrnes, J. F. 1979. Suggestions on writing the history of psychological data. History and Theory 16: 297-305.Campbell, E. J., J. G. Scadding, and R. J. Roberts. 1979. The concept of disease. British Medical Journal 2: 757-762.Carveth, D. 1988. In reply to Eagle's reply on "The epistemological foundations of psychoanalysis." Philosophy of the Social Sciences 18: 377-378.Chadwick, R. F. 1995. Commentary on "Karl Jaspers and Edmund Husserl." Philosophy, Psychiatry, & Psychology 2, no. 1: 83-84.Christiansen, B. 1964. The scientific status of psychoanalytic clinical evidence (III). Inquiry 7: 47-79.Davis, M. 1987. Realistic utilitarianism and the social conditions of cognitive psychotherapy. Social Theory & Practice 13: 237-259.Dega, W., et al. 1978. Ethics and mental health: Discussion. Dialectics and Humanism 5: 219-235.Dingle, H. 1949. The logical status of psycho-analysis. Analysis 9: 63-66.Dupeau, J. 1977. Freud and degeneracy. Diogenes Spring: 43-64.Eagle, M. 1988. A reply to Carveth's "The epistemological foundations of psychoanalysis. Philosophy of the Social Sciences 18: 371-375.Elevitch, B. 1974-75. Reasons, motives and psychoanalysis. Philosophical Forum (Boston) 6: 143- 162.Elliot, P. 1995. Policies, identity, and social change: Contested grounds in psychoanalytic feminism. Hypatia 10: 41-55.Fabrega Jr, H. 1980. The position of psychiatric illness in biomedical theory: A cultural analysis. Journal of Medicine and Philosophy 5: 145-168.Fisk, G. 1993. Accreditation of psychotherapists. British Journal of Hospital Medicine 50: 437-438.Flynn, B. G. 1985. Reading Habermas reading Freud. Human Studies 8: 57-76.Forrow, L., R. M. Arnold, and J. Frader. 1991. Teaching clinical ethics in the residency years--preparing competent professionals. Journal of Medicine and Philosophy 16: 93-112.Friedman, M. 1982. Philosophical anthropology and psychotherapy. Philosophical Context 12: 9-19.Galdston, I. 1969. The ontologic foundations of morality. Existential Psychiatry 7: 69-75.Gardner, S. 1995a. Commentary on "Irrationality and the dynamic unconscious." Philosophy, Psychiatry, & Psychology 2, no. 2: 175-176.Gardner, S. 1995b. Psychoanalysis, science, and commonsense. Philosophy, Psychiatry, & Psychology 2, no. 2: 93-113.Handelsman, M. M. et al. 1995. Does legally mandated consent to psychotherapy ensure ethical appropriateness? The Colorado experience. Ethics and Behavior 5, no. 2: 119-129.Hanlon, M. D. 1977. Commentary on Dunham's "Psychiatry, Sociology and Civil Liberties." Values and Ethics in Health Care 2: 275-278.Heaton, J. M. 1972. Insight in... (shrink)

The rapid development of COVID-19 vaccines in 2020 involved an unprecedented clinical research initiative. The case here involves a Phase I clinical trial of “second-generation” COVID-19 vaccines d...

Volume 20, Issue 4, May 2020, Page 102-103.

Currently, there is consensus that community engagement and partnerships are essential to inclusive patient-centered clinical research. Yet there is variation about what it means to do this well an...

Volume 20, Issue 10, October 2020, Page 90-91.

For many rare diseases, the availability of effective interventions is limited or non-existent. In this context, clinical research evaluating emerging interventions may be the only potentially “the...

A twenty‐person working group convened to discuss the ethical and policy considerations of the controversial intervention called “growth attenuation,” and if possible to develop practical guidance for health professionals. A consensus proved elusive, but most of the members did reach a compromise.

Volume 20, Issue 5, June 2020, Page 22-23.

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by (...) a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas. (shrink)

Table of contentsI1 Proceedings of the 4th World Conference on Research IntegrityConcurrent Sessions:1. Countries' systems and policies to foster research integrityCS01.1 Second time around: Implementing and embedding a review of responsible conduct of research policy and practice in an Australian research-intensive universitySusan Patricia O'BrienCS01.2 Measures to promote research integrity in a university: the case of an Asian universityDanny Chan, Frederick Leung2. Examples of research integrity education programmes in different countriesCS02.1 Development of a state-run “cyber education program of research ethics” in (...) KoreaEun Jung Ko, Jin Sun Kwak, TaeHwan Gwon, Ji Min Lee, Min-Ho LeeCS02.3 Responsible conduct of research teachers’ training courses in Germany: keeping on drilling through hard boards for more RCR teachersHelga Nolte, Michael Gommel, Gerlinde Sponholz3. The research environment and policies to encourage research integrityCS03.1 Challenges and best practices in research integrity: bridging the gap between policy and practiceYordanka Krastev, Yamini Sandiran, Julia Connell, Nicky SolomonCS03.2 The Slovenian initiative for better research: from national activities to global reflectionsUrsa Opara Krasovec, Renata SribarCS03.3 Organizational climate assessments to support research integrity: background of the Survey of Organizational Research Climate and the experience with its use at Michigan State UniversityBrian C. Martinson, Carol R. Thrush, C.K. Gunsalus4. Expressions of concern and retractionsCS04.1 Proposed guidelines for retraction notices and their disseminationIvan Oransky, Adam MarcusCS04.2 Watching retractions: analysis of process and practice, with data from the Wiley retraction archivesChris Graf, Verity Warne, Edward Wates, Sue JoshuaCS04.3 An exploratory content analysis of Expressions of ConcernMiguel RoigCS04.4 An ethics researcher in the retraction processMichael Mumford5. Funders' role in fostering research integrityCS05.1 The Fonds de Recherche du Québec’s institutional rules on the responsible conduct of research: introspection in the funding agency activitiesMylène Deschênes, Catherine Olivier, Raphaëlle Dupras-LeducCS05.2 U.S. Public Health Service funds in an international setting: research integrity and complianceZoë Hammatt, Raju Tamot, Robin Parker, Cynthia Ricard, Loc Nguyen-Khoa, Sandra TitusCS05.3 Analyzing decision making of funders of public research as a case of information asymmetryKarsten Klint JensenCS05.4 Research integrity management: Empirical investigation of academia versus industrySimon Godecharle, Ben Nemery, Kris Dierickx5A: Education: For whom, how, and what?CS05A.1 Research integrity or responsible conduct of research? What do we aim for?Mickey Gjerris, Maud Marion Laird Eriksen, Jeppe Berggren HoejCS05A.2 Teaching and learning about RCR at the same time: a report on Epigeum’s RCR poll questions and other assessment activitiesNicholas H. SteneckCS05A.4 Minding the gap in research ethics education: strategies to assess and improve research competencies in community health workers/promoteresCamille Nebeker, Michael Kalichman, Elizabeth Mejia Booen, Blanca Azucena Pacheco, Rebeca Espinosa Giacinto, Sheila Castaneda6. Country examples of research reward systems and integrityCS06.1 Improving systems to promote responsible research in the Chinese Academy of SciencesDing Li, Qiong Chen, Guoli Zhu, Zhonghe SunCS06.4 Exploring the perception of research integrity amongst public health researchers in IndiaParthasarathi Ganguly, Barna Ganguly7. Education and guidance on research integrity: country differencesCS07.1 From integrity to unity: how research integrity guidance differs across universities in Europe.Noémie Aubert Bonn, Kris Dierickx, Simon GodecharleCS07.2 Can education and training develop research integrity? The spirit of the UNESCO 1974 recommendation and its updatingDaniele Bourcier, Jacques Bordé, Michèle LeducCS07.3 The education and implementation mechanisms of research ethics in Taiwan's higher education: an experience in Chinese web-based curriculum development for responsible conduct of researchChien Chou, Sophia Jui-An PanCS07.4 Educating principal investigators in Swiss research institutions: present and future perspectivesLouis Xaver Tiefenauer8. Measuring and rewarding research productivityCS08.1 Altimpact: how research integrity underpins research impactDaniel Barr, Paul TaylorCS08.2 Publication incentives: just reward or misdirection of funds?Lyn Margaret HornCS08.3 Why Socrates never charged a fee: factors contributing to challenges for research integrity and publication ethicsDeborah Poff9. Plagiarism and falsification: Behaviour and detectionCS09.1 Personality traits predict attitude towards plagiarism of self and others in biomedicine: plagiarism, yes we can?Martina Mavrinac, Gordana Brumini, Mladen PetrovečkiCS09.2 Investigating the concept of and attitudes toward plagiarism for science teachers in Brazil: any challenges for research integrity and policy?Christiane Coelho Santos, Sonia VasconcelosCS09.3 What have we learnt?: The CrossCheck Service from CrossRefRachael LammeyCS09.4 High p-values as a sign of data fabrication/falsificationChris Hartgerink, Marcel van Assen, Jelte Wicherts10. Codes for research integrity and collaborationsCS10.1 Research integrity in cross-border cooperation: a Nordic exampleHanne Silje HaugeCS10.3 Research integrity, research misconduct, and the National Science Foundation's requirement for the responsible conduct of researchAaron MankaCS10.4 A code of conduct for international scientific cooperation: human rights and research integrity in scientific collaborations with international academic and industry partnersRaffael Iturrizaga11. Countries' efforts to establish mentoring and networksCS11.1 ENRIO : a network facilitating common approaches on research integrity in EuropeNicole FoegerCS11.2 Helping junior investigators develop in a resource-limited country: a mentoring program in PeruA. Roxana Lescano, Claudio Lanata, Gissella Vasquez, Leguia Mariana, Marita Silva, Mathew Kasper, Claudia Montero, Daniel Bausch, Andres G LescanoCS11.3 Netherlands Research Integrity Network: the first six monthsFenneke Blom, Lex BouterCS11.4 A South African framework for research ethics and integrity for researchers, postgraduate students, research managers and administratorsLaetus OK Lategan12. Training and education in research integrity at an early career stageCS12.1 Research integrity in curricula for medical studentsGustavo Fitas ManaiaCS12.2 Team-based learning for training in the responsible conduct of research supports ethical decision-makingWayne T. McCormack, William L. Allen, Shane Connelly, Joshua Crites, Jeffrey Engler, Victoria Freedman, Cynthia W. Garvan, Paul Haidet, Joel Hockensmith, William McElroy, Erik Sander, Rebecca Volpe, Michael F. VerderameCS12.4 Research integrity and career prospects of junior researchersSnezana Krstic13. Systems and research environments in institutionsCS13.1 Implementing systems in research institutions to improve quality and reduce riskLouise HandyCS13.2 Creating an institutional environment that supports research integrityDebra Schaller-DemersCS13.3 Ethics and Integrity Development Grants: a mechanism to foster cultures of ethics and integrityPaul Taylor, Daniel BarrCS13.4 A culture of integrity at KU LeuvenInge Lerouge, Gerard Cielen, Liliane Schoofs14. Peer review and its role in research integrityCS14.1 Peer review research across disciplines: transdomain action in the European Cooperation in Science and Technology “New Frontiers of Peer Review ”Ana Marusic, Flaminio SquazzoniCS14.2 Using blinding to reduce bias in peer reviewDavid VauxCS14.3 How to intensify the role of reviewers to promote research integrityKhalid Al-Wazzan, Ibrahim AlorainyCS14.4 Credit where credit’s due: professionalizing and rewarding the role of peer reviewerChris Graf, Verity Warne15. Research ethics and oversight for research integrity: Does it work?CS15.1 The psychology of decision-making in research ethics governance structures: a theory of bounded rationalityNolan O'Brien, Suzanne Guerin, Philip DoddCS15.2 Investigator irregularities: iniquity, ignorance or incompetence?Frank Wells, Catherine BlewettCS15.3 Academic plagiarismFredric M. Litto16. Research integrity in EuropeCS16.1 Whose responsibility is it anyway?: A comparative analysis of core concepts and practice at European research-intensive universities to identify and develop good practices in research integrityItziar De Lecuona, Erika Löfstrom, Katrien MaesCS16.2 Research integrity guidance in European research universitiesKris Dierickx, Noémie Bonn, Simon GodecharleCS16.3 Research Integrity: processes and initiatives in Science Europe member organisationsTony Peatfield, Olivier Boehme, Science Europe Working Group on Research IntegrityCS16.4 Promoting research integrity in Italy: the experience of the Research Ethics and Bioethics Advisory Committee of the Consiglio Nazionale delle Ricerche Cinzia Caporale, Daniele Fanelli17. Training programs for research integrity at different levels of experience and seniorityCS17.1 Meaningful ways to incorporate research integrity and the responsible conduct of research into undergraduate, graduate, postdoctoral and faculty training programsJohn Carfora, Eric Strauss, William LynnCS17.2 "Recognize, respond, champion": Developing a one-day interactive workshop to increase confidence in research integrity issuesDieter De Bruyn, Bracke Nele, Katrien De Gelder, Stefanie Van der BurghtCS17.4 “Train the trainer” on cultural challenges imposed by international research integrity conversations: lessons from a projectJosé Roberto Lapa e Silva, Sonia M. R. Vasconcelos18. Research and societal responsibilityCS18.1 Promoting the societal responsibility of research as an integral part of research integrityHelene IngierdCS18.2 Social responsibility as an ethical imperative for scientists: research, education and service to societyMark FrankelCS18.3 The intertwined nature of social responsibility and hope in scienceDaniel Vasgird, Stephanie BirdCS18.4 Common barriers that impede our ability to create a culture of trustworthiness in the research communityMark Yarborough19. Publication ethicsCS19.1 The authors' forum: A proposed tool to improve practices of journal editors and promote a responsible research environmentIbrahim Alorainy, Khalid Al-WazzanCS19.2 Quantifying research integrity and its impact with text analyticsHarold GarnerCS19.3 A closer look at authorship and publication ethics of multi- and interdisciplinary teamsLisa Campo-Engelstein, Zubin Master, Elise Smith, David Resnik, Bryn Williams-JonesCS19.4 Invisibility of duplicate publications in biomedicineMario Malicki, Ana Utrobicic, Ana Marusic20. The causes of bad and wasteful research: What can we do?CS20.1 From countries to individuals: unravelling the causes of bias and misconduct with multilevel meta-meta-analysisDaniele Fanelli, John PA IoannidisCS20.2 Reducing research waste by integrating systems of oversight and regulationGerben ter Riet, Tom Walley, Lex Marius BouterCS20.3 What are the determinants of selective reporting?: The example of palliative care for non-cancer conditionsJenny van der Steen, Lex BouterCS20.4 Perceptions of plagiarism, self-plagiarism and redundancy in research: preliminary results from a national survey of Brazilian PhDsSonia Vasconcelos, Martha Sorenson, Francisco Prosdocimi, Hatisaburo Masuda, Edson Watanabe, José Carlos Pinto, Marisa Palácios, José Lapa e Silva, Jacqueline Leta, Adalberto Vieyra, André Pinto, Mauricio Sant’Ana, Rosemary Shinkai21. Are there country-specific elements of misconduct?CS21.1 The battle with plagiarism in Russian science: latest developmentsBoris YudinCS21.2 Researchers between ethics and misconduct: A French survey on social representations of misconduct and ethical standards within the scientific communityEtienne Vergès, Anne-Sophie Brun-Wauthier, Géraldine VialCS21.3 Experience from different ways of dealing with research misconduct and promoting research integrity in some Nordic countriesTorkild VintherCS21.4 Are there specifics in German research misconduct and the ways to cope with it?Volker Bähr, Charité22. Research integrity teaching programmes and their challengesCS22.1 Faculty mentors and research integrityMichael Kalichman, Dena PlemmonsCS22.2 Training the next generation of scientists to use principles of research quality assurance to improve data integrity and reliabilityRebecca Lynn Davies, Katrina LaubeCS22.3 Fostering research integrity in a culturally-diverse environmentCynthia Scheopner, John GallandCS22.4 Towards a standard retraction formHervé Maisonneuve, Evelyne Decullier23. Commercial research and integrityCS23.1 The will to commercialize: matters of concern in the cultural economy of return-on-investment researchBrian NobleCS23.2 Quality in drug discovery data reporting: a mission impossible?Anja Gilis, David J. Gallacher, Tom Lavrijssen, Malwitz David, Malini Dasgupta, Hans MolsCS23.3 Instituting a research integrity policy in the context of semi-private-sector funding: an example in the field of occupational health and safetyPaul-Emile Boileau24. The interface of publication ethics and institutional policiesCS24.1 The open access ethical paradox in an open government effortTony SavardCS24.2 How journals and institutions can work together to promote responsible conductEric MahCS24.3 Improving cooperation between journals and research institutions in research integrity casesElizabeth Wager, Sabine Kleinert25. Reproducibility of research and retractionsCS25.1 Promoting transparency in publications to reduce irreproducibilityVeronique Kiermer, Andrew Hufton, Melanie ClyneCS25.2 Retraction notices issued for publications by Latin American authors: what lessons can we learn?Sonia Vasconcelos, Renan Moritz Almeida, Aldo Fontes-Pereira, Fernanda Catelani, Karina RochaCS25.3 A preliminary report of the findings from the Reproducibility Project: Cancer biologyElizabeth Iorns, William Gunn26. Research integrity and specific country initiativesCS26.1 Promoting research integrity at CNRS, FranceMichèle Leduc, Lucienne LetellierCS26.2 In pursuit of compliance: is the tail wagging the dog?Cornelia MalherbeCS26.3 Newly established research integrity policies and practices: oversight systems of Japanese research universitiesTakehito Kamata27. Responsible conduct of research and country guidelinesCS27.1 Incentives or guidelines? Promoting responsible research communication through economic incentives or ethical guidelines?Vidar EnebakkCS27.3 Responsible conduct of research: a view from CanadaLynn PenrodCS27.4 The Danish Code of Conduct for Research Integrity: a national initiative to promote research integrity in DenmarkThomas Nørgaard, Charlotte Elverdam28. Behaviour, trust and honestyCS28.1 The reasons behind non-ethical behaviour in academiaYves FassinCS28.2 The psychological profile of the dishonest scholarCynthia FekkenCS28.3 Considering the implications of Dan Ariely’s keynote speech at the 3rd World Conference on Research Integrity in MontréalJamal Adam, Melissa S. AndersonCS28.4 Two large surveys on psychologists’ views on peer review and replicationJelte WichertsBrett Buttliere29. Reporting and publication bias and how to overcome itCS29.1 Data sharing: Experience at two open-access general medical journalsTrish GrovesCS29.2 Overcoming publication bias and selective reporting: completing the published recordDaniel ShanahanCS29.3 The EQUATOR Network: promoting responsible reporting of health research studiesIveta Simera, Shona Kirtley, Eleana Villanueva, Caroline Struthers, Angela MacCarthy, Douglas Altman30. The research environment and its implications for integrityCS30.1 Ranking of scientists: the Russian experienceElena GrebenshchikovaCS30.4 From cradle to grave: research integrity, research misconduct and cultural shiftsBronwyn Greene, Ted RohrPARTNER SYMPOSIAPartner Symposium AOrganized by EQUATOR Network, Enhancing the Quality and Transparency of Health ResearchP1 Can we trust the medical research literature?: Poor reporting and its consequencesIveta SimeraP2 What can BioMed Central do to improve published research?Daniel Shanahan, Stephanie HarrimanP3 What can a "traditional" journal do to improve published research?Trish GrovesP4 Promoting good reporting practice for reliable and usable research papers: EQUATOR Network, reporting guidelines and other initiativesCaroline StruthersPartner Symposium COrganized by ENRIO, the European Network of Research Integrity OfficersP5 Transparency and independence in research integrity investigations in EuropeKrista Varantola, Helga Nolte, Ursa Opara, Torkild Vinther, Elizabeth Wager, Thomas NørgaardPartner Symposium DOrganized by IEEE, the Institute of Electrical and Electronics EngineersRe-educating our author community: IEEE's approach to bibliometric manipulation, plagiarism, and other inappropriate practicesP6 Dealing with plagiarism in the connected world: An Institute of Electrical and Electronics Engineers perspectiveJon RokneP7 Should evaluation of raises, promotion, and research proposals be tied to bibliometric indictors? What the Institute of Electrical and Electronics Engineers is doing to answer this questionGianluca SettiP8 Recommended practices to ensure conference content qualityGordon MacPhersonPartner Symposium EOrganized by the Committee on Freedom and Responsibility in the Conduct of Science of ICSU, the International Council for ScienceResearch assessment and quality in science: perspectives from international science and policy organisationsP9 Challenges for science and the problems of assessing researchEllen HazelkornP10 Research assessment and science policy developmentCarthage SmithP11 Research integrity in South Africa: the value of procedures and processes to global positioningRobert H. McLaughlinP12 Rewards, careers and integrity: perspectives of young scientists from around the worldTatiana Duque MartinsPartner Symposium FOrganized by the Online Resource Center for Ethics Education in Engineering and Science / Center for Engineering, Ethics, and Society of the National Academy of EngineeringP13 Research misconduct: conceptions and policy solutionsTetsuya Tanimoto, Nicholas Steneck, Daniele Fanelli, Ragnvald Kalleberg, Tajammul HusseinPartner Symposium HOrganized by ORI, the Office of Research Integrity; Universitas 21; and the Asia Pacific Research Integrity NetworkP14 International integrity networks: working together to ensure research integrityPing Sun, Ovid Tzeng, Krista Varantola, Susan ZimmermanPartner Symposium IOrganized by COPE, the Committee on Publication EthicsPublication without borders: Ethical challenges in a globalized worldP15 Authorship: credit and responsibility, including issues in large and interdisciplinary studiesRosemary ShinkaiPartner Symposium JOrganized by CITI, the Cooperative Institutional Training InitiativeExperiences on research integrity educational programs in Colombia, Costa Rica and PeruP16 Experiences in PeruRoxana LescanoP17 Experiences in Costa RicaElizabeth HeitmanP18 Experiences in ColumbiaMaria Andrea Rocio del Pilar Contreras NietoPoster Session B: Education, training, promotion and policyPT.01 The missing role of journal editors in promoting responsible researchIbrahim Alorainy, Khalid Al-WazzanPT.02 Honorary authorship in Taiwan: why and who should be in charge?Chien Chou, Sophia Jui-An PanPT.03 Authorship and citation manipulation in academic researchEric Fong, Al WilhitePT.04 Open peer review of research submission at medical journals: experience at BMJ Open and The BMJTrish GrovesPT.05 Exercising authorship: claiming rewards, practicing integrityDésirée Motta-RothPT.07 Medical scientists' views on publication culture: a focus group studyJoeri Tijdink, Yvo SmuldersPoster Session B: Education, training, promotion and policyPT.09 Ethical challenges in post-graduate supervisionLaetus OK LateganPT.10 The effects of viable ethics instruction on international studentsMichael Mumford, Logan Steele, Logan Watts, James Johnson, Shane Connelly, Lee WilliamsPT.11 Does language reflect the quality of research?Gerben ter Riet, Sufia Amini, Lotty Hooft, Halil KilicogluPT.12 Integrity complaints as a strategic tool in policy decision conflictsJanneke van Seters, Herman Eijsackers, Fons Voragen, Akke van der Zijpp and Frans BromPoster Session C: Ethics and integrity intersectionsPT.14 Regulations of informed consent: university-supported research processes and pitfalls in implementationBadaruddin Abbasi, Naif Nasser AlmasoudPT.15 A review of equipoise as a requirement in clinical trialsAdri LabuschagnePT.16 The Research Ethics Library: online resource for research ethics educationJohanne Severinsen, Espen EnghPT.17 Research integrity: the view from King Abdulaziz City for Science and TechnologyDaham Ismail AlaniPT. 18 Meeting global challenges in high-impact publications and research integrity: the case of the Malaysian Palm Oil BoardHJ. Kamaruzaman JusoffPT.19 University faculty perceptions of research practices and misconductAnita Gordon, Helen C. HartonPoster Session D: International perspectivesPT.21 The Commission for Scientific Integrity as a response to research fraudDieter De Bruyn, Stefanie Van der BurghtPT. 22 Are notions of the responsible conduct of research associated with compliance with requirements for research on humans in different disciplinary traditions in Brazil?Karina de Albuquerque Rocha, Sonia Maria Ramos de VasconcelosPT.23 Creating an environment that promotes research integrity: an institutional model of Malawi Liverpool Welcome TrustLimbanazo MatandikaPT.24 How do science policies in Brazil influence user-engaged ecological research?Aline Carolina de Oliveira Machado Prata, Mark William NeffPoster Session E: Perspectives on misconductPT.26 What “causes” scientific misconduct?: Testing major hypotheses by comparing corrected and retracted papersDaniele Fanelli, Rodrigo Costas, Vincent LarivièrePT.27 Perception of academic plagiarism among dentistry studentsDouglas Leonardo Gomes Filho, Diego Oliveira GuedesPT. 28 a few bad apples?: Prevalence, patterns and attitudes towards scientific misconduct among doctoral students at a German university hospitalVolker Bähr, Niklas Keller, Markus Feufel, Nikolas OffenhauserPT. 29 Analysis of retraction notices published by BioMed CentralMaria K. Kowalczuk, Elizabeth C. MoylanPT.31 "He did it" doesn't work: data security, incidents and partnersKatie SpeanburgPoster Session F: Views from the disciplinesPT.32 Robust procedures: a key to generating quality results in drug discoveryMalini Dasgupta, Mariusz Lubomirski, Tom Lavrijssen, David Malwitz, David Gallacher, Anja GillisPT.33 Health promotion: criteria for the design and the integrity of a research projectMaria Betânia de Freitas Marques, Laressa Lima Amâncio, Raphaela Dias Fernandes, Oliveira Patrocínio, and Cláudia Maria Correia Borges RechPT.34 Integrity of academic work from the perspective of students graduating in pharmacy: a brief research studyMaria Betânia de Freitas Marques, Cláudia Maria Correia Borges Rech, Adriana Nascimento SousaPT.35 Research integrity promotion in the Epidemiology and Health Services, the journal of the Brazilian Unified Health SystemLeila Posenato GarciaPT.36 When are clinical trials registered? An analysis of prospective versus retrospective registration of clinical trials published in the BioMed Central series, UKStephanie Harriman, Jigisha PatelPT.37 Maximizing welfare while promoting innovation in drug developmentFarida LadaOther posters that will be displayed but not presented orally:PT.38 Geoethics and the debate on research integrity in geosciencesGiuseppe Di Capua, Silvia PeppoloniPT.39 Introducing the Professionalism and Integrity in Research Program James M. DuBois, John Chibnall, Jillon Van der WallPT.40 Validation of the professional decision-making in research measureJames M. DuBois, John Chibnall, Jillon Van der Wall, Raymond TaitPT.41 General guidelines for research ethicsJacob HolenPT. 42 A national forum for research ethicsAdele Flakke Johannessen, Torunn EllefsenPT.43 Evaluation of integrity in coursework: an approach from the perspective of the higher education professorClaudia Rech, Adriana Sousa, Maria Betânia de Freitas MarquesPT.44 Principles of geoethics and research integrity applied to the European Multidisciplinary Seafloor and Water Column Observatory, a large-scale European environmental research infrastructureSilvia Peppoloni, Giuseppe Di Capua, Laura BeranzoliF1 Focus track on improving research systems: the role of fundersPaulo S.L. Beirão, Susan ZimmermanF2 Focus track on improving research systems: the role of countriesSabine Kleinert, Ana MarusicF3 Focus track on improving research systems: the role of institutionsMelissa S. Anderson, Lex Bouter. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy, Psychiatry, & Psychology 10.4 (2003) 295 [Access article in PDF] Agency, Narrative, and Self:A Philosophical Case Conference John Z. Sadler and K. W. M. Fulford This issue of PPP features our second "philosophical case conference," which addresses three important and interrelated concepts in the philosophy of psychiatry. Our first philosophical case conference (Philosophy, Psychiatry, and Psychology Volume 5, Number 2, 1998) featured detailed case material concerning (...) the manifold issues involved in psychiatric euthanasia. For this issue, guest edited by J. Melvin Woody, the rich cases supplied by Lloyd Wells provide the foundation for a discussion of narrative accounts of the self and what it means to be an agent.Philosophical case conferences are an occasional feature of PPP, and develop topics to satisfy one or more criteria: to provide discussions that are important to clinical practice or research, to embed current or perennial philosophical debates in the nitty gritty of clinical practice and personal experience, and/or to provide a clinical testing ground for new conceptual developments relevant to the philosophy of psychiatry.The format for this issue involves four feature articles, the first by Wells, presenting detailed case material of several patients, followed by discussions (by Kennett & Matthews, Phillips, and Woody) inspired by, or addressing explicitly, the philosophical questions implied in such cases. Following these four feature articles, a panel of commentators (Glas, Hardcastle, Radden, Thornton, Weiner, Woodbridge) respond to the four feature articles as they wish, providing the variations on the agency, narrative, and self themes. We think you will find this issue of PPP to be a fine example of what the philosophy of psychiatry can do, and we give our abundant thanks to Mel Woody for putting this issue together.... (shrink)

The nature, possibility, and implications of ethics expertise in general and of bioethics expertise in particular has been the focus of extensive debate for over thirty years. What is ethics expertise and what does it enable experts to do? Knowing what ethics expertise is can help answer another important question: What, if anything, makes a claim of expertise legitimate? In other words, how does someone earn the appellation “ethics expert?” There remains deep disagreement on whether ethics expertise is possible, and (...) if so, what constitutes such expertise and what it entails and legitimates. Discussion of bioethics expertise has become particularly important given the growing presence of bioethicists in the clinical setting as well as efforts to professionalize bioethics through codes of ethics and certification efforts. Unlike in the law or in engineering, where there may be a body of knowledge that professional organizations or others have articulated as important for education and training of experts, ethics expertise admits of no such body of knowledge or required experience. Nor is there an entity seen as having the authority to articulate the necessary scope of knowledge. Questions about whether there is such a body of knowledge for particular areas within bioethics have emerged and played a central role in professionalization efforts in recent years, especially in the area of clinical ethics. (shrink)

The Oxford Handbook of Psychiatric Ethics is the most comprehensive treatment of the field in history. The volume is organized into ten sections which survey the scope of the text: Introduction, People Come First, Specific Populations, Philosophy and Psychiatric Ethics, Religious Contexts of Psychiatric Ethics, Social Contexts of Psychiatric Ethics, Ethics in Psychiatric Citizenship and the Law, Ethics of Psychiatric Research, Ethics and Values in Psychiatric Assessment and Diagnosis, Ethics and Values in Psychiatric Treatment. Written and edited by an international (...) team of experts, this landmark book provides a powerful and compelling review of psychiatric ethics in the 21st Century. (shrink)

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...) research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked (...) to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy, Psychiatry, & Psychology 11.4 (2004) 357-359 [Access article in PDF] A Madness for the Philosophy of Psychiatry John Z. Sadler His enthusiasm brimming over with the rich set of ideas and problems he has discovered, Louis Charland's essay on identity, ethics, and the Internet should be grist for the philosophy of psychiatry mill for years. Indeed, a brief commentary cannot answer the many questions raised by (...) his paper. In response, I would like to focus on two general issues for this essay. Labels, Diagnoses, Reference, Experiences Many psychiatrists will take issue with Charland's use of the term label in reference to mental disorder concepts in this paper. I did not, but his relatively uncritical use of the labels and labeling terms in his essay prompts me to unpack some concepts that lurk behind the many other conceptual issues raised here. Psychiatric "labels" and "labeling" have a derogatory sense for many psychiatrists, because they are associated with a virulent antipsychiatry temperament dating back to the 1960s, at least in the United States (Sadler 2003). For many clinicians (as well as others) labeling implies that there is nothing more to psychiatric diagnosis and "mental illness" than the names given to various sorts of human diversity. This sort of psychiatric nominalism, the viewpoint goes, serves to pigeonhole people for the purposes, primarily, of political control or power. Charland's own viewpoint is more subtle than this, illustrated by his discussion of Hacking's "looping effects" and the related idea that social factors are influential in the manifestations, even causation, of mental disorders, but are not exhaustive in explaining mental disorders. However, because the whole matter of social construction of clinical phenomena is at the heart of Charland's discussion, further consideration of this metaphysical territory is warranted.The notion of a mental disorder concept as "label" betrays little about what, substantively, mental disorders are. A label on a can of peas tells us little, ultimately, about the nature of the contents; indeed, it is only a clue. When we shift labeling from a can of peas to a person—a self—then such a shallow clue to the "contents" of a person is an offensive simplification of a person's identity and selfhood. Hence the railing against psychiatric labeling in the 1960s through today.The general goals for psychiatric diagnosis and classification in systems like DSM-IV is are multiple, but at minimum, such denotations of clinical conditions are intended to advance the generation of knowledge about the conditions as well as provide a "shorthand" for clinicians in communicating about and understanding patients' conditions. How successful these diagnostic classification systems are for these and other purposes is a discussion for another time, but the [End Page 357] point here is that some sort of method of characterizing people's distresses is a precondition for understanding and explaining such distresses. The scientific processes of validation of psychiatric categories, at core, are to ensure that, as Gorenstein notes (1992), our clinical concepts are not empty, self-fulfilling prophecies, but rather refer to other, hopefully predictable, features of the patient's distress. Such validation of clinical "constructs" is the basis for developing and testing specific treatments, as well as understanding more richly and deeply the clinical phenomenon. To have a label, then, under this view, is to have an empty nominalization, which is offensive and scientifically vapid. To have a diagnostic construct—a disorder—is to have a concept which empirically refers to, as Paul Meehl put it, a "nomological network" of predictable, lawlike, implications (Sadler 2004a).However, as Charland, Hacking, and others have noted, the reflexivity of the human self and our ultimately crude ways of characterizing selves leads to a serious problem, even for the most rigorously validated psychological categories. That problem is the changeability of the self, the capacity of people to remake themselves according to their own ideas along with the sociocultural ether of ideas that surrounds us all. This means that our understanding of mental disorders, both as aggregates of features, and well as individual patients over time, are "moving targets," the... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy, Psychiatry, & Psychology 12.4 (2005) 307-310 [Access article in PDF] Aesthetics, Criticism, and Psychotherapy John Z. Sadler Keywords aesthetics, psychiatry, psychotherapy, Sibley In his wide-ranging survey of how Kantian aesthetic theory is implicated in psychothera-py, John Callender has raised at least a dozen potentially profound and rewarding possibilities in applying aesthetic theory to psychiatry and psychotherapy. Although the idea of marrying aesthetic theory to psychiatry (...) and psychotherapy is not new, Callender's direction of the merger is distinctively novel. The mid-twentieth century had a distinct literature in applying psychoanalytic and psychiatric theory to aesthetic experience, summarized by the sizable bibliography by Norman Kiell, Psychiatry and Psychology in the Visual Arts and Aesthetics: A Bibliography (1965). This line of interdisciplinary work influenced a later generation of art historians and literary theorists in applying (particularly) psychoanalytic theory to interpretation and appreciation of the arts, contributions that are still being developed today, along with the emergence of complementary viewpoints from cognitive neuroscience (Peretz and Zatorre 2003; Rose 2004; Zeki 1999). Callender's project, however, is quite the converse—he wishes to show how philosophical aesthetics can contribute to psychiatry and clinical psychology. Exploring the aesthetics of psychiatry is the innovation.Before focusing my own comments on a few of Callender's points, I wish to call attention to the substantive questions he has directly raised or implied by his discussions. These questions are worthy of further development in this and other journals, and I hope that Callender will succeed in engaging the minds of his readers and inspire them to work in this exciting area in the philosophy of psychiatry. In his elegant review of Kant's key theoretical points of aesthetics, his discussion provokes us to consider the kinds of evaluations that patients make of themselves (moral? aesthetic? others?), as well as the kinds of evaluations clinicians make in their judgments of psychopathology. Evolutionists may wonder about the adaptive significance of aesthetic capacities (e.g., derivatives of grooming? mating displays?). In presenting Kant's notion of "disinterestedness" or contemplative judgment, readers may wonder about overlap with notions of therapist neutrality and unconditional positive regard. Should therapist relationships with patients be dominated by a similar aesthetic sensibility? What does the aesthetic posture have to do with the therapist posture?Importantly, Callender notes the connections and ambiguities between moral values and aesthetic values. This is borne out in his later discussions of clinical case material (considered again below). He focuses primarily on the duplication of aesthetic and moral values in the same terms of praise (honesty, integrity, originality), but there is no question that aesthetic experiences are had by viewers of art exhibiting perverse or depraved [End Page 307] imagery (consider, for instance, Francis Bacon's "3 Screaming Popes" or, even more extremely, the grotesque staged photographs of Joel-Peter Witkin). The implication here is that (as an example) to understand the aesthetics of sadomasochistic art may help us to understand the psychology of sadomasochistic people.By the time he introduces his case material, Callender has raised the issue of intersubjectivity in aesthetic experience, an experience that may be devoid of discursive cognitive content but may be profound with emotional content, thus challenging tenets of cognitive psychology and psychotherapy. His discussion of cases reflecting elements of Kant's components of aesthetic judgment point toward new ways of understanding psychopathology as disturbances in aesthetic self-appraisal.I would like to return to the problem of moral and aesthetic judgments in psychotherapy and in psychopathology. Dr. Callender presents three cases—a woman who has been traumatized by multiple instances of sexual abuse, a young girl with postpartum depression with fears of losing her child because of bad mothering, and a third patient with anorexia nervosa who demonstrates the typically distorted body self-image. I suggest that the aesthetic nature of these patients' self-judgments is not so clear cut as Callender suggests. His sexual abuse case summary certainly suggests a woman consumed by shame. Because shame is a typical "moral emotion," the question is raised of moral badness being involved in her self-concept as well as, or perhaps... (shrink)

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...) highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research. (shrink)

We surveyed IRB chairs' perspectives on offering individual genetic research results to participants and families, including family members of deceased participants, and the IRB's role in addressing these issues. Given a particular hypothetical scenario, respondents favored offering results to participants but not family members, giving choices at the time of initial consent, and honoring elicited choices. They felt IRBs should have authority regarding the process issues, but a more limited role in medical and scientific issues.

The regulations dictating acceptable levels of risk in pediatric research were developed to protect pediatric research participants from unnecessary or excessive harms. These special protections we...

Volume 20, Issue 4, May 2020, Page 116-118.

In lieu of an abstract, here is a brief excerpt of the content:Editors’ NoteJames M. DuBois, Ana S. Iltis, and Heidi A. WalshFrom childhood, David Slakter had undergone tests and invasive procedures to monitor his nephritis. It was not a surprise when in 2015, doctors told him he needed a kidney transplant. The wife of a childhood friend was a close match and gave him one of her kidneys. Before his transplant, aerobic exercise was difficult; a few months after transplant, (...) Slakter could ride his bike, hike, and work out with a personal trainer. He no longer had to weigh food or gauge his potassium consumption, a concern for people with kidney failure. For Slakter, “life post-transplant has been a significant improvement.”Individuals or family members of those who have received an organ transplant from a living or deceased donor share their stories in this issue of Narrative Inquiry in Bioethics. The symposium is titled “Receiving the Gift of Life: Stories from Organ Transplant Recipients.” Organ transplantation can extend an individual’s life by decades. It can also greatly improve an individual’s quality of life, as was Slakter’s experience. At the same time, organ transplantation is expensive and stressful. Recipients can experience complications, including organ rejection, and there are few appealing alternatives.After her heart transplant, author Leilani R. Graham required four open-heart surgeries, ECMO, and an intra-aortic balloon pump. She experienced delirium, necrotizing pneumonia, and severe muscular atrophy that required her to re-learn how to walk. She struggled with weight gain, explosive mood swings, hair loss, and was terrified that her body would reject the new heart. For Graham, “[Transplant] was not the miracle [she] was hoping for.” Graham says she felt unprepared for and inadequately informed about what to expect after her transplant, which left her “battered, beaten, and bruised” with a 12-inch line from neck to navel and “bullet holes” up and down her torso from the chest tubes. When reflecting on her experience post-transplant, Graham says, “It wasn’t the physical trauma that hurt the most. It was that no one seemed surprised [by the aftereffects of transplant].” Seemingly no one, that is except Graham, who calls on transplant providers to “prioritize empathy.”The symposium editors are Jason T. Eberl and Tristan McIntosh. Three commentary articles, written by Macey Leigh Levan, Heather Lannon, and Vidya A. Fleetwood, Roslyn B. Mannon & Krista L. Lentine, offer important insights into the authors’ stories. The editors thank Mid-America Transplant, the UCSF Lung Transplant Program, Donor Connect, William L. Freeman, MD, MPH, MJIL, CIP, Janet Monk, and the individuals who gave anonymous donations to support the publication of this issue, an open-access VOICES edition of the symposium, and accompanying teaching guides.The research article in this issue, “‘A Shell of My Former Self’: Using Figurative Language to Promote Communication about Patient Suffering,” was written by Tyler Tate, Elizabeth Stein, and Robert A. Pearlman. The relief of suffering is a primary goal of medicine. However, the authors note that clinicians often miss or ignore suffering because they focus on the causes rather than the experience of suffering, or the subjective nature of suffering makes it difficult to discuss. The authors believe that “the key to communicating about suffering lies in finding [End Page vii] the right kind of words to describe the experience” and say that figurative language offers a promising approach. In their research, the authors performed qualitative analysis on 52 works of literature and identified 254 excerpts of figurative language with themes of non-physical or psychological suffering. The authors found 13 salient themes: brokenness, diminishment, disorientation, drowning, emptiness, imprisonment, battle, darkness, isolation, invisibility, lifelessness, punishment, and torture. The authors reiterate that developing a shared language of suffering could foster a therapeutic patient-clinician relationship and improve clinicians’ ability to recognize and address a patient’s experience of suffering.María Susana Ciruzzi wrote the first of two case studies included in this issue. “The Sword of King Solomon” addresses a tragic and difficult subject—how to navigate the situation posed by conjoined twins when “any decision will produce damage and suffering.” The case involves two infant male patients born at 37 weeks gestation as omphalo-ischiopagus conjoined twins... (shrink)