BackgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants (...) (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)

Introduction Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. Methods Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. Results 123 youth completed the questionnaire (mean age=15 (...) years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly. Conclusions Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking. (shrink)

Science and Community: Ending Obesity Improving Health (S&C) aimed to reduce obesity in Houston by developing community partnerships to identify research priorities and develop a sustainable obesity reduction program. Partnership members were recruited from S&C events and invited to participate in in‐depth interviews to gain insight into obesity prevalence, causes, and solutions. Members (n = 22) completed a 60–90‐min in‐depth interview. The interview guide consisted of 30 questions about pressing health problems in the community, potential solutions to health problems and (...) obesity and how the environment has impacted obesity and health behaviors in the community. Interviewees (n = 12 women and 10 men) were mostly Hispanic/Latino (n = 9) and African American (n = 7). Common problems identified were childhood obesity, balancing a healthy diet and physical inactivity. Interviewees identified obesity as a major problem in their communities and cited access to quality food and physical activity resources as both a problem and a solution. Additional emergent themes focused on solutions, including increasing awareness and education, coordinated efforts among organizations and using an ecologic approach to combat obesity. Community insight gleaned from this study may be used to enhance relevance and sustainability of programs developed to reduce obesity and suggests possible avenues for participatory research and intervention. (shrink)

A cross-sectional study to ascertain what the Singapore population would regard as material risk in the anaesthesia consent-taking process and identify demographic factors that predict patient preferences in medical decision-making to tailor a more patient-centered informed consent. A survey was performed involving patients 21 years old and above who attended the pre-operative evaluation clinic over a 1-month period in Singapore General Hospital. Questionnaires were administered to assess patients’ perception of material risks, by trained interviewers. Patients’ demographics were obtained. Mann–Whitney U (...) test and Kruskal-Wallis one-way analysis of variance was used. Statistical significance was taken at p < 0.05. Four hundred fourteen patients were eligible of which 26 refused to participate and 24 were excluded due to language barrier. 364 patients were recruited. A higher level of education, being employed and younger age group are factors identified in patients who wanted greater participation in medical decisions. Gender, marital status, type of surgery, and previous surgical history did not affect their level of participation. The complications most patients knew about were Nausea, Drowsiness and Surgical Wound Pain. Patients ranked Heart Attack, Death and Stroke as the most significant risks that they wanted to be informed about in greater detail. Most patients wanted to make a joint decision with the anaesthetist, instead of letting the doctor decide or deciding for themselves. Discussion with the anaesthetist is the preferred medium of communication compared to reading a pamphlet or watching a video. Age and educational level can influence medical decision-making. Despite the digital age, most patients still prefer a clinic consult instead of audio-visual multimedia for pre-operative anaesthetic counselling. The local population appears to place greater importance on rare but serious complications compared to common complications. This illustrates the need to contextualize information provided during informed consent to strengthen the doctor-patient relationship. (shrink)

Progressive supranuclear palsy is a movement disorder with prominent tau neuropathology. Brain diseases with abnormal tau deposits are called tauopathies, the most common of which is Alzheimer's disease. Environmental causes of tauopathies include repetitive head trauma associated with some sports. To identify common genetic variation contributing to risk for tauopathies, we carried out a genome-wide association study of 1,114 individuals with PSP and 3,247 controls followed by a second stage in which we genotyped 1,051 cases and 3,560 controls for the (...) stage 1 SNPs that yielded P ≤ 10-3. We found significant previously unidentified signals associated with PSP risk at STX6, EIF2AK3 and MOBP. We confirmed two independent variants in MAPT affecting risk for PSP, one of which influences MAPT brain expression. The genes implicated encode proteins for vesicle-membrane fusion at the Golgi-endosomal interface, for the endoplasmic reticulum unfolded protein response and for a myelin structural component. © 2011 Nature America, Inc. All rights reserved. (shrink)

In cognitive science, there is a tacit norm that phenomena such as cultural variation or synaesthesia are worthy examples of cognitive diversity that contribute to a better understanding of cognition, but that other forms of cognitive diversity (e.g., autism, attention deficit hyperactivity disorder/ADHD, and dyslexia) are primarily interesting only as examples of deficit, dysfunction, or impairment. This status quo is dehumanizing and holds back much-needed research. In contrast, the neurodiversity paradigm argues that such experiences are not necessarily deficits but rather (...) are natural reflections of biodiversity. Here, we propose that neurodiversity is an important topic for future research in cognitive science. We discuss why cognitive science has thus far failed to engage with neurodiversity, why this gap presents both ethical and scientific challenges for the field, and, crucially, why cognitive science will produce better theories of human cognition if the field engages with neurodiversity in the same way that it values other forms of cognitive diversity. Doing so will not only empower marginalized researchers but will also present an opportunity for cognitive science to benefit from the unique contributions of neurodivergent researchers and communities. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The University and Democracy: A Response to “Dewey, Implementation, and Creating a Democratic Civic University”Lee A. McBride IIIira harkavy has given us much to consider. His paper, “Dewey, Implementation, and Creating a Democratic Civic University,” invites us to critically assess our democracy and the role of colleges and universities in the propagation of our democratic way of life. Harkavy suggests that universities are failing to fulfill their function, that (...) is, “to educate students to be ethical, empathetic, engaged, democratic citizens, and advance knowledge for the continuous betterment of the human condition” (50). He suggests that universities are central societal institutions in the world, and research universities are most central—“they develop new ideas and technologies, incubate businesses, serve as cultural and artistic centers, and are engines of local, national, and global economics” (50). Our universities produce our teachers and our teachers’ teachers; they shape the learning, values, and the aspirations of students (Harkavy 50). But, again, universities are not fulfilling their social function of “creating and sustaining an inclusive, just democratic society” (Harkavy 51). Harkavy boldly asserts that a revolutionary change is required in higher education if it is to fulfill its democratic function.Closed LoopI have a concern about the role of Research 1 (R1) universities in this picture. I am led to believe that R1 universities, like the University of Pennsylvania, exist in rarefied air. Penn, for example, has a ridiculous endowment—more than $20 billion. Penn apparently accepts only 9% of its applicants. The resources and demographics of R1 institutions are unlike those at state schools and small liberal arts colleges. The various canons, the faculty, and the student body at elite R1 universities have historically represented the thoughts, [End Page 76] experiences, and perplexities of well-heeled white heteronormative men. The vast majority of the faculty and students at R1 universities are predominantly of Anglo-European descent and a higher socioeconomic status. This gives me pause. If R1 universities are placed as the central engines of democratic fomenting, I worry that the faculty and students at R1 universities will direct research and social amelioration projects in particular directions and retain particular presuppositions that will buttress the continued flourishing of elite R1 universities. A closed loop. I worry that both the material and the social capital needed to (re)shape social conditions will arise only from and circulate only between those who attend elite R1 universities. I mean, Harkavy suggests that the departments, programs, and institutes at R1 universities create and sustain those knowledges and skills that produce the scholars and thoughtful people who will drive our K–12 education, who will fashion new cooperatives and entrepreneurial ventures, and who will become our community activists and political leaders. As such, the knowledge and skills to implement a more just and inclusive democracy will be disseminated from the R1 university. Harkavy also explains that it is necessary that universities strive to be democratic civic universities, sites where university folk work alongside members of the surrounding communities to address and ameliorate the problems on the ground. This “would involve significant and ongoing engagement of an institution’s comprehensive assets (academic, human, cultural, and economic) in partnership with community members to produce knowledge and educate ethical students with the ability to help create and maintain just, anti-racist, democratic societies” (Harkavy 53). The democratic civic university would then nurture a culture of democracy that exceeds mere voting practices— democracy as a way of life (Dewey 226). Prima facie, this seems like a noble goal. And yet, I still worry that those university folks who do this work will be a small representative group of people who bear particular life experiences and perhaps phenotypic markers.I would suggest that other sites outside of the R1 university (e.g., the trade union meeting, the settlement house, the church, the community garden, etc.) will need to be taken as legitimate sites of knowledge creation or legitimate sites of communication and joint activity (Collins 269). This would at least bring differing life experiences to the table; that is, it would bring differing life experiences to the fore and recognize alternative non-academic sources of insight and wisdom. These sites and alternative... (shrink)

K G Fleming; Criteria of Learning and Teaching, Journal of Philosophy of Education, Volume 14, Issue 1, 30 May 2006, Pages 39–51, https://doi.org/10.1111/j.1467.

This paper was delivered at the 2009 annual conference of the National Council on Ethics in Human Research. It is a reflective piece based on many years of experience with human research ethics and the role of Research Ethics Boards in human participant research.

It is only when mixing two or more pure substances along a reversible path that the entropy of the mixing can be made physically manifest. It is not, in this case, a mere mathematical artifact. This mixing requires a process of successive stages. In any finite number of stages, the external manifestation of the entropy change, as a definite and measurable quantity of heat, isa fully continuous function of the relevant variables. It is only at an infinite and unattainable limit (...) thata non-uniform convergence occurs. And this occurs when considered in terms of the number of stages together with a distinguishability parameter appropriate to the particular device which is used to achieve reversibility. These considerations, which are of technological interest to chemical engineers, resolve a paradox derived in chemical theory called Gibbs'' Paradox. (shrink)

Irreversibility, it is claimed, is a much broader concept than is entropy increase, as is shown by the occurrence of certain processes which are irreversible without seeming to involve any intrinsic entropy change. These processes include the spreading outwards into space of particles, or of radiation, and they also include certain biological and mental phenomena. For instance, the irreversible and treelike branching which is characteristic of natural evolution is not entropic when it is considered in itself—i.e. in abstraction from accompanying (...) biochemical and physiological activity. What appears to be the common feature of all forms of irreversibility is the fanning out of trajectories, new entities or new states, in the temporal direction towards the future. (shrink)

Because the evolution of speech production is beyond our expertise (and perhaps beyond everyone's expertise) we restrict our comments to areas in which data actually exist. We provide articulatory evidence consistent with the claims made about syllable structure in adult speech and infant babbling, but we also voice some disagreement about speech errors and the typing data.

In ''''A Defense of Evolutionary Ethics'''' (1986), Robert J. Richardsendeavors to explain how moral ''oughts'' can be derived from thescience of evolutionary biology without committing the dreadednaturalistic fallacy. First, Richards assumes that ''ought'' as usedin ethical discourse bears the same meaning as ''ought'' used anywherein science, indicating merely that certain results or behaviors arepredicted based on prior structured contexts. To this extent, themoral behavior of animals, what they ''ought'' to do, could arguablybe predicted by evolutionary biology as effectively as, say,molecular (...) behavior may be predicted by chemistry. But afteracknowledging that biological inferences to this limited senseof ''ought'' were never contested by Moore''s naturalistic fallacy,Richard proposes to add to evolutionary ethics a decision procedureto determine which members of a set of predicted behaviors arethose which truly ought to occur – in the genuinelyprescriptive sense intended by ethical discourse. But theprocedure which Richards fabricates for this purpose appealsto such alleged ''facts'' as cultural conventions and moral opinionpolling, hardly a secure foundation for the sort of scientific ethics promised by Richards at the outset. (shrink)

As a result of the increase in genetic testing and the fear of discrimination by insurance companies, employers, and society as a result of genetic testing, the disciplines of ethics, public health, and genetics have converged. Whether relatives of someone with a positive predictive genetic test should be notified of the results and risks is a matter urgently in need of debate. Such a debate must encompass the moral and ethical obligations of the diagnosing physician and the patient. The decision (...) to inform or not will vary depending on what moral theory is used. Utilising the utilitarian and libertarian theories produces different outcomes. The principles of justice and non-maleficence will also play an important role in the decision. (shrink)

The papers collected in the present volume arose from a 2009 seminar organized by the Society of Legal Scholars and the University of Birmingham, and convened at the Law Society’s Hall in Bristol, England. The seminar, “Judges and Jurists: Reflections on the House of Lords,” commemorated the centenary of the Society; and it chiefly focused on the transition from the House of Lords, as the U.K.’s court of final appeals, to the prospects of the newly instituted United Kingdom Supreme Court. (...) “The aim of the volume,” according to the book-jacket description, “is to reflect upon the jurisprudence of the House of Lords and to consider the prospects for judging in the new Supreme Court.” Given the aims of the Society of Legal Scholars, considerable focus is placed on the relationship between the work of judges and that of scholars of law and jurisprudence. The book pervasively highlights the continuing voice of the scholars. Though their writings have no legal authority, the volume’s editor remarks in his Introduction that in 2009, “in six out of the seven final decisions of the House, reference was made to academic literature” (p. 2). (shrink)