Adolescence, defined in the US as 11–21 years of age, is a critical period for prevention, as it marks the onset of risk behaviors. Minor (<18 years) self-consent and inclusion in biomedical resear...

Background Structured training in research integrity, research ethics and responsible conduct of research is one strategy to reduce research misconduct and strengthen reliability of and trust in scientific evidence. However, how researchers develop their sense of integrity is not fully understood. We examined the factors and circumstances that shape researchers’ understanding of research integrity. Methods This study draws insights from in-depth, semi-structured interviews with 33 researchers in the life sciences and medicine, representing three seniority levels (...) across five research universities in Switzerland. Results The results of this study indicate that early education, moral values inculcated by the family and participation in team sports were the earliest influences on notions of honesty, integrity and fairness among researchers. Researchers’ personality traits, including degree of ambition and internal moral compass, were perceived as critical in determining the importance they attributed to conducting research with high ethical standards. Positive and negative experiences in early research life also had a significant impact on their views regarding research integrity. Two thirds of the study participants had not received any formal training in research integrity. Their awareness of training opportunities at their institutions was also limited. Conclusion Age-appropriate development of honesty and integrity starts as early as primary education. Research integrity training should be offered from the bachelors level and continue throughout the entire professional life of researchers. Although these courses may not imbue researchers with integrity itself, they are essential to improving the research culture, reinforcing integrity norms, and discouraging researchers who lack personal integrity from engaging in research misconduct. (shrink)

Scientific research is growingly increasingly reliant on "microwork" or "crowdsourcing" provided by digital platforms to collect new data. Digital platforms connect clients and workers, charging a fee for an algorithmically managed workflow based on Terms of Service agreements. Although these platforms offer a way to make a living or complement other sources of income, microworkers lack fundamental labor rights and basic safe working conditions, especially in the Global South. We ask how researchers and research institutions address the ethical (...) issues involved in considering microworkers as "human participants." We argue that current scientific research fails to treat microworkers in the same way as in-person human participants, producing de facto a double morality: one applied to people with rights acknowledged by states and international bodies (e.g., the Helsinki Declaration), the other to guest workers of digital autocracies who have almost no rights at all. We illustrate our argument by drawing on 57 interviews conducted with microworkers in Spanish-speaking countries. (shrink)

This article examines the privacy of personal medical information in the health research context. Arguing that biomedical research in Canada has been caught up in the government's broader neoliberal policy agenda that has positioned biotechnology as a strategic driver of economic growth, the author discusses the tension between informational privacy and the need for medical information for research purposes. Consideration is given to the debate about whether privacy for medical information serves or hinders the “public good” (...) in respect of medical research and to discussions of informed consent as an element of “fair information practices” designed to safeguard the privacy of personal information, including attempts to subvert requirements for informed consent in the medical research context. (shrink)

Social Justice, Health Inequities, and Access to New Age-Related Interventions Content Type Journal Article Category Original Paper Pages 281-295 DOI 10.1007/s12376-009-0027-3 Authors Hans-Jörg Ehni, University of Tuebingen, Tuebingen, Baden-Württemberg Germany Georg Marckmann, University of Tuebingen, Tuebingen, Baden-Württemberg Germany Journal Medicine Studies Online ISSN 1876-4541 Print ISSN 1876-4533 Journal Volume Volume 1 Journal Issue Volume 1, Number 3.

abstractBiomedical research in the United States has contributed enormously to science and human health and is conducted in several thousand institutions that vary widely in their histories, missions, operations, size, and cultures. Though these institutional differences have important consequences for the research they conduct, the organizational taxonomy of US biomedical research has received scant systematic attention. Consequently, many observers and even participants are surprisingly unaware of important distinguishing attributes of these diverse institutions. This essay provides a (...) high-level taxonomy of the institutional ecosystem of US biomedical research; illustrates key features of the ecosystem through portraits of eight institutions of varying age, size, culture, and missions, each representing a much larger class exhibiting additional diversity; and suggests topics for future research into the research output of institutional types that will be required to develop novel approaches to improving the function of the ecosystem. (shrink)

Besides offering opportunities in both clinical and non-clinical domains, the application of novel neuroimaging technologies raises pressing dilemmas. ‘Responsible Research and Innovation’ (RRI) aims to stimulate research and innovation activities that take ethical and social considerations into account from the outset. We previously identified that Dutch neuroscientists interpret “responsible innovation” as educating the public on neuroimaging technologies via the popular press. Their aim is to mitigate (neuro)hype, an aim shared with the wider emerging RRI community. Here, we present (...) results of a media-analysis undertaken to establish whether the body of articles in the Dutch popular press presents balanced conversations on neuroimaging research to the public. We found that reporting was mostly positive and framed in terms of (healthcare) progress. There was rarely a balance between technology opportunities and limitations, and even fewer articles addressed societal or ethical aspects of neuroimaging research. Furthermore, neuroimaging metaphors seem to favour oversimplification. Current reporting is therefore more likely to enable hype than to mitigate it. How can neuroscientists, given their self-ascribed social responsibility, address this conundrum? We make a case for a collective and shared responsibility among neuroscientists, journalists and other stakeholders, including funders, committed to responsible reporting on neuroimaging research. (shrink)

Aging is a topic of growing interest. As life expectancy in western societies is increasing, the growing number and proportion of ‘elderly’ persons raise urgent questions on how to age ‘well’. Predominantly, questions on aging are taken from biomedical and economic paradigms, which are intertwined. While people of age are seen as a cost in society, biomedical research aims at curing the declining effects of aging, thus furthering ideals of ‘healthy’ aging, ‘active’ (...) class='Hi'>aging, or ‘successful’ aging. In this book, Peter Derkx offers a comprehensive account of meaningful aging with Anthony Pinn responding in a fruitful and constructive way, for the benefit and edification of all of us. (shrink)

Research integrity climate is an important factor that influences an individual’s behavior. A strong research integrity culture can lead to better research practices and responsible conduct of research. Therefore, investigations on organizational climate can be a valuable tool to identify the strengths and weaknesses of each group and develop targeted initiatives. This study aims to assess the perceptions on integrity climate in three universities in Hungary. A cross-sectional study was conducted with PhD students, postdocs, and professors (...) from three Hungarian universities. The survey included demographic questions, such as gender, age, scientific field, academic rank, and the Survey of Organizational Research Climate. A total of 432 participants completed the survey. Our results show that postdocs and assistant professors perceived integrity climate more negatively than PhD students and full professors in every survey scale. Contrarily, PhD students perceive more positively than the other groups. Disciplinary differences show that researchers in the Biomedical sciences perceive regulatory bodies to be fairer when evaluating their projects than those in the Natural sciences. Natural sciences also perceive more negatively how the department values integrity when compared to Humanities. Humanities perceive more positively Advisor/Advisee Relations than Biomedical Sciences. Our results suggest that institutions should pay more attention to early career researchers, especially insecure and temporary positions like postdocs and assistant professors. They should provide RCR resources, socialize them in RCR, and set more reasonable expectations. Moreover, department leaders should develop initiatives to foster better integrity climates. (shrink)

Background Biomedical and ethnographic studies among indigenous people are common practice in health and geographical research. Prior health research misconduct has been documented, particularly when obtaining genetic material. The objective of this study was to crossmatch previously published data with the perceptions of the Waorani peoples about the trading of their genetic material and other biological samples. Methods We conducted a mixed methods study design using a tailored 15-item questionnaire in 72 participants and in-depth interviews in 55 (...) participants belonging to 20 Waorani communities about their experiences and perceptions of participating in biomedical research projects. Additionally, we conducted a systematic review of the literature in order to crossmatch the published results of studies stating the approval of an ethics committee and individual consent within their work. Results A total of 40 men and 32 women, with a mean age of 57 ± 15 years agreed to be interviewed for inclusion. Five main categories around the violation of good clinical practices were identified, concerning the obtention of blood samples from a recently contacted Waorani native community within the Amazonian region of Ecuador. These themes are related to the lack of adequate communication between community members and researchers as well as the voluntariness to participate in health research. Additionally, over 40 years, a total of 38 manuscripts related to the use of biological samples in Waorani indigenous people were published. The majority of the studies did not state within their article obtaining research ethics board approval, and 71% did not report obtaining the informed consent of the participants prior to the execution of the project. Conclusion Clinical Research on the Waorani community in the Ecuadorian Amazon basin has been performed on several occasions. Unfortunately, the majority of these projects did not follow the appropriate ethical and professional standards in either reporting the results or fulfilling them. The results of our investigation suggest that biological material, including genetic material, has been used by researchers globally, with some omitting the minimum information required to guarantee transparency and good clinical practices. We highlight the importance of stating ethics within research to avoid breaches in research transparency. (shrink)

Anti-aging medicine has emerged in the past two decades as both a medical practice and scientific objective largely aimed at intervening into the process of aging itself rather than its “associated” diseases. This has provoked a both excitement and concern in bioethical deliberations on the meaning and potential impact of an effective intervention. In this article, I examine the different ways in which bioethicists, other social scientists, and anti-aging proponents frame anti-aging goals, in particular, the construction (...) of immortality as its implicit and explicit aim. This research is based upon over 9 years of anthropological, ethnographic interview- and observation-based research in the field and draws substantially from the US President’s Council on Bioethics’ deliberations on this topic as well as from interview data and other publications/discussion on anti-aging medicine. I argue that while the framework of life and death provide the primary structure for many bioethical and social science critiques of anti-aging medicine, many if not most anti-aging practitioners, researchers, and advocates employ the alternative structure of health and pain to orient their work. These divergent orientations of life/death and health/pain beget competing conversations around anti-aging medicine; including voices from the front lines of anti-aging practice complicate bioethical critiques and ultimately beg different questions. Positioning the painful, physiological decline of aging as the ultimate adversary rather than death challenges traditional models of biomedical intervention based on “nature” and “disease” constructions. (shrink)

A goal of living as well as possible is central to practice and research with young adults living with home mechanical ventilation (HMV). Significant effort has been put into conceptualizing and measuring the quality of life (QOL) as a proxy for living well. Yet, dominant understandings of QOL have been influenced by normative, ableist, and biomedical discourses about what constitutes a good life that, when applied in practice and systems with those living with HMV, can contribute to exclusion (...) and constrain opportunities to live well. Inquiry into what certain understandings of living well can do is critical to opening up possibilities to reimagine living well with HMV. This paper draws on findings from a critical narrative inquiry that explored the experiences of five young adults (ages 18–40 years) living with HMV. Data were co‐constructed virtually through an initial interview and photo‐elicitation using participant‐generated photographs. A critical narrative analysis of participants' stories made visible the ideological effects of ableist, biomedical, and individualist discourses and how the young adults reproduced and resisted these dominant discourses. Their stories further opened up possibilities for nurses and other healthcare providers to see living well and QOL differently. (shrink)

Research into human ageing is a growing field of research with two central foci: geriatric medicine works to reduce the incidence and severity of age-related diseases and disabilities by devising adequate therapeutic and preventive strategies. A second focus, this time in the emerging field of biogerontology, is to bring about a general retardation of the ageing process and by this increase the average and maximum human lifespan. This contribution looks into the second focus, i.e. the possibility of age (...) retardation which, for the time being, is merely hypothetical. After outlining research strategies studying age retardation in animal experiments, it will ask how extending human life by technological interventions might play out on the individual, familial and social level. The central concern here will be autonomy-linked issues, seeing that in debates concerning the ethical implications of age-retarding techniques the argument from autonomy is one of the main arguments in favour of the prolongation of human life. In particular, this contribution will assess whether the argument from autonomy does, in fact, unequivocally support the recourse to age-retarding techniques. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Alzheimer's Disease, Aging, Chance, and RaceAtwood D. Gaines (bio)KeywordsAlzheimer’s disease, chance, mild cognitive impairment, racism, social constructionsThomas Kirkwood's comments are a welcome, articulate detailing of how and why we age with special reference to the brain. As well, his paper indicates clearly that processes reified as pathology and disease, such as Alzheimer's disease (AD), are in fact common and inevitable as the human brain ages. Doubtless, this is (...) the reason that aging is by far the greatest risk factor for the development of AD. A key notion, briefly mentioned by Kirkwood, is that of chance. He points out that, "cells (will be) burdened with protein aggregates and similar materials that will increase with aging. Once again, which cells will experience this fate and which will continue to function healthily is strongly influenced by chance" (Kirkwood 2006, 80–81). This mention of chance is most important for our paper, "Building a Mystery," and for an understanding of science as well. In "Building a Mystery," Peter Whitehouse and I sought to show that the history of AD was not inevitable and demonstrates a variety of chance and singular decisive occurrences of encounters, interpretations, social movements, government initiatives, and technological developments. Such decisive moments do not occur by virtue of some (natural) lawful process that is unfolding, but rather, these are chance events that could have happened in other ways. Indeed, science has been viewed as human attempts to "tame chance" (Hacking 1990). However, it often does so by sleight of hand, misinterpretation, and the biomedical discourse of hope. Increasingly, we are learning that chance is a commonality, not a rarity, in social and biological domains. The biomedical approach assumes the opposite. For example, it seeks to tame the chance appearance of AD in the case of Auguste D, and does so in part by reifying differences that exist, as Kirkwood notes, along a continuum rather than as the discrete entities implied by the labels Alzheimer's disease or mild cognitive impairment (MCI).We thus stand with Kirkwood's bold recognition of chance (see also Kirkwood 2003) in the biological domain and have applied the same idea to the social domain in which we consider the practice of biomedical science. We have elsewhere emphasized consensus statements in the making of AD (Gaines and Whitehouse 1998). In the present article, we add a number of other chance, decisive sociocultural moments to the mix of social processes producing AD and MCI. We have not considered in detail here a host of cultural features in the theory and practice of biomedicine with respect to AD. These include implicit, yet highly [End Page 83] implicative, cultural notions of bilateral kinship employed in genetic research on AD considered elsewhere (Gaines 1998).Bavidge's comments are cogent as well. With respect to the notion of my concept of the local biology of "race" (Gaines 2005), it is germane to point out here that such culturally constructed biologies are relevant to a discussion of AD and other dementias. Such constructions represent culture in science. We used the dramatic example of "race" in US biomedicine because it is experiencing a resurgence as an explanatory tool. For example, recently Haiman et al. (2006) presented research that suggests that "Among cigarette smokers, African Americans and native Hawaiians are more susceptible to lung cancer than whites, Japanese Americans and Latinos." The authors assert, as have many US studies, that their findings show differences relate to the alleged biology of the social groups concerned. Their problem and that of others, is that the groups are social, not biological, and most have mixed ancestry and do not stem from distinct groups. This is particularly true of African Americans and Latinos; both groups are substantially composed of individuals with European, West African, and Native American ancestry in widely varying proportions (Gaines 2005). Thus, they are different only in terms of their classification. Such work regularly overlooks influences, such as environmental racism, discrimination, poverty, and a lack of medical care, as well as other practices. These might include, in a study of smoking, pakalolo smoking (local marijuana) among Hawaiians, who themselves are usually part Portuguese, Japanese, Chinese, and or European... (shrink)

Of the many topics worthy of discussion regarding older adults and bioethics, two seem to provide an especially pointed opportunity for reflection on our aging society. First, is aging itself something that biomedical researchers should focus on as a deficit to be overcome through eventual anti-aging treatments? While aging may not fall neatly into the disease category, it is clearly the primary susceptibility factor for the innumerable diseases of older adults, and therefore its potential deceleration (...) consistent with the compression of morbidity might constitute a salutary biomedical goal. The aging society is no panacea to those who suffer from a host of chronic illnesses and feel overwhelmed by the burden of years. Second, we must concentrate on the most challenging problematic of our current aging society, assuming that anti-aging technologies will only become available in future decades. One immense problem is the harsh reality of irreversible progressive dementia, which will serve here as an example of the rise of chronic illness, for which age itself is the primary risk factor. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Fetal Tissue ResearchMary Carrington Coutts (bio)I. IntroductionThe use of tissue from fetal remains for transplantation and biomedical research has become a controversial issue in recent years, involving scientists, doctors, patients, and the federal government. Fetal tissue is potentially useful in a wide range of treatments for a number of serious diseases, some of them affecting millions of people. Despite the promise, transplantation research using fetal tissue (...) from induced abortion slowed dramatically in the U.S. in 1988, when a moratorium was declared on federal funding for such research involving humans. That moratorium was lifted by President Clinton on January 21, 1993. Though the future of fetal tissue transplantation research is brighter, public debate on the issue is likely to continue, exacerbated by the "acrimonious abortion debate" (VI, Post 1991, p. 14).Using fetal tissue in biomedical research and in transplantation is not a new practice. As early as 1928 unsuccessful attempts were made to transplant fetal pancreas cells into diabetics (VII, Fichera 1928). Fetal tissue was used effectively in biomedical research during the 1950s, and was instrumental in the culture of the polio virus, which led to the development of the polio vaccine. Fetal tissue cultures were also essential in the development of the rubella vaccine, and continue to be used in virology research. Transplantation of fetal thymus cells into patients with DiGeorge Syndrome has been recognized as effective therapy since the late 1960s.Many of the therapeutic applications involving fetal tissue are still experimental, so it is difficult to pinpoint fetal tissue transplantation's therapeutic potential. One promising application is the transplantation of human fetal brain cells into the substantia nigra of patients with Parkinson's disease to restore motor function. Fetal neural transplants have also shown promise for patients suffering from Alzheimer's disease, spinal cord and other neural tissue injuries, and possibly some forms of cortical blindness. Fetal liver cells may be useful for treatment of some kinds of bone marrow disease seen in leukemia and aplastic anemia patients. [End Page 81] Fetal tissue transplantation may also help those suffering from blood clotting disorders, such as sickle cell anemia, thalassemia, and hemophilia. Fetal pancreatic tissue has potential applications in the treatment of diabetes, especially juvenile onset diabetes. Human gene therapy may also employ embryonic and early fetal cells.The Center for Biomedical Ethics at the University of Minnesota reports that more than 1,000 patients have received transplanted fetal tissue worldwide. Countries where fetal tissue transplantation has occurred include: Australia, Canada, China, the Commonwealth of Independent States (formerly the U.S.S.R.), Cuba, Czechoslovakia, Finland, France, Germany, Great Britain, Hungary, India, Italy, Mexico, Norway, Spain, Sweden, and Yugoslavia (IV, Vawter 1992, p. 2; I, Spain 1988; VII, Reinikainen 1989).Fetal tissue has unique characteristics that make it especially valuable in some treatments. Fetal cells develop much faster than adult cells, hastening the therapeutic effect—a potentially significant benefit for gravely ill patients. They are also less likely to be rejected by transplant recipients because they are less antigenic than adult cells. This reduces the need for the exact tissue matches that can be so difficult to obtain. Fetal tissue is also easier to culture and proliferates more readily than comparable adult tissue. Furthermore, fetal tissue is in greater supply, due to the number of elective abortions.Questions about the use of fetuses and fetal tissue in biomedical research were raised in the United States in the early 1970s. Between 1969 and 1973, all 50 states enacted the Uniform Anatomical Gift Act, allowing for the donation of all or part of the body of a dead fetus for research or therapeutic research. Prospects for the use of fetal tissue increased after the Supreme Court decision in Roe v. Wade legalized abortion. As the availability of fetal tissue increased so did the concern over the potential for controversial research on living, soon-to-be-aborted fetuses, and anxiety over maltreatment of dead abortuses. Vivid examples include Geoffrey Chamberlain's 1968 report of an experiment on a fetus of 26 weeks gestational age. Delivered by hysterotomy from a 14-year-old patient, the fetus was attached to an "artificial placenta" and kept alive for more than... (shrink)

Scientists, bioethicists, and policy makers are currently engaged in a contentious debate about the scientific prospects and morality of efforts to increase human longevity. Some demographers and geneticists suggest that there is little reason to think that it will be possible to significantly extend the human lifespan. Other biodemographers and geneticists argue that there might well be increases in both life expectancy and lifespan. Bioethicists and policy makers are currently addressing many of the ethical, social, and economic issues raised by (...) life extension research. However, the emphasis on philosophical argument supporting or condemning efforts to increase human longevity means that much less attention is currently being given to the factors that might play a role in generating interest in efforts to increase human longevity. This analysis considers three factors that might play a role in heightening public interest in efforts to develop biomedical technologies capable of retarding or reversing aging processes. While discussions of life extension research can seem quite futuristic and impractical, there are some powerful existential factors that might well generate considerable public support for life extension strategies if effective biomedical interventions emerge. Rather than providing philosophical justifications supporting or condemning efforts to increase human longevity, this essay seeks to promote a better understanding of the factors generating contemporary interest in prolonging life and postponing death. (shrink)

The experience of the use of applied containerized biomedical software tools in cloud environment is summarized. The reproducibility of scientific computing in relation with modern technologies of scientific calculations is discussed. The main approaches to biomedical data preprocessing and integration in the framework of the intelligent analytical system are described. At the conditions of pandemic, the success of health care system depends significantly on the regular implementation of effective research tools and population monitoring. The earlier the risks (...) of disease can be identified, the more effective process of preventive measures or treatments can be. This publication is about the creation of a prototype for such a tool within the project «Development of methods, algorithms and intelligent analytical system for processing and analysis of heterogeneous clinical and biomedical data to improve the diagnosis of complex diseases», implementted by the V.M. Glushkov Institute of Cybernetics, National Academy of Sciences of Ukraine, together with the United Institute of Informatics Problems, National Academy of Sciences of Belarus. The insurers, entering the market, can insure mostly low risks by facilitating more frequent changes of insurers by consumers and mixing the overall health insurance market. Socio-demographic variables can be risk adjusters. Since age and gender have a relatively small explanatory power, other socio-demographic variables were studied – marital status, retirement status, disability status, educational level, income level. Because insurers have an interest in beneficial diagnoses for their policyholders, they are also interested in the ability to interpret relevant information – upcoding: insurers can encourage their policyholders to consult with doctors more often to select as many diagnoses as possible. Many countries and health care systems use diagnostic information to determine the reimbursement to a service provider, revealing the necessary data. For processing and analysis of these data, software implementations of construction for classifiers, allocation of informative features, processing of heterogeneous medical and biological variables for carrying out scientific research in the field of clinical medicine are developed. The experience of the use of applied containerized biomedical software tools in cloud environment is summarized. The reproducibility of scientific computing in relation with modern technologies of scientific calculations is discussed. Particularly, attention is paid to containerization of biomedical applications, this permits to get reproducibility of the conditions in which the calculations took place, technologies of software pipelining of calculations, that allows to organize flow calculations, and technologies for parameterization of software environment, that allows to reproduce, if necessary, an identical computing environment. The main approaches to biomedical data preprocessing and integration in the framework of the intelligent analytical system are described. The experience of using the developed linear classifier, gained during its testing on artificial and real data, allows us to conclude about several advantages provided by the containerized form of the created application: it permits to provide access to real data located in cloud environment; it is possible to perform calculations to solve research problems on cloud resources both with the help of developed tools and with the help of cloud services; such a form of research organization makes numerical experiments reproducible, i.e. any other researcher can compare the results of their developments on specific data that have already been studied by others, in order to verify the conclusions and technical feasibility of new results; there exists a universal opportunity to use the developed tools on technical devices of various classes from a personal computer to powerful cluster. (shrink)

Background: A fair distribution of healthcare services for older patients is an important challenge, but qualitative research exploring clinicians’ consideration in daily clinical prioritisation in healthcare services for the aged is scarce.Objectives: To explore what kind of criteria, values, and other relevant considerations are important in clinical prioritisations in healthcare services for older patients.Design: A semi-structured interview-guide was used to interview 45 clinicians working with older patients. The interviews were analysed qualitatively using hermeneutical content analysis and template organising style.Participants: (...) 20 physicians and 25 nurses working in public hospitals and nursing homes in different parts of Norway.Results and interpretations: Important dilemmas relate to under-provision of community care and comprehensive approaches, and over-utilisation of certain specialised services. Overt ageism is generally not reported, but the healthcare services for the aged seem to be inadequate due to more subtle processes, for example, dominating considerations and ideals and operating conditions that do not pay sufficient attention to older patients’ needs and considerations of justice. Clinical prioritisations are described as being dominated by adapting traditional biomedical approaches to the operating conditions. Many of the clinicians indicate that there is a potential for improving end of life decisions and for reducing exaggerated use of life-prolonging treatment and hospitalisations.Conclusion: The interviews in this study indicate that considerations of justice and patients’ perspectives should be given more attention to strike a balance between specialised medical approaches and more general and comprehensive approaches in healthcare services for older patients. (shrink)

The Infectious Disease Ontology (IDO) is a suite of interoperable ontology modules that aims to provide coverage of all aspects of the infectious disease domain, including biomedical research, clinical care, and public health. IDO Core is designed to be a disease and pathogen neutral ontology, covering just those types of entities and relations that are relevant to infectious diseases generally. IDO Core is then extended by a collection of ontology modules focusing on specific diseases and pathogens. In this (...) paper we present applications of IDO Core within various areas of infectious disease research, together with an overview of all IDO extension ontologies and the methodology on the basis of which they are built. We also survey recent developments involving IDO, including the creation of IDO Virus; the Coronaviruses Infectious Disease Ontology (CIDO); and an extension of CIDO focused on COVID-19 (IDO-CovID-19).We also discuss how these ontologies might assist in information-driven efforts to deal with the ongoing COVID-19 pandemic, to accelerate data discovery in the early stages of future pandemics, and to promote reproducibility of infectious disease research. (shrink)

Although there is clearly a need for evidenced‐based behavioral or biomedical prevention or treatment programs for suicide, substance abuse, and sexual health targeted to members of the LGBT population under the age of eighteen, few such programs exist, due in substantial part to limited research knowledge. Ambiguities in regulations that govern human subjects protections and the related inconsistencies in institutional review board (IRB) interpretations of regulatory language are the key reason for the lack of rigorous clinical trial evidence (...) to support treatment choices and prevention approaches to reducing health disparities for this population. Given the socially sensitive nature of suicide, substance abuse, and HIV and STI research in general and LGBT research specifically, in the absence of empirical data to guide their decisions, IRBs must often rely on subjective judgments of minimal risk, which can lead to overestimation of the magnitude and probability of psychological, social, and informational harms that might arise from LGBT youth participation in clinical trials. In addition, more than other youth, LGBT adolescents whose families are unaware of their sexual orientation or gender identity or whose families have victimized them on account of it may be reluctant to participate in studies that require guardian permission. This, in turn, intensifies problems of recruitment and unbiased sampling. However, many IRBs are reluctant to apply federal regulations permitting waiver of guardian permission under conditions in which such permission is clearly not “feasible” or “reasonable” to require. Consequently, many investigators have excluded LGBT individuals under eighteen years of age in health intervention research proposals because of anticipated or actual difficulties obtaining IRB approval. This situation is in conflict with current ethical discourse focusing on the right of youths to participate in trials that will protect them from receiving developmentally untested, inappropriate, and unsafe treatments. In this article, we describe these barriers and recommendations for providing LGBT youth safe and fair access to health research. (shrink)

Interest among historians, philosophers and sociologists of science in population-based biomedical research has focused on the randomised controlled trial to the detriment of the longitudinal study, the temporally extended, serial observation of individuals residing in the same community. This is perhaps because the longitudinal study is regarded as having played a secondary role in the debates about the validity of populations-based approaches that helped to establish epidemiology as one of the constitutive disciplines of contemporary biomedicine. Drawing on archival (...) data and publications relating to the Baltimore Longitudinal Study of Aging, we argue however that the historical development of the longitudinal study is richer and more significant than has been appreciated. We argue that this history is shaped by the tension between two sets of epistemic practices, devices and norms. On the one side there were those who emphasised randomisation and sampling to evidence claims about, and justify policies with respect to, the aetiology of disease. On the other side there were those who evoked the technical repertoire of physiological research, especially the notion of the ‘model organism’, to argue for a different integration of the individual in modern society. (shrink)

From organ transplants to genetic therapies by way of the manufacture of replacement tissue, regenerative medicine incarnates a biomedical reasoning that is unique to contemporary society. As a re-engineering of the body, regenerative medicine is the most accomplished manifestation of contemporary biopolitics: it concretely announces the emergence of what sociologist Karin Knorr Cetina calls the ‘culture of life’, in which individual existence is symbolically assimilated to biological conditions. This article will examine the symbolic and ethical issues of regenerative medicine, (...) notably regarding representations of the ageing body. In doing so, it will place this new branch of biomedical research back into the context from which it emerged, with the goal of grasping the social and cultural suppositions on which regenerative medicine is based. The growing number of elderly people in Western societies is one such central element. This article therefore intends to demonstrate how regenerative medicine is rooted in the modern biomedical deconstruction of death, which underlies the contemporary technoscientific fantasy of indefinitely extending longevity. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of human (...) subjects (45 CFR 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)

Background: Although fair distribution of healthcare services for older patients is an important challenge, qualitative research exploring clinicians’ considerations in clinical prioritisation within this field is scarce. Objectives: To explore how clinicians understand their professional role in clinical prioritisations in healthcare services for old patients. Design: A semi-structured interview-guide was employed to interview 45 clinicians working with older patients. The interviews were analysed qualitatively using hermeneutical content analysis. Participants: 20 physicians and 25 nurses working in public hospitals and nursing (...) homes in different parts of Norway. Results and interpretations: The clinicians struggle with not being able to attend to the comprehensive needs of older patients, and being unfaithful to professional ideals and expectations. There is a tendency towards lowering the standards and narrowing the role of the clinician. This is done in order to secure the vital needs of the patient, but is at the expense of good practice and holistic role modelling. Increased specialisation, advances and increase in medical interventions, economical incentives, organisational structures, and biomedical paradigms, may all contribute to a narrowing of the clinicians’ role. Conclusion: Distributing healthcare services in a fair way is generally not described as integral to the clinicians’ role in clinical prioritisations. If considerations of justice are not included in clinicians’ role, it is likely that others will shape major parts of their roles and responsibilities in clinical prioritisations. Fair distribution of healthcare services for older patients is possible only if clinicians accept responsibility in these questions. (shrink)

Objective: The objective of the current study was to maximise the amount of information children and adolescents understand about the risks and benefits associated with participation in a biomedical research study.Design: Participants were presented with one of six hypothetical research protocols describing how to fix a fractured thigh using either a “standard” cast or “new” pins procedure. Risks and benefits associated with each of the treatment options were manipulated so that for each one of the six protocols (...) there was either a correct or ambiguous choice.Participants and setting: Two hundred and fifty one children, ages 6–15 , and 237 adults were interviewed while waiting for a clinic appointment at the Hospital for Sick Children.Results: Using standardised procedures and questionnaires, it was determined that most participants, regardless of age group, were able to understand the basic purpose and procedures involved in the research, and most were able to choose the “correct” operation. The younger children, however, showed an overall preference for a cast operation, whereas the older participants were more likely to choose the pins.Conclusions: By creating age appropriate modules of information, children as young as six years can understand potentially difficult and complex concepts such as the risks and benefits associated with participation in biomedical research. It appears, however, that different criteria were used for treatment preference, regardless of associated risks; older participants tended to opt for mobility whereas younger participants stayed with the more familiar cast operation. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of (...) consent and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of (...) consent and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

In recent years, children and young people (CYP) have been increasingly included in patient and public involvement (PPI) in health research and innovation. Such initiatives intend to give a voice to CYP in such matters. Given that it is debated whether PPI in health care fosters the values of participation, public discussion and decision making put forward by deliberative democracy, this article examines three sets of challenges concerning the involvement of CYP by focusing on age biases. After describing some (...) existing initiatives, the paper critically examines why CYP are involved, how the CYP group is constituted and then investigates the moral status of CYP in biomedical settings. It shows that the rationale for involving CYP in PPI is mainly top-down and adult-centric, thereby questioning the authentic participation in decision making. It also suggests that to ensure democratic inclusion, the CYP group should be constituted by considering both age and politics. Lastly, the article indicates that, despite the increasing recognition of child-specific rights, the sociocultural norms and power dynamics in pediatrics undermine their moral status and challenge political equality. These three sets of considerations offer a preliminary theoretical contribution toward improving democratic legitimacy and representation of CYP in health research and innovation. (shrink)

In many regions around the world, those at highest risk for acquiring HIV are young adults and adolescents. Young men who have sex with men in the USA are the group at greatest risk for HIV acquisition, particularly if they are part of a racial or ethnic minority group.1 Adolescent girls and young women have the highest incidence rates of any demographic subgroup in sub-Saharan Africa.2 To reverse the global AIDS pandemic’s toll on these high-risk groups, it is important to (...) deploy the most effective HIV prevention tools to young MSM in the USA, to adolescent girls and young women in sub-Saharan Africa, and to any other adolescents and young adults at high risk for HIV as products are proven to be safe and efficacious. Although prevention interventions with proven efficacy, such as oral pre-exposure prophylaxis, are available,3–8 they have not been sufficient to stem the tide and an expanded prevention toolkit is urgently needed to serve these populations. The field of HIV prevention continues to identify promising leads in the development of new biomedical prevention products, either delivering antiviral drug topically or systemically. The dapivirine ring has been shown to provide modest protection and is currently being tested in open label studies while injectable cabotegravir is being tested in a large efficacy trial for preventing HIV acquisition. Advances in the field of HIV prevention mean that scientists and regulators must plan for how they will bring prevention tools to populations at high risk for HIV as they conduct efficacy and effectiveness trials. For instance, safety data from younger age groups can also be used in combination with efficacy data from adult studies, where appropriate, as bridging studies to expand labelling to younger ages. If these …. (shrink)

Xenotransplantation, or the grafting of organs from one species to another, may seem at first a far cry from brain death, but there is rising hope in some quarters of the biomedical community that such transplants may reduce, even obviate, the need to harvest human organs—and hence eliminate the primary reason for needing an unambiguous definition of brain death. As with all research on the frontiers of biomedicine, xenotransplantation raises its own ethical quandaries. One concern that has long (...) occupied ethical thought is the degree to which advances in science and technology should control the boundaries between the human and the nonhuman. Might the dimming of a previously entrenched bright line between species entail negative consequences for concepts, such as human dignity and bodily integrity, that historically anchored the protection of both human and animal subjects in biomedical treatment and research? To date, ethical thinking about xenotransplantation, and about gene editing, has largely been left in the hands of scientists, subject only to loose supervision by institutional review boards and animal welfare committees whose remit may be too narrow to address age‐old moral concerns. (shrink)

While aging research and policy aim to promote ‘health’ at all ages, there remains no convincing explanation of what this ‘health’ is. In this paper, I investigate whether we can find, implicit within the sciences of aging, a way to know what health is and how to measure it, i.e. a theory of health. To answer this, I start from scientific descriptions of aging and its modulators and then try to develop some generalizations about ‘health’ implicit (...) within this research. After discussing some of the core aspects of aging and the ways in which certain models describe spatial and temporal features specific to both aging and healthy phenotypes, I then extract, explicate, and evaluate one potential construct of health in these models. This suggests a theory of health based on the landscape of optimized phenotypic trajectories. I conclude by considering why it matters for more candidate theories to be proposed and evaluated by philosophers and scientists alike. (shrink)

Background: Academic productivity has been studied by scholars all round the world for many years. However, in Vietnam, this topic has scarcely been addressed. This research therefore aims at better understanding the correlations between gender, age, research experience, the leading role of corresponding authors, and the total number of their publications in the specific realm of social sciences and humanities. Methods: The study employed a Scopus dataset with publication profiles of 410 Vietnamese researchers between 2008 and 2017. Results: (...) Men did not differ from women in academic publications (P=0.827). The proficiency of corresponding authors positively correlated with the number of published papers (rs=0.61, P<0.001). Lastly, the age of lead authors strongly correlated with scientific output (rs=0.74, P<0.001 for authors between 40 and 50 years of age). Conclusion: While scientific output correlated with the author ages and number of articles in which they led, it was not correlated with their gender in Vietnamese social science and humanities authors. (shrink)

Department of Political Studies, Queen's University, 99 University Avenue, Kingston, Ontario, Canada, K7L 3N6. Email: farrelly{at}queensu.ca ' + u + '@' + d + ' '//--> Abstract Should we invest more public funding in basic aging research that could lead to medical interventions that permit us to safely and effectively retard human aging? In this paper I make the case for answering in the affirmative. I examine, and critique, what I call the Fairness Objection to making (...) class='Hi'>aging research a greater priority than it currently is. The Fairness Objection presumes that support for aging research is limited to a simplistic utilitarian justification. That is, a mode of justification that is aggregative and permits imposing high costs on a few so that small benefits could be enjoyed by numerous recipients. I develop two arguments to refute the Fairness Objection. The Fairness Objection mischaracterizes the utilitarian argument for retarding human aging. It does so by invoking the fallacious conceptual distinction between "saving lives" and "extending lives", as well as making a number of mistaken assumptions concerning the likely benefits of retarding human aging. Secondly, I argue that the case for tackling aging can be made on contractualist , in addition to utilitarian, grounds. Because the harms of senescence are "morally relevant" to the harms of disease, contractualists can permit aggregation within lives. And thus no one could reasonably reject, I contend, a principle that makes the aspiration to tackle human aging more of a priority than it currently is. CiteULike Connotea Del.icio.us What's this? (shrink)

The United States Department of Defense has, for at least 20 years, held the stated intention to enhance active military personnel (“warfighters”). This intention has become more acute in the face of dropping recruitment, an aging fighting force, and emerging strategic challenges. However, developing and testing enhancements is clouded by the ethically contested status of enhancements, the long history of abuse by military medical researchers, and new legislation in the guise of “health security” that has enabled the Department of (...) Defense to apply medical interventions without appropriate oversight. This paper aims to reconcile existing legal and regulatory frameworks on military biomedical research with ethical concerns about military enhancements. In what follows, we first outline one justification for military enhancements. The authors then briefly address existing definitional issues over what constitutes enhancement before addressing existing research ethics regulations governing military biomedical research. Next, they argue that two common justifications for rapid military innovation in science and technology, including enhancement, fail. These justifications are (a) to satisfy a compelling military need and (b) strategic dominance. The authors then turn to an objection that turns on the idea that we need not have these justifications if warfighters are willing to adopt enhancement, and argue that laissez-faire approaches to enhancement fail in the context of the military due to pressing and historically significant concerns about coercion and exploitation. The paper concludes with what is referred to as the “least-worst” justification: Given the rise of untested enhancements in civilian and military life, we have good reason to validate potential enhancements even if they do not satisfy reasons (a) or (b) above. (shrink)

Designing, building, and experimenting with physical simulation models are central problem‐solving practices in the engineering sciences. Model‐based simulation is an epistemic activity that includes exploration, generation and testing of hypotheses, explanation, and inference. This paper argues that to interpret and understand how these simulation models function in creating knowledge and technologies requires construing problem solving as accomplished by a researcher–artifact system. It draws on and further develops the framework of “distributed cognition” to interpret data collected in ethnographic and cognitive‐historical studies (...) of two biomedical engineering research laboratories, and articulates the notion of distributed model‐based cognition to answer the question posed in the title. (shrink)

What proper role should considerations of risk, particularly to research subjects, play when it comes to conducting research on human enhancement in the military context? We introduce the currently visible military enhancement techniques and the standard discussion of risk for these, in particular what we refer to as the ‘Assumption’, which states that the demands for risk-avoidance are higher for enhancement than for therapy. We challenge the Assumption through the introduction of three categories of enhancements : therapeutic, preventive, (...) and pure enhancements. This demands a revision of the Assumption, alongside which we propose some further general principles bearing on how to balance risks and benefits in the context of military enhancement research. We identify a particular type of therapeutic enhancements as providing a more responsible path to human trials of the relevant interventions than pure enhancement applications. Finally, we discuss some possible objections to our line of thought. While acknowledging their potential insights, we ultimately find them to be unpersuasive, at least provided that our proposal is understood as fully non-coercive towards the candidates for such therapeutic enhancement trials. (shrink)

Background: Genetics research is controversial in Native American communities, and the disposition and ownership of biological specimens are central issues. Within Native communities, there is considerable variety in tribal members’ views. This article reports the results from an ethnographic study conducted with a Native American community in the southwestern United States. The purpose of this study was to examine the relationship (past and present) between the tribe and biomedical/genetics research. Methods: Qualitative interviews were conducted with 53 members (...) of a Native American community. Interviewees were purposively recruited to include an approximately equal number of past research participants and nonparticipants, as well as individuals with and without diabetes. Tribal members were also asked whether they identified as a “traditional person,” an emic category used in the community. Results: Tribal members’ views on specimen disposition were linked with their identification as a traditional or nontraditional person. Individuals identifying as traditional people were more likely to believe that biological specimens should be returned at the end of a study and should not be used after the research participant's death, and that they were the property of the individual who provided them. These perspectives were related to broader concerns about fragmentation of the body-self. Conclusions: Through gaining an understanding of the cultural logic related to specimen disposition, researchers may be able to work more effectively with Native American communities on developing procedures for genetics studies. The process of informed consent and other study procedures can be adapted to be culturally respectful of Native American communities. (shrink)

What proper role should considerations of risk, particularly to research subjects, play when it comes to conducting research on human enhancement in the military context? We introduce the currently visible military enhancement techniques (1) and the standard discussion of risk for these (2), in particular what we refer to as the ‘Assumption’, which states that the demands for risk-avoidance are higher for enhancement than for therapy. We challenge the Assumption through the introduction of three categories of enhancements (3): (...) therapeutic, preventive, and pure enhancements. This demands a revision of the Assumption (4), alongside which we propose some further general principles bearing on how to balance risks and benefits in the context of military enhancement research. We identify a particular type of therapeutic enhancements as providing a more responsible path to human trials of the relevant interventions than pure enhancement applications. Finally, we discuss some possible objections to our line of thought (5). While acknowledging their potential insights, we ultimately find them to be unpersuasive, at least provided that our proposal is understood as fully non-coercive towards the candidates for such therapeutic enhancement trials. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Medicine-Based Values?Åge Wifstad (bio)KeywordsEthics committees, judgment, common moralityToulmin's DiagnosisIn his classical article with the unforgettable title "How medicine saved the life of ethics" (Toulmin 1982), Stephen Toulmin claims that medicine saved ethics by giving the philosophers a positive reality check through medical challenges: (1) Ethics in medicine is a serious topic, not just something to discuss at seminars. If, for example, both A and B need treatment and there (...) are only enough resources for one, the fundamental interests of these two people compete against each other. (2) In clinical medicine, the individual case might demand a different approach than that suggested by theory. Similarly, an ethicist who is confronted by a diversity of medical cases becomes aware of the fact that solutions drawn from ethical theory can be irrelevant in practice. (3) The moral philosopher has often focused on the individual and his or her universal commitments. The fact that ethical dilemmas can have deep roots in practical challenges and must be understood within a certain context has been "forgotten." (4) In clinically relevant ethics, it is important to find solutions that all involved parties find reasonable. This revitalizes central Aristotelian schools of thought on, for example, ethical judgment and situational understanding.Today, there is a common understanding that in both the education of doctors and in the implementation of medical knowledge and technology there needs to be ethical guidelines and control. Toulmin wants us to see that the background for this agreement is multifaceted. It was not just the ethicists who saved the doctors. The doctors helped the ethicists to escape their academic isolation.Ethics CommitteesThe establishment of ethics committees is perhaps the most interesting example of this. Here it is especially clear how ethical judgment establishes a basis for decision making: Each case presented to an ethics committee is special because one cannot reference decisions made in similar cases. At the same time, we are expected to handle similar cases equally. Consideration of the concrete, individual case must be balanced with the principle of similar treatment. Second, as a committee member, one must interpret and respect ethical principles that cannot be easily defined. Every principle must be interpreted and implemented within a specific and concrete context. Third, one must consider the law, but seen isolated, the implications of relevant rules can be difficult to determine. Fourth, the status of principles and rules are open for interpretation. The most important example of this is the Declaration of Helsinki, which was established through cooperation between the worlds' doctors unions. The strength and end result of such a document can be discussed. Fifth, multiple but partly conflicting juridical and ethical considerations can be [End Page 179] relevant at the same time. An example: Decisions about confidentiality can prevent data gathering that is crucial in ensuring that a research project is scientifically acceptable. Two important ethical considerations are then put up against one another. As a sixth and final point, it can be mentioned that the ethics committee is expected to make a qualitative, scientific judgment. But what kind of quality judgment and how detailed it should be is up for discussion.Two Definitions of Ethical JudgmentThe fact that the committee must base their holistic decision on ethical judgment means that the committee, in an important sense of the word, stands freely: It can be difficult to refer to specific ethical rules or laws when making an external review of the committee's decision. Unless the committee has clearly not followed known principles and rules, then the committee is able to confront criticism by replying that the decision is based on holistic considerations, where many views have been taken into account. In this way, the usage of ethical judgment makes sure that the committee has freedom to act. The catch here is that the committee's responsibility becomes even more obvious. One cannot simply say that the decision is made based on rules and principles formulated by others, such as the state. The committee must, as a unit, be able to defend their decision.The complexity of the work of the committee can, however, make it more tempting to think about ethics in... (shrink)

It is widely accepted that translational research practitioners need to acquire special skills and knowledge that will enable them to anticipate, analyze, and manage a range of ethical issues. While there is a small but growing literature that addresses the ethics of translational research, there is a dearth of scholarship regarding how this might apply to engineers. In this paper we examine engineers as key translators and argue that they are well positioned to ask transformative ethical questions. Asking (...) engineers to both broaden and deepen their consideration of ethics in their work, however, requires a shift in the way ethics is often portrayed and perceived in science and engineering communities. Rather than interpreting ethics as a roadblock to the success of translational research, we suggest that engineers should be encouraged to ask questions about the socio-ethical dimensions of their work. This requires expanding the conceptual framework of engineering beyond its traditional focus on “how” and “what” questions to also include “why” and “who” questions to facilitate the gathering of normative, socially-situated information. Empowering engineers to ask “why” and “who” questions should spur the development of technologies and practices that contribute to improving health outcomes. (shrink)

There are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects’ informed consent. Although an extensive literature on both of these aspects exists, virtually nothing has been written about human experimentation for which the objective is not to prevent, cure, or mitigate a disease or condition, but to enhance human capabilities. One exception is a 2004 article by Rebecca Dresser on preimplantation (...) genetic modification — one of the most controversial enhancement technologies — in which she states, “Under existing research ethics principles, it would be unethical for investigators to perform modifications exposing embryos expected to develop into healthy children to significant risk in exchange for a possible physical or mental enhancement.” But Dresser does not explain why such an experiment would be unethical under existing principles, and her conclusion is not self-evident. (shrink)

Intergenerational storytelling (IGS) has recently emerged as an arts- and humanities-focused approach to aging research. Despite growing appeal and applications, however, IGS methods, practices, and foundational concepts remain indistinct. In response to such heterogeneity, our objective was to comprehensively describe the state of IGS in aging research and assess the critical (e.g., conceptual, ethical, and social justice) issues raised by its current practice. Six databases (PsycINFO, MEDLINE, PubMed, Scopus, AgeLine, and Sociological Abstracts) were searched using search (...) terms relating to _age_, _intergenerational_, _story_, and _storytelling_. Peer-reviewed, English-language studies conducted with participants residing in non-clinical settings were included. One thousand one hundred six (1106) studies were initially retrieved; 70 underwent full review, and 26 fulfilled all inclusion criteria. Most studies characterized IGS as a practice involving older adults (> 50 years old) and conventionally-aged postsecondary/college students (17–19 years old). Typical methodologies included oral and, in more recent literature, digital storytelling. Critical issues included inconsistently reported participant data, vast variations in study design and methods, undefined key concepts, including _younger_ vs. _older_ cohorts, _generation_, _storytelling_, and whether IGS comprised an intentional _research method_ or a retrospective _outcome_. While IGS holds promise as an emerging field of arts- and humanities-based aging research, current limitations include a lack of shared data profiles and comparable study designs, limited cross-cultural representation, and insufficiently intersectional analysis of widespread IGS practices. To encourage more robust standards for future study design, data collection, and researcher reflexivity, we propose seven evidence-based recommendations for evolving IGS as a humanities-based approach to research in aging and intergenerational relations. (shrink)

This book offers cutting edge research on the modifications and disruptions of bodily experience in the context of anxiety, depression, trauma, chronic illness, pain, and aging. It presents original contributions in applied phenomenology, biomedical ethics, and the use of medical technologies.

As health care systems have been recast as innovation assets, commercial aims are increasingly prominent within states’ health and medical research policies. Despite this, the reformulation of notions of social and of scientific value and of long-standing relations between science and the state that is occurring in research policies remains comparatively unexamined. Addressing this lacuna, this article investigates the articulation of ‘actually existing neoliberalism' in research policy by examining a major Australian research policy and funding instrument, (...) the Medical Research Future Fund. We identify the MRFF and allied initiatives as a site of state activism: reallocating resources from primary and preventive health care to commercially-oriented biomedical research; privileging commercial objectives in research and casting health as a “flow on effect”; reorganising the publicly funded production of health and medical knowledge; and arrogating for political actors a newly prominent role in research grant assessment and funding allocation. We conclude that rather than the state’s assumption of a more activist role in medical research and innovation straightforwardly serving a ‘public good’, it is a driver of neoliberalisation that erodes commitments to redistributive justice in health care and significantly reconfigures science-state relations in research policy. (shrink)

The 2013 Rostock Symposium on Systems Biology and Bioinformatics in Aging Research was again dedicated to dissecting the aging process using in silico means. A particular focus was on ontologies, as these are a key technology to systematically integrate heterogeneous information about the aging process. Related topics were databases and data integration. Other talks tackled modeling issues and applications, the latter including talks focussed on marker development and cellular stress as well as on diseases, in particular (...) on diseases of kidney and skin. (shrink)