Home About us Contact
|
Home About us Contact | ||
|
|
||
Research Subjects (research + subject)
Selected AbstractsDoes the Emergency Exception from Informed Consent Process Protect Research Subjects?ACADEMIC EMERGENCY MEDICINE, Issue 11 2005Nicole M. Delorio MD Abstract Although subject protection is the cornerstone of medical ethics, when considered in the context of research using emergency exception from informed consent, its success is debatable. The participants of a breakout session at the 2005 Academic Emergency Medicine Consensus Conference discussed the issues surrounding subject protection and advanced the following recommendations. 1) There are no outcome measures that define "protection"; therefore, it is not currently known whether or not subjects are protected under the current rules. 2) Care must be taken to protect not only the individual from harm during research but also to protect society from unregulated research in other countries and an inability to appropriately advance medical knowledge. 3) Some surrogate markers/methods of protection whose efficacies are debatable include data safety monitoring board activity, the community consultation and public notification (CC/PN) process, and institutional review board approval. 4) Minimal-risk studies should be held to different standards of protection than those that involve more significant risk to the subject. 5) A handful of studies have been published regarding community consultation and notification, and the majority are case studies. Those that are specifically designed to discover the most successful methods are hindered by a lack of formal outcomes measures and tend to have negative results. 6) Follow-up data from the CC/PN process should be disclosed to the Food and Drug Administration and incorporated into study designs. 7) Focus groups and/or random-digit dialing have been suggested as promising methods for fulfilling the CC/PN requirements. 8) Studies need to be funded and performed that formally investigate the best means of CC/PN. 9) More funding for this research should be a priority in the emergency medicine and critical care communities. More data regarding terminated studies should be made available to the research community. 10) Quantifiable markers of success for CC/PN must be validated so that research may determine the most successful methods. 11) Data regarding subjects' and family members' experiences with exception from informed consent studies need to be obtained. [source] Mobile Methodologies: Theory, Technology and PracticeGEOGRAPHY COMPASS (ELECTRONIC), Issue 5 2008Jane Ricketts Hein This article reviews developments in ,mobile methodologies', looking at the theory, technologies and practice of mobile methods. We focus specifically on methods where the research subject and researcher are in motion in the ,field', and seek to understand what difference mobile methods can make to research. Drawing on the broader mobilities paradigm, we identify the key tenets of mobile methodologies, and then discuss the role that technologies such as geographical information systems can play in opening up this new approach to research. The article reviews past and present work that has utilised mobile methods, highlighting key opportunities and challenges. We consider current attempts to use geographical information systems to rigorously investigate the effect that walking has on an interview process, and conclude by summarising the potential for mobile methods to inform social scientific research. [source] Coaxial Metal Nano-/Microcables with Isolating Sheath: Synthetic Methodology and Their Application as InterconnectsADVANCED MATERIALS, Issue 17 2010Min-Rui Gao Abstract Synthesis of coaxial nano-/microcables has been an intensive research subject due to their heterogeneous structures, tuneable properties, and important applications in nano-/micrometer-scale electronic and optoelectronic devices. Research on the fabrication of nanocables via solution strategies has made great progress in the past few years. In this Research News article, rapidly emerging new solution strategies such as hydrothermal carbonization (HTC) and synergistic soft,hard templates (SSHTs) are highlighted. Unique and flexible coaxial nano-/microcables synthesized by those methods have obvious advantages such as long-term stability and their electrical transport properties, compared with bare counterparts, suggesting that they are potential candidates as interconnects in the future. [source] Generalization of rank reduction problems with Wedderburn's formulaJOURNAL OF CHEMOMETRICS, Issue 11 2003Joan Ferré Abstract In first- and second-order calibration methods based on spectroscopic data, the calculation of the space spanned by the spectra of the interferences has been an important research subject for, among many other applications, calculating the net analyte signal and obtaining figures of merit. Recently, many different calculation methods have been introduced. We show that the calculation of this space can be interpreted from a unified point of view, namely from the rank-one downdating Wedderburn formula. This formula enables one to better understand the properties of the calculation methods currently available. A number of recently introduced signal-preprocessing methods also fit into the proposed framework. Copyright © 2004 John Wiley & Sons, Ltd. [source] Equity at the Intersection: Public Administration and the Study of GenderPUBLIC ADMINISTRATION REVIEW, Issue 3 2009Domonic A. Bearfield While gender has emerged as an important research subject, the development of a feminist theory has been slow. This paper calls for a commitment to the development of a feminist theory of public administration. As part of this development, the author argues that the field also must embrace research focused on the intersection of multiple identity categories such as race and class. [source] On the regularity of flows with Ladyzhenskaya Shear-dependent viscosity and slip or non-slip boundary conditions,COMMUNICATIONS ON PURE & APPLIED MATHEMATICS, Issue 4 2005H. Beirão da Veiga Navier-Stokes equations with shear dependent viscosity under the classical non-slip boundary condition have been introduced and studied, in the sixties, by O. A. Ladyzhenskaya and, in the case of gradient dependent viscosity, by J.-L. Lions. A particular case is the well known Smagorinsky turbulence model. This is nowadays a central subject of investigation. On the other hand, boundary conditions of slip type seems to be more realistic in some situations, in particular in numerical applications. They are a main research subject. The existence of weak solutions u to the above problems, with slip (or non-slip) type boundary conditions, is well known in many cases. However, regularity up to the boundary still presents many open questions. In what follows we present some regularity results, in the stationary case, for weak solutions to this kind of problems; see Theorems 3.1 and 3.2. The evolution problem is studied in the forthcoming paper [6]; see the remark at the end of the introduction. © 2004 Wiley Periodicals, Inc. [source] BUDDHISM AND NEUROETHICS: THE ETHICS OF PHARMACEUTICAL COGNITIVE ENHANCEMENTDEVELOPING WORLD BIOETHICS, Issue 2 2009ANDREW FENTON ABSTRACT This paper integrates some Buddhist moral values, attitudes and self-cultivation techniques into a discussion of the ethics of cognitive enhancement technologies , in particular, pharmaceutical enhancements. Many Buddhists utilize meditation techniques that are both integral to their practice and are believed to enhance the cognitive and affective states of experienced practitioners. Additionally, Mah,y,na Buddhism's teaching on skillful means permits a liberal use of methods or techniques in Buddhist practice that yield insight into our selfnature or aid in alleviating or eliminating dukha (i.e. dissatisfaction). These features of many, if not most, Buddhist traditions will inform much of the Buddhist assessment of pharmaceutical enhancements offered in this paper. Some Buddhist concerns about the effects and context of the use of pharmaceutical enhancements will be canvassed in the discussion. Also, the author will consider Buddhist views of the possible harms that may befall human and nonhuman research subjects, interference with a recipient's karma, the artificiality of pharmaceutical enhancements, and the possible motivations or intentions of healthy individuals pursuing pharmacological enhancement. Perhaps surprisingly, none of these concerns will adequately ground a reflective Buddhist opposition to the further development and continued use of pharmaceutical enhancements, either in principle or in practice. The author argues that Buddhists, from at least certain traditions , particularly Mah,y,na Buddhist traditions , should advocate the development or use of pharmaceutical enhancements if a consequence of their use is further insight into our self-nature or the reduction or alleviation of dukha. [source] BENEFITS TO RESEARCH SUBJECTS IN INTERNATIONAL TRIALS: DO THEY REDUCE EXPLOITATION OR INCREASE UNDUE INDUCEMENT?DEVELOPING WORLD BIOETHICS, Issue 3 2008ANGELA BALLANTYNE ABSTRACT There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. It proceeds from the premise that there are good grounds for thinking that, at least some, international research sponsors exploit trial participants because they do not provide the research population with a fair share of the benefits of research. This provides a prima facie argument for increasing the benefits for research participants. Concern over undue inducement is a legitimate moral concern; however, if this concern is to prevent research populations from receiving their fair share of benefits from research there must be sufficient evidence that these benefits will unduly influence patients' decision-making regarding trial participation. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. [source] The Accuracy and Completeness of Data Collected by Prospective and Retrospective MethodsACADEMIC EMERGENCY MEDICINE, Issue 9 2005J. Tobias Nagurney MD Abstract Objectives: To describe and test a model that compares the accuracy of data gathered prospectively versus retrospectively among adult emergency department patients admitted with chest pain. Methods: The authors developed a model of information flow from subject to medical record to the clinical study case report form, based on a literature review. To test this model, a bidirectional (prospective and retrospective) study was conducted, enrolling all eligible adult patients who were admitted with a chief complaint of chest pain. The authors interviewed patients in the emergency department to determine their chest pain history and established a prospective database; this was considered the criterion standard. Then, patient medical records were reviewed to determine the accuracy and completeness of the information available through a retrospective medical record review. Results: The model described applies the concepts of reliability and validity to information passed on by the study subject, the clinician, and the medical record abstractor. This study was comprised of 104 subjects, of which 63% were men and the median age was 63 years. Subjects were uncertain of responses for 0,8% of questions and responded differently upon reinterview for subsets of questions 0,30% of the time. The sensitivity of the medical record for risk factors for coronary artery disease was 0.77 to 0.93. Among the 88 subjects (85%) who indicated that their chest pain was substernal or left chest, the medical record described this location in 44%. Timing of the chest pain was the most difficult item to accurately capture from the medical record. Conclusions: Information obtained retrospectively from the abstraction of medical records is measurably less accurate than information obtained prospectively from research subjects. For certain items, more than half of the information is not available. This loss of information is related to the data types included in the study and by the assumptions that a researcher performing a retrospective study makes about implied versus explicitly stated responses. A model of information flow that incorporates the concepts of reliability and validity can be used to measure some of the loss of information that occurs at each step along the way from subject to clinician to medical record abstractor. [source] A review of studies on the electric field and the current induced in a human body exposed to electromagnetic fieldsIEEJ TRANSACTIONS ON ELECTRICAL AND ELECTRONIC ENGINEERING, Issue 2 2006Tadasu Takuma Member Abstract How high an electric field or current is induced inside a human body when exposed to an electromagnetic field has recently attracted much attention. The background for this is twofold; concern about the possible health effects of electromagnetic fields (usually called ,EMF issues'), and their positive application to medical treatment or new research subjects. This paper reviews various aspects related to this topic in terms of the following items: basic formulas for field calculation, effect of electromagnetic fields, calculation methods, an Investigation Committee in the IEEJ, and future research subjects. © 2006 Institute of Electrical Engineers of Japan. Published by John Wiley & Sons, Inc. [source] Irony, critique and ethnomethodology in the study of computer work: irreconcilable tensions?INFORMATION SYSTEMS JOURNAL, Issue 2 2008Teresa Marcon Abstract. To broaden discussion of critique in the field of information systems beyond current approaches, we look outside the core management discourse and examine the critical element in ethnomethodological research on computer-based work environments. Our examination reveals a form of critique that is above all without irony, seeking always to be respectful of the competence of research subjects, and informed by an in-depth understanding of participants' practices. We argue that ethnomethodology is an often unrecognised critical approach that attempts to speak from within a community of practice and deliver critical insights that are responsive to the kinds of practical problems of interest to practitioners. [source] PROD-screen , a screen for prodromal symptoms of psychosisINTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, Issue 2 2003M. Heinimaa Abstract The aim of this study was to describe the PROD-screen, an instrument for screening prodromal symptoms indicating risk for psychotic conversion in the near future. PROD-screen consists of 29 questions assessing performance and symptoms. Clinical construct validity was tested by comparing scores from the unselected general population (GP, n = 64) with those of general psychiatric patients from a community mental health centre (CMHC, n = 107). The concordant validity of PROD-screen for prodromal symptoms of psychosis was assessed in a large epidemiologically mixed sample of research subjects (n = 132) by comparing PROD-screen scores with the prodromal diagnosis made by Structured Interview for Prodromal Symptoms as a gold standard. Using the cut-off point of 2/12 specific symptoms, PROD-screen gave correct classification of prodromal status in 77% of cases, distinguishing prodromal from non-prodromal subjects with reasonable sensitivity (80%) and specificity (75%) in the epidemiologically mixed sample. According to subsample analysis PROD-screen functions well with first-degree relatives of schizophrenic patients and probably also with general population samples, but not with psychiatric outpatients. In conclusion, PROD-screen is a useful tool for screening prodromal symptoms of psychosis and selecting subjects for more extensive research interviews. Copyright © 2003 Whurr Publishers Ltd. [source] Social inclusion in research: reflecting on a research project involving young mothers in careINTERNATIONAL JOURNAL OF SOCIAL WELFARE, Issue 1 2005Lena Dominelli This article considers social inclusion in research by reflecting upon a project involving young mothers in care, which used grounded theory methodology (GTM) to theorise their situations and emphasise their voice, a key issue in inclusion, and yielded mixed outcomes. GTM dealt poorly with inclusivity and was supplemented by a feminist orientation. This also failed young mothers. They were included by sitting on an Advisory Com-mittee, being paid an honorarium and assisting in disseminating results. These efforts were unable to overturn power dynamics that privileged researchers' ownership of the findings, and enabled them to benefit from doing research and their rela-tionship with funders. The attempt to change policies and practices that served clients badly was thwarted by an election that brought in a régime with different goals. The young women authored their own stories and spoke authoritatively of their experiences. However, inclusion was not fully secured in and by the research process. Their positioning as research subjects curtailed their potential in this regard. [source] Robust Methods for the Analysis of Income Distribution, Inequality and PovertyINTERNATIONAL STATISTICAL REVIEW, Issue 3 2000Maria-Pia Victoria-Feser Summary Income distribution embeds a large field of research subjects in economics. It is important to study how incomes are distributed among the members of a population in order for example to determine tax policies for redistribution to decrease inequality, or to implement social policies to reduce poverty. The available data come mostly from surveys (and not censuses as it is often believed) and often subject to long debates about their reliability because the sources of errors are numerous. Moreover the forms in which the data are availabe is not always as one would expect, i.e. complete and continuous (microdata) but one also can only have data in a grouped form (in income classes) and/or truncated data where a portion of the original data has been omitted from the sample or simply not recorded. Because of these data features, it is important to complement classical statistical procedures with robust ones. In tis paper such methods are presented, especially for model selection, model fitting with several types of data, inequality and poverty analysis and ordering tools. The approach is based on the Influence Function (IF) developed by Hampel (1974) and further developed by Hampel, Ronchetti, Rousseeuw & Stahel (1986). It is also shown through the analysis of real UK and Tunisian data, that robust techniques can give another picture of income distribution, inequality or poverty when compared to classical ones. [source] Ethical Considerations for a Child's Participation in ResearchJOURNAL FOR SPECIALISTS IN PEDIATRIC NURSING, Issue 1 2004Sheri Kanner MSN ISSUES AND PURPOSE To analyze ethical considerations for a child's involvement in research. CONCLUSIONS Pediatric research can proceed only when the welfare of children is protected. Although research with children as research subjects constitutes only a small portion of research efforts, its continual growth requires nurses be aware of the rights of pediatric subjects. PRACTICE IMPLICATIONS As nursing research increases in sophistication, the nurse should include an assessment of the informed consent process in the care of the patient, including the child's comprehension, the age and development of the child, and the child's perception of the research. [source] Ethical Issues in HIV Research in Poor CountriesJOURNAL OF NURSING SCHOLARSHIP, Issue 2 2001Gladys Mabunda Purpose: To increase awareness of the potential for conducting unethical research in poor nations in the name of scientific inquiry, and to enumerate ethical questions in HIV/AIDS research. Organizing construct: Principles of ethics and ethical analysis in clinical research. Sources and methods: Review of literature on ethical principles of research in developing nations. Findings: People who participate in clinical trials in poor countries often do so because that may be the only way to gain access to health care. However, access to tested drugs beyond clinical trials is not guaranteed. Participants often do not understand the consequences of being research subjects. Conclusions: Conducting research in poor nations requires recognition of ethical issues and maintenance of ethical standards, regardless of material wealth of the countries. Ethical standards also indicate including people from the target population in decisions relating to designing and conducting clinical trials. [source] Outcomes Important to People With Intellectual DisabilitiesJOURNAL OF POLICY AND PRACTICE IN INTELLECTUAL DISABILITIES, Issue 3 2008Emma Miller Abstract, An emphasis on the outcomes of health and social care services has become increasingly apparent within public policy in the United Kingdom. Alongside this, working in partnership has been a key theme, despite a relatively underdeveloped evidence base. Of central importance, however, must be whether directives toward partnership working are delivering improved outcomes, and in particular, the outcomes that are valued by service users. The authors describe a project that sought to identify the outcomes important to people with intellectual disabilities, and where possible, whether partnerships delivered these outcomes. The research was primarily based on interviews with service users and carers, and involved people with intellectual disabilities as both researchers and research subjects. The project categorized key outcomes in two categories (quality of life and process) and identified ways in which health and social care partnerships can deliver the outcomes service users want. If agencies are to deliver good outcomes to users, as increasingly emphasized in policy, this focus should accurately reflect the outcomes that users themselves define as important. [source] Field and Laboratory Alcohol Detection With 2 Types of Transdermal DevicesALCOHOLISM, Issue 4 2009Paul R. Marques Background:, Two types of transdermal electrochemical sensors that detect alcohol at the skin surface were evaluated. One, the AMS SCRAMÔ device, is locked onto the ankle and is based on a fuel cell sensor; the other, a Giner WrisTASÔ device, worn on the wrist, is based on a proton exchange membrane. SCRAM is used by several court systems in the United States to monitor alcohol offenders, WrisTAS, a research prototype, is not commercially available. Methods:, The 2 devices were worn concurrently by 22 paid research subjects (15 men, 7 women), for a combined total of 96 weeks. Subjects participated in both laboratory-dosed drinking to a target of 0.08 g/dl blood alcohol concentration (BAC), and normal drinking on their own; all subjects were trained to use and carry a portable fuel-cell breath tester for BAC determinations. Overall 271 drinking episodes with BAC , 0.02 g/dl formed the signal for detection,60 from laboratory dosing, and 211 from self-dosed drinking, with BAC ranging from 0.02 to 0.230 g/dl (mean 0.077 g/dl). Results:, False negatives were defined as a transdermal alcohol concentration response equivalent <0.02 g/dl when BAC , 0.02 g/dl. The overall true-positive hit rate detected by WrisTAS was 24%. The low detection rate was due to erratic output and not recording during nearly 67% of all episodes; reportedly a chipset, not a sensor problem. SCRAM correctly detected 57% across all BAC events, with another 22% (total 79%) detected, but as <0.02 g/dl. When subjects dosed themselves to BAC , 0.08 g/dl, SCRAM correctly detected 88% of these events. SCRAM devices lost accuracy over time likely due to water accumulation in the sensor housing. Neither unit had false-positive problems when true BAC was <0.02 g/dl. Conclusions:, Each device had peculiarities that reduced performance, but both types are able to detect alcohol at the skin surface. With product improvements, transdermal sensing may become a valuable way to monitor the alcohol consumption of those who should be abstaining. [source] Communication and Miscommunication in Informed Consent to ResearchMEDICAL ANTHROPOLOGY QUARTERLY, Issue 4 2004PAMELA SANKAR Biomedical ethics require that research subjects be aware that the drugs they take or procedures they undergo are designed to fulfill the conditions of the experiment and not to benefit a subject's health. This apparently straightforward distinction between research and treatment is a source of much controversy and misunderstanding. Ethicists have labeled this problem the "therapeutic misconception." This misconception and, more broadly, informed consent have been studied extensively. Nonetheless, the therapeutic misconception persists among research subjects. This paper argues that one factor overlooked in the persistence of the therapeutic misconception is the effect of the theoretical paradigm that guides the practice and analysis of informed consent. The paradigm poses an idealized model of communication that ignores social context. This paper examines informed consent practices associated with a cancer research trial to demonstrate an alternative approach to studying informed consent to research. Through analysis of informed consent session transcripts, it demonstrates the importance of taking account of not only what is said, but how and by whom it is said. [source] Microsurgical tracheotomy: A pediatric model in growing ratsMICROSURGERY, Issue 5 2003Mônica Cecília Bochetti Manna M.D. Previous studies described controversial opinions about pediatric tracheotomy concerning type of tracheal incision and long-term results, which remain as important research subjects. Experimental studies on rat tracheas are scarce, probably because of technical difficulties related to the structures' small dimensions. As many rat organ and system operative procedures were studied successfully by using microsurgical techniques, we decided to develop a pediatric tracheotomy model in growing rats which would permit long-term studies. Forty-four Wistar EPM-1 growing rats weighing 86 g and aged 35 days were divided into three groups: submitted to longitudinal, transverse, and segment excision of the trachea. Under sterile technique and intramuscular anesthesia (ketamine/xylazine), the trachea was exposed and incised, according to group, and a hand-made endotracheal cannula was inserted into the organ. This cannula was assembled using a segment of 1.5-cm-long 3 French silicone catheter passed through hexagonal-shaped silicone screen. The tracheal cannula was removed after 7 days, when we evaluated body weight, secretions, and dehiscence. In conclusion, this microsurgical tracheotomy model in growing rats is feasible, allowing studies on long-term repercussions of pediatric tracheotomy. © 2003 Wiley-Liss, Inc. MICROSURGERY 23:530,534 2003 [source] An animal model for Epstein,Barr virus (EBV)-associated lymphomagenesis in the human: Malignant lymphoma induction of rabbits by EBV-related herpesvirus from cynomolgusPATHOLOGY INTERNATIONAL, Issue 2 2000Kazuhiko Hayashi It is very important to develop and analyze animal models of Epstein,Barr virus (EBV)-associated tumors in the human. However, only a few reports on the animal models of EBV infection have been reported. Here we review those previous models and describe the details on our newly developed rabbit model of malignant lymphoma induced by EBV-related virus from cynomolgus. In brief, Si-IIA-EBV or Cyno-EBV induced T-cell lymphomas in rabbits inoculated intravenously (77,90%), orally (82,89%), subcutaneously (3/3) and intraperitoneally (2/3) about 2,5 months later. EBV-DNA was detected in peripheral blood by polymerase chain reaction 2 days after oral inoculation of Cyno-EBV while antiviral capsid antigen immunoglobulin G (IgG) was raised 3 weeks after the inoculation. Rabbit lymphomas and their cell lines contained EBV-DNA and expressed EBV-encoded small RNA-1 and EBV-associated nuclear antigen. Rabbit lymphoma cell lines, some of which have specific chromosomal abnormality, showed tumorigenicity in nude mice. The significance and further research subjects of this animal model will be discussed. We believe that the present rabbit model of lymphoma with specific chromosomal abnormalities is very useful for clarifying the role of EBV in human EBV-associated lymphoma and provides a means for studying prophylactic and therapeutic regimens. [source] Towards Desistance: Theoretical Underpinnings for an Empirical StudyTHE HOWARD JOURNAL OF CRIMINAL JUSTICE, Issue 4 2004Anthony Bottoms It is argued that significant crime-free gaps appropriately form part of the subject matter of desistance. An interactive theoretical framework is presented, involving ,programmed potential', ,social context' (structures, culture, situations) and ,agency'. It is argued that agency, while rightly attracting increasing interest within criminology, needs to be used with greater precision. Aspects of the social context of the research subjects' lives are summarised, with special reference to their age-transitional status and the relevance of ,community' in their lives. Since most criminal careers, even of recidivists, are short, the implications of subjects' movement from conformity to criminality and back to conformity require greater thought among criminologists and criminal justice professionals. However, these broad movements contain significant oscillations, and ,crime' is not a unidimensional concept in the lives of the research subjects. Capturing and explaining the complexity of these matters longitudinally is a significant challenge for the research. [source] Ethics Review for Sale?THE MILBANK QUARTERLY, Issue 4 2000Commercial Research Review Boards, Conflict of Interest Research review boards, established to protect the rights and welfare of human research subjects, have to ensure that conflicts of interest do not interfere with the ethical conduct of medical research. Private, commercial review boards, which increasingly review research protocols, are themselves affected by a structural conflict of interest. Within the regulatory setting, procedural conflict-of-interest rules are essential because of the absence of clear substantive rules in research review and the reliance on the fairness and good judgment of institutional review board members. Current guidelines and regulations lack adequate conflict-of-interest rules and provide insufficient details on the substantive rules. Because commercial review boards are similar to administrative courts and tribunals, rules of administrative law on bias are applied to determine when a conflict of interest jeopardizes the purposes of research review; administrative law has always judged financial conflicts of interest severely. The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process. [source] Comparison of ACINUS, caspase-3, and TUNEL as apoptotic markers in determination of tumor growth rates of clinically localized prostate cancer using image analysisTHE PROSTATE, Issue 15 2009Swaroop S. Singh Abstract BACKGROUND The balance between apoptotic and proliferative processes determines the enlargement of a tumor. Accurate measurement of apoptotic and proliferative rates from diagnostic prostate biopsies would allow calculation of tumor growth rates in a population-based prostate cancer (CaP) study. Automated image analysis may be used if proliferation and apoptotic biomarkers provide clearly resolved immunostained images. METHODS Clinical CaP aggressiveness was assigned as low, intermediate or high using clinical criteria for 46 research subjects with newly diagnosed CaP. Diagnostic biopsy sections from the research subjects were dual-labeled for proliferation biomarker, Ki-67 and apoptotic biomarker, apoptotic chromatin condensation inducer in the nucleus (ACINUS). Apoptotic biomarkers, caspase-3 and terminal deoxyribonucleotidyltransferase mediated dUTP-biotin nick end labeling (TUNEL) were labeled separately. Images from immunostained sections were analyzed using automated image analysis and tumor growth rates computed. Association between clinical CaP aggressiveness and tumor growth rates was explored. RESULTS Sixteen subjects had high, 17 had intermediate, and 13 had low clinical CaP aggressiveness. Positive immunostaining was localized to the nucleus for Ki-67, ACINUS, and TUNEL. A statistically significant linear trend across clinical CaP aggressiveness categories was found when tumor growth rates were calculated using ACINUS (P,=,0.046). Logistic regression and ROC plots generated showed ACINUS (AUC,=,0.677, P,=,0.048) and caspase-3 (AUC,=,0.694, P,=,0.038) to be better predictors than TUNEL (AUC,=,0.669, P,=,0.110). CONCLUSIONS ACINUS met the criteria for automated image analysis and for calculation of apoptotic rate. Tumor growth rates determined using automated image analysis should be evaluated for clinical prediction of CaP aggressiveness, treatment response, recurrence, and mortality. Prostate 69: 1603,1610, 2009. © 2009 Wiley-Liss, Inc. [source] Decreased cerebrospinal fluid A,42 correlates with brain atrophy in cognitively normal elderly,ANNALS OF NEUROLOGY, Issue 2 2009Anne M. Fagan PhD Objective For therapies for Alzheimer's disease (AD) to have the greatest impact, it will likely be necessary to treat individuals in the "preclinical" (presymptomatic) stage. Fluid and neuroimaging measures are being explored as possible biomarkers of AD pathology that could aid in identifying individuals in this stage to target them for clinical trials and to direct and monitor therapy. The objective of this study was to determine whether cerebrospinal fluid (CSF) biomarkers for AD suggest the presence of brain damage in the preclinical stage of AD. Methods We investigated the relation between structural neuroimaging measures (whole-brain volume) and levels of CSF amyloid-, (A,)40, A,42, tau, and phosphorylated tau181 (ptau181), and plasma A,40 and A,42 in well-characterized research subjects with very mild and mild dementia of the Alzheimer type (n = 29) and age-matched, cognitively normal control subjects (n = 69). Results Levels of CSF tau and ptau181, but not A,42, correlated inversely with whole-brain volume in very mild and mild dementia of the Alzheimer type, whereas levels of CSF A,42, but not tau or ptau181, were positively correlated with whole-brain volume in nondemented control subjects. Interpretation Reduction in CSF A,42, likely reflecting A, aggregation in the brain, is associated with brain atrophy in the preclinical phase of AD. This suggests that there is toxicity associated with A, aggregation before the onset of clinically detectable disease. Increases in CSF tau (and ptau181) are later events that correlate with further structural damage and occur with clinical onset and progression. Ann Neurol 2009;65:176,183 [source] When Classic Ethnographic Work Is Made Impossible: The Human Politics of Research in IndiaANTHROPOLOGY & HUMANISM, Issue 2 2009Pnina Motzafi-Haller SUMMARY In this personal account, I describe the first days of research I begun in Rajasthan, in India in the winter of 2008. This graphic narrative of my encounters with my research interlocutors includes not only what I learned from my research subjects, a group of multiply marginalized people known as the Banjara. It also depicts my conversations with academic colleagues and assistants, local officials, and translators. It describes the human politics that had, in fact, blocked my ability to carry out classical ethnographic research work that I was so intent on carrying out and offers the readers a look into the scene that is often excluded from ethnographic reports. I propose that these encounters are part and parcel of the learning process in a new setting. I argue that a detailed exploration of my own position in the field,one that exposes the confusion, the ignorance, the struggles, the affection, and the dislike I develop toward a range of people I met in these first days,is necessary for writing in a humanistic way about the process through which we learn what we claim we know. Through this reflexive article, I offer a model for anthropological writing that is intellectually engaging, politically aware, and humane. [source] ON THE MORALITY OF GUINEA-PIG RECRUITMENTBIOETHICS, Issue 6 2010MIKHAIL VALDMAN ABSTRACT Can it be wrong to conduct medical research on human subjects even with their informed consent and even when the transaction between the subjects and researchers is expected to be mutually beneficial? This question is especially pressing today in light of the rise of a semi-professional class of ,guinea pigs', human research subjects that sell researchers a right of access to their bodies in exchange for money. Can these exchanges be morally problematic even when they are consensual and mutually beneficial? I argue that there are two general kinds of concern one can have about such transactions , concerns about the nature of what is sold and concerns about the conditions in which the selling occurs. The former involves worries about degradation and the possible wrongness of selling a right of access to one's body. These worries, I argue, are not very serious. The latter involves worries about coercion, exploitation, and undue influence , about how, by virtue of their ignorance, impulsiveness, or desperation, guinea pigs can be taken advantage of by medical researchers. These worries are quite serious but I argue that, at least in cases where the exchange between guinea pigs and researchers is consensual and mutually beneficial, they do not raise insurmountable moral problems. [source] Managing Change Across Boundaries: Boundary-Shaking Practices1BRITISH JOURNAL OF MANAGEMENT, Issue 4 2005Julia Balogun To date, boundary spanning has primarily been conceived of as an activity relating an organization to its environment, including other organizations with which it cooperates and competes. In contrast, this study focuses on the boundary spanning practices of individuals acting as change agents to implement boundary- shaking change initiatives across intra -organizational boundaries. These boundary-shaking individuals all work for blue-chip organizations in sectors as diverse as pharmaceuticals, consultancy and automotive. The change initiatives are equally diverse, including post-merger integration, exploitation of across-business synergies and implementing more integrative structures. Through our examination of boundary-shakers we are able to extend what we know about internal change agency and change agent skills and practices. Our starting point is that organizations are comprised of networks of people with a degree of common interest. Our research shows our research subjects to be active movers and shakers in these networks, using their knowledge of the organizational political context and the motivations of others to create new networks (or new meanings within old networks), which then enables them to pursue their change objectives. [source] Informed Consent for Research: Current Practices in Academic Emergency MedicineACADEMIC EMERGENCY MEDICINE, Issue 6 2008Edward Monico MD Abstract Background:, The emergency department (ED) environment presents unique barriers to the process of obtaining informed consent for research. Objectives:, The objective was to identify commonalities and differences in informed consent practices for research employed in academic EDs. Methods:, Between July 1, 2006, and June 30, 2007, an online survey was sent to the research directors of 142 academic emergency medicine (EM) residency training programs identified through the Accreditation Council for Graduate Medical Education (ACGME). Results:, Seventy-one (50%) responded. The average number of simultaneous clinical ED-based research projects reported was 7.3 (95% confidence interval [CI] = 5.53 to 9.07). Almost half (49.3%) of respondents reported that EM residents are responsible for obtaining consent. Twenty-nine (41.4%) participating institutions do not require documentation of an individual resident's knowledge of the specific research protocol and consent procedure before he or she is allowed to obtain consent from research subjects. Conclusions:, It is common practice in academic EDs for clinical investigators to rely on on-duty health care personnel to obtain research informed consent from potential research subjects. This practice raises questions regarding the sufficiency of the information received by research subjects, and further study is needed to determine the compliance of this consent process with federal guidelines. [source] U.S. Federal Regulations for Emergency Research: A Practical Guide and CommentaryACADEMIC EMERGENCY MEDICINE, Issue 1 2008Andrew McRae MD Abstract Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems. [source] | ||||||||||||||||||||||