This article explores two questions: (1) whether portable MRI research might escape regulatory oversight altogether under existing U.S. privacy and research ethical frameworks, leaving research participants without adequate protections, and (2) whether existing regulatory frameworks, when they do apply, can guard society’s broader interest in ensuring that portable MRI research pursues socially beneficial, ethically sound aims that minimize the potential for externalities affecting nonparticipating individuals and groups, who might be stigmatized or otherwise harmed even (...) if they decline participation in the research. (shrink)

Highly portable and accessible MRI technology will allow researchers to conduct field-based MRI research in community settings. Previous guidance for researchers working with fixed MRI does not address the novel ethical, legal, and societal issues (ELSI) of portable MRI (pMRI). Our interdisciplinary Working Group (WG) previously identified 15 core ELSI challenges associated with pMRI research and recommended solutions. In this article, we distill those detailed recommendations into a Portable MRI Research ELSI Checklist that offers (...) practical operational guidance for researchers contemplating using this technology. (shrink)

Portable MRI (pMRI) technology, which promises to transform brain imaging research by facilitating scanning in new geographic areas and the participation of new, diverse populations, raises many ethical, legal, and societal issues (ELSI). To understand this emerging pMRI ELSI landscape, we surveyed expert stakeholder views on ELSI challenges and solutions associated with pMRI research.

Portable MRI for neuroimaging research in remote field settings can reach populations previously excluded from research, including communities underrepresented in current brain neuroscience databases and marginalized in health care. However, research conducted far from a medical institution and potentially in populations facing barriers to health care access raises the question of how to manage incidental findings (IFs) that may warrant clinical workup. Researchers should not withhold information about IFs from historically excluded and underserved population when members (...) consent to receive it, and instead should facilitate access to information and a pathway to clinical care. (shrink)

The paucity of existing baseline data for understanding neurologic health and the effects of injury on people from Indigenous populations is causally related to the limited representation of communities in neuroimaging research to date. In this paper, we explore ways to change this trend in the context of portable MRI, where portability has opened up imaging to communities that have been neglected or inaccessible in the past. We discuss pathways to engage local leadership, foster the participation of communities (...) for this unprecedented opportunity, and empower field-based researchers to bring the holistic worldview embraced by Indigenous communities to neuroimaging research. (shrink)

People of low socioeconomic status (SES) are often underrepresented in biomedical research. The importance of demographically diverse research samples is widely recognized, especially given socioeconomic disparities in health, but have been challenging to achieve. One barrier to research participation by low SES individuals is their distance from research centers and the difficulty of traveling. This article examines the promise of portable magnetic resonance imaging (pMRI) for enrolling participants of diverse SES in structural neuroimaging studies, and (...) anticipates some of the challenges, practical and ethical, that may arise in the course of such research. (shrink)

The introduction of portable MRI (pMRI) has the potential to directly impact dementia research and ultimately clinical care. In this paper, we explore two ethical challenges facing the introduction of pMRI in dementia research. The first is the need to ensure that pMRI enhances rather than undermines efforts aimed at improving ethnoracial representation in dementia research. The second is the need to implement pMRI in dementia research in a dementia-friendly way that attends to the social (...) context and lived experience of people with dementia. (shrink)

The emergence of innovative neuroimaging technologies, particularly highly portable magnetic resonance imaging (pMRI), has the potential to spawn a transformative era in neuroscience research. Resourced academic institutional review boards (IRBs) with experience overseeing traditional MRI have a special role to play in ethical governance of pMRI research and should facilitate the collaborative development of nuanced and culturally sensitive guidelines and educational resources for pMRI protocols. This paper explores the ethical challenges of pMRI in neuroscience research and (...) the dynamic leadership role that IRBs should play to promote ethical oversight of emerging pMRI research. (shrink)

In order to illuminate the potential harms of MRI research, we present data obtained by examining MRI research proposal files that had been submitted for review to several Canadian Research Ethics Boards. The data reveal that REB review of the studies contained omissions, considerable variability, and sometimes confusion regarding MRI research risks and risk classification. If our findings reflect the general state of REB review of MRI research in Canada and elsewhere, there is a pressing (...) need for REBs to be educated about MRI risks in order to responsibly facilitate the disclosure of these research risks in consent forms and during the consent process. Developing a standard template consent form that discloses MRI research risks might be a way to ensure attention to and disclosure of risks. (shrink)

In this paper, we first briefly describe neuroimaging technology, our reasons for studying magnetic resonance imaging (MRI) technology, and then provide a discussion of what we have identified as priority issues for paediatric MRI research. We examine the issues of respectful involvement of children in the consent process as well as privacy and confidentiality for this group of MRI research participants. In addition, we explore the implications of unexpected findings for paediatric MRI research participants. Finally, we explore (...) the ethical issues concerning advances in functional MRI. This paper aims to provide a clear description of priority paediatric MRI research ethics issues to make some preliminary recommendations regarding next steps. (shrink)

Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identify four ethical issues. After describing each issue, we propose potential solutions which would make a patient’s participation in research compatible with her rights and interests. First, we defend (...) the need for traditional proxy consent against two alternative approaches. Second, we examine the impact of the intensive care unit environment on the informed consent process. Third, we discuss the therapeutic misconception and its potential influence on informed consent. Finally, we deal with issues of timing in recruiting participants and related factors which may affect the risks of participation. (shrink)

How far does a researcher’s responsibility extend when an incidental finding is identified? Balancing pertinent ethical principles such as beneficence, respect for persons, and duty to rescue is not always straightforward, particularly in neuroimaging research where empirical data that might help guide decision making are lacking. We conducted a systematic survey of perceptions and preferences of 396 investigators, research participants, and Institutional Review Board members at our institution. Using the partial entrustment model as described by Richardson, we argue (...) that our data supports universal reading by a neuroradiologist of all research MRI scans for incidental findings and providing full disclosure to all participants. (shrink)

The question of how to handle incidental findings has sparked a heated debate among neuroimaging researchers and medical ethicists, a debate whose urgency stems largely from the recent explosion in the number of imaging studies being conducted and in the sheer volume of scans being acquired. Perhaps the point of greatest controversy within this debate is whether the magnetic resonance imaging scans of all research participants should be reviewed in an active search for pathology and, moreover, whether this search (...) should be performed by a radiologist. Resistance to routine readings performed by radiologists, as opposed to selective review of those scans on which investigators have spotted a possible IF, has been fueled in part by the obvious and enormous cost — financial and logistical — of engaging radiologists to read massive numbers of scans. This cost would be especially burdensome, even prohibitive, to investigators who are not affiliated with a medical center, because of their limited access to radiologists and other medical expertise. (shrink)

BackgroundResearch ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review) are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards.MethodsWe examined approved consent forms for Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) studies approved by Canadian research ethics boards (REBs).ResultsWe found evidence of variability in consent forms in matters of physical and (...) psychological risk reporting. Approaches used to tackle the emerging issue of incidental findings exposed extensive variability between and within research sites.ConclusionThe causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions. (shrink)

This study aims to disclose how the magnetic resonance imaging neuroimaging approach has been applied in education studies, and what kind of learning themes has been investigated in the reviewed MRI neuroimaging research. Based on the keywords “brain or neuroimaging or neuroscience” and “MRI or diffusion tensor imaging or white matter or gray matter or resting-state,” a total of 25 papers were selected from the subject areas “Educational Psychology” and “Education and Educational Research” from the Web of Science (...) and Scopus from 2000 to 2019. Content analysis showed that MRI neuroimaging and learning were studied under the following three major topics and nine subtopics: cognitive function, science education, and brain development. As for the type of MRI neuroimaging research, the most frequently used approaches were functional MRI, followed by structural MRI and DTI, although the choice of approach was often motivated by the specific research question. Research development trends show that the neural plasticity theme has become more prominent recently. This study concludes that in educational research, the MRI neuroimaging approach provides objective and empirical evidence to connect learning processes, outcomes, and brain mechanisms. (shrink)

This article describes research pursued by members of the McDonnell Collaborative on Causal Learning. A number of members independently converged on a similar idea: one of the central functions served by claims of actual causation is to highlight patterns of dependence that are highly portable into novel contexts. I describe in detail how this idea emerged in my own work and also in that of the psychologist Tania Lombrozo. In addition, I use the occasion to reflect on the (...) nature of interdisciplinary collaboration in general and on the interaction between philosophy and psychology in particular. (shrink)

Magnetic resonance imaging is a noninvasive imaging tool that utilizes a strong magnetic field and radio frequency waves to visualize in great detail organs, soft tissue, and bone. Unlike conventional x-rays, there is no exposure to ionizing radiation and at most field strengths the procedure is considered safe for nearly every age group. Because it is non-invasive and possesses excellent spatial resolution, the use of MRI as a research tool has increased exponentially over the past decade. Uses have ranged (...) from add-ons to a clinical study to studies of brain development in typically developing children. In addition, a major effort has been made in recent years to use MRI to study brain function. Because the clinical utility of fMRI has not yet been realized, fMRI is still considered highly exploratory, and we cannot yet identify incidental findings of a functional nature. (shrink)

Magnetic resonance imaging (MRI) is an imaging technique with a rapidly expanding application range. This methodology, which relies on quantum physics and substance magnetic properties, is now being routinely used in the clinics and medical research. With the advent of measuring functional brain activity with MRI (functional MRI), this methodology has reached a larger section of the neuroscience community (e.g. psychologists, neurobiologists). In the past, the use of MRI as a biomarker or as an assay to probe tissue pathophysiological (...) condition was limited. However, with the new applications of MRI: molecular imaging, contrast‐enhanced imaging and diffusion imaging, MRI is turning into a powerful tool for in vivo characterization of tissue pathophysiology. This review focuses on the diffusion MRI. Although it only measures the averaged Brownian translational motion of water molecules, using different analysis schemes, one can extract a wide range of quantitative indices that represent tissue morphology and compartmentalization. Statistical and visualization routines help to relate these indices to biologically relevant measures such as cell density, water content and size distribution. The aim of this review is to shed light on the potential of this methodology to be used in biological research. To that end, this review is intended for the non‐MRI specialists who wish to pursue biological research with this methodology. We will overview the current applications of diffusion MRI and its relation to cellular biology of brain tissue. BioEssays 30:1235–1245, 2008. © 2008 Wiley Periodicals, Inc. (shrink)

For the past three decades, notebooks and note?taking practices have elicited growing interest in various fields of research: anthropology, media and literature studies, history of the book, history of science. In this renewal, however, scientific travelers? notes have not received all the attention they deserve. To be sure, historians of discovery and exploration are used to considering travel diaries and field notes as a principal resource, on the basis of which they can assess a traveler?s accomplishment or document his (...) itinerary. From a different perspective, field journals offer rich material to literary scholars, critics, and specialists of travel writing. Notebooks of well?known travelers like Bougainville or Humboldt are thus scrutinized in their poetic and aesthetic dimensions, from the perspective of the genesis of travel writing. Still, few studies have taken up the task, a rather mundane and down?to?earth endeavor, to look at travel notebooks for their own sake, as material objects, made of paper and cardboard, and meant to store observational data and to insure their availability through time and space. The paper sets out to do just that: to take a set of manuscript notebooks written by eighteenth? and early nineteenth?century French, German, and Swiss naturalist travelers and scientists on the move together with the techniques at work in their writing, as the focus of a historical investigation. (shrink)

Background: There is limited research on brain lesions in children with cerebral visual impairment of heterogeneous etiologies and according to associated subtyping and vision dysfunctions. This study was part of a larger project establishing data-driven subtypes of childhood CVI according to visual dysfunctions. Currently there is no consensus in relation to assessment, diagnosis and classification of CVI and more information about brain lesions may be of potential diagnostic value.Aim: This study aimed to investigate overall patterns of brain lesions and (...) associations with level of visual dysfunction and to compare the patterns between the classification subgroups in children with CVI.Methods: School-aged children with CVI received ophthalmological and neuro-psychological/developmental assessments to establish CVI-related subtyping. Other pediatric information was collected from medical records. MRI scans were coded according to a semi-quantitative template including brain regions and summed for total scores. Non-parametric analyses were conducted.Results: 28 children had clinical brain MRI scans available [44% of total sample, Group A n = 16, Group B n = 12]. Total brain scores ranged between 0 and 18 and were widespread across regions. 71 per cent had post-geniculate visual pathway damage. The median total brain and hemisphere scores of Group B were higher than subgroup A but differences did not reach statistical significance. No statistically significant associations were found between brain scores and vision variables.Conclusion: This study found a spread of lesions across all regions on the brain scans in children with congenital CVI. The majority had damage in the postgeniculate visual pathways and visual cortex region suggesting this is an area of interest and potentially informative for diagnosis. However the subtyping classification did not show differences in number or region of lesions though the trend was higher toward Group B. This study confirms the complex diffuse and variable nature of brain lesions in children with congenital CVI, many of whom have other neurological impairments. (shrink)

The understanding of locomotion in neurological disorders requires technologies for quantitative gait analysis. Numerous modalities are available today to objectively capture spatiotemporal gait and postural control features. Nevertheless, many obstacles prevent the application of these technologies to their full potential in neurological research and especially clinical practice. These include the required expert knowledge, time for data collection, and missing standards for data analysis and reporting. Here, we provide a technological review of wearable and vision-based portable motion analysis tools (...) that emerged in the last decade with recent applications in neurological disorders such as Parkinson's disease and Multiple Sclerosis. The goal is to enable the reader to understand the available technologies with their individual strengths and limitations in order to make an informed decision for own investigations and clinical applications. We foresee that ongoing developments toward user-friendly automated devices will allow for closed-loop applications, long-term monitoring, and telemedical consulting in real-life environments. (shrink)

Current clinical research lacks diversity in those that participate. This lack of diversity is concerning given its importance for successful drug development. The frequency and severity of many diseases, along with the pharmacological properties of therapies, can display significant differences based on patient diversity. A clinical trial population that is more reflective of these differences will help researchers better understand the therapeutic profile of the treatment and provide generalizable knowledge to the medical community. The advent of decentralized clinical trial (...) designs is meant to help address this lack of diversity by using portable digital health technologies and virtual interactions to enhance clinical trial access and broaden participation. By leveraging these technologies, trial conduct can occur at locations other than traditional research sites. This shift in trial location may help address some of the logistical, educational, engagement, and trust barriers that have historically prevented enrollment of diverse populations. However, these types of trials still have limitations. Ethical concerns around justice, equity, and diversity will still exist with decentralized clinical trials, which could be mediated using clinical research vehicles. When utilized, this modality may enhance the scientific design and conduct of clinical trials and better follow these ethical principles. These enhancements and improved ethical direction could be accomplished through increasing community involvement, improving health literacy, supporting more diverse trial sites, creating community‐based research footholds, fostering connections with researchers, limiting technical challenges, and preventing data security issues. (shrink)

Since its development about 15 years ago, functional magnetic resonance imaging (fMRI) has become the leading research tool for mapping brain activity. The technique works by detecting the levels of oxygen in the blood, point by point, throughout the brain. In other words, it relies on a surrogate signal, resulting from changes in oxygenation, blood volume and flow, and does not directly measure neural activity. Although a relationship between changes in brain activity and blood flow has long been speculated, (...) indirectly examined and suggested and surely anticipated and expected, the neural basis of the fMRI signal was only recently demonstrated directly in experiments using combined imaging and intracortical recordings. In the present paper, we discuss the results obtained from such combined experiments. We also discuss our current knowledge of the extracellularly measured signals of the neural processes that they represent and of the structural and functional neurovascular coupling, which links such processes with the hemodynamic changes that offer the surrogate signal that we use to map brain activity. We conclude by considering applications of invasive MRI, including injections of paramagnetic tracers for the study of connectivity in the living animal and simultaneous imaging and electrical microstimulation. D 2004 Elsevier Inc. All rights reserved. (shrink)

While an accurate assessment of risk is always important, it is especially so in pediatric research. Recognizing the pivotal nature of the minimal-risk standard, we set out to determine under what circumstances pediatric magnetic resonance imaging research does or does not meet this standard. We found that while the physical and psychological risks that attend the MRI procedure do not exceed minimal risk, the sedation and contrast enhancement that are sometimes associated with MRI research do, as both (...) exceed the level of risk encountered by typical, healthy children in their everyday experiences. (shrink)

Vast archives of fragmentary structural brain scans that are routinely acquired in medical clinics for diagnostic purposes have so far been considered to be unusable for neuroscientific research. Yet, recent studies have proposed that by deploying machine learning algorithms to fill in the missing anatomy, clinical scans could, in future, be used by researchers to gain new insights into various brain disorders. This chapter focuses on a study published in2019, whose authors developed a novel unsupervised machine learning algorithm for (...) synthesising missing anatomy in extremely sparse clinical MRI scans of thousands of stroke patients. By approaching the study from a media-theoretical perspective, I analyse how its authors dis-cursively negotiated the anatomical and operative plausibility of the unobserved anatomy that their black-boxed algorithm reconstructed from the existing sparse data. My analysis fore-grounds the processual, relational, context-dependent, and essentially unstable character of the thus established plausibility of the algorithmically synthesised neuroanatomy. (shrink)

This paper examines the use of tablet personal computers and how they interfere with Nigerian undergraduates reading culture and love for educational books. The study adopts a descriptive research design. The University of Ilorin undergraduates constitute the population for this study while 200 level students of three faculties across the university constitute the target population. Stratified sampling technique was used to sample the needed respondents. A researchers’ designed questionnaire was use for data collection. The collected data was analysed using (...) descriptive statistics. The findings revealed that access to tablet computer influence the undergraduate reading culture. Also, 55.7% of 200 level undergraduates read more electronic materials on their tablet computer than printed texts. Based on the findings of this study, it is recommended that students should be encouraged to visit the library and read textbooks since there is certain fundamental knowledge that might not be accessible on the net. (shrink)

Background and ObjectivesFocal cortical dysplasia is a type of malformations of cortical development and one of the leading causes of drug-resistant epilepsy. Postoperative results improve the diagnosis of lesions on structural MRIs. Advances in quantitative algorithms have increased the identification of FCD lesions. However, due to significant differences in size, shape, and location of the lesion in different patients and a big deal of time for the objective diagnosis of lesion as well as the dependence of individual interpretation, sensitive approaches (...) are required to address the challenge of lesion diagnosis. In this research, a FCD computer-aided diagnostic system to improve existing methods is presented.MethodsMagnetic resonance imaging data were collected from 58 participants. Morphological and intensity-based features were calculated for each cortical surface and inserted into an artificial neural network. Statistical examinations evaluated classifier efficiency.ResultsNeural network evaluation metrics—sensitivity, specificity, and accuracy—were 96.7, 100, and 98.6%, respectively. Furthermore, the accuracy of the classifier for the detection of the lobe and hemisphere of the brain, where the FCD lesion is located, was 84.2 and 77.3%, respectively.ConclusionAnalyzing surface-based features by automated machine learning can give a quantitative and objective diagnosis of FCD lesions in presurgical assessment and improve postsurgical outcomes. (shrink)

Electroencephalography provides a non-invasive means to advancing our understanding of the development and function of the brain. However, the majority of the world’s population residing in low and middle income countries has historically been limited from contributing to, and thereby benefiting from, such neurophysiological research, due to lack of scalable validated methods of EEG data collection. In this study, we establish a standard operating protocol to collect approximately 3 min each of eyes-open and eyes-closed resting-state EEG data using a (...) low-cost portable EEG device in rural households through formative work in the community. We then evaluate the acceptability of these EEG assessments to young children and feasibility of administering them through non-specialist workers. Finally, we describe properties of the EEG recordings obtained using this novel approach to EEG data collection. The formative phase was conducted with 9 families which informed protocols for consenting, child engagement strategies and data collection. The protocol was then implemented on 1265 families. 977 children and 1199 adults provided resting-state data for this study. 259 children refused to wear the EEG cap or removed it, and 58 children refused the eyes-closed recording session. Hardware or software issues were experienced during 30 and 25 recordings in eyes-open and eyes-closed conditions respectively. Disturbances during the recording sessions were rare and included participants moving their heads, touching the EEG headset with their hands, opening their eyes within the eyes-closed recording session, and presence of loud sounds in the testing environment. Similar to findings in laboratory-based studies from high-income settings, the percentage of recordings which showed an alpha peak was higher in eyes-closed than eyes-open condition, with the peak occurring most frequently in electrodes at O1 and O2 positions, and the mean frequency of the alpha peak was found to be lower in children as compared to adults. We observed a deterioration in the EEG signal with prolonged device usage. This study demonstrates the acceptability, feasibility and utility of conducting EEG research at scale in a rural low-resource community, while highlighting its potential limitations, and offers the impetus needed to further refine the methods and devices and validate such scalable methods to overcome existing research inequity. (shrink)

Experience-dependent neural plasticity is high in the developing brain, presenting a unique window of opportunity for training. To optimize existing training programs and develop new interventions, it is important to understand what processes take place in the developing brain during training. Here, we systematically review MRI-based evidence of training-induced neural plasticity in children and adolescents. A total of 71 articles were included in the review. Significant changes in brain activation, structure, microstructure, and structural and functional connectivity were reported with different (...) types of trainings in the majority of the studies. Significant correlation of performance improvement with neural changes was reported in 51% of the studies. Yet, only 48% of the studies had a control condition. Overall, the review supports the hypothesized neural changes with training while at the same time charting empirical and methodological desiderata for future research. (shrink)

A brain tumor is an abnormal mass or growth of a cell that leads to certain death, and this is still a challenging task in clinical practice. Early and correct diagnosis of this type of cancer is very important for the treatment process. For this reason, this study aimed to develop computer-aided systems for the diagnosis of brain tumors. In this research, we proposed three different end-to-end deep learning approaches for analyzing effects of local and deep features for brain (...) MRI images anomaly detection. The first proposed system is Directional Bit-Planes Deep Autoencoder which extracts and learns local and direction features. The DBP-DAE by decomposition of a local binary pattern into eight bit-planes extracts are directional and inherent local-structure features from the input image and learns robust feature for classification purposes. The second one is a Dilated Separable Residual Convolutional Network which extracts high and low-level features. The main advantage of this approach is that it is robust and shows stable results regardless to size of image database and to solve overfitting problems. To explore the effects of mixture of local and deep extracted feature on accuracy of classification of brain anomaly, a multibranch convolutional neural network approach is proposed. This approach is designed according to combination of DBP-DAE and DSRCN in an end-to-end manner. Extensive experiments conducted based on brain tumor in MRI image public access databases and achieves significant results compared to state-of-the-art algorithms. In addition, we discussed the effectiveness and applicability of CNNs with a variety of different features and architectures for brain abnormalities such as Alzheimer’s. (shrink)

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act Privacy Rule and the Federal Policy for Protection of Human Subjects. Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In (...) addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations. (shrink)

Computer users are often the last line of defense in computer security. However, with repeated exposures to system messages and computer security warnings, neural and behavioral responses show evidence of habituation. Habituation has been demonstrated at a neural level as repetition suppression where responses are attenuated with subsequent repetitions. In the brain, repetition suppression to visual stimuli has been demonstrated in multiple cortical areas, including the occipital lobe and medial temporal lobe. Prior research into the repetition suppression effect has (...) generally focused on a single repetition and has not examined the pattern of signal suppression with repeated exposures. We used complex, everyday stimuli, in the form of images of computer programs or security warning messages, to examine the repetition suppression effect across repeated exposures. The use of computer warnings as stimuli also allowed us to examine the activation of learned fearful stimuli. We observed widespread linear decreases in activation with repeated exposures, suggesting that repetition suppression continues after the first repetition. Further, we found greater activation for warning messages compared to neutral images in the anterior insula, pre-supplemental motor area, and inferior frontal gyrus, suggesting differential processing of security warning messages. However, the repetition suppression effect was similar in these regions for both warning messages and neutral images. Additionally, we observed an increase of activation in the default mode network with repeated exposures, suggestive of increased mind wandering with continuing habituation. (shrink)

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects. As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act, however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the (...) rules diverge. In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards. In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research. (shrink)

Background: The vascular depression hypothesis emphasizes the significance of vascular lesions in late-life depression. At present, no meta-analytic model has investigated whether a difference in hyperintensity burden compared to controls between late-life and late-onset depression is evident. By including a substantial number of studies, focusing on a meaningful outcome measure, and considering several moderating and control variables, the present meta-analysis investigates the severity of hyperintensity burden in major depressive disorder (MDD) and bipolar disorder (BD). A major focus of the present (...) meta-analysis refers to the role of age at illness onset. It is analyzed whether late-onset rather than late-life depression characterizes vascular depression. Method: In total, 68 studies were included in the meta-analysis and a multilevel random effects model was calculated using Hedges’ g as the effect size measure. Results: The severity of hyperintensity burden was significantly greater in the patient group compared to the control group. This effect was evident regarding the whole patient group (g = 0.229) as well as both depression subgroups, with a significantly greater effect in BD (g = 0.374) compared to MDD (g = 0.189). Hyperintensity burden was more pronounced in late-onset depression than in early-onset depression or late-life depression. A considerable heterogeneity between the included studies was observed, which is reflected by the large variability in effects sizes. Conclusion: In conclusion, the present meta-analysis underscores the association of hyperintensities with MDD and BD. Especially late-onset depression is associated with an increased hyperintensity burden, which is in line with the vascular depression hypothesis. The results suggest that it might be more feasible to confine the concept of vascular depression specifically to late-onset depression as opposed to late-life depression. Further research is needed to understand the causal mechanisms that might underlie the relation between hyperintensity burden and depression. (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)

As automobile manufacturers have begun to design, engineer, and test autonomous driving systems of the future, brain imaging with functional near-infrared spectroscopy can provide unique insights about cognitive processes associated with evolving levels of autonomy implemented in the automobile. Modern fNIRS devices provide a portable, relatively affordable, and robust form of functional neuroimaging that allows researchers to investigate brain function in real-world environments. The trend toward “naturalistic neuroscience” is evident in the growing number of studies that leverage the methodological (...) flexibility of fNIRS, and in doing so, significantly expand the scope of cognitive function that is accessible to observation via functional brain imaging. While more than a decade’s worth of study in this field of fNIRS driving research has led to many interesting findings, the number of studies applying fNIRS during autonomous modes of operation is limited. To support future research that directly addresses this lack in autonomous driving research with fNIRS, we argue that a cogent distillation of the methods used to date will help facilitate and streamline this research of tomorrow. To that end, here we provide a methodological review of the existing fNIRS driving research, with the overarching goal of highlighting the current diversity in methodological approaches. We argue that standardization of these approaches will facilitate greater overlap of methods by researchers from all disciplines, which will, in-turn, allow for meta-analysis of future results. We conclude by providing recommendations for advancing the use of such fNIRS technology in furthering understanding the adoption of safe autonomous vehicle technology. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.3 (2002) 299-303 [Access article in PDF] Bioethics Inside the Beltway What Should IRBs Consider When Applying the Privacy Rule to Research? Julie Waltz Gerlach In 1996, Congress mandated the establishment of standards for the privacy of individually identifiable health information through the Health Insurance and Portability and Accountability Act of 1996 (HIPAA). Until the establishment of HIPAA, personal health information could be (...) distributed without notice or consent for reasons that had nothing to do with a patient's medical treatment or health care reimbursement. Patient information held by a health plan could be passed on to a lender who then might deny the patient's application for a home mortgage or a credit card or to an employer who might use it for personnel decisions. Congress failed to meet its 21 August 1996 deadline established by HIPAA to pass privacy legislation; the Act passed the responsibility to Department of Health and Human Services (DHHS). On 28 December 2000, the Secretary of Health and Human Services released final privacy regulations relating to the protection of patients' individually identifiable health information. The "Standards for Privacy of Individually Identifiable Health Information" (Privacy Rule/current) took effect 14 April 2001. As required by HIPAA, the Privacy Rule established conditions for the collection, use, and disclosure of protected health information by covered entities for research purposes. Covered entities, defined as health plans, health care clearinghouses, and health care providers that engage electronically in a wide range of financial and administrative transactions related to payment and reimbursement, must comply by 14 April 2003 (DHHS 2000, p. 82462). To ensure that the provisions of the final rule provide strong privacy protection without hindering access to health care, the Department of Health and Human Services (DHHS 2002, p. 14776) has proposed modifications to the Privacy Rule.The final Privacy Rule (DHHS 2001) grants substantial rights to individuals/research participants to be informed of how their protected health information is maintained and how that information may be used or disclosed. It also defines individual's/research participants' rights with regard to gaining access to information about themselves, when such information is held by covered entities. [End Page 299]The Privacy Rule requires researchers either to receive authorization from individuals/research participants to collect, use, and disclose protected health information, or to obtain a waiver of authorization that is approved by an institutional review board (IRB) or Privacy Board, or to use de-identified data. Section 164.508 of the Privacy Rule, entitled "Use and Disclosures for Which an Authorization Is Required," describes how IRBs will be directly affected. The rule focuses not just on research but on the overall privacy of all identifiable health information. Institutions have the option of adding these required duties to IRBs or establishing "privacy boards." Privacy boards, as defined by the Privacy Rule, are to be composed of members with varying backgrounds and professional competency to review the effect of the research protocol on the individual/research participant's privacy rights. The board must include at least one member who is not affiliated with the covered entity, or any entity conducting or sponsoring the research, and not related to any person who is affiliated with such entities. Board members cannot participate in the review of any research project in which the member has a conflict of interest.The basic concepts and tenets of privacy and confidentiality are well known to IRBs in the United States, which operate under the Common Rule (45 CFR 46) and/or the Food and Drug Administration's (FDA) human subject protection regulations. Both sets of regulations require IRBs to ensure that risks (including privacy risks) are minimized. Under these regulations, IRBs must consider the confidentiality of research data and whether researchers should have access to confidential medical information. IRBs also must review the consent form as a process of communication that will inform research subjects about the research study.One noteworthy aspect of the Privacy Rule is its application to all research regardless of funding source. Currently, research funded by... (shrink)

IntroductionThis study aimed to evaluate, in adults with mild cognitive impairment, the brain atrophy that may distinguish between three AT biomarker-based profiles, and to determine its clinical value.MethodsStructural MRI was employed to evaluate the volume and cortical thickness differences in MCI patients with different AT profiles, namely, A−T−−: normal AD biomarkers; A+T−−: AD pathologic change; and A+T++: prodromal AD. Sensitivity and specificity of these changes were also estimated.ResultsAn initial atrophy in medial temporal lobe areas was found in the A+T−− and (...) A+T++ groups, spreading toward the parietal and frontal regions in A+T++ patients. These structural changes allowed distinguishing AT profiles within the AD continuum; however, the profiles and their pattern of neurodegeneration were unsuccessful to determine the current clinical status.ConclusionsMRI is useful in the determination of the specific brain structural changes of AT profiles along the AD continuum, allowing differentiation between MCI adults with or without pathological AD biomarkers. (shrink)

Current economic conditions have coincided with the implementation of the Health Insurance Portability and Accountability Act and forced public health officials to consider how to ethically incorporate compliance into their already strained budgets, while maintaining the integrity and intent of the legislation.As of April 14, 2003, the HIPAA Privacy Rule provides a new federal floor of protections for personal health information. The Privacy Rule establishes standards for the protection of health information held by many physicians’ offices, health plans, and health (...) care clearinghouses. The Rule protects personal health information by establishing conditions regulating the use and disclosure of individually identifiable health information by these entities, also referred to as covered entities. The Rule does not prevent the daily operations of health care establishments. (shrink)

Forensic science and its influence on policing and the criminal justice system have increased since the beginning of the twentieth century. While the philosophies of the forensic science pioneers remain the pillar of modern practice, rapid advances in technology and the underpinning sciences have seen an explosion in the number of disciplines and tools. Consequently, the way in which we exploit and interpret the remnant of criminal activity are adapting to this changing environment. In order to best exploit the trace, (...) an interdisciplinary approach to both research and investigation is required. In this paper, nine postdoctoral research fellows from a multidisciplinary team discuss their vision for the future of forensic science at the crime scene, in the laboratory and beyond. This paper does not pretend to be exhaustive of all fields of forensic science, but describes a portion of the postdoctoral fellows’ interests and skills. (shrink)

After severe brain injury, one of the key challenges for medical doctors is to determine the patient’s prognosis. Who will do well? Who will not do well? Physicians need to know this, and families need to do this too, to address choices regarding the continuation of life supporting therapies. However, current prognostication methods are insufficient to provide a reliable prognosis. -/- Functional Magnetic Resonance Imaging (MRI) holds considerable promise for improving the accuracy of prognosis in acute brain injury patients. Nonetheless, (...) research on functional MRI in the intensive care unit context is ethically challenging. These studies raise several ethical issues that have not been addressed so far. In this article, Prof. Charles Weijer and his co-workers provide a framework for researchers and ethics committees to design and review these studies in an ethically sound way. (shrink)

With the advancement ofin vivomagnetic resonance imaging (MRI) technique, more detailed information about the human brain at high altitude (HA) has been revealed. The present review aimed to draw a conclusion regarding changes in the human brain in both unacclimatized and acclimatized states in a natural HA environment. Using multiple advanced analysis methods that based on MRI as well as electroencephalography, the modulations of brain gray and white matter morphology and the electrophysiological mechanisms underlying processing of cognitive activity have been (...) explored in certain extent. The visual, motor and insular cortices are brain regions seen to be consistently affected in both HA immigrants and natives. Current findings regarding cortical electrophysiological and blood dynamic signals may be related to cardiovascular and respiratory regulations, and may clarify the mechanisms underlying some behaviors at HA. In general, in the past 10 years, researches on the brain at HA have gone beyond cognitive tests. Due to the sample size is not large enough, the current findings in HA brain are not very reliable, and thus much more researches are needed. Moreover, the histological and genetic bases of brain structures at HA are also needed to be elucidated. (shrink)

Functional MRI of fully awake and unrestrained dog ’volunteers' has been proven an effective tool to understand the neural circuitry and functioning of the canine brain. Although every dog owner would vouch that dogs are perceptive, cognitive, intuitive and capable of positive emotions/empathy, as indeed substantiated by ethological studies for some time, neurological investigations now corroborate this. These studies show that there exists a striking similarity between dogs and humans in the functioning of the caudate nucleus, and dogs experience positive (...) emotions, empathic-like responses and demonstrate human bonding which, some scientists claim, may be at least comparable with human children. There exists an area analogous to the ’voice area' in the canine brain, enabling dogs to comprehend and respond to emotional cues/valence in human voices, and evidence of a region in the temporal cortex of dogs involved in the processing of faces, as also observed in humans and monkeys. We therefore contend that using dogs in invasive and/or harmful research, and toxicity testing, cannot be ethically justifiable. (shrink)

The research described in this paper was designed to identify the factors that influence the importance small-scale farmers place on different marketing channels of short food supply chains. The focus concerns two entirely different types of market that are present in the bigger cities in Hungary: ‘conventional’ markets where there are no restrictions on locality but the farmer-market relationship is based on binding contracts, and newly-emergent farmers’ markets at which only local growers can sell ad hoc, using their own (...) portable facilities. Results are based on a survey that was conducted in 2013 among 156 Hungarian market oriented farmer-vendors at different types of market and confirm that different markets are visited by different types of farmers. Farmers who favour conventional markets are typically less educated, operate on smaller scales and are more committed to their chosen markets via long-term contracts. The preference for farmers’ markets is stronger with farmers who are more open to cooperation, have specific investment plans for developing their farms and among those who are specifically looking to directly interact with their customers to avoid middlemen. The relevance of the findings is highlighted by the ongoing Short Food Supply Chain Thematic Sub-programme in the present European Union financing period; farmers’ profiles in any given marketing channel must be understood if short food supply chains are to be effectively promoted. Different types of small-scale farmers will benefit from different supporting frameworks, interventions, and initiatives. (shrink)