L’encadrement juridique des biobanques populationnelles et leurs obligations au Québec

La mise en banque d’échantillons humains et de données connexes n’est pas une pratique récente. Toutefois, dans les dernières décennies, ce phénomène a pris une ampleur sans précédent avec la création des biobanques populationnelles. Défini comme étant des infrastructures de recherche conçues pour durer plusieurs décennies, ce type de biobanques invite des milliers et, dans certains cas, des centaines de milliers de personnes à y participer en fournissant des échantillons, en se soumettant à des tests physiques et biochimiques, et en répondant à diverses questions sur leur santé et leur environnement sociodémographique. Mais quelles sont les obligations des biobanques et de leurs chercheurs face aux participants? Considérant leur longue durée, quel est l’encadrement juridique de ces biobanques populationnelles au Québec? Ce sont les deux questions que pose ce mémoire. Quant à l’encadrement, nous utilisons trois axes d’analyse : i) les lois, les règlements, la déontologie professionnelle et les normes applicables; ii) la qualification juridique de l’acte de mise en banque d’échantillons et de données; et iii) les obligations découlant de la nature même de l’objet de la relation juridique. Notre analyse révèle que cet encadrement est une mosaïque législative, contractuelle, déontologique et normative qui, malgré ses complexités et ses défis d’accessibilité pour les participants, assure une certaine protection pour ces derniers. Quant aux obligations incombant à la biobanque et à ses chercheurs, elles sont pour la majorité teintées par des caractéristiques particulières aux biobanques populationnelles. Ainsi, il existe des défis particuliers en ce qui concerne notamment le consentement, le devoir d’information, le retour de résultats et la sécurité des échantillons et des données. Étant donné la nature évolutive de ces obligations, nous proposons une approche basée sur le meilleur intérêt du participant pour déterminer la nature et l’intensité des obligations incombant à une biobanque et à ses chercheurs.

Nurse-led trials of medical devices: General principles and good practice

Aim To provide an overview of key governance matters relating to medical device trials and practical advice for nurses wishing to initiate or lead them. Background Medical device trials, which are formal research studies that examine the benefits and risks of therapeutic, non-drug treatment medical devices, have traditionally been the purview of physicians and scientists. The role of nurses in medical device trials historically has been as data collectors or co-ordinators rather than as principal investigators. Nurses more recently play an increasing role in initiating and leading medical device trials. Review Methods A review article of nurse-led trials of medical devices. Discussion Central to the quality and safety of all clinical trials is adherence to the International Conference on Harmonization Guidelines for Good Clinical Practice, which is the internationally-agreed standard for the ethically- and scientifically-sound design, conduct and monitoring of a medical device trial, as well as the analysis, reporting and verification of the data derived from that trial. Key considerations include the class of the medical device, type of medical device trial, regulatory status of the device, implementation of standard operating procedures, obligations of the trial sponsor, indemnity of relevant parties, scrutiny of the trial conduct, trial registration, and reporting and publication of the results. Conclusion Nurse-led trials of medical devices are demanding but rewarding research enterprises. As nursing practice and research increasingly embrace technical interventions, it is vital that nurse researchers contemplating such trials understand and implement the principles of Good Clinical Practice to protect both study participants and the research team.

Semantic judgement of medical concepts : combining syntagmatic and paradigmatic information with the tensor encoding model

This paper outlines a novel approach for modelling semantic relationships within medical documents. Medical terminologies contain a rich source of semantic information critical to a number of techniques in medical informatics, including medical information retrieval. Recent research suggests that corpus-driven approaches are effective at automatically capturing semantic similarities between medical concepts, thus making them an attractive option for accessing semantic information. Most previous corpus-driven methods only considered syntagmatic associations. In this paper, we adapt a recent approach that explicitly models both syntagmatic and paradigmatic associations. We show that the implicit similarity between certain medical concepts can only be modelled using paradigmatic associations. In addition, the inclusion of both types of associations overcomes the sensitivity to the training corpus experienced by previous approaches, making our method both more effective and more robust. This finding may have implications for researchers in the area of medical information retrieval.

On the time spent preparing grant proposals : an observational study of Australian researchers

Objective: To estimate the time spent by the researchers for preparing grant proposals, and to examine whether spending more time increase the chances of success. Design: Observational study. Setting: The National Health and Medical Research Council (NHMRC) of Australia. Participants: Researchers who submitted one or more NHMRC Project Grant proposals in March 2012. Main outcome measures: Total researcher time spent preparing proposals; funding success as predicted by the time spent. Results: The NHMRC received 3727 proposals of which 3570 were reviewed and 731 (21%) were funded. Among our 285 participants who submitted 632 proposals, 21% were successful. Preparing a new proposal took an average of 38 working days of researcher time and a resubmitted proposal took 28 working days, an overall average of 34 days per proposal. An estimated 550 working years of researchers' time (95% CI 513 to 589) was spent preparing the 3727 proposals, which translates into annual salary costs of AU$66 million. More time spent preparing a proposal did not increase the chances of success for the lead researcher (prevalence ratio (PR) of success for 10 day increase=0.91, 95% credible interval 0.78 to 1.04) or other researchers (PR=0.89, 95% CI 0.67 to 1.17). Conclusions: Considerable time is spent preparing NHMRC Project Grant proposals. As success rates are historically 20–25%, much of this time has no immediate benefit to either the researcher or society, and there are large opportunity costs in lost research output. The application process could be shortened so that only information relevant for peer review, not administration, is collected. This would have little impact on the quality of peer review and the time saved could be reinvested into research.

The life course of Australian researchers : experiences of applying for research funding

The life course of Australian researchers includes regular funding applications, which incur large personal and time costs. We previously estimated that Australian researchers spent 550 years preparing 3,727 proposals for the 2012 NHMRC Project Grant funding round, at an estimated annual salary cost of AU$66 million. Despite the worldwide importance of funding rounds, there is little evidence on what researchers think of the application process. We conducted a web-based survey of Australian researchers (May–July 2013) asking about their experience with NHMRC Project Grants. Almost all researchers (n=224 at 31 May) supported changes to the application (96%) and peer-review (88%) processes; 73% supported the introduction of shorter initial Expressions of Interest; and half (50%) provided extensive comments on the NHMRC processes. Researchers agreed preparing their proposals always took top priority over other work (97%) and personal (87%) commitments. More than half (57%) provided extensive comments on the ongoing personal impact of concurrent grant-writing and holiday seasons on family, children and other relationships. Researchers with experience on Grant Review Panels (34%) or as External Reviewers (78%) reported many sections of the proposals were rarely or never read, which suggests these sections could be cut with no impact on the quality of peer review. Our findings provide evidence on the experience of Australian researchers as applicants. The process of preparing, submitting and reviewing proposals could be streamlined to minimise the burden on applicants and peer reviewers, giving Australian researchers more time to work on actual research and be with their families.

The impact of funding deadlines on personal workloads, stress and family relationships : a qualitative study of Australian researchers

Objective To examine the impact of applying for funding on personal workloads, stress and family relationships. Design Qualitative study of researchers preparing grant proposals. Setting Web-based survey on applying for the annual National Health and Medical Research Council (NHMRC) Project Grant scheme. Participants Australian researchers (n=215). Results Almost all agreed that preparing their proposals always took top priority over other work (97%) and personal (87%) commitments. Almost all researchers agreed that they became stressed by the workload (93%) and restricted their holidays during the grant writing season (88%). Most researchers agreed that they submitted proposals because chance is involved in being successful (75%), due to performance requirements at their institution (60%) and pressure from their colleagues to submit proposals (53%). Almost all researchers supported changes to the current processes to submit proposals (95%) and peer review (90%). Most researchers (59%) provided extensive comments on the impact of writing proposals on their work life and home life. Six major work life themes were: (1) top priority; (2) career development; (3) stress at work; (4) benefits at work; (5) time spent at work and (6) pressure from colleagues. Six major home life themes were: (1) restricting family holidays; (2) time spent on work at home; (3) impact on children; (4) stress at home; (5) impact on family and friends and (6) impact on partner. Additional impacts on the mental health and well-being of researchers were identified. Conclusions The process of preparing grant proposals for a single annual deadline is stressful, time consuming and conflicts with family responsibilities. The timing of the funding cycle could be shifted to minimise applicant burden, give Australian researchers more time to work on actual research and to be with their families.

The impact of a streamlined funding application process on application time: Two cross-sectional surveys of Australian researchers

Objective: To examine if streamlining a medical research funding application process saved time for applicants. Design: Cross-sectional surveys before and after the streamlining. Setting: The National Health and Medical Research Council (NHMRC) of Australia. Participants: Researchers who submitted one or more NHMRC Project Grant applications in 2012 or 2014. Main outcome measures: Average researcher time spent preparing an application and the total time for all applications in working days. Results: The average time per application increased from 34 working days before streamlining (95% CI 33 to 35) to 38 working days after streamlining (95% CI 37 to 39; mean difference 4 days, bootstrap p value <0.001). The estimated total time spent by all researchers on applications after streamlining was 614 working years, a 67-year increase from before streamlining. Conclusions: Streamlined applications were shorter but took longer to prepare on average. Researchers may be allocating a fixed amount of time to preparing funding applications based on their expected return, or may be increasing their time in response to increased competition. Many potentially productive years of researcher time are still being lost to preparing failed applications.

Data Integration Protocol In Ten-steps (DIPIT) : a new standard for medical researchers

The exponential increase in data, computing power and the availability of readily accessible analytical software has allowed organisations around the world to leverage the benefits of integrating multiple heterogeneous data files for enterprise-level planning and decision making. Benefits from effective data integration to the health and medical research community include more trustworthy research, higher service quality, improved personnel efficiency, reduction of redundant tasks, facilitation of auditing and more timely, relevant and specific information. The costs of poor quality processes elevate the risk of erroneous outcomes, an erosion of confidence in the data and the organisations using these data. To date there are no documented set of standards for best practice integration of heterogeneous data files for research purposes. Therefore, the aim of this paper is to describe a set of clear protocol for data file integration (Data Integration Protocol In Ten-steps; DIPIT) translational to any field of research.

e-MIR2: a public online inventory of medical informatics resources

Background. Over the last years, the number of available informatics resources in medicine has grown exponentially. While specific inventories of such resources have already begun to be developed for Bioinformatics (BI), comparable inventories are as yet not available for Medical Informatics (MI) field, so that locating and accessing them currently remains a hard and time-consuming task. Description. We have created a repository of MI resources from the scientific literature, providing free access to its contents through a web-based service. Relevant information describing the resources is automatically extracted from manuscripts published in top-ranked MI journals. We used a pattern matching approach to detect the resources? names and their main features. Detected resources are classified according to three different criteria: functionality, resource type and domain. To facilitate these tasks, we have built three different taxonomies by following a novel approach based on folksonomies and social tagging. We adopted the terminology most frequently used by MI researchers in their publications to create the concepts and hierarchical relationships belonging to the taxonomies. The classification algorithm identifies the categories associated to resources and annotates them accordingly. The database is then populated with this data after manual curation and validation. Conclusions. We have created an online repository of MI resources to assist researchers in locating and accessing the most suitable resources to perform specific tasks. The database contained 282 resources at the time of writing. We are continuing to expand the number of available resources by taking into account further publications as well as suggestions from users and resource developers.

DHEW obligations to medical schools, fiscal years 1967-1969.

This publication was prepared by Richard Giza and Catherine Burns under the direction of Dr. Herbert H. Rosenberg.

Shining the light on the dark side of medical leadership - a qualitative study in Australia

Purpose The paper aims to explore the beliefs of doctors in leadership roles of the concept of "the dark side", using data collected from interviews carried out with 45 doctors in medical leadership roles across Australia. The paper looks at the beliefs from the perspectives of doctors who are already in leadership roles themselves; to identify potential barriers they might have encountered and to arrive at better-informed strategies to engage more doctors in the leadership of the Australian health system. The research question is: "What are the beliefs of medical leaders that form the key themes or dimensions of the negative perception of the 'dark side'?". Design/methodology/approach The paper analysed data from two similar qualitative studies examining medical leadership and engagement in Australia by the same author, in collaboration with other researchers, which used in-depth semi-structured interviews with 45 purposively sampled senior medical leaders in leadership roles across Australia in health services, private and public hospitals, professional associations and health departments. The data were analysed using deductive and inductive approaches through a coding framework based on the interview data and literature review, with all sections of coded data grouped into themes. Findings Medical leaders had four key beliefs about the "dark side" as perceived through the eyes of their own past clinical experience and/or their clinical colleagues. These four beliefs or dimensions of the negative perception colloquially known as "the dark side" are the belief that they lack both managerial and clinical credibility, they have confused identities, they may be in conflict with clinicians, their clinical colleagues lack insight into the complexities of medical leadership and, as a result, doctors are actively discouraged from making the transition from clinical practice to medical leadership roles in the first place. Research limitations/implications This research was conducted within the Western developed-nation setting of Australia and only involved interviews with doctors in medical leadership roles. The findings are therefore limited to the doctors' own perceptions of themselves based on their past experiences and beliefs. Future research involving doctors who have not chosen to transition to leadership roles, or other health practitioners in other settings, may provide a broader perspective. Also, this research was exploratory and descriptive in nature using qualitative methods, and quantitative research can be carried out in the future to extend this research for statistical generalisation. Practical implications The paper includes implications for health organisations, training providers, medical employers and health departments and describes a multi-prong strategy to address this important issue. Originality/value This paper fulfils an identified need to study the concept of "moving to the dark side" as a negative perception of medical leadership and contributes to the evidence in this under-researched area. This paper has used data from two similar studies, combined together for the first time, with new analysis and coding, looking at the concept of the "dark side" to discover new emergent findings.

The criminalisation of medical mistakes in Canada : a review

The issue of health professionals facing criminal charges of manslaughter or criminal negligence causing death or grievous bodily harm as a result of alleged negligence in their professional practice was thrown into stark relief by the recent acquittal of four physicians accused of mismanaging Canada’s blood system in the early 1980s. Stories like these, as well as international reports detailing an increase in the numbers of physicians being charged with (and in some cases convicted of) serious criminal offences as the result of alleged negligence in their professional practice, have resulted in some anxiety about the apparent increase in the incidence of such charges and their appropriateness in the healthcare context. Whilst research has focused on the incidence, nature and appropriateness of criminal charges against health professionals, particularly physicians, for alleged negligence in their professional practice in the United Kingdom, the United States, Japan, and New Zealand, the Canadian context has yet to be examined. This article examines the Canadian context and how the criminal law is used to regulate the negligent acts or omissions of a health care professional in the course of their professional practice. It also assesses the appropriateness of such use. It is important at this point to state that the analysis in this article does not focus on those, fortunately few, cases where a health professional has intentionally killed his or her patients but rather when patients’ deaths or grievous injuries were allegedly as a result of that health professional’s negligent acts or omissions when providing health services to that patient.

Nutritional status and information needs of medical oncology patients receiving treatment at an Australian public hospital

This study aimed to identify: i) the prevalence of malnutrition according to the scored Patient Generated-Subjective Global Assessment (PG-SGA); ii) utilization of available nutrition resources; iii) patient nutrition information needs; and iv) external sources of nutrition information. An observational, cross-sectional study was undertaken at an Australian public hospital on 191 patients receiving oncology services. According to PG-SGA, 49% of patients were malnourished and 46% required improved symptom management and/or nutrition intervention. Commonly reported nutrition-impact symptoms included: peculiar tastes (31%), no appetite (24%) and nausea (24%). External sources of nutrition information were accessed by 37%, with popular choices being media/internet (n=19) and family/friends (n=13). In a sub-sample (n=65), 32 patients were aware of the available nutrition resources, 23 thought the information sufficient and 19 patients had actually read them. Additional information on supplements and modifying side effects was requested by 26 patients. Malnutrition is common in oncology patients receiving treatment at an Australian public hospital and almost half require improved symptom management and/or nutrition intervention. Patients who read the available nutrition information found it useful, however awareness of these nutrition resources and the provision of information on supplementation and managing symptoms requires attention.

The impact of health information technology on the quality of medical and health care : a systematic review

Objective: To systematically review the published evidence of the impact of health information technology (HIT) on the quality of medical and health care specifically clinicians’ adherence to evidence-based guidelines and the corresponding impact this had on patient clinical outcomes. In order to be as inclusive as possible the research examined literature discussing the use of health information technologies and systems in both medical care such as clinical and surgical, and other health care such as allied health and preventive services.----- Design: Systematic review----- Data Sources: Relevant literature was systematically searched on English language studies indexed in MEDLINE and CINAHL(1998 to 2008), Cochrane Library, PubMed, Database of Abstracts of Review of Effectiveness (DARE), Google scholar and other relevant electronic databases. A search for eligible studies (matching the inclusion criteria) was also performed by searching relevant conference proceedings available through internet and electronic databases, as well as using reference lists identified from cited papers.----- Selection criteria: Studies were included in the review if they examined the impact of Electronic Health Record (EHR), Computerised Provider Order-Entry (CPOE), or Decision Support System (DS); and if the primary outcomes of the studies were focused on the level of compliance with evidence-based guidelines among clinicians. Measures could be either changes in clinical processes resulting from a change of the providers’ behaviour or specific patient outcomes that demonstrated the effectiveness of a particular treatment given by providers. ----- Methods: Studies were reviewed and summarised in tabular and text form. Due to heterogeneity between studies, meta-analysis was not performed.----- Results: Out of 17 studies that assessed the impact of health information technology on health care practitioners’ performance, 14 studies revealed a positive improvement in relation to their compliance with evidence-based guidelines. The primary domain of improvement was evident from preventive care and drug ordering studies. Results from the studies that included an assessment for patient outcomes however, were insufficient to detect either clinically or statistically important improvements as only a small proportion of these studies found benefits. For instance, only 3 studies had shown positive improvement, while 5 studies revealed either no change or adverse outcomes.----- Conclusion: Although the number of included studies was relatively small for reaching a conclusive statement about the effectiveness of health information technologies and systems on clinical care, the results demonstrated consistency with other systematic reviews previously undertaken. Widescale use of HIT has been shown to increase clinician’s adherence to guidelines in this review. Therefore, it presents ongoing opportunities to maximise the uptake of research evidence into practice for health care organisations, policy makers and stakeholders.