Who's minding the shop?:the role of Canadian research ethics boards in the creation and uses of registries and biobanks

Abstract. Background. The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks. Methods. Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank. Results. There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied. Conclusion. Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.

Human resource management practices in the multinational company: A test of system, societal, and dominance effects

Does the use of HRM practices by multinational companies (MNCs) reflect their national origins or are practices similar regardless of context? To the extent that practices are similar, is there any evidence of global best standards? The authors use the system, societal, and dominance framework to address these questions through analysis of 1,100 MNC subsidiaries in Canada, Ireland, Spain, and the United Kingdom. They argue that this framework offers a richer account than alternatives such as varieties of capitalism. The study moves beyond previous research by differentiating between system effects at the global level and dominance effects arising from the diffusion of practices from a dominant economy. It shows that both effects are present, as are some differences at the societal level. Results suggest that MNCs configure their HRM practices in response to all three forces rather than to some uniform global best practices or to their national institutional contexts.

Due North? Do American Theories of Legislative Committees Apply to Canada?

Several theories of legislative organisation have been proposed to explain committee selection in American legislatures, but do these theories travel outside the United States? This paper tests whether these theories apply to data from the Canadian House of Commons. It was found that the distributive and partisan models of legislative organisation explain committee composition in Canada. In many cases, committees in the House of Commons are made up of preference outliers. As predicted by partisan models, it was also found that the governing party stacks committees with its members, but this is conditional upon the strength of the governing party.

Sharing Power: The Case for Public Consultations in Trade

Since the 1960s, public consultation has emerged as an important democratic tool, allowing governments to inform, debate, and learn from the general public. Since the 1980s, international trade agreements have wielded significant influence over domestic law making, as an ever more ‘comprehensive’ set of topics are regulated via treaty. In Canada, these two trends have yet to meet. Neither public nor Parliament is involved in trade policy making raising concerns about the democratic legitimacy of expansive trade agreements. Through the lens of the recent Canada-EU CETA, this article examines whether trade law’s consultation practices can be aligned with those of other federal government departments. We identify five key values that make consultations successful—diversity, education, commitment, accountability, and transparency—and consider the viability of their inclusion in trade consultations.

Panning for Gold: The Standardizing Work of Filling “Autistic” Shells – Using institutional ethnography to explore textually mediated health relations in the diagnostic process of autism.

Health reform practices in Canada and elsewhere have restructured the purpose and use of diagnostic labels and the processes of naming such labels. Diagnoses are no longer only a means to tell doctors and patients what may be wrong and indicate potential courses of treatment; some diagnoses activate specialized services and supports for persons with a disability and those who provide care for them. In British Columbia, a standardized process of diagnosis with the outcome of an autism spectrum disorder gives access to government provided health care and educational services and supports. Such processes enter individuals into a complex of text mediated relations, regulated by the principles of evidence-based medicine. However, the diagnosis of autism in children is notoriously uncertain. Because of this ambiguity, standardizing the diagnostic process creates a hurdle in gaining help and support for parents who have children with problems that could lead to a diagnosis on the autism spectrum. Such processes and their organizing relations are problematized, explored and explicated below. Grounded in the epistemological and ontological shift offered by Dorothy E. Smith (1987; 1990a; 1999; 2005), this article reports on the findings of an institutional ethnographic study that explored the diagnostic process of autism in British Columbia. More specifically, this article focuses on the processes involved in going from mothers talking from their experience about their childrens problems to the formalized and standardized, and thus “virtually” produced, diagnoses that may or may not give access to services and supports in different systems of care. Two psychologists, a developmental pediatrician, a social worker – members of a specialized multidisciplinary assessment team – and several mothers of children with a diagnosis on the autism spectrum were interviewed. The implications of standardizing the diagnosis process of a disability that is not clear-cut and has funding attached are discussed. This ethnography also provides a glimpse of the implications of current and ongoing reforms in the state-supported health care system in British Columbia, and more generally in Canada, for people’s everyday doings.

Global surveillance of cancer survival 1995–2009: analysis of individual data for 25 676 887 patients from 279 population-based registries in 67 countries (CONCORD-2)

BACKGROUND: Worldwide data for cancer survival are scarce. We aimed to initiate worldwide surveillance of cancer survival by central analysis of population-based registry data, as a metric of the effectiveness of health systems, and to inform global policy on cancer control.

METHODS: Individual tumour records were submitted by 279 population-based cancer registries in 67 countries for 25·7 million adults (age 15-99 years) and 75,000 children (age 0-14 years) diagnosed with cancer during 1995-2009 and followed up to Dec 31, 2009, or later. We looked at cancers of the stomach, colon, rectum, liver, lung, breast (women), cervix, ovary, and prostate in adults, and adult and childhood leukaemia. Standardised quality control procedures were applied; errors were corrected by the registry concerned. We estimated 5-year net survival, adjusted for background mortality in every country or region by age (single year), sex, and calendar year, and by race or ethnic origin in some countries. Estimates were age-standardised with the International Cancer Survival Standard weights.

FINDINGS: 5-year survival from colon, rectal, and breast cancers has increased steadily in most developed countries. For patients diagnosed during 2005-09, survival for colon and rectal cancer reached 60% or more in 22 countries around the world; for breast cancer, 5-year survival rose to 85% or higher in 17 countries worldwide. Liver and lung cancer remain lethal in all nations: for both cancers, 5-year survival is below 20% everywhere in Europe, in the range 15-19% in North America, and as low as 7-9% in Mongolia and Thailand. Striking rises in 5-year survival from prostate cancer have occurred in many countries: survival rose by 10-20% between 1995-99 and 2005-09 in 22 countries in South America, Asia, and Europe, but survival still varies widely around the world, from less than 60% in Bulgaria and Thailand to 95% or more in Brazil, Puerto Rico, and the USA. For cervical cancer, national estimates of 5-year survival range from less than 50% to more than 70%; regional variations are much wider, and improvements between 1995-99 and 2005-09 have generally been slight. For women diagnosed with ovarian cancer in 2005-09, 5-year survival was 40% or higher only in Ecuador, the USA, and 17 countries in Asia and Europe. 5-year survival for stomach cancer in 2005-09 was high (54-58%) in Japan and South Korea, compared with less than 40% in other countries. By contrast, 5-year survival from adult leukaemia in Japan and South Korea (18-23%) is lower than in most other countries. 5-year survival from childhood acute lymphoblastic leukaemia is less than 60% in several countries, but as high as 90% in Canada and four European countries, which suggests major deficiencies in the management of a largely curable disease.

INTERPRETATION: International comparison of survival trends reveals very wide differences that are likely to be attributable to differences in access to early diagnosis and optimum treatment. Continuous worldwide surveillance of cancer survival should become an indispensable source of information for cancer patients and researchers and a stimulus for politicians to improve health policy and health-care systems.

The effectiveness of a nurse practitioner-led pain management team in long-term care: A mixed methods study

BACKGROUND: Considering the high rates of pain as well as its under-management in long-term care (LTC) settings, research is needed to explore innovations in pain management that take into account limited resource realities. It has been suggested that nurse practitioners, working within an inter-professional model, could potentially address the under-management of pain in LTC.

OBJECTIVES: This study evaluated the effectiveness of implementing a nurse practitioner-led, inter-professional pain management team in LTC in improving (a) pain-related resident outcomes; (b) clinical practice behaviours (e.g., documentation of pain assessments, use of non-pharmacological and pharmacological interventions); and, (c) quality of pain medication prescribing practices.

METHODS: A mixed method design was used to evaluate a nurse practitioner-led pain management team, including both a quantitative and qualitative component. Using a controlled before-after study, six LTC homes were allocated to one of three groups: 1) a nurse practitioner-led pain team (full intervention); 2) nurse practitioner but no pain management team (partial intervention); or, 3) no nurse practitioner, no pain management team (control group). In total, 345 LTC residents were recruited to participate in the study; 139 residents for the full intervention group, 108 for the partial intervention group, and 98 residents for the control group. Data was collected in Canada from 2010 to 2012.

RESULTS: Implementing a nurse practitioner-led pain team in LTC significantly reduced residents' pain and improved functional status compared to usual care without access to a nurse practitioner. Positive changes in clinical practice behaviours (e.g., assessing pain, developing care plans related to pain management, documenting effectiveness of pain interventions) occurred over the intervention period for both the nurse practitioner-led pain team and nurse practitioner-only groups; these changes did not occur to the same extent, if at all, in the control group. Qualitative analysis highlighted the perceived benefits of LTC staff about having access to a nurse practitioner and benefits of the pain team, along with barriers to managing pain in LTC.

CONCLUSIONS: The findings from this study showed that implementing a nurse practitioner-led pain team can significantly improve resident pain and functional status as well as clinical practice behaviours of LTC staff. LTC homes should employ a nurse practitioner, ideally located onsite as opposed to an offsite consultative role, to enhance inter-professional collaboration and facilitate more consistent and timely access to pain management.

'Trusting the numbers': mineral prospecting, raising finance and the governance of knowledge

Mineral prospecting and raising finance for ‘junior’ mining firms has historically been regarded as a speculative activity. For the regulators of securities markets upon which ‘junior’ mining companies seek to raise capital, a perennial problem has been handling not only the indeterminacy of scientific claims, but also the social basis of epistemic practices. This paper examines the production of a system of public warrant and associated knowledge practices intended to enable investors to differentiate between ‘destructive’ and ‘productive’ varieties of financial speculation. It traces the use of the notion of ‘disclosure’ in constructing and legitimizing the ‘juniors’ market in Canada. It argues that though the work of ‘economics’ may be necessary in the construction of markets, it is by no means sufficient. Attention must also be given to the ways in which legal models of ‘the free-market’ can be translated and constantly re-worked across the sites and spaces of regulatory practice, animating the geographies of markets.

Immune responses and vaccine-induced immunity against Porcine circovirus type 2

Porcine circovirus type 2 (PCV2) is essential but not sufficient for postweaning multi-systemic wasting syndrome (PMWS) occurrence in pigs. The outcome of PCV2 infection depends on the specific immune responses that are developing during the infection. Diseased pigs are immunosupressed and unable to mount effective immune responses to clear the virus from circulation. In the final stage, PMWS-affected pigs suffer from extensive lymphoid lesions and altered cytokine expression patterns in peripheral blood mononuclear cells (PBMCs) and lymphoid organs. PCV2 infection can also be asymptomatic, demonstrating that not every infection will guarantee the occurrence of severe immunopathological disturbances. Asymptomatic animals have higher virus specific and neutralising antibody titres than PMWS-affected animals. Recent results have pointed out that the mechanisms by which PCV2 can affect the immune responses involve the induction of IL-10, virus accumulation into and modulation of plasmacytoid dendritic cells and the role of viral DNA in regulation of immune cell functions. Fourteen years after the first description of PMWS in Canada, efficient commercial vaccines against PCV2 are available. The vaccine success is based on activated humoral and cellular immune responses against PCV2. This review focuses on the recent research on immunological aspects during PCV2 infections and summarizes what is currently known about the vaccine-induced immunity. (C) 2010 Elsevier B.V. All rights reserved.

'Trusting the numbers': mineral prospecting, raising finance and the governance of knowledge

Mineral prospecting and raising finance for ‘junior’ mining firms has historically been regarded as a speculative activity. For the regulators of securities markets upon which ‘junior’ mining companies seek to raise capital, a perennial problem has been handling not only the indeterminacy of scientific claims, but also the social basis of epistemic practices. This paper examines the production of a system of public warrant and associated knowledge practices intended to enable investors to differentiate between ‘destructive’ and ‘productive’ varieties of financial speculation. It traces the use of the notion of ‘disclosure’ in constructing and legitimizing the ‘juniors’ market in Canada. It argues that though the work of ‘economics’ may be necessary in the construction of markets, it is by no means sufficient. Attention must also be given to the ways in which legal models of ‘the free-market’ can be translated and constantly re-worked across the sites and spaces of regulatory practice, animating the geographies of markets.

'Talk to me': a mixed methods study on preferred physician behaviours during end-of-life communication from the patient perspective

Background
Despite the recognized importance of end-of-life (EOL) communication between patients and physicians, the extent and quality of such communication is lacking.

Objective
We sought to understand patient perspectives on physician behaviours during EOL communication.

Design
In this mixed methods study, we conducted quantitative and qualitative strands and then merged data sets during a mixed methods analysis phase. In the quantitative strand, we used the quality of communication tool (QOC) to measure physician behaviours that predict global rating of satisfaction in EOL communication skills, while in the qualitative strand we conducted semi-structured interviews. During the mixed methods analysis, we compared and contrasted qualitative and quantitative data.

Setting and Participants
Seriously ill inpatients at three tertiary care hospitals in Canada.

Results
We found convergence between qualitative and quantitative strands: patients desire candid information from their physician and a sense of familiarity. The quantitative results (n = 132) suggest a paucity of certain EOL communication behaviours in this seriously ill population with a limited prognosis. The qualitative findings (n = 16) suggest that at times, physicians did not engage in EOL communication despite patient readiness, while sometimes this may represent an appropriate deferral after assessment of a patient's lack of readiness.

Conclusions
Avoidance of certain EOL topics may not always be a failure if it is a result of an assessment of lack of patient readiness. This has implications for future tool development: a measure could be built in to assess whether physician behaviours align with patient readiness.

What counts and what is being counted – The social organization of knowledge on the front lines of emergency medical services.

Paramedics are trained to use specialized medical knowledge and a variety of medical procedures and pharmaceutical interventions to “save patients and prevent further damage” in emergency situations, both as members of “health-care teams” in hospital emergency departments (Swanson, 2005: 96) and on the streets – unstandardized contexts “rife with chaotic, dangerous, and often uncontrollable elements” (Campeau, 2008: 3). The paramedic’s unique skill-set and ability to function in diverse situations have resulted in the occupation becoming ever more important to health care systems (Alberta Health and Wellness, 2008: 12).
Today, prehospital emergency services, while varying, exist in every major city and many rural areas throughout North America (Paramedics Association of Canada, 2008) and other countries around the world (Roudsari et al., 2007). Services in North America, for instance, treat and/or transport 2 million Canadians (over 250,000 in Alberta alone ) and between 25 and 30 million Americans annually (Emergency Medical Services Chiefs of Canada, 2006; National EMS Research Agenda, 2001). In Canada, paramedics make up one of the largest groups of health care professionals, with numbers exceeding 20,000 (Pike and Gibbons, 2008; Paramedics Association of Canada, 2008). However, there is little known about the work practices of paramedics, especially in light of recent changes to how their work is organized, making the profession “rich with unexplored opportunities for research on the full range of paramedic work” (Campeau, 2008: 2).

This presentation reports on findings from an institutional ethnography that explored the work of paramedics and different technologies of knowledge and governance that intersect with and organize their work practices. More specifically, my tentative focus of this presentation is on discussing some of the ruling discourses central to many of the technologies used on the front lines of EMS in Alberta and the consequences of such governance practices for both the front line workers and their patients. In doing so, I will demonstrate how IE can be used to answer Rankin and Campbell’s (2006) call for additional research into “the social organization of information in health care and attention to the (often unintended) ways ‘such textual products may accomplish…ruling purposes but otherwise fail people and, moreover, obscure that failure’ (p. 182)” (cited in McCoy, 2008: 709).