The Canadian agency for the oversight of research involving humans: a reform proposal

In this paper, I propose the creation of a Canadian agency for the oversight of research involving humans. I describe first a series of significant problems with Canada's current system of oversight. I then argue for the creation of a national-level agency, covering all research involving humans, with three branches (policy and standards, education, and compliance). Of particular note, the proposed compliance branch consists of a number of independent national and regional Research Ethics Boards (i.e., REBs no longer reside within institutions). There is also an Audit Committee and a Non-compliance Committee (with supporting staff of auditors and compliance officers) to ensure compliance with the policies and standards set by the Policy and Standards Branch. Finally, I answer a series of "frequently asked questions" about the proposed agency design such as "What about 'local context'?" and "Why not have a system of accreditation of institutional REBs instead?" In sum, radical reform is needed and, in this paper, I present a proposal for such reform.     

The therapeutic misconception: a threat to valid parental consent for pediatric neuroimaging research

Neuroimaging research has brought major advances to child health and wellbeing. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of parents that new medical advances can benefit their child, pediatric neuroimaging research presents significant challenges to the general problem of consent in the context of research involving children. A particular challenge in this domain is created by the presence of therapeutic misconception on the part of parents and other key research stakeholders. This article revierws the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues that this misconception can compromise consent given by parents for the involvement of their children in research as healthy controls or as persons with neurological and developmental conditions. The article further contends that therapeutic misconception can undermine the research ethics review process for proposed and ongoing neuroimaging studies. Against this backdrop, the article concludes with recommendations for mitigating the effects of therapeutic misconception in pediatric neuroimaging research.     

Unfinished business: ongoing ethical exceptionalism in the oversight of human pluripotent stem cell research in Canada

In this article, we critically examine the arguments for and against the exceptional status given human pluripotent stem cell research in Canada (through the latest [December 2010] revision of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans), and conclude that this exceptionalism is unwarranted and ethically unsound. In our view, the three federal research granting agencies should honor their longstanding commitment that researchers, research sponsors, and Research Ethics Boards in Canada have access to "a single reference document for all research involving humans conducted under the auspices of institutions eligible for Agency funding." As well, responsibility for the development, interpretation, and implementation of Canada's research ethics guidelines should be under the authority of a single oversight body that is independent of the federal research granting Agencies.     

The Therapeutic Misconception: A Threat to Valid Parental Consent for Pediatric Neuroimaging Research

Neuroimaging research has brought major advances to child health and well-being. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of parents that new medical advances can benefit their child, pediatric neuroimaging research presents significant challenges to the general problem of consent in the context of research involving children. A particular challenge in this domain is created by the presence of therapeutic misconception on the part of parents and other key research stakeholders. This article reviews the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues that this misconception can compromise consent given by parents for the involvement of their children in research as healthy controls or as persons with neurological and developmental conditions. The article further contends that therapeutic misconception can undermine the research ethics review process for proposed and ongoing neuroimaging studies. Against this backdrop, the article concludes with recommendations for mitigating the effects of therapeutic misconception in pediatric neuroimaging research.     

Providing perinatal loss care: satisfying and dissatisfying aspects for midwives

PURPOSE: There is limited midwifery research that focuses on midwives experiences and attitudes to providing care for women who experience the death of a baby. There is also limited research investigating care components, and evidence to inform the basis of clinical practice in Australia and internationally. This paper presents the qualitative findings of a small study that aimed to investigate midwives experience, confidence and satisfaction with providing care for women who experienced perinatal loss. PROCEDURE: Eighty-three Western Australian midwives responded to an open ended question asking them to describe the most and least satisfying aspects of their role when providing care to women who experienced a perinatal loss. Thematic analysis was used to analyse the data. FINDINGS: The analysis revealed that Australian midwives gained most satisfaction from providing skilled midwifery care that they considered made a difference to women. This was enabled when midwives were afforded the opportunity to provide continuity of midwifery carer to women throughout the labour, birth and early postnatal period. In terms of the least satisfying aspects of care, midwives identified that they struggled with the emotional commitment needed to provide perinatal loss care, as well as with how to communicate openly and share information with women. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Within the context of the study setting, midwifery care for women following perinatal loss reflects the care components espoused in the literature. There are, however, organisational issues within health care that require commitment to continuity of care and further education of practitioners to enhance outcomes for clients.     

Children living with their grandparents: resilience and wellbeing

Downie JM, Hay DA, Horner BJ, Wichmann H, Hislop AL. Children living with their grandparents: resilience and wellbeing
Int J Soc Welfare 2010: 19: 8–22 © 2009 Curtin University of Technology, Journal compilation © 2009 Blackwell Publishing Ltd and the International Journal of Social Welfare. A non‐comparative design and mixed‐methods approach was used to examine the resilience and wellbeing of 20 children in the full‐time care of their grandparents. A self‐report measure of self‐concept and emotional wellbeing, and a semi‐structured interview were used to explore the personal experiences and impact of children living with their grandparents. Scores derived from the self‐report measure indicated that the children's self‐worth and emotional health were within the range expected of children of comparative age and sex. Qualitative data, however, suggested a complex emotional environment and a continuum of responses. Analysis revealed three themes that captured broad issues around Emotional health, Material factors, Current issues and Past experiences and Coping strategies. The results of the study reveal the ongoing concerns associated with the children's family circumstances, as well as the notable adaptation and resilience of the children in managing their life experiences.     

Why Faster,Higher, Stronger isn’t Necessarily Better—The Relations of Paralympian and Women’s Soccer Teams’ Performance to National Well-being

The present study considers how the athletic performance of minority groups relates to national subjective well-being (SWB) and life expectancy. Based on the argument that sports represent a microcosm of society and the reliable finding that national inequality is associated with reduced SWB, we hypothesized that greater opportunities for typically disadvantaged groups within sports should be positively related to national indicators of well-being. Study 1 compared the relation of success in the Paralympics versus the Olympics to national subjective well-being and life expectancy. The results supported our hypothesis. In Study 2 we conceptually replicated these results using the standings of national men’s and women’s soccer teams. Overall, it appears that the opportunities to compete in sports that nations afford to members of disadvantaged groups reflect on the health and well-being of the entire society.

Bad news about bad news: the disclosure of risks to insurability in research consent processes

One of the phenomena associated with research is "incidental findings," that is, unexpected findings made during the research, and outside the scope of the research, which have potential health importance. One underappreciated risk of incidental findings is the potential loss of the research subject's insurability; or if a research subject fails to disclose incidental findings when applying for insurance, the insurance contract may be voidable by the insurer. In this article, we seek to explain the insurability risks associated with incidental findings and to make recommendations for how researchers and research ethics committees should address the issue of disclosure of these risks.