Disclosure of Unknown Harms in Magnetic Resonance Imaging Research

Unknown harms are by their nature difficult to communicate. While magnetic resonance imaging (MRI) has known risks (e.g., metal projectiles, dislodgement of medical implants), this imaging modality also has potential unknown long-term negative health effects associated with its static magnetic fields. We carried out a research ethics board (REB) file review of previously approved MRI research studies and found that unknown risks were either left undisclosed or were inadequately disclosed to research participants and REBs. This article outlines issues raised by our REB file review and suggests steps that should be taken in order to satisfactorily communicate information about potential unknown harms of MRI.     

Chronic Child Abuse: The Characteristics and Careers of Children Caught in the Child Protection System

The introduction of the Quality Protects initiative in Englandand the focus on performance management has challenged socialservices departments to examine the systems, processes and outcomesfor children who have their name on a child protection register.Research indicates that approximately one-quarter of the situationsin which children are registered could be described as chronic—thatis, they remain on the child protection register for significantperiods of time, experience more than one period of registrationor suffer a further incident of significant harm whilst subjectto a child protection plan. In this article, the findings froma research study conducted into this group of vulnerable childrenare reported, focusing on the characteristics of the childrenand their families, and their careers in the child protectionsystem. The paper concludes with observations about the weakconceptualization of performance management and the need torecognize the complexity of the factors that influence children’scareers in the child protection system.     

Child protection and research: understanding the messages

This paper contributes to the debate which has followed publication of the recent Department of Health research in child protection. From the viewpoint of one of the researchers, it surveys the criticisms presented by Nigel Parton (Parton 19%). It suggests that the problems he identifies are not irresolvable, and that improve-ments in social work policy and practice are feasible, as long as the stance taken by the researchers is correctly understood.     

Child Welfare in England: Problems, Promises and Prospects

This paper discusses developments in child welfare services in England in recent years and, particularly, the role and contribution of research. It is shown that a more significant and coherent body of child welfare research has been developed, which has linked formally to the policy process. Research programmes in England have highlighted specific problems in three areas: first, moving away from a narrow focus on child protection to an approach that provides broader family support for children in need; second, the absence of policies relating to services for adolescents; and, lastly, problems in the delivery of residential care for young people. A major programme of reform has been introduced by the new Labour government, consistent with research messages. It is concluded that research has had an impact on the development of child welfare services in England, although influencing the structure of services, social work practice and outcomes for young people are highly complex issues.     

Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network

PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.     

Minimal Risk in Pediatric Research: A Philosophical Review and Reconsideration

Despite more than thirty years of debate, disagreement persists among research ethicists about the most appropriate way to interpret the U.S. regulations on pediatric research, specifically the categories of “minimal risk” and a “minor increase over minimal risk.” Focusing primarily on the definition of “minimal risk,” we argue in this article that the continued debate about the pediatric risk categories is at least partly because their conceptual status is seldom considered directly. Once this is done, it becomes clear that the most popular strategy for interpreting “minimal risk”—defining it as a specific set of risks—is indefensible and, from a pragmatic perspective, unlikely to resolve disagreement. Primarily this is because judgments about minimal risk are both normative and heavily intuitive in nature and thus cannot easily be captured by reductions to a given set of risks. We suggest instead that a more defensible approach to evaluating risk should incorporate room for reflection and deliberation. This dispositional, deliberative framework can nonetheless accommodate a number of intellectual resources for reducing reliance on sheer intuition and improving the quality of risk evaluations.     

Child Support, Fatherhood, and Marriage: Findings from the First 5 Years of the Fragile Families and Child Wellbeing Study

In this article, we review what has been learned to date from the first 5 years of the Fragile Families and Child Wellbeing study about child support, fatherhood, and marriage. The article first describes the parents' circumstances at the time of the child's birth, then examines the trajectories of parents' relationships (with each other and others), fathers' financial contributions and other indicators of fathers' involvement with their children 5 years later; and finally reviews what has been learned about the effect of child support enforcement on these three aspects of families' lives. We find that most unmarried parents are either cohabiting or romantically involved at the time of the child's birth, but are a distinctly disadvantaged group as compared with married parents. Five years later, most of these parents are no longer romantically involved, however, most of the fathers are still seeing their children on a regular basis, and about half are contributing either formally or informally to their support. Strong child support enforcement appears to increase formal and decrease informal support from fathers, reduce marriage among parents, and have a weak positive effect on father involvement. More research is necessary to understand whether these findings are robust over time and across samples of unmarried parents.     

Research as Profession and Practice: Frameworks for Guiding the Responsible Conduct of Research

Programs in the responsible conduct of research (RCR) vary between institutions, demonstrated by disparate structures and goals. These variations may be attributed to the absence of grounding frameworks within which to examine research and RCR education programs. This article examines research as a practice and a profession, using these frames to draw out defining features of research and the moral obligations entailed. Situating research within virtue ethics can clarify how researchers might cultivate the virtues necessary for meeting its obligations and aims. By elucidating these features, these perspectives can serve to guide the development of RCR education programs.     

'Text-work' in Research Ethics Review: The significance of documents in and beyond committee meetings

ABSTRACT

This article analyzes how a formal text (the Ethics Review Form) available at National Health Service Research Ethics Committees (NHSRECs) in the United Kingdom was used in meetings. Derived from the work of Dorothy Smith on incorporating texts into institutional ethnography (IE), it proposes the concept of “text work” as a way into understanding more about decision-making in ethics review and describes the extent to which this formal text shaped and influenced review work. The research study used observations of committee meetings, field-notes and interviews to produce an ethnographic mapping of Research Ethics Committees’ (RECs) work. This article draws on one aspect of the research which was the process of isolating a particular, ubiquitous text and analyzing how it worked and was worked on in the meetings. The analysis contributes to contemporary discussion offering an alternative to ongoing debates about idealized ways of conducting ethics review. Finally, some tentative suggestions are made about improving training, based on and starting from the work which reviewers undertake.     

Dealing with Misconduct in Biomedical Research: A Review of the Problems and the Proposed Methods for Improvement

The increasing complexity of scientific research has been followed by increasing varieties of research misconduct. Dealing with misconduct involves the processes of detection, reporting, and investigation of misconduct. Each of these steps is associated with numerous problems which need to be addressed. Misconduct investigation should not stop with inquiries and disciplinary actions in specific episodes of misconduct. It is necessary to decrease the personal price paid by those who expose misconduct and to protect the personal and professional interests of honest researchers accused of misconduct unfairly or mistakenly. There is no dearth of suggestions to improve the objectivity and fairness of investigations. What is needed is the willingness to test the various options and implement the most suitable ones.     

Effective Practices in the Delivery of Research Ethics Education: A Qualitative Review of Instructional Methods

In order to delineate best practices for courses on research ethics, the goal of the present effort was to identify themes related to instructional methods reflected in effective research ethics and responsible conduct of research (RCR) courses. By utilizing a qualitative review, four themes relevant to instructional methods were identified in effective research ethics courses: active participation, case-based activities, a combination of individual and group approaches, and a small number of instructional methods. Three instructional method themes associated with less effective courses were also identified: passive learning, a group-based approach, and a large number of instructional methods. Key characteristics of each theme, along with example courses relative to each theme, are described. Additionally, implications regarding these instructional method themes and recommendations for best practices in research ethics courses are discussed.     

Department of Health Research Overviews – Past, Present and Future: An evaluation of the dissemination of the Blue Book, Child Protection: Messages from Research

Since 1985 the Department of Health has been providing child care research overviews as a means of bringing together the findings of its funded research programmes. With each successive publication a pattern of design and dissemination has emerged. This is illustrated by Child Protection: Messages from Research ( Department of Health 1995 ), an overview of 20 studies of child protection. It included an introductory essay, summaries of each project and a set of 'True for Us' exercises. Publication was followed by national seminars and widespread distribution of free copies. Given the substantial investment, it seems timely to assess the impact of the dissemination process in terms of reaching and affecting practice. The survey sought to assess awareness, use and opinions of the report from social services, education and health professionals. It consisted of questionnaires administered by post and telephone calls to a representative sample of 600 professionals working in child protection, 292 of whom replied. The results demonstrate that the book is very well known among most professionals working in child welfare, particularly in social services, and is perceived to have affected the practice of over half of the respondents. The study supports the structure adopted for the report but suggests further benefits in employing a variety of dissemination strategies for different professional groups. Finally, the paper discusses the relationship between overviews and evidence-based services.     

Biomedical Research and the Commercialization Agenda: A Review of main Considerations for Neuroscience

This article reviews a range of issues associated with the commercialization of biomedical research and speculates on how these issues might apply to the neuroscience context. Drawing on existing studies of the impact of research commercialization activities on various areas of biotechnology research, the authors explore normative benchmarks for assessing and resolving issues likely to arise from the commercialization of neuroscientific research, including such topics as patenting, marketing pressures, and representations of research prospects.     

From walls to homes: Child care reform and deinstitutionalisation in Ghana

In 2006, the Ghanaian government, in partnership with the United Nations Children's Fund (UNICEF), began to reform the child welfare system. The main aim of this reform was to provide a sustainable and culturally appropriate system of care for children without parental care by shifting from an institutional‐based model to a family and community‐based one. Drawing on existing peer‐reviewed and grey literature, this article provides an overview of the major components of the reform, including reintegration with the extended family, foster care and adoption. In addition, the article discusses the prospects and challenges involved in achieving the reform's intended component. Key Practitioner Message: ● Use community development techniques to raise the resources needed to provide family support services for vulnerable families; ● Social work practitioners partner with non‐governmental organisations to train community members as para‐social workers; ● Social workers, especially in developing countries, understand the challenges they face when embarking on deinstitutionalisation.     

The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research

The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research that is being conducted. The intersection between IRB review and free speech is also explored. In general, it is argued that the review system for human subjects research (HSR) should be modified in order to limit the scope of IRB review.     

Adult Problem Solving: Contributor to Parenting and Child Outcomes in Divorced Families

This cross-sectional study extends child outcome models by focusing on factors in the adult social domain as contributors to parenting. The sample included 138 divorced mothers, their focal sons, and their support confidants assessed approximately 5 years after marital separation. The multimethod latent variable analysis tested a hypothesized progression stating observed confidant support would enhance problem solving outcomes achieved by mothers and confidants. Resolving parenting and personal issues for the mother was expected to benefit parenting practices (i.e., monitoring, discipline, and mother/child problem solving), which in turn would predict a macro level measure of child antisocial behavior. Analysis of the simplex model supported the progression. The final model explained 36% of the variance in antisocial behavior, 15% of the variance in parenting, and 53% of the variance in problem solving outcome. Dyads with cohabiting partners scored higher on problem solving outcomes than did dyads with friends or family members. The model is discussed in the context of social interactional and social learning theory.     

Emphasizing the experiences of researchers after RCR instructions: Introduction to Responsible Conduct of Research (RCR) in Malaysia

The purpose of this study is to highlight the experiences of individuals who participate in the Responsible Conduct of Research (RCR) training program held at various universities in Malaysia. In response to a mailing request sent to 40 individuals who had undertaken a RCR training program, 15 participants agreed to be interviewed. The results of the study showed that the three main reasons for participating in the training were as follows: anticipation for knowledge gained; personal experience with research misconduct; and establishing a new network of researchers. In terms of the positive effects gained from undertaking the training, the participants highlighted an increased awareness of the issues and problems related to research misconduct; the need to promote integrity in research conduct; a change in the way they conduct their research; and a change in the way they confront and address misconduct. The findings of this study should be valuable for policy makers and those involved in the management of research programs and ethics, as it demonstrated the importance of RCR training in equipping researchers with the necessary knowledge to conduct research responsibly, and to avoid research misconduct.     

Researching Vulnerable Groups: Ethical Issues and the Effective Conduct of Research in Local Authorities

The Data Protection Act 1998 and Research Governance Frameworkfor Health and Social Care (Department of Health, 2003a) havebrought consideration of ethical issues in the conduct of researchinto sharper focus. This paper, based primarily on the authors’experiences of conducting research on children in need and outcomesfor vulnerable children, examines the impact these changes havehad on the research process. The difficulties experienced byresearchers in gaining access to research participants in orderto develop evidence-based policy and practice are explored.Finally, the paper outlines some practical steps that can betaken to facilitate the effective conduct of research.