Current issues in clinical research and the development of new pharmaceuticals

As a normal part of the drug development process, U.S. pharmaceutical companies conduct many thousands of clinical trials each year. Only after a reasonable assurance of safety is made can the drug be given to patients who have the underlying medical condition that the drug is designed to treat. Patient welfare is assured by adhering to the Food and Drug Administration's interpretation of the “common rule”; if the data will be used to support a licensing application. 21 CFR Part 50 sets forth the regulations along with the principles of informed consent and the use of institutional review boards (IRBs) that assure patients’ rights are protected. Any potential conflict of interest on the part of a clinical investigator must be reported to the FDA. Pharmaceutical companies extensively monitor ongoing clinical trials for compliance with appropriate regulations. The recent revision of the Declaration of Helsinki governing placebo‐controlled clinical trials may adversely impact drug development     

A choice of one's own research advance directives: Anticipatory planning for research subjects with fluctuating or prospective decisionmaking impairments

Mental disorders that may affect decisionmaking capacity, like schizophrenia, have a deleterious effect not only on persons who are afflicted with the disorders but also on their families, their friends, and their communities. Realizing research to develop generalizable knowledge that may benefit this heterogeneous population is crucial. The moral challenge is to fashion processes that both respect research subjects’ autonomy and protect their wellbeing. Research advance directives may provide a mechanism that authorizes potential research subjects to make choices of their own regarding whether they wish to participate in a research protocol, to choose and appoint a surrogate decision maker, and to secure an array of protections for themselves should they lose their decisionmaking capacity during the period of the research protocol. Such research advance directives may be used by persons with fluctuating, limited or prospective decisionmaking impairments.     

Guinea Pigs on the payroll: The ethics of paying research subjects

Regulatory bodies and scholars have traditionally conceptualized biomedical research on healthy subjects in the same way as research on patients. Guidelines and regulations have portrayed payment to a healthy subject as a potential constraint, or “undue influence,”; on the subject's free consent. In this essay we suggest an alternative way of conceptualizing research on healthy subjects, which sees the basic issue not as one of undue influence but as one of justice. Healthy subjects generally enroll in research protocols not for humanitarian reasons but for the money they will receive. Many of these protocols are conducted by profit‐driven corporations. Yet current guidelines and regulations prohibit subjects from negotiating for fair payment for the risks, discomforts and inconveniences they undergo, and IRBs are not staffed adequately to monitor the subject's safety. We propose to remedy the situation by regulating payment to healthy subjects as a labor relation.     

Making sense of common sense: examining the decision‐making of politically appointed representatives in Swedish child protection

A distinguishing feature of Swedish child protection is the direct and indirect influence on decision‐making in individual cases by representatives appointed by their elected political parties. As members of local committees, they take the most interventionist and costly decisions themselves, informed by care proposals submitted by professional social workers. Other decisions are delegated to professional social workers. In direct decision‐making, they are supposed to act as laypersons using their own judgement and experience, not as politicians. The aim of this paper is to describe and analyse these committees, their role and responsibilities, and possible influence of politics on child protection. A mixed method was used, with a survey sent to 467 representatives, structured interviews with 99 secretaries of local committees and data drawn from national statistics. The Swedish model is discussed as a hybrid system influenced not only by professional, bureaucratic, political and market governance logics but also by laypersons. One conclusion is that although child protection is directly influenced by politics, the reverse is also true. By exposing politicians to the difficult life circumstances and societal shortcomings experienced by vulnerable children, the system can, in turn, have an impact on politics at the municipal level.     

On the margins of the child protection system: creating space for relational social work practice

In the UK, a threshold divides between two categories of children, child protection (CP) and child in need. Each category tends to be treated as a homogeneous entity, despite containing heterogeneous levels and forms of risk and need. CP practice, accompanied by regulation, protocols and procedures, aspires to achieve a coordinated multi‐agency response to identified concerns with available resources targeted towards this category. However, it is well known that those children assessed as falling just below the CP threshold can still have high levels of need and risk, requiring a level of social work involvement beyond the low‐resource and low‐oversight model that generally accompanies a child in need categorisation. This paper probes an approach to practice, which divides levels of risk within the child in need category enabling adequate, coordinated support and oversight to be provided for children and families with complex needs. Evidence from our study evaluating this approach suggests that a simple protocol provided a clear process within, which social workers and agency partners felt confident and safe to practice outside of the formal CP framework. The protocol prevented drift and helped to create a space within, which relational social work practice flourished.     

Noticing and helping the neglected child: towards an international research agenda

This systematic review examined the evidence on the extent to which practitioners are equipped to recognize and respond to the indications that a child's needs are likely to be, or are being neglected. This paper examines the methodological issues arising from the review. A systematic process of progressive filtering yielded 112 papers representing primary studies that inform the international research agenda for child neglect. A final dataset of 63 studies was of sufficient quality and usefulness for inclusion. The review raised a number of methodological issues of relevance for research in child protection in general, and on neglect in particular. Researchers and practitioners can benefit from an enhanced understanding of the issues that make neglect difficult to understand. Common issues were identified to inform future research. For example, there was a tendency for studies to use a range of proxy measures rather than direct observation of the outcome of interest, and a wide range of different outcome measures was used. Many of the studies were small scale or retrospective in design. Many studies conflated neglect and other forms of maltreatment, and it was often difficult to extract specific messages for neglect.     

National,independent oversight: Reinforcing the safety net for human subjects research*

National, independent oversight is vital to resolve the problems and inconsistencies in oversight of human subjects research. Three key functions that must be considered in any proposal for such a mechanism are (1) issue spotting, (2) guidance on identified issues, and (3) sampling and follow‐up. The 1998 report and recommendations of the National Bioethics Advisory Commission concerning research involving persons with mental disorders that may affect decisionmaking capacity address these functions in part, but application is limited to a small segment of the research population. Incorporation of these three key functions in a formal, national, independent oversight process is necessary in order to ensure accountability and maintain public trust in research.     

Sharing personal information in the child protection context: Impediments in the Australian legal framework

Professionals, including social workers, in the child protection context are frequently required to make decisions on whether to share sensitive personal information about children, their families, and others with colleagues and across institutional and jurisdictional boundaries. Sharing information across agencies and organisations is essential to allow joined‐up service provision and to effectively protect and support children and their families. A legal framework that supports this decision making is a necessary, although not sufficient, condition for effective information sharing. This article examines the complex legal framework that governs information sharing across the Australian states and territories. It identifies a number of structural and regulatory elements that unnecessarily limit information sharing or have a tendency to create a culture that is risk averse, rather than proactive, in sharing information. The article suggests structural and regulatory reforms that would improve the legal framework for sharing information, while at the same time giving due recognition to the human rights that come into tension in this policy context: the right to privacy and the rights of the child.     

Enriching Resources for the Poor: Lessons from the Philippines

The paper provides an overview of the poverty situation in the Philippines, followed by a brief profile and assessment of two anti‐poverty programs: the Kapit‐Bisig Laban sa Kahirapan‐Comprehensive and Integrated Delivery of Social Services (KALAHI‐CIDSS) program and the Pantawid Pamilyang Pilipino Program (4Ps). Official statistics disclose that the global economic crisis in 2008 adversely affected Filipino households, leading to higher levels of poverty especially in rural areas. In response, government introduced an Economic Resiliency Program with social protection as one component. Sixty‐six social protection programs were launched, including the two under review. KALAHI‐CIDSS and the 4Ps apply poverty reduction strategies that focus on the development of human and social capital, rather than economic capital. They involve processes and relationships that aim to improve the other dimensions of poverty, such as lack of access to opportunities or deprivation of basic human necessities. Qualitative and quantitative reports describe generally favorable outcomes from both programs. However, these gains at the household level need to be supported by relevant policy, enhanced public services and badly‐needed infrastructure programs from government, in order to sustain achievements culled from social protection programs and attain broader developmental impacts.     

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.     

Protective support and supportive protection for families “in the middle”: Learning from the Irish context

This paper critically examines the relationship between statutory family support and child protection using the case study of Ireland. It builds on the work of Devaney and McGregor (2017) to offer an additional contribution to existing frameworks for practice through adapting the Hardiker Exton and Barker (1991) model of prevention. Using evidence from current Irish developments, the case for moving away from linear and simplistic differentiation of family support and child protection is made. Evidence from three main sources in Ireland is presented to develop the argument. This evidence includes the Child Care Law Reporting project (Coulter, 2015, 2018); a recent evaluation of a family support practice model called Meitheal (Rodriguez Cassidy and Devaney, 2018) and recent findings about public awareness of family support (McGregor and NicGabhainn, 2018). We argue that special attention should be paid to families “in the middle” who are in need of both support and protection and propose an adapted version of Hardiker et al. model to aid in this work. We identify what should happen at different levels for macrostructural to micropractice levels. We conclude that the learning from the Irish case study can be applied to an international context.     

‘You've got to trust her and she's got to trust you’: children's views on participation in the child protection system

Participation by children in child protection remains a complex area of practice. This paper presents findings from a qualitative study exploring the views of 26 children, aged 6–17 years, about their participation in the child protection system in England. All of the children were subject to a child protection plan and were living at home at the time of interview. The children's understanding of the child protection process was categorized, and the majority of children, including the youngest, were found be at least partially aware of the child protection process, often struggling to make sense of the professional intervention in their families on the basis of partial information. It is argued that decisions about children's involvement should take into account not only children's age and understanding, but be seen in the context of wider family dynamics. Participation in formal processes such as child protection conferences was experienced as difficult and emotive. The child's relationship with their social worker was central to meaningful participation.     

‘It's about the whole family’: family contact for children in kinship care

Contact with family for children in care is identified as a right under the United Nations Convention on the Rights of the Child. However, such contact often presents challenges because of the protective concerns that have led to care arrangements being made. The Family Links: Kinship Care and Family Contact research study explored the nature and extent of family contact in kinship care, with a particular focus on the circumstances that create positive contact and foster family relationships. Findings included evidence of a large proportion of parental contact that was negatively affecting children's well‐being, and was sometimes unsafe. By contrast, the frequent contact that children were enjoying with their siblings and wider family was reported to be mostly positive and supportive. Kinship carers described a range of services needed to facilitate more positive parental contact and to enable children to keep contact with significant family members.     

Assessing the value of family safety networks in child protective services: Early findings from Minnesota

The considerable number of families served continues to place systemic challenges on the child welfare system. Jurisdictions are turning to new strategies to increase family engagement in services and to leverage taxed or limited resources. Signs of Safety® is a strengths‐based and safety‐focused approach to child protection work that is grounded in partnership and collaboration. This exploratory pilot study with a referred participant sample used interviews with 26 parents and 32 safety network members to explore respondents' perceptions and use of a safety plan and safety network, core components of the Signs of Safety framework. Findings from this pilot investigation include insights about how safety plans and safety networks are established, how they function, and opportunities for enhancing their use with families with the goal of providing supports that increase the likelihood of continued safety for children after case closure. Preliminary results also suggest these tools may contribute to reduced re‐reports to child protection.     

Vulnerable children's rights to participation,protection, and provision: The process of defining the problem in Swedish child and family welfare

This study addresses the relationship between children's participation and the protection and provision offered to them by social services in Sweden. It applies a theoretical framework for analysing child welfare that is anchored in the United Nations Convention on the Rights of the Child. How child participation may affect child protection and provision is examined empirically using case documentation from 2 municipalities. The main finding is that when children are not given voice or opportunity to influence the framing of what “the problem” is, the design of protection and care tends to be poorly matched to the actual problems documented in the child investigation and vice versa; when children can influence framing, this is associated with well‐matched protection and care. This suggests that traditional child welfare ethos, to the effect that protection should be of such overriding concern that children even should be protected from participation, is misguided. The study further illustrates the intrinsic problems with the family orientation of Swedish social services and its reliance on partnership with parents, which makes it difficult to live up to the Convention on the Rights of the Child. Incorporating child participation into existing service models can transform Swedish social services to an augmented child‐focused system that by ensuring participation also promotes protection and provision.