The ethical review of medical research: a social movement to protect the interests of research subjects

This paper is based upon observations made in the United States regarding the operation of the Institutional Review Boards. Institutional Review Boards are an essential part of the American system for the ethical review of human subjects research and it is argued that their importance is due in part to the American approach to the protection of minority groups. It is important to evaluate the effectiveness of the Institutional Review Boards since a similar model is being proposed by the National Health & Medical Research Council as part of the ethical review of medical research projects conducted in Australia.     

Supporting ethical use of electronic monitoring for people living with dementia: Social work’s role in assessment,decision-making,and review

Walking outdoors supports health and well-being, but some people living with dementia are at increased risk of getting lost and of harm while missing. Electronic monitoring can potentially play an important preventative role by enabling the person’s location to be continuously monitored by caregivers. However, there are considerable ethical concerns arising from electronic monitoring. This paper explores these thematically, drawing attention to its implications for autonomy and liberty; privacy; dignity; the rights and needs of caregivers and families; beneficence and nonmaleficence. Following from this, key questions for consideration in social work assessment are identified. The ethical issues necessitate assessment of the person’s unique circumstances and preferences and that of their caregivers, and careful ethical deliberation in decision-making. Social work can play an important role in facilitating inclusive assessment and decision-making, leading to consensus on intervening with electronic monitoring. The need for the ongoing review following implementation is discussed to track whether decisions need modification in light of the experience of usage. In conclusion, while legislative instruments and professional codes of ethics frame social work practice responses, there is need for a nuanced debate about ethical use of electronic monitoring and specific guidance to inform assessment, decision-making, and review.     

Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia

The review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible for the inspection and oversight of these registered RECs to ensure that they comply with the regulatory requirements. However, this study highlights that each REC in Malaysia has a different standard operating procedure and ethical review process. Other procedural challenges identified include inadequate membership, poor mechanism for research monitoring after ethical approval, and insufficient resources. Establishments of a national standard of REC and a central ethics committee are suggested to ensure procedural compliance in the oversight of clinical trials in Malaysia. While there is a growing concern that procedural compliance may not have a direct impact on the protection of human subjects, our key point is that an ethical review system compliant with the national standards could serve as a strong framework to support and enhance the ethical quality of decision-making and judgement. We believe that being aware of how influential procedural compliance can be would help committees improve the ethical quality of their research review.     

An opinion and practice survey on the structure and management of data and safety monitoring boards

There is little to no empirical data available on how data and safety monitoring boards (DSMBs) are structured and how they operate. The purpose of this study was to provide data on this. To accomplish this goal, we administered a random survey on current structure and management practices and opinions as reported by principal investigators (PIs) and biostatisticians. We also surveyed Institutional Review Board (IRB) community members, as proxies for the public, as to their opinions on how DSMBs should be structured and managed. A final purpose was to compare opinions about what should be taking place to what is actually happening.     

Risk Assessment as a Paradox: When Actions of an IRB Become Incompatible with Ethical Principles

As anecdotal evidence mounts up of Institutional Review Boards becoming an impediment to research, I share a personal experience in this article to argue how the conduct of an Institutional Review Board was incompatible with a number of ethical principles such as Respect for Persons, Deception, Informed Consent, and Justice. I conclude by promoting Evidence-Based Ethical Problem Solving to facilitate and enhance risk assessments through empirical evidence.     

Monitoring the Monitors: Medicaid Integration of Passive Remote Monitoring Technology

Implementation of passive remote monitoring is advancing faster than our knowledge base about appropriate and ethical use. For all the media and research attention these technologies are getting, there has been very little discussion about how they are positioned to be integrated into health plans, yet their integration is key to how they will be incorporated into social work practice. As coverage of passive remote monitoring technologies expands in Medicaid home and community-based services (HCBS), new policies that support informed decision-making, consenting processes, and regulations for ethical, appropriate use are urgently needed. Research translation often trails policy, but the rapid development and implementation of technologies that passively collect and transmit new information about older adults call for a more responsive approach. In this commentary, I describe passive remote monitoring technologies, their implementation in Medicaid HCBS, and ethical issues. I conclude with specific suggestions for policy and practice to start addressing these issues.     

‘Street‐level Bureaucracy’ Revisited: The Changing Face of Frontline Discretion in Adult Social Care in England

This reassessment of the continuing significance of Lipsky's (1980 ) work on ‘street‐level bureaucracy’ for frontline decision making is based on a retrospective review of the author's research on assessment practice in adult social care in England. The studies span the past two decades during which time successive governments have restructured and modernized social services departments. When these were established in 1970, they represented the high watermark of bureau‐professionalism – a mode of administration which dominated social welfare at the time Lipsky was writing. The subsequent dismantling of bureau‐professionalism calls into question the validity of his findings, and the author draws on her own research to assess conflicting views about the impact of social care reforms on the discretion which social workers exercise as street‐level bureaucrats. She concludes that the distinct types of discretion to emerge from her findings, represented in a taxonomy, are shaped by the differing micro environments of frontline practice which, in turn, affect the relative force of managerialism, professionalism and user empowerment in countering the defensive exercise of discretion described by Lipsky. Whilst her analysis affirms the continuing significance of Lipsky's analysis, it also points to the need for some revision to accommodate major shifts in welfare administration since the publication of his work. She highlights the potential relevance of these insights for investigating the next planned transformation of adult social care, personalization, as well as for the implementation literature more widely.     

FALSE PRINCIPLES OF WELFARE REFORM

Welfare reform both in Australia and throughout the OECD invokes various moral principles. These are articulated in arguments about ‘consent’, on both a micro‐ and macro‐level, and the ‘mutual obligation’ that ostensibly arises from consent. There are also frankly ‘paternalistic’ arguments, whether weak or strong, to the effect that forcing people into work is good for them. A critical assessment demonstrates that none of these arguments can justify the kind of welfare reform which is currently mooted. The real aim of such reform seems instead to be simply that of ‘clearing the welfare rolls ’. This has worrying ethical consequences.     

Management of quality assurance in clinical trials

Good Clinical Practices (GCP) were first established by the FDA and are now actively implemented by different countries. This becomes necessary as multinational large clinical programs are more complex, involving a large diversity of personnel and locations, with different practices of medicine and local regulatory requirements.

The responsibility of an independent Quality Assurance (QA) organization is to oversee the quality and integrity of research activities, and to assure compliance with company's regulatory requirements, and ethical considerations in order to facilitate worldwide registration of new compounds. The goal of a Clinical QA group is to provide continuous assistance to monitoring teams and investigators to ascertain authentic and reliable clinical trials. The Clinical QA programs must be flexible, calling for active communication and good understanding of quality requirements.

Clinical auditing is one of the instruments of Clinical QA. Study audit activities begin with the protocol, encompass all facets of the clinical trial and end with the final study report.

The focus of the presentation is geared towards auditing activities at investigator's site, purpose of which is to ensure that data gathered in the final clinical study report reflects the raw data collected at the source.     

Researchers’ Views of the Acceptability of Restrictive Provisions in Clinical Trial Agreements with Industry Sponsors

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators’ academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.     

Accountability and the design of an anticorruption agency in a parliamentary democracy

This article explores the institutional requirements of accountability for an anticorruption agency in a parliamentary democracy. It suggests that approaching public accountability as ‘the satisfaction of legitimate expectations about the use of discretion’ is useful in understanding or designing an accountability regime for such a powerful agency requiring independence from the executive. The approach facilitates identification of a variety of stakeholders and a range of institutional means by which their legitimate expectations may be satisfied. Despite the recognition, in consequence, of multiple agents and channels of accountability, parliament must remain central to the accountability regime and can achieve this through an appropriately designed oversight committee. Examination of a selected Australian agency, the Western Australian Corruption and Crime Commission, provides support for these propositions. Particular controversies involving this agency are used to demonstrate the requirements of a parliamentary oversight committee, and that independent review of determinations of misconduct, as well as appropriately regulated public hearings where there is a strong public interest in matters under investigation, are important elements of public accountability for an anticorruption agency.     

Social workers' attitudes towards family group conferences in Sweden and the UK

The New Zealand family group conference (FGC) approach to decision making in child welfare and protection has attracted strong interest among policy makers and professionals all over the world. While New Zealand’s legislation makes use of FGCs more or less mandatory in child protection, other countries permit social workers to refer families to an FGC at their own discretion. Knowledge about social workers’ attitudes towards the model is thus paramount if we want to understand implementation and evaluations of FGCs outside New Zealand. This study looks at attitudes towards and actual referrals to FGCs amongst 219 social workers from 18 local authorities in Sweden and the UK. Results reveal an overwhelmingly positive attitude towards FGCs in both countries. Given these attitudes it was striking that only 42% of the social workers had initiated at least one FGC over an 18‐month period. The number of implemented FGCs was almost exactly the same in Sweden and the UK, after adjusting for time and number of social workers. Possible explanations for this paradox are discussed, using data from the survey and child welfare literature.     

Ethical consideration of the research proposal and the informed-consent process: An online survey of researchers and ethics committee members in Thailand

Researchers designing and conducting studies using human data should consider the values and principles of ethical conduct. Research ethics committees (RECs) typically evaluate the ethical acceptability of research proposals. Sometimes, differences arise between how researchers and RECs interpret ethical principles, and how they decide what constitutes ethical conduct. This study aimed to explore the opinions of these two groups about the importance of core ethical issues in the proposal and in the informed-consent process. An anonymous online questionnaire was distributed to a target population in health-related academic/research institutes across Thailand; 219 researchers and 72 REC members participated. Significantly, more REC members than researchers attributed the highest importance to three core ethical considerations – risk/benefit, vulnerability, and confidentiality/privacy. For the informed-consent process, significant differences were found for communication of risks, decision-making authority for consent, process for approaching study participants, and availability of a contact for study deviations/violations. The different ratings indicate differences in the groups’ perspectives on ethical principles, which may affect focal congruence on ethical issues in the proposal. Communication of these findings should help close gaps between REC and researcher perceptions. Further study should investigate how RECs and researchers perceive equivocal ethics terms.     

The Experiences of Frontline Staff Working with Children Seeking Asylum

The focus of this paper is welfare professionals’ accounts of their work with children who are seeking asylum. The empirical basis is a commissioned study of children seeking asylum in Wales. As well as qualitative research with children (which is not discussed in this paper), 62 professionals took part in interviews and focus groups. This sample included staff from social services, health, housing, education, police and the voluntary sector. Research findings are presented in relation to the experience of these frontline staff. We attempt to identify some of the sites of tension and the nature of the professional dilemmas, as well as discussing the potential for the exercise of discretion to be exercised. We conclude that there is very little room for manoeuvre within the asylum system for welfare professionals, but that there is evidence of questioning and even minor challenge of current policy from frontline staff. We discuss the extent to which the professional dilemmas raised by the asylum system are of a different order from those experienced throughout social welfare work.     

Discretion in Welfare Provision

While discretion has been studied in systems of distribution which are governed by rules, or in those where there is a crucial gatekeeper, there remain many informal and diffuse systems where little is known about the discretion used. An example is the allocation of community services. In such cases, a useful strategy is to analyze the informal rationing system along lines which are discussed, and by this means to identify as discretionary the cases which emerge as anomalous.
Possibilities are outlined for comparing the amount of discretion used and its bias, in areas with different resource levels or degrees of regulation; and the paper concludes with a detailed illustration, drawn from an area study of community services for the elderly, of changes in the use of discretion with increasing pressure on resources.     

Giving Voice to Research Participants: Should IRBs Hear From Research Participant Representatives?

The current decision-making model for the review of human research contains inadequate mechanisms to ensure that the interests and perspectives of research participants are considered by Institutional Review Boards, whose decisions may profoundly affect the safety and well-being of participants. As a result, this model is far from being optimized to realize Institutional Review Boards' principal mandate and undermines the credibility of the research review process. This article proposes a procedural mechanism that would ameliorate these systemic deficiencies by allowing “research participant representatives” to give voice to participants during the research review process.     

Who to Serve? The Ethical Dilemma of Employment Consultants in Nonprofit Disability Employment Network Organisations

The Welfare‐to‐work policy, implemented in July 2006 by the Federal Government, imposed a new work and activity obligation on people applying for the Disability Support Pension. This requirement not only created a new obligation for people with disability but also for employment consultants working in nonprofit Disability Employment Network organisations to monitor the conduct of this new cohort on behalf of Centrelink. For many employment consultants traditionally drawn to the nonprofit disability sector for altruistic reasons, this has created an ethical dilemma between their duty to their employer, and acting in the best interests of their clients. Drawing on aspects of ethical theory we find that, although most employment consultants justify their actions in terms of duty to the organisation, some find themselves in an ethical dilemma of ‘who to serve’ when the interests of the organisation and the welfare of the client are mismatched.     

Giving voice to research participants: should IRBs hear from research participant representatives?

The current decision-making model for the review of human research contains inadequate mechanisms to ensure that the interests and perspectives of research participants are considered by Institutional Review Boards, whose decisions may profoundly affect the safety and well-being of participants. As a result, this model is far from being optimized to realize Institutional Review Boards' principal mandate and undermines the credibility of the research review process. This article proposes a procedural mechanism that would ameliorate these systemic deficiencies by allowing "research participant representatives" to give voice to participants during the research review process.     

Ethical values and social change: Mahatma Gandhi,Martin Luther King,Jr. and Ahn Chang Ho

Mahatma Gandhi, Martin Luther King, Jr. and Ahn Chang Ho exemplify the leaders who brought social change by applying their belief in non-violence and love of humanity to the accomplishment of their respective goals. Gandhi’s goal was securing India’s independence from British colonialism, and King’s was to rid America from racial segregation. Irony about England and the US was that they had a long history of commitment to human rights and democracy. Hence, Gandhi and King’s struggle for justice focused on reminding their adversaries of their hypocrisy, a gulf between their commitment and actions. Ahn had to deal with Japanese colonialists, who had little respect for and commitment to human rights and civil liberties. Ahn’s job was, therefore, more complicated than Gandhi’s or King’s. Ahn insisted that for the Koreans to achieve their political independence from Japan, they must build their inner strength first, and do this by self-cultivation of moral and ethical values. Building moral and ethical strength ought to also accompany receiving modern education, acquiring marketable skills, and building financial resources. At the same time he condoned the militant approach to the Korean independence movement, as necessary. Ahn was a complex figure, a blend of a moralist, a strategist, and a pragmatist.     

Playing,Sitting Out,and Observing the Game: An Investigation of Faculty Members’ Perspectives on Political Behavior in Ethical Decision Making

Ethical dilemmas are inherently ambiguous, complex, and ill-defined. Additionally, these dilemmas involve multiple stakeholders. These characteristics may induce political behavior as a resolution tactic. Thus, the goal of the present effort was to investigate perspectives on politics among researchers in an ethical decision-making context. A qualitative analysis of interviews with university faculty members revealed that faculty members’ perspectives on political behavior in an ethical decision-making context fall into a number of categories, including positive, negative, and realistic views of political activity. The implications of these varying perspectives on ethical decision making are discussed.