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.     

Centralized and non-centralized ethics review: a five nation study

The research ethics review process is now an inherent part of conducting research and a topic of much discussion. On the negative side it has been presented as cumbersome, expensive, time consuming, and potentially a system that does not adequately deal with the concerns it was set up to address. One common, but often controversial, proposal to address some of these concerns has been the institutionalization of centralized systems of review. This paper uses data on the review systems in place in five countries (Australia, Canada, New Zealand, the USA and the U.K.), some with and some without versions of centralized review, to explore issues related to centralization of the review process. It suggests that there are at least three types of systems (fully centralized, dual, and decentralized or multicommittee) in place; all are made up of two, interrelated components (the administrative and ethics review). We suggest that both components need to be considered in discussions about centralized review. Serious consideration of centralization of the administrative component may address many concerns. Centralization of the ethics review may provide a context that deals with other issues and may encourage reviews that more effectively focus on the ethical issues involved.     

Unethical Research and the C.I.A. Inspector General Report of 2004: Observations Implicit in Terms of the Common Rule

Declassification of documents has given rise to the allegation that the Central Intelligence Agency may have conducted unethical research targeting detainee subjects. That allegation is examined using document analysis and the development of research goals and roles as defined in the Common Rule. This article sets aside issues as to whether enhanced interrogation techniques described in the declassified documents rise to legal definitions of torture. Instead, it presents a post hoc ethics review raising questions addressed by Institutional Review Boards recommending the filing of a for-cause noncompliance complaint with the Office for Human Research Protection against the Central Intelligence Agency.     

Plagiarism: A Shared Responsibility of All,Current Situation,and Future Actions in Yemen

As combating plagiarism is a shared responsibility of all, this article focuses on presenting the current situation of higher education in Yemen. The critical review of four implementable policy documents and interviews revealed the absence of research ethics code, research misconduct policy, and institutional policies in the country. This led to the presence of several acts of research dishonesty. The article concludes with an initiative for necessary future actions in the nation.     

Reforming the oversight of multi-site clinical research: a review of two possible solutions

The current system for the ethical oversight of clinical research suffers from structural, procedural, and performance assessment problems. Initially conceived primarily to handle local investigator-initiated single-site studies, the system of institutionally-based committee review has become progressively more inefficient given the increased prevalence of commercially or federally sponsored multi-center trials. To date, proposed solutions do not adequately address these problems. Beginning with a review of these structural, procedural, and performance assessment problems, this article will then consider two proposals for addressing these deficiencies: (a) regional ethics organizations; and (b) IRBNet, a newly developed web-based program for cooperative IRB review. The strengths and weaknesses of these two approaches will be evaluated in light of recent experience with centralized review. The proposal to establish a system of regional ethics organizations presents a comprehensive approach to many of the problems faced by the current system. However, IRBNet offers an immediate and feasible solution to many of the problems faced by the review of multi-site clinical studies.     

Student Projects in Medicine: A Lesson in Science and Ethics

Regulation of biomedical research is the subject of considerable debate in the bioethics and health policy worlds. The ethics and governance of medical student projects is becoming an increasingly important topic in its own right, especially in the U.K., where there are periodic calls to change it. My main claim is that there seems to be no good reason for treating student projects differently from projects led by qualified and more experienced scientists and hence no good grounds for changing the current system of ethics review. I first suggest that the educational objectives cannot be met without laying down standards of good science, whatever they may be. Weak science is unnecessary for educational purposes, and it is, in any case, unlikely to produce good researchers in the future. Furthermore, it is curious to want to change the system of ethics review specifically for students when it is the science that is at stake, and when the science now falls largely outside the ethics remit. I further show that ethics review is nevertheless important since students carry a new potential conflict of interests that warrants independent oversight which supervisory support does not offer. This potential conflict may become more morally troublesome the greater the risks to the subjects of the research, and students may impose greater risks on their subjects (relative to professional researchers) by virtue of being inexperienced, whatever the nature of the project. Pragmatic concerns may finally be allayed by organizing the current system more efficiently at critical times of the university calendar.     

Human embryonic stem cell research: an argument for national research review

The US National Academy of Sciences (NAS) recently published voluntary guidelines for human embryonic stem (hES) cell research. The NAS guidelines propose two levels of oversight. AT the local level, research institutions are to create Embryonic Stem Cell Research Oversight (ESCRO) committees with a mandate to assess the scientific merit and ethical acceptability of hES cell research. At the national level, a new committee is to be created, not to review specific research proposals, but rather to periodically assess, and as needed revise, the NAS guidelines. In this article, we critically assess this proposal. In particular, we review the benefits and limitations of local research review. On this basis, we argue that local review is insufficient for hES cell research and that while there are obvious pragmatic and political reasons for the NAS to favor local research review, there are more compelling reasons for the NAS to have recommended national review of hES cell research proposals.     

Self-experimentation

Except in certain cases of unusual risk, self-experimentation should not be encouraged. It is usually scientifically inadequate for lack of proper controls and sufficient subjects to generate meaningful results. It is also inadequate as an ethical test because even if lay persons are also enrolled, self-experimentation is neither necessary nor sufficient to establish that they may participate. It is not necessary to establish that lay persons may participate because institutional ethics review and informed consent are better ways to determine this. It is not sufficient because the investigator may be more risk accepting or not medically typical. Moreover, because scientific research is now done in teams, self-experimentation may involve undue influence when junior investigators participate as research subjects.     

Normative, Gain and Hedonic Goal Frames Guiding Environmental Behavior

This article discusses new developments about goal-dependent framing and multiple goal frames (sometimes also called "multiple motives"), which are highly relevant for understanding environmental behavior. We introduce goal-framing theory, which postulates that goals "frame" the way people process information and act upon it. Three goal frames are distinguished: a hedonic, gain, and normative goal frame. In general, multiple goals are active at any given time, which may (or may not) be compatible; that is, the strength of the focal goal may be influenced by other goals that are in the background. Based on an extensive review of studies in environmental psychology, we suggest those conditions under which each goal frame may be dominant in influencing environmental behavior. In the environmental context, normative goal frames imply acting pro-environmentally, while gain and hedonic goal frames often result in not acting in an environmentally sound manner. Next, we argue that pro-environmental behavior may be promoted by strengthening normative goals or by making gain and hedonic goals less incompatible with normative goals. Finally, based on goal-framing theory, we suggest questions to be addressed in future research.     

Research Review: Sibling placement in foster care: a review of the evidence

This research review was undertaken to explore the current evidence pertaining to sibling placement in the foster care system. The review specifically addresses the following questions: (1) Which theories inform research on siblings in foster care? (2) Which designs and methodology are used to study brothers and sisters in out of home placement? (3) How do researchers define ‘siblings’ when investigating child placement? and (4) What are the findings of studies pertaining to siblings in the foster care system? This review suggests that incorporation of theory into research regarding siblings in foster care is quite limited. Additionally, few studies clearly state how siblings were identified and defined. A major strength of the research, however, is the diversity of design and methodology used. Overall, the evidence presented in this review strongly supports keeping sibling groups intact unless there is a compelling reason for separate placements.     

Balancing Scientific and Community Interests in Community-Based Participatory Research

Community-based participatory research is an approach to studying human populations that emphasizes extensive partnerships between researchers and community members. While there are many advantages of this approach, it also faces a number of conceptual and practical challenges, one of which is managing the conflict that sometimes arises between promoting scientific and community interests. This essay explores the potential conflict between scientific and community interests in several different stages of community-based participatory research, including research design, data interpretation, and publication, and makes some suggestions for practice and policy. To manage potential conflicts between scientific and community interests, investigators and community partners should enter into written agreements at the beginning of the study. In some cases, it may be necessary for a third party, such as a review committee from a supporting institution, the community, or a funding agency, to help investigators and community partners resolve disagreements. It may also be useful, in some situations, to publish a dissenting opinion when investigators and community partners cannot agree on how to interpret findings resulting from a study. These strategies may help address some of the challenges of implementing community-based participatory research.     

Promoting stability and continuity of care for looked after children: a survey and critical review

This paper reports on a two‐pronged research study: a critical review of reported research concerning continuity and stability for children looked after away from home, and a telephone survey of UK managers responsible for looked after children. The review found limited research in this specific field that met the criteria of the critical review, but reports some evidence in favour of sibling co‐placement, kinship care, parental participation, professional foster care and individualized, multidimensional support. The survey revealed a culture of innovation in this field in the UK voluntary and statutory sectors, but with little evaluation of the independent effects of new interventions. The paper places the research in the context of current policy initiatives in the UK and discusses the implications of the findings for research and practice.     

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.     

Reforming the Oversight of Multi-Site Clinical Research: A Review of Two Possible Solutions

The current system for the ethical oversight of clinical research suffers from structural, procedural, and performance assessment problems. Initially conceived primarily to handle local investigator-initiated single-site studies, the system of institutionally-based committee review has become progressively more inefficient given the increased prevalence of commercially or federally sponsored multi-center trials. To date, proposed solutions do not adequately address these problems.

Beginning with a review of these structural, procedural, and performance assessment problems, this article will then consider two proposals for addressing these deficiencies: (a) regional ethics organizations; and (b) IRBNet?, a newly developed web-based program for cooperative IRB review. The strengths and weaknesses of these two approaches will be evaluated in light of recent experience with centralized review. The proposal to establish a system of regional ethics organizations presents a comprehensive approach to many of the problems faced by the current system. However, IRBNet? offers an immediate and feasible solution to many of the problems faced by the review of multi-site clinical studies.     

Child protection social workers' constructions of children and childhood: An integrative review

Social workers' constructions of children and childhood are central to how professionals interact with children and support their needs. The aim of this integrative review was to provide a comprehensive portrayal of child protection social workers' constructions of children and childhood. We analysed and synthesized 35 empirical studies with samples of social workers in the child protection domain where issues regarding the child or the child's situation were the study focus. The findings show that children and youth are constructed as a generalized group viewed in light of their parents. We see a fragmented and context‐free child produced by causal shortcuts strongly informed by specific and, at times, simplified and biased psychological knowledge. Moreover, we identify constructions of the child in need of protection and thereby position children as objects for intervention, separating that from children as subjects in their own rights. Although the participatory child is visible in the data material, the actual practice of involving children seems arbitrary.     

Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices

Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.     

Participation and health – a research review of child participation in planning and decision‐making

Effective child participation in child protection proceedings has proved difficult to achieve in Norway. Although participation is in principle accepted as a human right and something of benefit to children, when children's health is at stake there is a tendency to view participation in decision‐making processes by children as potentially disruptive to their well‐being. The purpose of this study is to review the research evidence for effects, positive or negative, of participation on health outcomes for children in care. A scoping review of major health and social work research databases was undertaken. Searches in five databases yielded 1830 studies of which 21 were finally included in this review. Studies were included if a relationship between health and participation was evident from the data presented, even if this was not the main objective in the study at hand. We conclude that when participation is successful, it may have beneficial side effects. Chief among these are that participation may improve children's safety, increase the success of care arrangements and increase feelings of well‐being for children involved. Evidence for long‐term effects of successful or failed participation attempts on subsequent health outcomes is however largely absent.     

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.     

论应用伦理学的判例模式

应用伦理学的"判例模式"可以取代日益受到质疑的"工程模式"。"判例模式"的运用是在伦理委员会这个"道德实验室"里进行的。它指通过一定的程序,在先前的与现实的道德事件的比较权衡中来解决道德困境,作出道德决策的过程。应用伦理学的"判例模式"的确立,有助于通过一种循序渐进的方法,实现道德与社会需要的动态统一与均衡、创造出新的道德结构。     

'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.