In this article we examine ethical aspects of the involvement of children in clinical research, specifically those who are incapable of giving informed consent to participate. The topic is, of course, not a new one in medical ethics but there are some tensions in current guidelines that, in our view, need to be made explicit and which need to be responded to by the relevant official bodies. In particular, we focus on tensions between the World Medical Association Declaration of Helsinki, (...) and the guidance offered by the British Medical Association, the Royal College of Paediatrics and Child Health , and the Council for International Organizations of Medical Sciences. We conclude with a call for these organisations to make their guidance explicit in relation to the World Medical Association Declaration. (shrink)

Neuroimaging has provided insight into numerous neurological disorders in children, such as epilepsy and cerebral palsy. Many clinicians and investigators believe that neuroimaging holds great promise, especially in the areas of behavioral and cognitive disorders. However, concerns about the risks of various neuroimaging modalities and the potential for misinterpretation of imaging results are mounting. Imaging evaluations also raise questions about stigmatization, allocation of resources, and confidentiality. Children are particularly vulnerable in this milieu and require special attention with regards to safety (...) guidelines and modality adaptations. This article examines pediatric neuroimaging practice through an ethics lens. Most authors in the field of neuroethics focus on the future concerns of neuroimaging. In contrast, our paper examines ethical matters surrounding current clinical applications in the pediatric population. We first provide a brief overview of the neuroimaging technologies most commonly used in a pediatric clinical context and then discuss a variety of ethical issues arising from the use of these technologies. (shrink)

Objective: To examine how research ethics boards review research projects in emerging disciplines such as functional neuroimaging.Design: To compare the criteria applied and the decisions reached by REBs that reviewed the same mock research protocol in functional neuroimaging.Participants: 44 Canadian biomedical REBs, mostly working in public university or hospital settings.Main measurements: The mock research protocol “The Neurobiology of Social Behavior” included several ethical issues operating at all three levels: personal, institutional and social. Data consisting of responses to closed questions were (...) analysed quantitatively. Qualitative analysis of open-question responses used mixed classification.Results: Similar criteria were used by most participating REBs. Yet the project was unconditionally approved by 3 REBs, approved conditionally by 10 and rejected by 30.Conclusions: The results point to the difficulty for REBs of reviewing all kinds of research projects, regardless of field, by relying on international and national norms framed in general terms and a possible variation between REBs in the interpretation of their mandate for the protection of research subjects. (shrink)

Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable (...) amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration. (shrink)

Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable (...) amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration. (shrink)

Research ethics committees are charged with providing an opinion on whether research proposals are ethical. These committees are overseen by a central office that acts for the Department of Health and hence the State. An advisory group has recently reported back to the Department of Health, recommending that it should deal with inconsistency in the decisions made by different RECs. This article questions the desirability and feasibility of questing for consistent ethical decisions.

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§ 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped (...) IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria. (shrink)

In a recent paper Edwards, Kirchin, and Huxtable have argued that research ethics committees (RECs) are often wrongfully paternalistic in their approach to medical research. They argue that it should be left to competent potential research subjects to make judgments about the acceptability of harms and benefits relating to research, and that this is not a legitimate role for any REC. They allow an exception to their overall antipaternalism, however, in that they think RECs should have the power to prohibit (...) the use of financial inducements to recruit research subjects into trials. In this paper it is argued that these claims are unjustified and implausible. A sketch is provided of an alternative model of the role of the REC as an expert body making judgments about the acceptability of research proposals through a consensual weighing of different moral considerations. (shrink)

Introduction: Variation across research ethics boards in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy.Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study (...) with open-ended responses. Interviews were recorded, transcribed and coded manually.Results: Fourteen sites required individual patient consent for the study to proceed as proposed. Three indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites did not require consent. Two suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites required full committee review. Sixteen allowed an external research assistant to abstract information from the health record.Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions. (shrink)

The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated in research (...) are not greater than those encountered during the performance of routine physical or psychological examinations or tests”. (shrink)

Objectives: Clinical trials in humans in Germany—as in many other countries—must be approved by local research ethics committees . The current study has been designed to document and evaluate decisions of chairpersons of RECs in the problematic field of non-therapeutic research with minors. The authors’ purpose was to examine whether non-therapeutic research was acceptable for chairpersons at all, and whether there was certainty on how to decide in research trials involving more than minimal risk.Design: In a questionnaire, REC chairpersons had (...) to evaluate five different scenarios with non-therapeutic research. The scenarios described realistic potential research projects with minors, involving increasing levels of risk for the research participants. The chairpersons had to decide whether the respective projects should be approved.Methods: A total of 49 German REC chairpersons were sent questionnaires; 29 questionnaires were returned. The main measurements were approval or rejection of research scenarios.Results: Chairpersons of German RECs generally tend to accept non-therapeutic research with minors if the apparent risk for the participating children is low. If the risk is clearly higher than “minimal”, the chairpersons’ decisions differ widely.Conclusion: The fact that there seem to be different attitudes of chairpersons to non-therapeutic research with minors is problematic from an ethical point of view. It suggests a general uncertainty about the standards of protection for minor research participants in Germany. Therefore, further ethical and legal regulation of non-therapeutic research with minors in Germany seems necessary. (shrink)

Research ethics committees—animal ethics committees for animal-based research and institutional research boards for human subjects—have a key role in research governance, but there has been little study of the factors influencing their effectiveness. The objectives of this study were to examine how the effectiveness of a research ethics committee is influenced by committee composition and dynamics, recruitment of members, workload, participation level and member turnover. As a model, 28 members of AECs at four universities in western Canada were interviewed. Committees (...) were selected to represent variation in the number and type of protocols reviewed, and participants were selected to include different types of committee members. We found that a bias towards institutional or scientific interests may result from a preponderance of institutional and scientist members, an intimidating atmosphere for community members and other minority members, recruitment of community members who are affiliated with the institution and members joining for reasons other than to fulfil the committee mandate. Thoroughness of protocol review may be influenced by heavy workloads, type of review process and lack of full committee participation. These results, together with results from the literature on research ethics committees, suggested potential ways to improve the effectiveness of research ethics committees. (shrink)

BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs (...) can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.ConclusionOutcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed? (shrink)

To protect the welfare and rights of participants in research and to facilitate research that will be of benefit, as well as protect them against litigation, universities and research-funding agencies in Australia adopted the National Statement on Ethical Conduct in Research Involving Humans (NHMRC 1999).1 In many other countries there are similar statements. However, the ways in which such statements are often implemented by Human Research Ethics Committees (HRECs) 2 are in conflict with an important stream of industrial sociological research. (...) This stream seeks to deconstruct workplaces and de-layer management rhetoric to understand the realities and complexities of the social relations of production. There is a pluralist basis for much industrial sociology that challenges the unitarist view of the workplace as essentially harmonious. While views of workplaces as being conflictual and exploitative have to be tempered with an understanding of the accommodative and cooperative nature of workplace relations, there is nevertheless a general recognition of acts of resistance, as well as those of cooperation. The way in which the National Statement is typically implemented in Australia means that many HRECs require written, informed consent, which in the first instance will usually be that of management. An unintended consequence is a research focus on consensus, which is at best one-sided and at worst seriously misleading. It is unlikely that managerial consent will be granted unless there is a ‘good news story’ guaranteed. This article explores the ways in which HRECs may influence workplace research. The publication of the revised National Statement provides a valuable opportunity not to be missed by HRECs to implement more effective and efficient practices which would not have the unintended consequences of the earlier version. This would deserve the support of researchers in industrial sociology and other branches of the social sciences. (shrink)