Towards beneficence for young children in research : challenges for bioethics committees

Bioethics committees are the focus of international scrutiny,particularly in relation to their application of the principle of beneficence,ensuring that risks incurred in research are outweighed by benefits to those involved directly and to the broader society. Beneficence, in turn, has become an international focus in research with young children, who hitherto had been rarely seen or heard in their own right in research.Twenty years ago, The United Nations Convention on the Rights of the Child 1989 raised global awareness of children’s human rights to both participation and protection, and articulation of children’s rights came to inform understandings of young children’s rights in research. In the intervening period, countries such as Australia came to favour child protection and risk minimisation in research over the notion of children’s bone fide participation in research. A key element of the protection regime was the theoretical understanding of young children as developmentally unable and, therefore, unfit to understand, consent to and fully participate as research participants. This understanding has been challenged in recent decades by new theoretical understandings of children’s competence, where children can be seen to demonstrate competence, even at an early age, in consenting to, participating in and withdrawing from research. The paper draws on these understandings to provide insights for human research gatekeepers, such as bioethics committees, to deal with the challenges of research with young children and to realize the benefits that may accrue to children in research.

Aspectos bioéticos del trasplante con donantes vivos

Resumen: El 4 de junio de 2010 se solicita al Comité de Bioética del Hospital Privado de Córdoba, Argentina, una consulta para que se analicen los aspectos éticos de un trasplante pulmonar lobar bilateral, con donante vivo relacionado para dos hermanas gemelas de 17 años con diagnóstico de fibrosis quística (Acta 172). Este caso nos permite revisar dos ejes esenciales de la constitución de la Bioética como son las funciones y actuación de los comités de Bioética en las instituciones hospitalarias, y la licitud de los trasplantes de órganos cuando hay donantes vivos. Se justificará la actuación del Comité de Bioética en este caso, analizando los puntos a tener en cuenta y los recaudos y recomendaciones que habrían de considerarse frente a esta situación planteada.

La Déclaration universelle sur la bioéthique et les droits de l'homme : une vision du bien commun dans un contexte mondial de pluralité et de diversité culturelle?

En octobre 2005, l’assemblée générale de l’UNESCO adoptait la Déclaration universelle sur la bioéthique et les droits de l’Homme. Le projet de cette déclaration a été élaboré par le Comité international de bioéthique (CIB) en consultation avec le Comité intergouvernemental de bioéthique (CIGB), les États membres, le comité interagences des Nations Unies, des organisations gouvernementales et non gouvernementales, des comités nationaux d’éthiques et de multiples acteurs impliqués en bioéthique. Cette déclaration faisait suite à deux autres textes sur le même sujet produits en 1997 et 2003, la Déclaration sur le génome humain et les droits de l’homme et la Déclaration internationale sur les données génétiques humaines. Les nouvelles questions éthiques que suscitaient les développements scientifiques et technologiques ainsi que la mondialisation de la recherche avaient incité cette organisation à se doter d’instruments normatifs pouvant rejoindre toutes les nations. Seule organisation mondiale ayant une vocation spécifique en éthique, l’UNESCO a voulu par cette dernière déclaration fournir à ses États membres un cadre normatif susceptible de les aider à formuler des lois et des lignes directrices. Ayant été impliquée, à titre de présidente du Comité international de bioéthique dans la préparation de cet instrument nous nous sommes posée la question suivante : Dans un contexte de mondialisation, une bioéthique qui vise le bien commun universel est-elle possible au sein de la diversité et de la pluralité culturelle des nations ? L’exemple de l’élaboration de la déclaration universelle sur la bioéthique et les droits de l’homme de l’UNESCO. Le bien commun étant un concept fréquemment mentionné et à peu près jamais défini clairement, il nous a semblé intéressant d’en retracer l’histoire et de dégager un cadre conceptuel qui a ensuite servi à étudier et dégager le sens donné à ces concepts dans la préparation de la déclaration. Un premier chapitre présente le contexte et la problématique. Le deuxième chapitre présente la revue de la littérature et la définition des concepts ainsi que le cadre conceptuel. Le troisième chapitre présente le cadre théorique et les données analysées et la méthodologie. Le quatrième chapitre présente l’analyse détaillée des différentes étapes de l’élaboration de la déclaration. Le cinquième chapitre présente la portée et les limites de la thèse et le cinquième chapitre la conclusion. Nous concluons que la déclaration en ayant utilisé une méthode de consultation, de délibération et de consensus pragmatique, offre un texte avec une vision d’un bien commun universel susceptible d’être utilisé dans tous les contextes culturels et par toutes les nations, spécialement les nations en développement. En effet, son architecture flexible et son souci de ne pas catégoriser les principes, mais plutôt de les utiliser en complémentarité les uns avec les autres, en fait un texte souple et adaptable au plan mondial. Ce travail pourra aussi contribuer à enrichir la réflexion et l’action des organisations internationales impliquées en bioéthique. Il pourra aussi inspirer les recherches actuelles en sciences politiques et en droit alors que sont explorés de nouveaux modèles de gouvernance et de nouvelles façons de construire les législations et les normes et de faire face aux défis actuels qui se posent aux droits de l’homme.

Comités de bioética : su constitución y relevancia

Los Comités de Bioética son espacios de deliberación, interdisciplinarios, pluraIistas, críticos. Hay distintos tipos de comités: ética de la investigación, ética asistencial. ética de las organizaciones. Sus Integrantes, además de pertenecer a diferentes profesiones o actividades, deben tener una sólida formación en Bioética. Se promueve su constitución y funcionamiento en las instituciones para contribuir a resolver conflictos donde están en juego los valores morales de las personas.

Committees for ethics in research involving human subjects

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Parliamentary committees are important in developing policy: evidence from a Queensland case study

Abstract This paper uses a case study to identify the impact of a Queensland parliamentary committee on policy. In 2003, the Travelsafe Committee undertook two inquiries investigating young driver and rider issues. In 2007, the Queensland Parliament passed legislation that provided the power to make regulations that changed the graduated driver licensing laws in Queensland. The analysis of the second reading speeches for this bill suggests that parliamentary committees can help set the agenda for government policy. The role of the Travelsafe Committee in this process was recognised by both government and non-government members of Parliament and by those that had been, or were currently, members of the committee and by those that had no membership experience of the Travelsafe Committee prior to the debate of the legislation. This paper suggests that in order for committees to successfully participate in policy work they need to have strong ideas, work to a consistently high standard and the chair needs to be dedicated to the work of the committee. This case study indicates the importance of parliamentary committees in the policy work of a parliament.

Preventing injuries on a state-wide basis : researchers and parliamentary committees are partners in turning injury prevention and safety research into practice and policy

Context: Parliamentary committees established in Westminster parliaments, such as Queensland, provide a cross-party structure that enables them to recommend policy and legislative changes that may otherwise be difficult for one party to recommend. The overall parliamentary committee process tends to be more cooperative and less adversarial than the main chamber of parliament and, as a result, this process permits parliamentary committees to make recommendations more on the available research evidence and less on political or party considerations. Objectives: This paper considers the contributions that parliamentary committees in Queensland have made in the past in the areas of road safety, drug use as well as organ and tissue donation. The paper also discusses the importance of researchers actively engaging with parliamentary committees to ensure the best evidence based policy outcomes. Key messages: In the past, parliamentary committees have successfully facilitated important safety changes with many committee recommendations based on research results. In order to maximise the benefits of the parliamentary committee process it is essential that researchers inform committees about their work and become key stakeholders in the inquiry process. Researchers can keep committees informed by making submissions to their inquiries, responding to requests for information and appearing as witnesses at public hearings. Researchers should emphasise the key findings and implications of their research as well as considering the jurisdictional implications and political consequences. It is important that researchers understand the differences between lobbying and providing informed recommendations when interacting with committees. Discussion and conclusions: Parliamentary committees in Queensland have successfully assisted in the introduction of evidence based policy and legislation. In order to present best practice recommendations, committees rely on the evidence presented to them including the results of researchers. Actively engaging with parliamentary committees will help researchers to turn their results into practice with a corresponding decrease in injuries and fatalities. Developing an understanding of parliamentary committees, and the typical inquiry process used by these committees, will help researchers to present their research results in a manner that will encourage the adoption of their ideas by parliamentary committees, the presentation of these results as recommendations within the report and the subsequent enactment of the committee’s recommendations by the government.

A capabilities-based approach to obtaining a deeper understanding of information technology governance effectiveness : evidence from IT steering committees

Given the substantial investment in information technology (IT), and the significant impact IT has on organizational success, organizations consume considerable resources to manage acquisition and use of their IT resources. While various arguments proposed suggest which IT governance arrangements may work best, our understanding of the effectiveness of such initiatives is limited. We examine the relationship between the effectiveness of IT steering committee driven IT governance initiatives and firm's IT management and IT infrastructure related capabilities. We further propose that firm's ITrelated capabilities generated through IT governance initiatives should improve its business processes and firm-level performance. We test these relationships empirically by a field survey. Results suggest that firms' effectiveness of IT steering committee driven IT governance initiatives positively relates to the level of their IT-related capabilities. We also found positive relationships between IT-related capabilities and internal process-level performance. Our results also support that improvement in internal process-level performance positively relates to improvement in customer service and firm-level performance.

Corporate governance and risk management : the role of risk management and compensation committees

This paper examines the role of compensation and risk committees in managing and monitoring the risk behaviour of Australian financial firms in the period leading up to the global financial crisis (2006–2008). This empirical study of 711 observations of financial sector firms demonstrates how the coordination of risk management and compensation committees reduces information asymmetry. The study shows that the composition of the risk and compensation committees is positively associated with risk, which, in turn, is associated with firm performance. More importantly, information asymmetry is reduced when a director is a member of both the risk and compensation committees which moderate the negative association between risk and firm performance for firms with high risk.

Preventing public sector corruption : the relationship between parliamentary committees and corruption commissions

Parliamentary committees fulfil several important functions within the Parliament, with one of these being the oversight of various agencies including those that are designed to reduce corruption within the police service and other public sector agencies. The cross-party nature of committees combined with the protections of Parliament make them powerful agencies. Prenzler & Faulkner (2010) suggest that the ideal system for an agency that has oversight of a public sector integrity commission should include monitoring by a parliamentary committee, with an inspector attached to the committee. This occurs in Queensland, New South Wales and Western Australia. There has been very little research conducted on the role of parliamentary committees with oversight responsibilities for public sector integrity agencies. This paper will address this gap by examining the relationship between a parliamentary committee, a parliamentary inspector and a corruption commission. Queensland’s Parliamentary Crime and Misconduct Committee (PCMC/the Committee) and the Parliamentary Crime and Misconduct Commissioner (the Commissioner) provide oversight of the Crime and Misconduct Commission (CMC). By focussing on the PCMC and the Commissioner, the paper will examine the legislative basis for the Committee and Commissioner and their respective roles in providing oversight of the CMC. One key method by which the PCMC provides oversight of the CMC is to conduct and publish a review of the CMC every three years. Additionally, the paper will identify some of the similarities and differences between the PCMC and other committees that operate within the Queensland Parliament. By doing so, the paper will provide insights into the relationships that exist between corruption commissions, parliamentary committees and parliamentary inspectors and demonstrate the important role of the parliamentary committee in preventing instances of public sector corruption.

Gender inequities in health research : an Australian perspective

This chapter presents the current challenges facing legislators, regulators, researchers, and ethics committees in determining how and when to include women appropriately in research, and ensure that sex analysis of research results is routinely performed. It offers five issues that require attention to address these challenges: that national regulatory statements could provide researchers with definitions of the terms ‘sex’ , ‘gender’, and ‘gender equity’ in research; that sex and gender analysis should be built into health research protocols; the lack of internationally comparable data regarding the rates of inclusion of men and women presents a major hurdle for analysing the efficacy of different regulatory strategies; the accessibility of data would be facilitated by a requirement for publication of the results of health research to include descriptions of sex analysis performed on research data; and that institutional review boards, research ethics committees, and researchers themselves require better education about the scientific and ethical importance of including of women in clinical research.

Globalisation and Health : Challenges for Health Law and Bioethics

This timely collection explores ethical and legal dilemmas in healthcare arising from globalization. Conflicts between public interests and individual rights, the challenge of regulating professionals and access to health services, and the effects of a global market all feature prominently in contemporary debates in this area. As a result of globalization, issues in health law and bioethics can no longer be understood solely within political boundaries that define traditional notions of individuals and communities. Rather, solutions for emerging problems require a global conception of rights and obligations, including the re-evaluation of ethical frameworks and legal regimes that currently govern exchanges in healthcare. Leading scholars in bioethics, law, medicine and philosophy from various jurisdictions engage these themes in this volume, and demonstrate the need for transnational solutions in a global age of healthcare.