Ethical Challenges and Evolving Practices in Research on Ethics in Health Research
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Notice bibliographique
Résumé
Introduction 'Research ethics' are moral principles guiding research, from its inception through to completion and publication of results and beyond. (1) Ethical review offers guidelines concerning the rights, dignity and safety of human subjects, and plays a critical role in governance, the formalized system set in place to maintain and monitor the integrity of the research enterprise. (2) Although ethical issues in health research are well documented, empirical evidence based on the experiences of those involved in research, is limited. Such knowledge could enhance understanding of the research process and research ethics and underpin an evidence-based system of human subject protection. (3) The current oversight system does not systemically assess performance and outcomes in health research. (4) As noted by the Institute of Medicine a systems-based approach to protecting research participants is needed, but absence of sufficient data regarding human research activities significantly impedes the examination of system performance. (5) In this paper we identify some of the ethical challenges that both researchers and reviewers face when conducting or reviewing human subject health research. We also describe evolving practices for conducting research on ethical aspects of health research and show how empirical evidence which explores the perspectives of those involved in research can improve research governance. An evidence-based foundation for research ethics is particularly timely in the context of structural, organizational and political changes which continue to reverberate through the research community. The traditional model of researcher--subject relationship scrutinized by a local REB has been replaced by an increasingly complex model in a dynamic landscape of large-scale multidisciplinary, multi-investigator, multi-site and often global projects. Such developments introduce complications to health research. For example, multidisciplinary projects require negotiation between investigators and institutions about issues on which there may be disagreement (e.g. the securing of informed consent and defining minimal risk). Further complications may arise in multi-site or international studies where traditional notions of autonomy in the consent process may be a source of disagreement between individualistic and community based models. There have also been significant funding changes. For instance, there has been a huge increase in the number of drug and device trials being undertaken in the private sector that are often conducted or coordinated by contract research organizations. (6) Moreover, the increasing adoption of participatory action research has, in some cases, transformed the once passive human subject to an active research participant, with significant implications for the priorization of core values informing ethical review as well as research practice. (7) Approaches to Research on Ethical Aspects of Health Research Given the emerging complexities of research and the paucity of systematic evidence on the utility of ethics review and governance, a fresh, evidence--based approach is timely. Exploring the research process from multiple perspectives within the health research community (i.e. clinical and social science researchers, REB members, sponsors and policy makers) alongside subject perspectives would add valuable insight to the health research and ethics process. Systematic scrutiny of diverse standpoints allows comparisons to be made, and similarities and differences to be identified, revealing key challenges for ethical oversight of health research involving humans. This could yield new awareness of significant differences in risk predictions by REBs (private and public), researchers, and research subjects, (8) or varied views on the provision of information dissemination in clinical trials. (9) Canada could play a leading role in developing a research agenda that would contribute to a systematic body of evidence on research ethics. …
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,037 | 0,067 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,003 | 0,003 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,000 | 0,002 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,031 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle