Research Ethics Boards and Challenges for Public Participation
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Notice bibliographique
Résumé
Background Governments increasingly emphasize the importance of public input in processes related to policy and decision making. (1) Over the last decades, public input has become standard practice in, for example, prioritizing the funding of research, (2) health service planning, (3) public health, (4) and on research ethics boards. (5) Prior to implementing a research study, all research protocols must be reviewed and approved. Furthermore, as established by the Nuremberg Code (6) (1947) and the World Medical Association Declaration of Helsinki (7) (1964), potential research participants are expected to have sufficient knowledge of the research project to make voluntary and informed choices. Research Ethics Boards (REBs) have been instituted to assess the risks and benefits of the research, (8) to review the rights and welfare of the participants, to monitor the informed consent process, and to safeguard the privacy and confidentiality rights of the participants. (9) The principal role of the REB historically has been to review whether the research protocol respects these ethical standards so as to protect the interests of research participants. However, it has become incumbent upon REBs to embrace a wider mandate that includes enhanced transparency and accountability towards the public, to increase public understanding of the issues hand, and to ensure respect for broader community values. UNESCO's guidance documents for establishing and operating REBs serve as a case in point as they embrace this broader vision. In their Guide No. 1 Establishing Bioethics Committees, and in Guide No.2 Bioethics Committees Work: Procedures and Policies, (10) research ethics reviews are deemed the public's business. In Guide no. 1, UNESCO states that, In an increasingly open and critical society, institutions are concerned for their public image. They are concerned about their integrity and reliability. In some countries it creates anxiety to minimize the risk of lawsuits. Committees demonstrate that scientists and health professionals seek guidance from peers, groups and committees in order to share responsibility. (11) Moreover, UNESCO continues that, ... scientific decision-making is no longer simply a one-on-one affair and that researchers and health care personnel must be responsive to a variety of publics. When there are bioethical conflicts, their resolution may not be achieved simply by appealing to scientific and medical judgements alone. Policy decisions will have to be taken that extend far beyond a single researcher or physician's expertise. (12) In light of these statements and to gain a better understanding of the role of community members on REBs, this paper explores several questions: i) Who is the public? ii) Why involve the public? iii) What role should the public representatives play on the REB? iv) Does the public representative need a certain level of education and training to participate on the REB? and v) How are the contributions of the public representatives to the REB evaluated? Each of these questions may have important implications for REBs in determining how best to implement the recommendations regarding the presence of a public or community member on a research ethics board. Although the focus of this article is on these questions, we begin with an overview of the situation of community representation in REBs in Canada. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) advocates the inclusion of at least one person not affiliated with the organization ... who are using the services. (13) Article 1.3 (d) states: The Agencies consider it essential that effective community representation be maintained. Thus as the size of an REB increases beyond the minimum of five members, the number of community representatives should also increase. …
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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 | 0,007 | 0,014 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,004 | 0,001 |
| Communication savante | 0,000 | 0,004 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,006 |
| 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