Suchergebnisse

Ethical foundations of clinical practice -- Decision making and decisional capacity in adults -- Informed consent and refusal -- Truth telling : disclosure, privacy, and confidentiality -- Special decision-making concerns of minors -- Ethical issues in reproduction -- Special decision-making concerns of the elderly -- Ethical issues in the care of disabled persons -- End-of-life issues -- Palliation -- Justice, health, and access to health care -- Organizational ethics -- Ethics committees and research -- Profile of ethics committees -- Clinical ethics consultation -- Ethics education -- Sample clinical cases -- Sample policies and procedures.

Institutional ethics committees (lECs) in health care facilities now create moral policy, provide moral education, and consult with physicians and other health care workers. After sketching reasons for the development of IECs, this paper first examines the predominant moral standards it is often assumed lECs are now using, these standards being neo-Kantian principles of justice and utilitarian principles of the greatest good. Then, it is argued that a feminine ethics of care, as posited by Carol Gilligan and Nel Noddings, is an unacknowledged basis for /EC discussions and decisions. Further, it is suggested that feminine ethics of care can and should provide underlying theoretical tools and standards for lECs.

The Law of 3 January 2018 established in Italy the "National Centre for the Coordination of Regional Ethics Committees for Clinical Trials of Medicines and Medical Devices for Human Use" and reduced the number of ethics committees in the country to 40. This Act should, amongst other things, facilitate Italy's compliance with the provisions set forth in European Regulation (EU) 536/2014. Hopefully, in addition to the provisions set forth in the Law, the National Centre will strive to foster the harmonisation of ethics committee procedures, in order to reform Italian legislation on the evaluation of clinical trials and, more generally, biomedical studies. Unfortunately, certain organizational and structural conditions do not bode well for the success of the National Centre.

Progress through the application of science cannot be achieved if the results of scientific studies are not communicated appropriately. This is particularly relevant in medical research, where experiments are often conducted on human volunteers. Expensive new innovations cannot be produced without returns for investigators, but the distortion of the evidence base by long term withholding of data, either for financial gain or simply through negligence, can do real harm to patients. To tackle this problem the World Medical Association has set standards for the conduct and dissemination of research, but the sheer number of funders and researchers make it difficult even to identify trials that have been conducted, let alone to discover whether the results have been reported accurately. This problem, called reporting bias, has become increasingly prominent both in the public's consciousness and politically. Efforts to tackle the problem include trial registration, consensus based statements on how to report research, and audit attempts by funders, companies, and research organisations. However, these solutions lack coordination and examine only limited populations of researchers. What is needed is a larger and more systematic method for detecting this substantial ethical problem. The Declaration of Helsinki states that "any experiment involving human beings must be submitted to an independent committee for review, comment, and guidance," and these research ethics committees could hold the answer. For example, in England the Health Research Authority coordinates 66 committees that review the ethical aspects of all research on human participants conducted in the NHS (or subject to certain regulations). Researchers submit an application form and protocol for review, including a clear statement of the intended outcomes and how they will report the study. This process results in a substantial and comprehensive database of trials with human participants. Such databases represent an untapped resource, both for making the objectives and methods of planned trials in human participants available, and for determining whether the research has been reported.

Where did the ethics review process go wrong for qualitative research, and how can we make it right, or at least better? This paper begins with an excerpt from an ethnography of attempting to attend an ethics review-related workshop, which exemplifies that the ethics-review process is based on epistemological assumptions aligned with positivistic research, and does not fit the qualitative research process. We suggest that a new format for ethics review, based on assumptions associated with qualitative research and ethnography, might be a better fit. In this model the researcher becomes the expert and the committee the learner or ethnographer. In this process the ethics review process is guided by four core open-ended questions that facilitate a fuller and richer exchange of information. The second part of this paper presents strategies that may lessen the risks associated with the unknown or emergent aspects of qualitative research. These strategies include a dual consent process and the co-opting of journal editors or thesis review boards to review ethical considerations prior to publication or sign off, and a renewed focus of ethics training.

Timely communication from Research Ethics Committees (REC) to researchers is essential to meet deadlines. We conducted a capacity building program for REC members, REC and research administrators, and researchers from seven RECs in Uganda in order to improve the research regulatory approval cycle. The training was delivered from March 2020 to July 2021. Trainees were evaluated using pre and post-training tests. There was an increase in the average score from 38% to 53% in pre and post-training test respectively for the personal effectiveness and leadership programme for REC and research administrators. There was an increase in the average score of from 53.9% to 70.1% in pre and post-training test respectively for training on emerging and complex study designs. We achieved shift in knowledge and skills in use of the National Research Information Management System. We recommend regular training of REC members and administrators for efficient review of research protocols.

Human Research Ethics Committees have become an established part of the institutional structure of research in the humanities and social sciences over the last two decades in Australia, a development which many in the political disciplines have regarded with ambiguity or outright hostility. My purpose is to consider some of the particular problems which arise for the political disciplines from the form of research ethics review which has become institutionalized in Australia, and to suggest some reforms which would significantly ameliorate these problems. Adapted from the source document.

Ethical evaluation of projects involving animal testing is mandatory within the EU and other countries. However, the evaluation process has been subject to criticism, e.g., that the committees are not balanced or democratic enough and that the utilitarian weighting of harm and benefit that is normally prescribed is difficult to carry out in practice. In this study, members of Swedish Animal Ethics Committees (AECs) completed a survey aiming to further investigate the decision-making process. We found that researchers and animal laypersons make significantly different ethical judgments, and hold disparate views on which ethical aspects are the most relevant. Researchers were significantly more content than laypersons with the functioning of the committees, indicating that the ethical model used suited their preferences better. We argue that in order to secure a democratic and proper ethical evaluation, the expectations of a scientific discourse must be acknowledged, while giving room for different viewpoints. Further, to fulfil the purpose of the project evaluations and meet public concern, the functions of the different AEC member categories need to be clarified. We suggest that one way of achieving a more thorough, balanced and inclusive ethical evaluation is to allow for more than one model of ethical reasoning.