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The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams.

ABSTRACT: The complexity of developing and applying increasingly sophisticated new medicinal products has led to the participation of many non-medically qualified scientists in multi-disciplinary non-clinical and clinical drug development teams world-wide. In this introductory paper to the "IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists" it is argued that all members of such multidisciplinary teams must share the scientific and ethical responsibilities since they all influence directly or indirectly both the outcome of the various phases of the medicines development projects and the safety of the research subjects involved. The participating medical practitioner retains the overriding responsibility and the final decision to stop a trial if the well-being of the research subjects is seriously endangered. All the team members should follow the main ethical principles governing human research, the respect for autonomy, justice, beneficence and non-maleficence. Nevertheless, the weighing of these principles might be different under various conditions according to the specialty of the members.

SUBMITTER: Kerpel-Fronius S

PROVIDER: S-EPMC6130227 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams.

Kerpel-Fronius Sandor S Becker Sander S Barrett Jane J Brun Johan J Carlesi Roberto R Chan Anthony A Collia Luis F LF Dubois Dominique J DJ Kleist Peter P Koski Greg G Kurihara Chieko C Laranjeira Luis F LF Schenk Johanna J Silva Honorio H

Frontiers in pharmacology 20180903

The complexity of developing and applying increasingly sophisticated new medicinal products has led to the participation of many non-medically qualified scientists in multi-disciplinary non-clinical and clinical drug development teams world-wide. In this introductory paper to the "IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists" it is argued that all members of such multidisciplinary teams must share the scientific and ethical responsibilit ...[more]

PMID: 30233356

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Project description:In commercial aviation, fatigue is defined as a physiological state of reduced mental or physical performance capability resulting from sleep loss, extended wakefulness, circadian phase, and/or workload. The International Civil Aviation Organisation mandates that responsibility for fatigue risk management is shared between airline management, pilots, and support staff. However, to date, the majority of research relating to fatigue mitigations in long range operations has focused on the mitigations required or recommended by regulators and operators. Little research attention has been paid to the views or operational experience of the pilots who use these (or other) mitigations. This study focused on pilots' views and experiences of in-flight sleep as the primary fatigue mitigation on long range flights. It also sought information about other fatigue mitigation strategies they use. Thematic analysis was used to explore written comments from diary and survey data collected during long range and ultra-long range trips (N = 291 pilots on three different aircraft types, 17 different out-and-back trips, and four airlines based on three continents). The findings indicate that the recommended fatigue mitigation strategies on long-haul flights (particularly in-flight sleep) are effective and well-utilised, consistent with quantitative findings from the same trips. Importantly however, the analyses also highlight areas that require further investigation, including flight preparation strategies in relation to the uncertainty of in-flight break allocation. There were two strategies for sleep prior to a flight: maximising sleep if pilots were expecting later breaks in the flight; or minimising sleep if they were expecting breaks earlier or at unfavourable times in the circadian cycle. They also provide a broader view of the factors that affect the amount and quality of pilots' in-flight sleep, about which evidence has previously been largely anecdotal. The study underscores the value of including the views and experience of pilots in fatigue risk management.

Project description:IntroductionCorporate social responsibility (CSR) practices refer to the deliberate actions and strategies implemented by a company or organization to generate positive outcomes for its stakeholders beyond the sole objective of profit maximization. Internal CSR is a significant management and investment concept within enterprises, such as hospitals, that enhances organizational performance excellence.ObjectivesThe article aims to trace how hospitals thrive in nurses' job performance by leveraging internal CSR practices.MethodsCross-sectional design quantitative research through structured questionnaire interviews on 215 nurses in Vietnam. Data collection was conducted from May 2023 to August 2023. Partial least squares structural equation modeling was applied to test the hypotheses.ResultsThe study has proven that a hospital's internal CSR practices impact nurses' job performance. Income and benefits, human resource training and development, and work-related quality of life directly and significantly impact three dimensions of a nurse's job performance (competence to practice patient care, attitude to performance work, and management and professional development capacity). Connection and trust in the workplace and health and safety at work significantly affect two dimensions of a nurse's job performance (namely, competence to practice patient care and attitude to performance work). Diversity in the workplace impacts nurses' competence in practicing patient care and their management and professional development capacity. Demographic variables did not correlate statistically significantly with dimensions of internal CSR and nurses' job performance.ConclusionThe study presents significant findings on the influence of internal CSR on nurses' job performance within the hospital management theory of an emerging market. The results of the present study contribute to a better understanding of the benefits of hospitals' socially responsible actions and contribute further to resource management in hospitals, especially nursing. If the nursing staff positively perceives the hospital's internal CSR practices, they will be more able to perform their job, impacting the hospital's overall performance. This study has certain limitations regarding the representative nature of the sample, the use of the self-report survey instrument, and the use of cross-sectional data.

Dataset Information

The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams.

Publications

The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams.

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