A new horizon in health research ethics

Kurihara, Chieko

doi:10.4324/9780429318436-13

Cited by 3 publications

(3 citation statements)

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“…Among all, the 2016 revision of the Guidelines for Health-related Research by the Council for International Organizations of Medical Sciences (CIOMS) recommends community engagement from the early stage of research and development in order to ensure product availability in this target community ( Council for International Organizations of Medical Sciences, 2016 ). This requires several structural reformations of internal mechanisms of research and development ( Kurihara et al, 2021 ) to achieve distributive justice of allocation of the risks and benefits among the relevant stakeholders, most importantly, the study target individuals and communities, which could lead to the fairness of benefit sharing.…”

Section: The Advancement Of Medicines Development Methodologies and T...mentioning

confidence: 99%

Utilization of genetic information for medicines development and equitable benefit sharing

Matsuyama¹,

Kurihara²,

Crawley³

et al. 2023

Front. Genet.

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Advances in genomic research have significantly enhanced modern drug development. However, equitable benefit sharing of the results of scientific advancement has not always been achieved. This paper shows how molecular biology has modified medicines development while also leaving open significant challenges for benefit sharing. Presented here is a conceptual modeling describing the processes in genetic-related medicines development and how these are related to specific ethical considerations. The focus is on three important areas: 1) population genetics and the need for discrimination prevention; 2) pharmacogenomics and the need for inclusive governance; and 3) global health to be achieved in open science frameworks. Benefit sharing is taken as the ethical value that underlies all these aspects. The implementation of benefit sharing requires a value shift in which the outcomes of health science are not viewed simply as trade commodities but also as a “global public good”. This approach should lead to genetic science to contribute to promoting the fundamental human right to health to all members of the global community.

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Section: The Advancement Of Medicines Development Methodologies and T...mentioning

confidence: 99%

Utilization of genetic information for medicines development and equitable benefit sharing

Matsuyama¹,

Kurihara²,

Crawley³

et al. 2023

Front. Genet.

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“…The DoH has been the model for more than half a century with its paternalistic nature to clarify an individual physician’s obligation to an individual patient ( 46 ). Meanwhile, authors participate in the Ethics Working Group (EWG) of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP).…”

Section: Future-oriented Framework For Co-creationmentioning

confidence: 99%

“…It is worth noting that our comments for the revision of the DoH have been constructed through extensive communication with and learning from patient and public positioning groups or individuals. For example, in Japan, patients and citizens, who have been well emancipated through a systematic educational programme (48), have expressed their own opinions on the DoH (15) with the aspiration for social value in research, ensuring the dignity and rights of research participants.…”

Section: Interdisciplinary Study Team and Patient Public Involvementmentioning

confidence: 99%

Declaration of Helsinki: ethical norm in pursuit of common global goals

Kurihara,

Kerpel-Fronius,

Becker

et al. 2024

Front. Med.

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The World Medical Association’s Declaration of Helsinki is in the process of being revised. The following amendments are recommended to be incorporated in pursuit of the common goal of promoting health for all. 1. Data-driven research that facilitates broad informed consent and dynamic consent, assuring participant’s rights, and the sharing of individual participant data (IPD) and research results to promote open science and generate social value. 2. Risk minimisation in a placebo-controlled study and post-trial access to the best-proven interventions for all who need them. 3. A future-oriented research framework for co-creation with all the relevant stakeholders.

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Vulnerability, social value and the equitable sharing of benefits from research: beyond the placebo and access debates

Kurihara,

Greco,

Dhai

et al. 2024

Front. Med.

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The vulnerability of research participants is a critical topic for the 2024 revision of the Declaration of Helsinki, with the proposal to include “social value. ” However, this proposal has been withdrawn and the relationship between the two concepts has not been clarified. This paper attempts to clarify: (1) the recent reform for the ethical inclusion of vulnerable study participants to promote diversity; (2) the social value, prerequisite for everyone, especially for those who are vulnerable and the most in need; (3) the requirements for promoting the inclusion of vulnerable participants, in particular the review of the norms for placebo-controlled trials and post-trial access; (4) finally, the direction of research ethics reform to achieve social value and equitable global health.

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A new horizon in health research ethics

Cited by 3 publications

References 0 publications

Utilization of genetic information for medicines development and equitable benefit sharing

Utilization of genetic information for medicines development and equitable benefit sharing

Declaration of Helsinki: ethical norm in pursuit of common global goals

Vulnerability, social value and the equitable sharing of benefits from research: beyond the placebo and access debates

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