Ethical Review of Research on Human Subjects at Unilever: Reflections on Governance

Sheehan, Mark; Marti, Vernon; Roberts, Tony

doi:10.1111/bioe.12040

Cited by 2 publications

(1 citation statement)

References 7 publications

(5 reference statements)

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“…To our best knowledge, a similar in-depth nationwide survey on the practice of RECs reviewing academic research projects involving human subjects has never been conducted in Czechia or in any other European country. According to the published literature, the process of ethical review of research projects was analyzed for RECs in UK [7,8,9], Germany [10], in Australia particularly for research with participation of social workers [11] or for commercial research on human subjects in Unilever as a large multinational company [12]. Nevertheless, these studies were not based on direct surveys among REC members and provided only the external analyses of the REC functioning in the countries or companies, respectively.…”

Section: Discussionmentioning

confidence: 99%

Human research subjects and current practice of research ethics committees in Czech academic environment: national regulation is urgently needed

Veselska,

Sirucek,

Kure

2024

Preprint

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Background: The primary objective of this study was to conduct a comprehensive questionnaire survey on the practices of research ethics committees that review academic research projects, specifically related to the Additional Protocol on Biomedical Research CETS No. 195, which was ratified and implemented in 2020. The study aims to provide an unbiased and objective assessment of the current practices employed by the research ethics committees. This research is unique and has never been conducted in Czechia. Methods: To assess the situation, we developed an online questionnaire containing 18 questions concerning several aspects of the functioning of research ethics committees. The questionnaire was in Czech language and was administered through the Qualtrics platform anonymously. The target group of 61 RECs at research institutions was approached by emails and we received 43 completely filled questionnaires, i.e., response rate of 67%. Results: We obtained valuable data on the functioning of research ethics committees in Czechia in three main domains: the mandate and composition of the committee; the scope of its agenda; the process of evaluation including the voting procedure. From the results is evident that even more than twenty years after the ratification of the Oviedo Convention ETS No. 164 and three years after the ratification of its Additional Protocol on Biomedical Research CETS No. 195, the responsible assessment of the ethics of research involving human subjects is still not satisfactorily addressed and established for routine practice in Czechia. Conclusions: The outcomes of our study revealed that the main problem of research ethics in Czechia is the lack of national legislation on research ethics governance. To address this problem, the country requires a legislation framework accompanied by supportive measures aimed at guiding and assisting research ethics committees in the Czech academic environment.

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Section: Discussionmentioning

confidence: 99%

Human research subjects and current practice of research ethics committees in Czech academic environment: national regulation is urgently needed

Veselska,

Sirucek,

Kure

2024

Preprint

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Authority and the Future of Consent in Population-Level Biomedical Research

Sheehan

Thompson

Fistein³

et al. 2019

Public Health Ethics

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Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach.

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Ethical Review of Research on Human Subjects at Unilever: Reflections on Governance

Cited by 2 publications

References 7 publications

Human research subjects and current practice of research ethics committees in Czech academic environment: national regulation is urgently needed

Human research subjects and current practice of research ethics committees in Czech academic environment: national regulation is urgently needed

Authority and the Future of Consent in Population-Level Biomedical Research

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