Substantiating the Social Value Requirement for Research: An Introduction

Rid, Annette; Shah, Seema K.

doi:10.1111/bioe.12321

Cited by 11 publications

(9 citation statements)

References 16 publications

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“…Second, risks to individual trial participants are often justified by the prospect of benefit that would accrue only or primarily to future patients 44,47 . Indeed, Miller and Joffe 39 argue that “risk–benefit assessment, geared to the purpose of clinical trials in developing knowledge to inform health-policy decisions for populations of patients,” is more important to assessing a trial’s ethical permissibility than the presence of equipoise as traditionally understood.…”

Section: Research Ethicsmentioning

confidence: 99%

Designing development programs for non-traditional antibacterial agents

et al. 2019

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In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and non-traditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits that would benefit from extension of current paradigms. Discussion of such potential paradigms should be undertaken by the development community.

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Section: Research Ethicsmentioning

confidence: 99%

Designing development programs for non-traditional antibacterial agents

et al. 2019

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“…Firstly, social value is—compared to scientific value—a more contested concept concerning its meaning as well as its scope, even in clinical research (see e.g. [31,75,76]). Secondly, and related to the first point, applying the requirement of social value specifically to bioethical research seems more difficult than applying the requirement of scientific value.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, more practice-oriented aspects of the quality of bioethics are being currently discussed, for example, concerning Clinical Ethics Support Services [25, 26, 27], ELSI (ethical, legal and social issues) research [28], or ethics in HTA (health technology assessment) [29, 30]. Besides quality, however, also the “social value” of research—as vague the term often is [31]—can be of importance, as social value could be low even when quality is sufficient. Notwithstanding, a more general analysis of the value dimensions of bioethical research is still outstanding and would contribute to an overall estimation of the impact of bioethics on the advancement of research and on societal welfare.…”

Section: Introductionmentioning

confidence: 99%

The value of bioethical research: A qualitative literature analysis of researchers’ statements

2019

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Introduction Value and waste in preclinical and clinical research projects are intensively debated in biomedicine at present. Such different aspects as the need for setting objectives and priorities, improving study design, quality of reporting, and problematic incentives of the academic reward system are addressed. While this debate is also fueled by ethical considerations and thus informed by bioethical research, up to now, the field of bioethics lacks a similar extensive debate. Nonetheless, bioethical research should not go unquestioned regarding its scientific or social value. What exactly constitutes the value of bioethical research, however, remains widely unclear so far. Methods This explorative study investigated possible value dimensions for bioethical research by conducting a qualitative literature analysis of researchers’ statements about the value of their studies. 40 bioethics articles published 2015 in four relevant journals ( The American Journal of Bioethics , Bioethics , BMC Medical Ethics and Journal of Medical Ethics ) were analyzed. The value dimensions of “advancing knowledge” (e.g. research results that are relevant for science itself and for further research) and “application” (e.g. increasing applicability of research results in practice) were used as main deductive categories for the analysis. Further subcategories were inductively generated. Results The analysis resulted in 62 subcategories representing a wide range of value dimensions for bioethical research. Of these, 45 were subcategories of “advancing knowledge” and 17 of “application”. In 21 articles, no value dimensions related to “application” was found; the remaining 19 articles mentioned “advancing knowledge” as well as “application”. The value dimensions related to “advancing knowledge” were, in general, more fine-grained. Conclusions Even though limitations arise regarding the sample, the study revealed a plethora of value dimensions that can inform further debates about what makes bioethical research valuable for science and society. Besides theoretical reflections on the value of bioethics more meta-research in bioethics is needed.

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“…Traditionally, social value has been located in the context of clinical research, but more recently the concept has also been introduced in health systems research and into the global health ethics debate. 29 Whereas the concept, as discussed above, in clinical research focuses on the knowledge to be gained for society in general, in public and global health ethics the requirement seems to have a different role. For instance, according to Nicola Barsdorf and Joseph Millum, social value should be seen as 'a function of expected benefits of the research and the priorities that beneficiaries deserve'.…”

Section: Social Value In Scholarly Debatementioning

confidence: 99%

Social Value

Delden¹,

Graaf²

2021

The Cambridge Handbook of Health Research Regulation

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Social ValueJohannes J. M. van Delden and Rieke van der Graaf introductionThis chapter starts from the assumption that science is a matter of co-creation. To open up science to democracy means that we have to think about the social value of research, which in itself we cannot leave to science to evaluate. This raises detailed questions around patient and public involvement (PPI) in deciding which research to perform, and about how to handle conflicts between individual and public interests. These are addressed elsewhere in this volume. 1 In this chapter we focus on social value in health-related research involving humans, including data driven research. We first describe the background to the concept of social value and its meaning. Then we examine the concept itself and define the social value of an intervention as the value that an intervention could eventually have on the well-being of groups of patients and/or society. We also discuss some of the open issues in the scholarly debate about the concept of social value.We find that to state a requirement for social value is one thing; to actually evaluate the social value of a research project in a Research Ethics Committee (REC) is another. We therefore elaborate on how the requirement of social value can be applied. We argue, first, that it is important to have this requirement as a separate condition. To increase systematisation, we further discuss how social value can be assessed in the steps that together constitute the riskbenefit task of RECs.Returning to our opening statement, we argue that the addition of the requirement of social value can be seen as a consequence of a change in the sociology of science. It illustrates the move away from a science-internal understanding of scientific validity into an inclusive understanding of social value. Accepting social value as a requirement for research to be evaluated by a REC means that social value has matured from an attractive but illusive idea into something that has to be assessed, evaluated and optimised and can be used to address some of the justice issues in healthcare.

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Substantiating the Social Value Requirement for Research: An Introduction

Cited by 11 publications

References 16 publications

Designing development programs for non-traditional antibacterial agents

Designing development programs for non-traditional antibacterial agents

The value of bioethical research: A qualitative literature analysis of researchers’ statements

Social Value

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