Regulatory Stewardship of Health Research最新文献

The making of RECs as health research regulators 将RECs作为健康研究监管机构

Regulatory Stewardship of Health Research Pub Date : 2020-02-03 DOI: 10.4337/9781788975353.00008

E. Dove

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Conceptual framework—setting the scene for ‘protection’ and ‘promotion’ 概念框架——为“保护”和“促进”设定场景

Regulatory Stewardship of Health Research Pub Date : 2020-02-03 DOI: 10.4337/9781788975353.00007

E. Dove

{"title":"Conceptual framework—setting the scene for ‘protection’ and ‘promotion’","authors":"E. Dove","doi":"10.4337/9781788975353.00007","DOIUrl":"https://doi.org/10.4337/9781788975353.00007","url":null,"abstract":"Human health research, which can be defined as research into matters relating to people’s physical or mental health, is a formalized, institutionalized, and regulated activity, replete with actors, rules, tools, policies, and diffuse sets of social constraints. Researchers who wish to gather data, investigate questions, test hypotheses, and build new generalizable knowledge on topics that involve human participants confront at the earliest stages of their project design the application of abstract ethical principles such as respect for persons, social value, beneficence, and justice, not to mention rules regarding informed consent and confidentiality. Additionally, researchers confront a panoply of law and regulation. When it comes to health research involving humans, determination of its ethical acceptability has taken a particularly regulated, technocratic, and structured form, with specific groups of individuals wielding power to decide whether a research project may proceed on ethical grounds. This group is known as a research ethics committee (REC), which is also known as an institutional review board (IRB) and research ethics board (REB). This book will explore the mandate and operation of one particular type of REC in the UK, the NHS REC, drawing on both governance instruments and policies and original empirical research. This chapter begins the process by querying whether the practices of these RECs align with their recently established regulatory mandate—as set out in instruments promulgated by the UK government, devolved administrations, and regulatory bodies—which has modified the regulatory environment involving human health research. In particular, it explores a shift from a protectionist model that has been seen by some as paternalistic, with regulators disproportionately focusing on research risks in comparison to research benefits and inexplicably road-blocking otherwise ethical research, to a more broadly facilitative model, undergirded by law, that","PeriodicalId":351584,"journal":{"name":"Regulatory Stewardship of Health Research","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133240934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Charting a framework for regulatory stewardship 制定监管管理框架

Regulatory Stewardship of Health Research Pub Date : 2020-02-03 DOI: 10.4337/9781788975353.00011

E. Dove

{"title":"Charting a framework for regulatory stewardship","authors":"E. Dove","doi":"10.4337/9781788975353.00011","DOIUrl":"https://doi.org/10.4337/9781788975353.00011","url":null,"abstract":"In the previous chapter, I examined the ways in which certain actors in health research—particularly RECs—are affected by regulation, and similarly, the ways in which they can affect regulation. The findings revealed that research ethics review is an essential component of health research regulation and the ethics review system overall appears to be operating relatively smoothly, at least in comparison to previous decades. At the same time, though, the evidence suggests that several regulatory components can be refined. In this chapter, I unpack further the significance of the liminality of RECs and the ability of actors within the health research regulatory space to serve as ‘regulatory stewards’. I do so by taking up the normative dimension of anthropology of regulation, suggesting a model of what a regulatory framework for health research oversight ought to look like if it were to incorporate the findings from this empirical investigation. This would include explicit endorsement of regulatory stewardship and a charting of how protection and promotion can and should work together in regulatory design and practice. This proposed framework has application at two levels, which can be seen as both top-down and bottom-up: (1) the government and managing regulators (e.g. Department of Health and Social Care, HRA), and (2) RECs and regulatees (e.g. researchers, sponsors, institutions). As the evidence in Chapter 5 indicates, RECs are embedded in multiple overlapping, interconnecting regulatory spaces, yet their roles and the roles of other actors are not always manifest in regulation. Further, the conversations between regulators, namely between RECs and the HRA, can be sporadic and at times less effective as compared to the conversations between regulators and regulatees (here, being RECs and researchers). This can cause disconnected spaces to appear within a given regulatory space where hazards may occur. A reformulated framework could work to improve regulatory conversations between actors, provide ongoing","PeriodicalId":351584,"journal":{"name":"Regulatory Stewardship of Health Research","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132761424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Conclusion 结论

Regulatory Stewardship of Health Research Pub Date : 1900-01-01 DOI: 10.4337/9781788975353.00012

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