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Improving information for research participation
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Shearman, Kirstie Heidi (2022) Improving information for research participation. PhD thesis, University of Warwick.
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Official URL: http://webcat.warwick.ac.uk/record=b3849948
Abstract
Rationale: The provision of information, usually through a written participant information sheet (PIS), is thought to protect potential participants’ autonomy by facilitating informed participation decisions. While previous work suggests that PISs are ineffective in achieving this aim, relatively little is known about how PISs are developed and with what purpose/s in mind.
Objective: To undertake a detailed study of PIS design processes and the attitudes/views underpinning them in order to propose policy recommendations for improving the provision of information in health research.
Method: An empirical bioethics approach is employed, combining a philosophical analysis with the collection and analysis of empirical data. A document analysis of existing PISs (n=90) identified changes made to PISs throughout the development process. Qualitative interviews (n=41) explored what information stakeholders included in PISs, and the overall design, purpose, and use of PISs. Ethical insights are used to examine how stakeholders viewed and understood relevant ethical concepts, and to make normative judgements about the defensibility of PIS design processes and underlying views.
Results: Information was added, but rarely removed, at each stage of the design process. Some additions were not thought to aid participants. Stakeholders identified several purposes of the PIS. Tools for PIS design were thought to be lacking, and some stakeholder groups were thought to act outside of their remit.
Conclusions: PISs justifiably serve different stakeholders in different ways, and greater awareness and acceptable of this would improve PIS design. Better tools and training for those who develop PISs will enable authors/reviewers to produce PISs that better achieve all intended purposes. This will be bolstered by a reconfiguration of the roles and responsibilities of each stakeholder group involved in PIS design. Drawing on these conclusions, five recommendations for policy are proposed.
Item Type: | Thesis (PhD) | ||||
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Subjects: | Q Science > Q Science (General) R Medicine > R Medicine (General) |
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Library of Congress Subject Headings (LCSH): | Clinical trials -- Methodology, Clinical medicine -- Research -- Methodology, Data collection, Informed consent (Medical law), Medical ethics | ||||
Official Date: | January 2022 | ||||
Dates: |
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Institution: | University of Warwick | ||||
Theses Department: | Warwick Medical School | ||||
Thesis Type: | PhD | ||||
Publication Status: | Unpublished | ||||
Supervisor(s)/Advisor: | Draper, Heather ; Moorlock, Greg | ||||
Sponsors: | Warwick Medical School | ||||
Format of File: | |||||
Extent: | xii, 346 leaves : charts | ||||
Language: | eng |
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