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Table 3 Examples of justifications given for not involving the public in research

From: Public involvement could usefully inform ethical review, but rarely does: what are the implications?

• Experienced professionals (clinicians and researchers) have already developed the study design
• Commercial sensitivities in relation to clinical trials
• Phase 1 or 2 trials with healthy volunteers, and little room to influence study design
• Concerns about access to confidential data
• Highly technical nature of the research means that patients/ the public would lack the knowledge/ skills required
• Lack of resources
• Research involves basic science or minimal participation of patients e.g. use of a biopsy sample
• Challenges of finding patients to involve (e.g. people infected by extremely rare conditions)
• Challenges of involving children in research
• Little room for patients to influence the design of the study e.g. comparison of two technical measures
• The study was designed outside of the UK so no involvement of UK patients
• The study is a pilot study or proof of concept study
• The responsibility for the design of the study lies with the sponsor
• The study does not require any deviation from routine clinical practice
• The study is using the same approach as a previous study and therefore no new issues for patients to consider
• Involvement is not necessary or appropriate for the study (without stating why)