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

• 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)