Abstract
Though patient information leaflets (PILs) are provided to those invited to take part in medical research, they usually fall short in facilitating informed decisions about participation. We aimed to explore why there is an enduring requirement for a process that seems not to 'work', and to explain why the problems have proven resistant to correction. We analysed applications for ethical approval for 13 oncology trials and related official guidance. We interviewed 26 patients invited to participate in the trials. Data analysis was based on the constant comparative method. We show that PILs function latently to satisfy purposes other than their manifest function as a decision-facilitating tool. PILs are the outcome of a process of institutional scripting that is strongly shaped by the accountability demands inherent in the ethical review process. This results in the PIL being made to serve purposes both as a prospectus and as a contract. Though PILs have value for some patients, most do not recognise these documents as operating primarily in their interests. Patients make decisions in ways that deviate from official ideals. This analysis is important in recognising that no simple technical fix is available, and in enhancing sociological understanding of the institutional role of documents.
Highlights
Do infor med consent documents for cancer tr ials do what they should? A study of manifest and latent functions
As part of our analysis, we suggest that attention to the latent functions (Merton, 1968) of the patient Information Leaflets (PIL) helps to explain why readability and understanding challenges seem quite so remarkably resistant to correction, and why, even though they often poorly perform their manifest functions and neglect to address patients’ own priorities for communication and decision-making, the PIL remains institutionalized as an indispensible element of research practice
Tracking the PIL as it moves through the ethical review process, from official guidance through to submissions to Research Ethics Committee (REC), negotiations between triallists and RECs, and on to patients as end-users, allowed analysis of the different social functions played by the PIL as it circulates between intersecting social worlds (Star and Griesemer, 1989; Clarke, 2005)
Summary
Do infor med consent documents for cancer tr ials do what they should? A study of manifest and latent functions. PILs are the outcome of a process of institutional scripting that is strongly shaped by the accountability demands inherent in the ethical review process. This results in the PIL being made to serve purposes both as a prospectus and as a contract. Patients make decisions in ways that deviate from official ideals This analysis is important in recognising that no simple technical fix is available, and in enhancing sociological understanding of the institutional role of documents. Providing informed consent documents to candidates for research participation is a longestablished practice, intended to satisfy legal and ethical requirements to respect participants’
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