Background: Concern has been expressed about the process of consent to clinical trials, particularly in phase I “first-in-man” trials. Trial participant information sheets are often lengthy and technical. Content-based readability testing of sheets, which is often required to obtain research ethics approval for trials in the USA, is limited and cannot indicate how information will perform. Methods: An independent-groups design was used to study the user-testing performance of the participant information sheet from the phase I TGN1412 trial. Members of the (...) public were asked to read it, then find and demonstrate understanding of 21 key aspects of the trial. The participant information sheet was then rewritten, redesigned and tested on 20 members of the public, using the same 21-item questionnaire. Results: On the original TGN1412 participant information sheet, participants could not find answers and some of the found information was not understood. Six of 21 questions, including those relating to placebo, follow-up visits and the emergency phone number, were found by eight or fewer of 10 participants. The revised information sheet performed better, with the answers to 17 of 21 questions found and understood by all 20 participants. Conclusions: Tests showed that the TGN1412 participant information sheet may not inform participants adequately for consent. Revising its content and design led to significant improvements. Writers of materials for trial participants should take account of good practice in information design. Performance-based user testing may be a useful method to indicate strengths and weaknesses in trial materials. (shrink)

Gillian Rose here follows her masterful critical exposition of Adorno and the Frankfurt School, The Melancholy Science, with a broad interpretation of Hegel focused on contemporary problems of method in the social sciences. Rose aims to retrieve the Hegelian speculative experience, and the first chapter is devoted to the discovery, analysis and unmasking of the barriers which stand in the way of any such rereading. Rose argues that all forms of sociology operate within the narrow limits of a neo-Kantian paradigm (...) of validity and value, first formulated by Lotze. In this, Lotze attempted a Kantian grounding of knowledge via the dual criteria of validity and values; i.e., either theory may be grounded in the validity of necessary truths and given facts, or theory may be grounded in the values of absolute standards. Rose suggests that each of these criteria was later given primacy. In late nineteenth century philosophy the criterion of validity was developed by the Marburg school of neo-Kantian philosophers. The criterion of values was given priority in the work of the Heidelberg school. (shrink)