ABSTRACT
INTRODUCTION: The most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by encouraging enrollment preferentially among the poor. Neither of these concerns has been shown to manifest in studies testing the effects of incentives on decisions to participate in hypothetical randomized clinical trials (RCTs), but neither has been assessed in real RCTs. METHODS AND ANALYSES: We are conducting randomized trials of real incentives embedded within two parent RCTs. In each of two trials conducted in parallel, we are randomizing 576 participants to one of three incentive groups. Following preliminary determination of patients' eligibility in the parent RCT, we assess patients' research attitudes, demographic characteristics, perceived research risks, time spent reviewing consent documents, ability to distinguish research from patient care, and comprehension of key trial features. These quantitative assessments will be supplemented by semi-structured interviews for a selected group of participants that more deeply explore patients' motivations for trial participation. The trials are each designed to have adequate power to rule out undue and unjust inducement. We are also exploring potential benefits of incentives, including possible increased attention to research risks and cost-effectiveness.
Subject(s)
Decision Making , Informed Consent , Motivation/ethics , Patient Participation , Patient Selection/ethics , Attitude to Health , Coercion , Comprehension , Humans , Perception , Randomized Controlled Trials as Topic , Research Subjects , Risk , Therapeutic MisconceptionABSTRACT
Students who entered nurse training from September 2007 onwards are required to have a sign-off mentor (SOM) in their final clinical placement. The sign-off mentor is responsible for confirming to the Nursing and Midwifery Council (NMC) that a student nurse has met all the requirements of pre-registration clinical assessment and can be registered as a nurse. This became mandatory in September 2010, and this article describes how one acute NHS foundation Trust implemented and managed this process, with contributions from practice education facilitators, an SOM and a student.
