Prior to any research data collection a proposal outlining methods and protocols is required to undergo ethical scrutiny. The issues surrounding a research ethics review process within sport and exercise science departments are not dissimilar to other subject areas. In particular, the ethical review process may be unclear to the researcher and can either present a difficult and time-consuming challenge or be merely perceived as a tick-box exercise. The aim of this study was to explore and compare research ethics processes (...) and decisions within sport and exercise science departments and institutions across the UK. Participants were asked to provide decisions and justification of those decisions on ten typical sports and exercise science proposals. Results found that all respondents cited evidence of informed consent and subject information sheets, detailed methodology and data protection procedures as highly important across all scenarios. Additionally it was found that similar processes occur regarding research ethical scrutiny and similar decisions are made at the departmental level. However, confidence fluctuates for individuals when reviewing in non-specialist subject areas and qualitative data collected calls for more research ethics training. (shrink)

This is the fourth in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper explores the role of ethics committees in reviewing proposed conditions for recruiting human subjects and in checking the intended procedures for gaining consent. In so doing the paper will reiterate the conditions which are traditionally thought to make (...) consent valid, identify a number of limitations to meeting these conditions, and show when consent, however broadly construed or indeterminately focused, may be unnecessary. (shrink)

This systematic review identifies and critically evaluates instruments that have been developed to measure clinical trial informed consent comprehension in non-cognitively-impaired adults. Literature searches were carried out on Medline (Ovid), PsycInfo, CINHAL, ERIC, ScienceDirect, and Cochrane Library for English language articles published between January 1980 and September 2008. Instruments were excluded if they focused on consent onto paediatric trials, the construct under study was primarily capacity or competency, or the instrument was developed specifically for psychiatric or cognitively-impaired populations. Instruments selected (...) for review were evaluated against the following criteria: (1) method of item generation; (2) type and format of test items; (3) administration and interpretation of test results; and (4) psychometric properties. Three instruments met our defined inclusion criteria: the Deaconess Informed Consent Comprehension Test (DICCT), the Quality of Informed Consent (QuIC) questionnaire and the Brief Informed Consent Protocol (BICEP). Each instrument varied in terms of content measured. Significantly, these are the first standardized instruments developed to assess comprehension in non-cognitively-impaired adults. Yet, each instrument had its own set of limitations such as the lack of generalizability and the absence of details pertaining to how test results should be used to guide clinical decision-making. Standardized clinical trial informed consent comprehension assessments have been developed to identify gaps in research participants' understanding and ensure that respect for patient autonomy is satisfied. (shrink)