Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.

The objective of this study is to describe researchers', health-care providers' and other stakeholders' views of ethical review and research governance procedures. The study design involved qualitative semi-structured interviews. Participants included 60 individuals who either undertook research in the subspecialty of cancer genetics (n = 40) or were involved in biomedical research in other capacities (n = 20), e.g. research governance and oversight, patient support groups or research funding. While all interviewees observed that oversight is necessary to protect research participants, (...) ethical review and research governance (ERG) arrangements were described negatively throughout these interviews. Interviewees identified a number of problems with ERG, including: over-bureaucratization, over-standardization of information requirements for different types of research, a lack of standardization in the types of information required by different committees for the same research and a lack of consistency in different committees' responses. A number of solutions were proposed including streamlining application procedures and harmonizing committees' responses and information requirements. Recent reports suggest that ethical review procedures and research governance arrangements threaten the possibility of undertaking clinical research in the UK, hence the introduction of the Integrated Research Application System (IRAS) is long overdue. However, while IRAS may solve some of the problems identified by interviewees, it remains to be seen to what extent it will impact upon the very negative perceptions of ethics and research governance procedures reported here. (shrink)

In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial examination (to assess knowledge in (...) bioethics), information on research legislation, obtaining permissions from authorities, writing an essay on research ethics, preparing one’s own study protocol, and a final exam. All assignments were designed with an idea of supporting students to reflect on their learning with their own research. (shrink)

The length of participant information sheets for research and difficulties in their comprehension have been a cause of increasing concern. We aimed to examine the information sheets in research proposals submitted to an Australian HREC in one year, comparing the results with national recommendations and published data. Information sheets in all 86 research submissions were analysed using available software. The work of Flesch was used for Reading Ease or Readability and that of Flesch and Kincaid for the level of education (...) required for comprehension, the Reading Grade Level. The mean length of 86 information sheets was 3110 words; many had more than 5000 words. Using the Flesch scale of 0 to 100, with 0 meaning most difficult and 100 very easy to read, the mean readability level was 47. The mean length of education needed to easily grasp the information was 11.6 years, equivalent to senior secondary school. Information sheets in research projects submitted to an HREC were often too long to be read in a reasonable time and too difficult to be easily understood. Recommended standards for information sheets were infrequently met. (shrink)