To establish the empirical evidence base for the information that participants want to know about medical research and to assess how this relates to current guidance from the National Research Ethics Service (NRES).
Medline, Web of Science, Applied Social Sciences Index and Abstracts, Sociological abstracts, Health Management Information Consortium, Cochrane Library, thesis index's, grey literature databases, reference and cited article lists, key journals, Google Scholar and correspondence with expert authors.
Original research studies published between 1950 and October 2010 that asked potential participants to indicate how much or what types of information they wanted to be told about a research study or asked them to rate the importance of a specific piece of information were included.
Study appraisal and synthesis methods
Studies were appraised based on the generalisability of results to the UK potential research participant population. A metadata analysis using basic thematic analysis was used to split results from papers into themes based on the sections of information that NRES recommends should be included in a participant information sheet.
14 studies were included. Of the 20 pieces of information that NRES recommend should be included in patient information sheets for research pooled proportions could be calculated for seven themes. Results showed that potential participants wanted to be offered information about result dissemination (91% (95% CI 85% to 95%)), investigator conflicts of interest (48% (95% CI 27% to 69%)), the purpose of the study (76% (95% CI 27% to 100%)), voluntariness (39% (95% CI 2% to 100%)), how long the research would last (61% (95% CI 16% to 97%)), potential benefits (57% (95% CI 7% to 98%)) and confidentiality (44% (95% CI 10% to 82%)). The level of detail participants wanted to know was not explored comprehensively in the studies. There was no empirical evidence to support the level of information provision required by participants on the remaining seven items.
There is limited empirical evidence on what potential participants want to know about research. The existing empirical evidence suggests that individuals may have very different needs and a more tailored evidence-based approach may be necessary.
What information do potential participants want to know when they are deciding whether to take part in research?
What is the established empirical evidence base?
How does the current empirical evidence base relate to current guidance from the NRES?
There is little empirical evidence of what information potential participants want to know about research when they are making the decision to take part.
The limited empirical evidence available suggests that potential participants may have very different information needs.
Further research is required to determine what potential participants really want to know about research and how this can be delivered in a way that takes into account their different informational needs.
Strengths and limitations of this study
An extensive search strategy ensured that the review was systematic in capturing all available empirical evidence.
Papers included in the review differed in their methodologies and presentation of results, making comparisons between papers extremely difficult.