|Authors / Year of Publication||Country||Research participants||Method of data collection||Main findings|
|1. Robinson et al. 2014 ||USA||229 patients; parents/guardian of paediatric patients and family members as controls||Structured interview and open ended questions||Over 25 % of the research participants did not remember that they signed a informed consent document to participate in a genomic study. The majority (54 %) could not correctly identify with whom they had agreed to share their genomic data. Participants felt that they understood enough to make an informed decision.|
|2. Cervo et al. 2013 ||Italy||430 cancer patients||Structured questionnaire||
36.5 % of research participants indicated that they knew what a biobank was before participating in the study. After the multisource informed consent procedure more than 95 % of patients were aware of participating in a biobank project subsequent to the consent procedure.|
The final assessment showed more than 95 % correct answers. The information received was judged to be “very understandable” by 44.9 % and “fairly understandable” by 53.8 % of the research participants.
|3. Oliver et al. 2012 ||USA||229 patients; parents/guardian of paediatric patients and family members as controls||Structured interview and open ended questions||Subsequent to information about three different types of consent with different scopes for data sharing, research participants in all three groups indicated that they would be more restrictive compared with their actual decision before debriefing. Qualitative findings support the more skeptical view on data sharing subsequent to being informed about different options of consent with limits to data sharing. Research participants’ trade-off regarding privacy and utility of research was significantly associated with participants’ decision about data release subsequent to debriefing.|
|4. McGuire et al. 2011 ||USA||
parents/guardian of paediatric patients and family members as controls made initial data release decision prior to be informed about different consent options. 323 research participants made final data release decisions subsequent to debriefing.
|Structured interview on data release decision and socio-demographic data.||Before being informed about different consent options 83.9 % of participants chose public data release. After debriefing, 53.1 % chose public data release, 33.1 % chose restricted (controlled access database) release, and 13.7 % opted out of data sharing. Hispanic background, not being married and college degree were associated with choice for restricted data release.|
|5. Watanabe et al. 2011 ||Japan||1378 patients||Structured questionnaire (in addition report of qualitative narratives by research coordinators on patients’ perception)||Information about biobank research was judged as understandable in 76.8 % subsequent to personal discussion compared to 60 % after information via brochures and 56.9 % via DVD. Interest in personal data was positively associated with better recall rate, in younger patients, higher satisfaction with consent process and with willingness to participate in future study. Research coordinators indicate need among research participants to get more information following consent procedure.|
|6. Valle-Mansilla 2010 ||Spain (USA)||279 patients (30 patients from US sample)||Structured questionnaire||230 patients (82.4 %) remembered giving consent to biobank research. 40.3 % preferred general consent for future use of sample, 49.8 % preferred limited or specified consent. Support for broad consent was less supported in industry-sponsored research.|
|7. Lipworth et al. 2009 ||Australia||12 patients, parents of patients and other lay stakeholders||Semi-structured in depth interviews||Participants’ supported making use of material/data subsequent to participation in biobank research. There was evidence for expectation regarding direct benefit of research for research participants and little awareness of harm.|
|8. Ormond et al. 2009 ||USA||200 patients||Structured interviews including open ended question||
The best understood domains included the nature of the study, benefit to future patients, and the voluntary nature of participation. Lower knowledge scores included potential risks and discomforts, experimental nature of the research, procedures in the event of study-related injury, and confidentiality issues.|
Only 10 % of participants explicitly stated they had no
expectations for personal benefit.
|9. McGuire et al. 2008 ||USA||15 patients and controls from a genomic study on epilepsy||Focus groups including one Follow up focus group with presentation and discussion of findings from initial focus groups.||There was a general interest in receiving information and making decisions about data sharing. Participants preferred multiple data sharing options. However, they were more likely to consent to public data release when given fewer options. Most participants felt that genomic information should not be publicly released without explicit consent from research participants.|
|10. Hoyer et al. 2005 ||Sweden||930 research participants||Structured questionnaire||64.5 % of participants were aware that they had consented to donate a blood sample, 55.4 % thought that they had consented to donate phenotypic information, and 31.6 % believed that they could withdraw their consent. 85.9 % acceped surrogate decision making by regional research ethics committees.|