Table 3 Study characteristics

1

Aitken, M., 2011, Linking Social Care, Housing and Health Data: Social care clients’ and patients’ views Scottish Government Social Research

To explore the perspectives of social care clients, patients and carers in regards to linking social care, housing support and health data in statistical research and their views of possible impacts on privacy.

May 2011 (comparative study with data collected between October 2010 and February 2011).

North Ayrshire, Edinburgh and Tayside; Scotland

Patients, service users, carers and the wider public (N = 20): 85 % female and 57 % over the age of 60 (70–79 years = 14 %; 60–69 years = 43 %; 50–59 years =14 %; 40–49 years = 5 %; no reported age = 24 %). Over half (60 %) of the sample stated they suffered from a health problem or disability for at least 12 months.

-

A series of consumer panels (N = 3) involving semi-structured group discussions

2

Asai, A., Ohnishi, M., Nishigaki, E., Sekimoto, M., Fukuhara, S., & Fukui, T, 2002, ‘Attitudes of the Japanese public and doctors towards use of archived information and samples without informed consent: Preliminary findings based on focus group interviews’ BMC Medical Ethics 3(1): 1

To explore lay attitudes toward the use of archived health materials and to compare their views with those of physicians involved in medical research.

November 2000

Osaka, Japan

Men of the general public (N = 7), women of the general public (N = 7), and male physicians (N = 7), all between 35 and 55 years old (members of the general public were married with children)

-

Focus-group interviews (n = 3), one for each sample group

3

Bond, C. S., Ahmed, O. H., Hind, M., Thomas, B., & Hewitt-Taylor, J., 2013, ‘The conceptual and practical ethical dilemmas of using health discussion board posts as research data’ Journal of Medical Internet Research 15(6)

To explore the perspectives of contributors to online diabetes discussion boards to better understand their opinions towards how their shared information should be used by health researchers.

April to May 2012

World Wide Web

People living with diabetes who use online discussion boards (N = 26): male (N = 12), female (N = 9), unknown (N = 6).

-

Online semi-structured asynchronous email interviews

4

Damschroder, L. J., Pritts, J. L., Neblo, M. A., Kalarickal, R. J., Creswell, J. W., & Hayward, R. A., 2007, ‘Patients, privacy and trust: Patients’ willingness to allow researchers to access their medical records’ Social Science & Medicine 64(1):223-235

To better understand why there was wide variation in consent process recommendations despite a high inclination to share medical records for research.

November 2003 to June 2004

Four diverse Veteran Affairs (VA) facilities, USA

Patients from 4 Veterans Affairs facilities (N = 217); 95 % male; 37 % minorities; average age was 65 years.

Random and purposive sampling, stratifying for clinic visits, age and race/ethnicity

Mixed methods: Deliberation sessions (N = 39), preceded by a baseline-phone-administered survey and proceeded by another phone administered survey 4–6 weeks after the deliberation session.

5

Davidson, S., McLean, C., Cunningham-Burley, S. & Pagliari, C. 2012, Public Acceptability of Cross-Sectoral Data Linkage: Deliberative research findings Scottish Government Social Research

To explore public opinion on the acceptability of linking personal data for statistical and research purposes, by identifying particular sensitivities and possible barriers to public confidence and exploring ways to overcome concerns.

26 May to 9 June 2012

Stirling, Inverness and Glasgow; Scotland

Members of the public (N = 73): Male (N = 35); female (N = 38). Age groups: 18–34 years (N = 25), 35–49 years (N = 23) and 50+ years (N = 25).

Quota sampling

Series of public deliberative event: Half-day workshops were held in each location (N = 3).

6

Davidson, S., McLean, C., Treanor, S., Aitken, M., Cunningham-Burley, S., Laurie, G., Pagliari, C & Sethi, N., 2013, Public Acceptability of Data Sharing Between the Public, Private and Third Sectors for Research Purposes (Social Research series). Scottish Government

To build on previous research, existing literature and practical examples to better understand the issues related to data sharing across the public, private and third sectors for statistical and research purposes.

Oban - 29 June 2013; Aberdeen - 6 July 2013; Glasgow - 13 July 2013; Galashiels - 20 July 2013; and Edinburgh - 3 August 2013.

Oban, Aberdeen, Glasgow, Galashiels and Edinburgh; Scotland

Participants attending the general public workshops (N = 105): Men (N = 52) and women (N = 53). Age bands: 18–34 years (N = 28); 35–49 years (N = 32); and 50+ years (N = 35). Pregnant/child < 1 year old (N = 13). Participants attending the LGBT workshop (N = 12): Men (N = 6) and women (N = 6). Age bands: 18–34 years (N = 5); 35–49 years (N = 5); 50+ years (N = 2).

Quota sampling

Primary and secondary research methods: Literature reviews (N = 2) and a series of deliberative events (4 half-day events with members of the general public and a separate, smaller scale event of LGBT people).

7

Grant, A., Ure, J., Nicolson, D. J., Hanley, J., Sheikh, A., McKinstry, B., & Sullivan, F., 2013, ‘Acceptability and perceived barriers and facilitators to creating a national research register to enable 'direct to patient' enrolment into research: the Scottish Health Research Register (SHARE)’ BMC Health Services Research 13(1): 422

To explore patients’, clinicians’, healthcare management staff and researchers’ acceptability and feasibility of the national research register model to better understand their perspectives on the main facilitators and barriers to engagement in research.

Between February and June 2011

Local health centres in Tayside and Lothian areas in Scotland

Patients (N = 37); health service researchers (N = 10); general practitioners and practice managers (N = 17).

Purposive and convenience sampling

Focus groups with patients (N = 7); additional focus group with health service researchers (N = 1); semi-structured interviews with health service staff (N = 17).

8

Haddow, G., Bruce, A., Sathanandam, S., & Wyatt, J. C., 2011, ‘‘Nothing is really safe’: a focus group study on the processes of anonymizing and sharing of health data for research purposes’ Journal of Evaluation in Clinical Practice 17(6): 1140-1146

To explore lay opinions about the anonymisation and data-sharing processes to Scotland’s ‘warehouse’ model and to discuss whether consent is necessary.

May and June 2009

North East of Scotland

Lay participants from the Public Partnership Group (N = 19): Males (N = 6); females (N = 12); 1 participant did not reveal their gender. Ages 75 and over (N = 3); ages 60 to 74 (N = 15); ages 60 and under (N = 1). Participants with a chronic health condition (N = 13, 68 %).

-

Focus groups (N = 3).

9

Haga, S. B., & O’Daniel, J., 2011, ‘Public perspectives regarding data-sharing practices in genomics research’ Public Health Genomics 14(6): 319

To explore public attitudes, predominantly of African Americans, toward data sharing in genetic and/or genomic research and the possible impact of said practices on research involvement.

February 2008 to February 2009

Various locations across Durham, North Carolina, USA

Total participants (N = 100): 73 % female; 76 % African-American; median age of 40–49 years; 26 % had some college education but no degree.

-

Mixed methods: Focus groups (N = 10) ending with a survey.

10

Hill, E. M., Turner, E. L., Martin, R. M., & Donovan, J. L., 2013, ‘“Let’s get the best quality research we can”: public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study’ BMC Medical Research Methodology 13(1): 72

To determine the varying opinions of the public regarding the use of existing medical data for research and to explore their views on consent to a secondary review of medical records for research purposes.

-

Dorset, England

Older male participants (N = 19): Ages 54 to 69 years; mean age 61 years; White British (N = 18) and White Other (N = 1).

Random sampling

Primary and secondary research methods: Systematic review (N = 1) and focus groups (N = 3).

11

Ipsos MORI, 2014, Dialogue on Data: Exploring the public’s views on using linked administrative data for research purposes HYPERLINK "https://www.ipsos-mori.com/DownloadPublication/1657_sri-dialogue-on-data-2014-census.pdf" www.ipsos-mori.com

To explore public views of the use of government administrative data in social research and to determine what kind of procedures, concepts and language are needed to be applied to build public confidence in the safety and security of the linking of their public records.

October to November 2013

England (London, King’s Lynn and Manchester), Wales (Cardiff and Wrexham), Scotland (Stirling), Northern Ireland (Belfast).

Public members (N = 129) and experts (N = 20).

Quota sampling

Seven sets of reconvened public dialogue workshops (N = 14 in total)

12

McGuire, A. L., Hamilton, J. A., Lunstroth, R., McCullough, L. B., & Goldman, A., 2008, ‘DNA Data Sharing: research participants' perspectives’ Genetics in Medicine 10(1): 46-53

To explore research participants’ attitudes and judgments toward data release and their preferences for differing levels of control over decision-making through three alternative types of consent (traditional, binary and tiered).

-

USA

Patients and controls (N = 15) from a genetic study on epilepsy. Age ranges of 18–70 years; females (N = 11); males (N = 4). Age bands 46–55 years and 56–65 years had the most participants for both focus-group sessions. Most participants had prior experience with medical research (N = 13).

-

Focus-group sessions (N = 3) containing both cases and control.

13

Melas, P. A., Sjöholm, L. K., Forsner, T., Edhborg, M., Juth, N., Forsell, Y., & Lavebratt, C., 2010, ‘Examining the public refusal to consent to DNA biobanking: empirical data from a Swedish population-based study’ Journal of Medical Ethics 36(2): 93-98

To empirically explore the motivations for not consenting to DNA biobanking in a population-based study and to examine the implications.

A longitudinal epidemiological project (PART) ongoing since 1998. The DNA-collection wave took place from 2006 to 2007.

Stockholm, Sweden

Participants from a longitudinal epidemiological project that had declined to contribute saliva samples for the DNA-collection wave. Participants interviewed (n = 23). Participants in ‘interview subgroup 1’ (N = 15): men (N = 8), mean age 48 years, range 33–61 years; women (N = 7), mean age 47 years, range 38–69 years. Participants in ‘interview subgroup II’ (N = 8): men (N = 4), mean age 49.7 years, range 34–68 years; women (N = 4), mean age 48.7 years, range 38–69 years. Individuals completing the non-participation questionnaire (N = 903).

-

Mixed methods: longitudinal population-based study (PART) of structured questionnaires and semi-structured interviews (N = 23).

14

MRC & Ipsos MORI, 2007, The Use of Personal Health Information in Medical Research: General Public Consultation - Final Report HYPERLINK "http://www.mrc.ac.uk" www.mrc.ac.uk

To identify public concerns and misconceptions in relation to the secondary use of personal health information for medical research.

29 July 2006 - public workshops in London and Cardiff; 5 August 2006 - general workshop in Edinburgh; 14 to 18 September 2006 - large-scale quantitative survey

London, Cardiff and Edinburgh; UK

Workshop participants reflecting the general public (N = 63). Interviews with disabled people and people with long-term/chronic conditions or their carers (N = 6). A nationally representative sample completed the survey (N = 2106).

Quota sampling

Mixed methods: general public workshops (N = 3), in-depth interviews over the telephone (N = 6) and a large-scale quantitative survey.

15

Nair, K., Willison, D., Holbrook, A., & Keshavjee, K., 2004, ‘Patients' consent preferences regarding the use of their health information for research purposes: a qualitative study’ Journal of Health Services Research & Policy 9(1): 22-27

To investigate the consent preferences of patients whose de-identified health data are presently being used in research.

March 1999 to May 2000

Hamilton area, Ontario, Canada

Patients (N = 17): Male (N = 6); female (N = 11); mean age was 52 years. Patients had been with their physician for an average of 10 years. The median number of physician visits were 4/year.

Convenience sampling

Individual semi-structured interviews (N = 17).

16

O’Kane, A. A., Mentis, H. M., & Thereska, E., 2013, ‘Non-static nature of patient consent: shifting privacy perspectives in health information sharing’ Proceedings of the 2013 Conference on Computer Supported Cooperative Work (CSCW-2013) 553–562. New York: ACM

To explore the views of chronically ill patients and their carers towards the use of their personal medical information and how it has impacted their perspectives of sharing their records with healthcare providers and secondary-use organisations.

-

Eastern England and the Greater London area; England

Diabetic patients (N = 27) diagnosed with Type I or Type II diabetes who were in charge of their own self-care and diabetic specialists (N = 6): Male (N = 15); female (N = 12); 18–73 years age ranges; 2–32 years diagnosis ranges; patients who had Type I diabetes (N = 12); patients who had Type II diabetes (N = 15). Diabetes health specialists (N = 6).

Theoretical, non-probabilistic sampling

(Convenience sampling to interview the diabetes specialists)

Individual interviews (patients and specialists) and a group interview with 12 patients.

17

Robling, M. R., Hood, K., Houston, H., Pill, R., Fay, J., & Evans, H. M., 2004, ‘Public attitudes towards the use of primary care patient record data in medical research without consent: a qualitative study’ Journal of Medical Ethics 30(1): 104-109

To explore public and lay opinions about the use of primary care records for research when patient consent has not been sought.

-

South Wales

Members of the public participated in the focus groups (N = 49): participants older than 50 (N = 32; 71 %); participants in a non-manual social class (N = 36). Non-medical members of local community health councils participated in the key informant interviews (N = 4).

Stratification of groups by gender, geographical setting and level of deprivation.

Focus-group meetings (N = 8) and semi-structured key informant interviews (N = 4).

18

Saxena, N., & Canadian Policy Research Networks. Public Involvement Network, 2006, Understanding Canadians' attitudes and expectations: citizens' dialogue on privacy and the use of personal information for health research in Canada CPRN= RCRPP

To explore Canadian’s views about personal privacy and the use of personal information for health research purposes.

April to May 2005

Hamilton, Halifax, Vancouver, Montreal, Toronto; Canada

Members of the public (N = 98): male (N = 40); female (N = 58). Age ranges: 20–39 years (N = 37), 40–59 years (N = 35), 60+ years (N = 26). Women were over-represented at the dialogue in comparison to the general population (59 % to 51 %, respectively).

Random-digit dialling

One-day citizen dialogue sessions in English (N = 5) and French (N = 2).

19

Spruill, I. J., Gibbs, Y. C., Laken, M., & Williams, T., 2014, ‘Perceptions toward establishing a biobank and clinical data warehouse: Voices from the community’ Clinical Nursing Studies 2(3): 97

To assess community opinions of the proposed Biobank practices and policies for storing biomaterial for future research, and to determine the best practice for educating the public regarding the biobank and Clinical Data Warehouse (CDW).

-

Charleston, Beaufort, Berkeley, Dorchester, Georgetown and Horry; South Carolina, USA

Total participants (N = 67): key informants (N = 10) and general community members (N = 57). Focus-group participants were mostly African-American females from Georgetown and Beaufort counties. The cognitive-interview sample included key informants from the faith/scientific community, medical staff and formal/informal community leaders.

N/a

Focus groups of general community members (N = 7) and individual key informant interviews (N = 10).

20

Stone, M. A., Redsell, S. A., Ling, J. T., & Hay, A. D., 2005, ‘Sharing patient data: competing demands of privacy, trust and research in primary care’ British Journal of General Practice 55(519): 783-789

To explore the knowledge and attitudes of patients and primary healthcare staff regarding the sharing of data held in medical records, particularly for research and how this may affect trust between patients and healthcare professionals.

-

Five general practices in Leicestershire, England.

Patients (N = 20) and healthcare professionals/managers (N = 15).

Purposive and quota sampling

Semi-structured interviews

21

TNS 2012, Open Data Dialogue: Final Report

To examine how open data principles and policies in research should be developed and implemented.

Late February to early March 2012

Swindon, Oldham and London; England

Members of the public (N = 40). The same participants engaged in both Wave 1 and Wave 2.

-

Primary and secondary research methods: Literature and policy review (N = 1); public-dialogue workshops (N = 2); stakeholders mapping and scoping workshop (N = 1); and producing a report for dissemination (N = 1).

22

Trinidad, S. B., Fullerton, S. M., Bares, J. M., Jarvik, G. P., Larson, E. B., & Burke, W.,2010, ‘Genomic research and wide data sharing: views of prospective participants’ Genetics in Medicine 12(8): 486-495

To explore the views of current and possible future research participants regarding genome-wide association studies (GWAS) and repository-based research.

March to August 2008

Seattle metropolitan areas, Washington, USA.

Current research participants in the Adults Changes in Thought (ACT) Study; ACT surrogate decision-makers; and three age-defined cohorts of Group Health members not in the ACT Study of 18–34 years, 35–50 years and 50+ years (N = 79). Mean age was 56.4 years; age range was 18–89 years; 48 % female.

Random sampling

Series of focus-group discussions (N = 10): Two sessions were held for each of the 5-selected population groups.

23

Trinidad, S. B., Fullerton, S. M., Bares, J. M., Jarvik, G. P., Larson, E. B., & Burke, W., 2012, ‘Informed consent in genome-scale research: what do prospective participants think?’ AJOB primary research 3(3): 3-11

To explore the views of research participants and members of the general public toward informed consent and issues involving genome-wide association studies (GWAS) and other similar kinds of genomic research.

March to August 2008

Seattle, Washington, USA

Members of the Group Health Cooperative (N = 45): Mean age was 45 years; 40 % were female. Two separate sessions were held with members aged 18 to 34 years, members aged 35 to 50 years and members older than 50 years.

Random sampling

Focus groups (N = 6)

24

Weitzman, E. R., Kaci, L., & Mandl, K. D., 2010, ‘Sharing medical data for health research: the early personal health record experience’ Journal of Medical Internet Research 12(2)

To understand consumer willingness to share data from Personally Controlled Health Records (PCHR) for health research purposes and to explore the conditions and contexts that encourage willingness to share.

-

Urban area within the northeastern region of the USA.

Early adopter sample of PCHR users completed the surveys (N = 151). PCHR usability testers (N = 13) were recruited for the structured interviews and community members (N = 17) participated in the focus groups. Average age in the usability test group was 45 years, reflecting an employee and student population. Average age across focus-group participants was 71 years, drawn from a retiree and health advocacy mailing list. Females outnumbered males in all groups.

-

Mixed methods: Surveys, interviews and focus groups.

25

Willison, D. J., Keshavjee, K., Nair, K., Goldsmith, C., & Holbrook, A. M., 2003, ‘Patients' consent preferences for research uses of information in electronic medical records: interview and survey data’ BMJ 326(7385): 373

To determine patients’ preferred method of consent for the use of information from electronic medical records for research purposes.

-

Southern Ontario, Canada

Patients of doctors in the COMPETE study (N = 123). Participants interviewed (N = 17): Male (N = 7); female (N = 11). Patients who completed a survey (N = 106).

-

Mixed methods: Semi-structured interviews and a structured fixed-response survey