Skip to main content

Table 2 Included studies

From: A systematic literature review of health consumer attitudes towards secondary use and sharing of health administrative and clinical trial data: a focus on privacy, trust, and transparency

Author, location, data collection date Methodology, sampling, analysis Health condition/setting No. of participants (N) Participant demographics
n (%)
Key themes (alphabetical) Outcomes, result(s) QualSyst Score
Qualitative
[15], Britain, October to December 2004 Questionnaire, results expressed in percentages Recently discharged medical and surgical patients / hospital 166 Not reported Privacy
Transparency
Privacy
• UK law currently allow for data use if the data is necessary and the risk to privacy is proportionate.
Transparency
• Public education on the secondary use of data promotes transparency.
0.9
[16], Europe, March to May 2018 Survey, descriptive statistics, and chi-square test for independence Rare diseases/ patients and their families with rare diseases 2013 Age, years
2 (0), 15–17
70 (3), 18–24
293 (15), 25–34
852 (42), 35–49
644 (32), 50–64
152 (8), ≥65
Sex, male
473 (23)
Location
1775 (88), EU
238 (12), non-EU
Diagnostic status
1909 (95), diagnosed
104 (5), undiagnosed
Number of rare disease (n= 1909)
1664 (87), 1
174 (9), 2
44 (2), 3
13 (1), 4
14 (1), ≥5
Privacy
Transparency
Trust
Privacy
Willingness to share data is underscored by the need to respect the individual’s privacy wishes and choices regarding the use of their data.
Transparency
Improved communication will increase transparency in research, particularly in the setting of shared data.
Trust
• Not-for-profit stakeholders (89% for medical doctors, 79% researchers from non-profit organisations, 77% for patient organisations, 69% for healthcare professionals other than medical doctors) is considerably higher than trust in for-profit stakeholders.
• Participants with higher levels of education tend to trust government and institutions from their country more (53%) than those who finished school earlier (44% among those who finished school before 20 years old).
Distrust
• 45% are in favour and 50% are opposed to sharing data with researchers from the pharmaceutical industry.
• 16% are in favour and 80% are opposed data with insurance companies
Older respondents are less likely to trust the private sector: 57% of respondents under 25 trust researchers from pharmaceutical industry compared to 36% for respondents over 65 and only 28% compared to 9% for insurance companies.
0.95
[17], Europe, 2012 Questionnaire, results expressed in percentages Leukodystrophy/ Leukodystrophy patients and family 195 (149 family, 46 patients) Age, years
121 (62), 40–64
Country
130 (66.7), France
24 (12.3), Italy
9 (4.6), Belgium
6 (3.1), Spain
26 (13.3), Germany
Privacy
Transparency
Trust
Privacy
• Ethics committees protect ‘patients’ rights and privacy’.
Transparency
• Information and transparency are needed on database governance.
• Patient organisations should help with the development of clinical trials.
• Transparency needed on the use of data, data storage and the length of data accessibility.
• Information on secondary use should be provided at initial consent.
• Pharmaceutical industry access to data was supported by some, if transparent.
Trust
• High level of trust in researchers using the database.
• Patient’s/families had great hope and trust in the development of database research.
0.85
[18], Finland, not reported Survey, descriptive statistics General medical/general public 418 Age, years
44 (10.5), ≤30
47 (11.2), 31–40
57 (13.6), 41–50
88 (21.1), 51–60
126 (30.1), 61–70
49 (11.7), >70
7 (1.7), missing
Education
74 (17.7), PS
44 (10.5), SS
165 (39.5), HS
80 (19.1), University of Applied Sciences or bachelor’s degree
52 (12.4), Master’s degree or higher
3 (0.7), missing
Privacy
Trust
Privacy
• Privacy protection was the most common concern for register-based research.
• 80% considered protection of their health information important or very important. 56% had positive attitude towards their own information being used for research.
• Sex, education, and health status did not affect this view significantly.
• Studies of major public health impact are more important than individual privacy protection—25% somewhat disagreed and 12% strongly disagreed.
• Respondents in good health more likely to agree than those with poor health.
• >70 years less concerned with privacy than younger age groups; 92% (31–40 years) stated privacy of health information was very important or important.
Trust
• 56% had a positive or very positive attitude about their information being used research purposes, 31% were neutral suggesting trust in research organisations and data protection practices.
• Younger participants, despite higher concern for privacy, trust researchers and were willing to let their information be used for research.
0.85
[19], Japan, October to November 1995 Survey, Fisher’s exact test and Mantel-Haenszel chi-square Cancer/outpatients, and inpatients 293 Age, years
11 (3.8), ≤29
30 (10.2), 30–39
49 (16.7), 40–49
71, (24.2), 50–59
81 (27.6), 60–69
48 (16.4), ≥70
Sex, male
115 (39)
Privacy Privacy
• 82.6% did not mind their own clinical data being used for healthcare and treatment skills improvement under the condition that privacy would not be violated.
• Younger males seemed most positive to the use of data to improve healthcare and treatment skills.
• No significant difference in responses among three sources of patients.
0.5
[20], Canada, August 2014 and May 2015 Survey, descriptive statistics and Student’s t tests and nonparametric tests Cancer/outpatient clinic 569 Age, years
59, median
Cancer type
109 (19.2), breast
86 (15.1), gastrointestinal
83 (14.6) genitourinary
70 (12.3), thoracic
73 (12.8), hematologic
73 (12.8), head and neck
63 (11.1), gynaecologic
12 (2.1), other
Clinical trial participation, yes
183 (32.2)
Education
346 (60.8), university, college, professional
39 (6.9), vocational, technical, diploma
169 (29.7), elementary, HS
15 (2.6), prefer not to answer or missing
Sex, male
234 (41)
Privacy Privacy
• Willingness to provide health information for research.
• Cultural differences between large cities and smaller communities may alter an individual’s level of concern about privacy and confidentiality.
• Linkage of clinical trial data with administrative databases requires consideration of ethics and regulatory principles and processes to ensure privacy.
0.75
[21], USA, not reported Structured survey, univariate statistics, logistic regression models Clinical trial data /interventional clinical trial participants 771 Age, years (n= 762)
63 (8.3), <25
177 (23.2), 25–44
286 (37.5), 45–64
236 (31), ≥65
Sex, male
382 (51.1)
Ethnicity (n= 768)
518 (67.4), white
113 (14.7), Black or African American
51 (6.6), American Indian or Alaskan Native
25 (3.3), Asian
61 (7.9), Other
Education (n= 752)
40 (5.3), < HS
125 (16.6), HS
206 (27.4) some college
238 (31.6), college
143 (19), graduate degree
Privacy
Trust
Privacy
93% of respondents were very or somewhat likely to allow their data to be shared with university researchers
82% were very or somewhat likely to share their data with researchers from for-profit companies.
• This willingness did not change of the purpose for the use of data, except for use in litigation.
Provided adequate safeguards were in place, most were willing to share their data for research.
Trust
• Some believed that sharing this data may reduce participation rates in clinical research (37%), were concerned that it would be used for marketing purposes (34%), stolen (30%), used to discriminate (22%), or for profit (20%).
• Respondents had less trust in pharmaceutical companies (18% trusted a great deal or a lot) and insurance companies (15%) compared to universities (63%).
• 8% were unwilling to share with for-profit companies, 92% would be very or somewhat willing to share with these companies.
• Multivariable modelling found that those who believed that the negative aspects of data sharing outweighed the positives, was significantly higher in those who felt that other people could generally not be trusted, those concerned about being re-identified, or those concerned about information theft.
• Those with a college degree were also associated with feeling the negative aspects outweighed the benefits.
• Low levels of trust resulted in less willingness to share data with researchers from both not-for-profit and for-profit companies.
0.9
[22], Hong Kong, not reported RCT nested within a cohort, chi-square test, multivariable logistic regression, likelihood ratio test General medical/subsample of the FAMILY cohort 1200 Age, years
94 (7.8), 18–29
197 (16.4), 30–44
423 (35.3), 45–59
307 (25.6), 60–74
179 (14.9), ≥75
Education
436 (36.3), primary
587 (48.9), secondary
177 (14.8), tertiary
Sex, male
456 (38)
Privacy Privacy
• Requesting HKID significantly reduced consent for data linkage among adults aged 18–44 years (9.9%) compared to other age groups reflecting privacy concerns.
• 60–74 years were most likely to agree to data linkage (40.7%).
0.95
[23], Canada, November 2003 Survey, descriptive statistics, multiple logistic regression AIDS, MS, mental health / outpatients 235 Age, years
68 (28.9), 20–39
129 (54.9), 40–59
34 (14.5), ≥60
4 (1.7), unknown
Education
39 (16.6), <grade 12
35 (14.9), grade 12
156 (66.4), attended/ finished post-secondary
5 (2.1), no answer
Previous experience with medical research, yes
127 (54)
Sex, male
86 (36.6)
Privacy
Trust
Privacy
• Privacy of health and financial records of most concern to respondents.
• To maintain privacy, consent to access medical records should be sought.
• Concerns included harm due to others accessing record; information being available to ‘many people’.
• Privacy and autonomy are of importance.
• There was not a willingness to trade loss of privacy for public good.
Trust
• Easier to trust researchers when the individual is involved and meets someone involved in the research.
• Education is needed to foster trust in health research processes and to provide more information on societal perspectives of personal health data.
0.85
[24], USA, August to November 2014 Health Information National Trends Survey (HINTS), multivariate regression analyses General medical/general public 3212 Age, years, mean
53.48
Sex, male
1317 (41)
Privacy
Trust
Privacy
• Three key facets of health privacy: capital awareness of privacy, attitude towards the importance of privacy and data sharing, and confidence in the ability to maintain privacy.
• Positive relationship between privacy capital and engagement.
• Development of health privacy capital is susceptible to sociodemographic disparities.
• Higher levels of education and income associated with higher levels of health privacy capital.
• Awareness and confidence were also related to the social capital index.
• Females and older people were more likely to be aware of health information.
• Those with higher levels of health privacy capital were more likely to report higher levels of digital interaction with health professionals.
• Higher levels of income were found to do consistently better in health outcomes, and they tended to be more actively engaged in digital interaction with health professionals.
Trust
• Privacy awareness as a predictor seems to play an enabling role for those who lack basic social networks because it helps them fully trust and efficiently navigate the health system to their benefit.
• Promoting trust in health service is important.
0.9
[25], Europe, August to November 2013 Survey, descriptive analysis and choice modelling analysis, Westin’s methodology General medical/general public 20,882 Age, years
2163 (10.4), 18–24
3512 (16.8), 25–34
3719 (17.8), 35–44
3763 (18), 45–54
3735 (17.9), 55–64
3990 (19.1), ≥65
Health status, self-rated
12,823 (61.4), good or very good
Sex, male
9960 (47.7)
Privacy Privacy
• 48.9% to 60.6% of respondents expressed concerns about different levels of access to health data.
• 38.4% of respondents agreed that healthcare providers are currently successful in providing effective data security.
Sweden, Slovenia, and Denmark had the highest proportions respondents not concerned about privacy; highest conference was in Lithuanian respondents.
• Anonymised sharing of information with academic researchers was not preferred, thus pointing towards a preference for individual-level benefits over broader population-level benefits.
• Respondents were averse to sharing health information with third parties, such as insurance providers and pharmaceutical companies.
1
[26], Northern Ireland, September to December 2015 NILT survey, univariate and multivariate analyses General medical/general public 1202 Results of weighted demographics
Age, years
144 (12), 18–24
175 (14.6), 25–34
172 (14.3), 35–44
214 (17.8), 45–54
180 (15.0), 55–64
310 (25.8), ≥65
7 (0.6), not answered/ refused
Education
224 (18.6), no qualification
555 (46.2), school level
369 (30.7), graduate level
54 (4.5), not answered/ refused
Sex, male
559 (46.5)
Privacy
Transparency
Trust
Privacy
• 85% agreed data should be used for research which benefits society if anonymous and privacy were maintained.
• 95% in favour of sharing data within the health service, over two thirds were in favour of health information being shared to improve access to services provided by other government departments.
• Not willing to share data with ‘just anyone’:
• 16% happy for university researchers to use data; 39% did not want commercial access to their data; 20% did not care who used their data
• 74% did not mind how their data was used if anonymised; 46% believed that even if the data were de-identified you can still identify the person.
• 83% believed that the right to privacy should be respected over everything else.
• A significant minority showed limited support for data sharing.
Transparency
• Minimum requirements for trust: transparency, knowledge about what information is held and what it is used for, and data security.
• Transparent communication should help improve trust.
Trust
Trust in keep information secure and use appropriately:
• 91% GP surgery; 86% NHS; 73% government departments; 72% academic researchers; 51% charities; 41% commercial organisations.
• 5% of respondents did not trust any of the organisations.
• 42% had ever had concerns about how any of those organisations used the information they kept.
• Low levels of trust were associated with a need for consent to use data.
• Support for data sharing based on: trust in organisations, data protection measures, and public benefit.
Levels of trust differed between:
• Sex – females – generally more trusting of organisations.
• Age – ≥55 years less trusting of commercial organisations while 25–44 years were more trusting of academic researchers.
• Trust included the ability to keep data secure, accurate records, capacity to change or delete incorrect data, data used to discriminate against individual.
• 50% believed that commercial organisations should be required to provide more data safeguards, compared to other organisations.
0.9
[27], United Kingdom, 2009 BHPS Wave 18, multivariate bivariate probit models General medicine/BHPS Wave 18 participants 6433 Not reported Privacy Privacy
• Attitudes to privacy are related to views on consenting to data linkage.
• Privacy concerns were the strongest negative predictor for consent.
Trust
• General trust in others positively affect consent.
0.65
[28], New Zealand, not reported Survey, chi-square tests General medical/general public 203 Age, years
106 (56), 18–34
69 (37), 31–60
14 (7), ≥61
Sex, male
61 (32)
Privacy
Trust
Privacy
• Respondents more willing to share health information if identity removed.
• 60% concerned about sharing even anonymous information with people other than health professionals.
Trust
• If an individual’s privacy requirements are not met it may lead to a reduction of trust.
0.7
[29], Canada, March to April 2005 Survey, response frequencies General medical/general public 1230 Age, years
480 (39), 18–39
504 (41), 40–59
246 (20), ≥ 60
Education
406 (33), HS or less
172 (14), some post-secondary
492 (40), completed post-secondary
123 (10), post-graduate or professional degree
Sex, male
554 (45)
Privacy
Trust
Privacy
• Protection of privacy of their personal information was very important (74%) to respondents.
• 56% increased concern about privacy in the past 5 years.
• 68% agreed with the statement: ‘research that could be beneficial to people’s health is more important than protecting people’s privacy’.
Trust
• High levels of trust (26–35%) in disease-based foundations, hospitals, university researchers, and data collection organisations.
• High levels of distrust in the insurance industry (42%), drug companies (28%), and government (27%).
1
Qualitative
[30], United Kingdom, not reported Interviews, thematic analysis was undertaken using the Framework approach General medical/individuals included in the ALSPAC birth cohort study 55 Age, years
12 (21.8), 17
35 (63.6), 18
8 (14.5), 19
Education
7 (12.7), at university
25 (45.5), A-levels
8 (14.5), GCSE’s
12 (12.8), other
3 (5.45), none
Health status, self-reported
9 (16.4), disability/long-term illness
46 (83.6), no disability/long-term illness
Sex, male
24 (43.6)
Privacy
Transparency
Trust
Privacy
• Data linkage best practice provides enough privacy protection.
• Threat to privacy was a potential harm.
• Data anonymisation was a solution to privacy concerns.
Transparency
• Data linkage processes should be clear and transparent.
Trust
• A lack of trust about how data would be used.
• Trust was associated with the need for consent.
• Important that research does not undermine an individual’s trust in research.
0.95
[31], England, Wales, and Scotland (UK), March to April 2008 Face to face interviews, adjusted proportions National cancer database/ general public 2872 Age, years
1315 (46), 16–44
997 (35), 45–64
564 (20), ≥65
Education
542 (19), Degree or higher
1496 (52), Below degree
837 (29), No qualifications
Ever had cancer? No
2701 (94)
Sex, male
1319 (46)
Privacy Privacy
• 81% would support legislation to underpin the National Cancer Registry.
• 95% did not believe that a letter from their primary care trust inviting them to a cancer screening test was an invasion of privacy.
• 80% did not consider the inclusion of their postcode or name and address in the registry, or the receipt of a letter inviting them to take part in a research study, was an invasion of their privacy.
• 2% saw all three scenarios as an invasion of privacy.
• Small but significant differences were found according to country, ethnicity, socioeconomic status, housing tenure, and the experience of cancer in the immediate family.
• The majority did not consider the confidential use of personal, identifiable information by the National Cancer Registry for the purposes of public health research and surveillance to be an invasion of privacy.
• The confidential use of identifiable health information for research without individuals’ consent has not damaged the public’s trust so far.
0.95
[32], Belgium, February 2017 Interviews, deductive analysis using QUAGOL Reuse of clinical trial samples and data/ clinical trial participants 16 Age, years
35–79, mean 62, median 64
Sex, male
7 (43.75)
Education
10 (62.5), higher education
6 (37.5), college or university
Ethnicity
15 (93.5), Belgium
1 (6.25) Polish
Cancer types
4 (25), colorectal
3 (18.75), ovarian
1 (6.25), gastric and lung
1 (6.25), colorectal and lung
2 (12.5), pancreatic
2 (12.5), gastric
1 (6.25), cholangiocarcinoma
1 (6.25), unreported
Privacy
Transparency
Trust
Only results about data sharing are reported
Data was seen by participants to be a similar resource to tissue samples; however, this position is not supported legally where the samples are not considered the same.
Privacy
2 (6.25) explicitly specified that information provided to other research groups would be coded, illustrating a wish to protect their privacy.
• If this is protected, then there was a willingness to share data for research.
Participants supported medical research and the reuse of data for altruistic reasons. Most interviewed believed that the data can and should be reused. However, the participants should little interest in the specific purpose for reuse.
• 2 (12.5) expressed a duty to contribute to science and wanted the maximum potential extracted from their data.
The privacy and security of systems to exchange data is essential.
Transparency
Some participants wanted to be informed when their data was being used as this increases research transparency.
Participants were mostly positive about digitisation in health as the use of these tools may increase control and transparency and allow for greater participation in research.
Trust
Participants were generally trusting of the initial research team.
• 1 (6.25) participant noted that further research was acceptable, if it ‘stays within the oncology area’.
Responses showed that participants trusted their clinicians to use the data correctly in their disease setting.
General trust in the health services and clinicians.
14 () trusted the ethics committees to be the decision maker about access to data.
Distrust
• 2 (12.5) participant distrusted ‘unknown’ researchers, particularly the potential for data misuse and security.
1 (6.25) participant expressed his distrust in electronic systems generally as they become alternatives to traditional provision of care.
0.9
[33], England, September 2015 to December 2017 Interviews and online survey, thematic analysis Human Fertilisation and Embryology Authority registry/fertility clinic attendees 60 (20, interview, 40, online survey) Interview population
Age, years
36 median, 30–46 range
Ethnicity
16 (80, British white
Sex, male
5 (25)
Occupation
14 (70), managerial or professional
2 (10), intermediate
3 (15) routine or manual
1 (5), student
Privacy
Transparency
Trust
Interview population
14 (70) agreed to share data
2 (10) refused to share their data
3 (15) were unsure about sharing data
1 (5) agreed and disagreed with data sharing at different times
Online survey
32 (80), agreed to share data
4 (10), refused to share their data
2 (5), were unsure about sharing data
2 (5), agreed and disagreed with data sharing at different times
Privacy
Differences in sharing were seen by professional status, with those in intermediate or manual or routine jobs being more likely to share data (interview participants only).
Sharing data for the greater good was important to some, however others believed that it may cause harm (fraud, identity theft, targeted for marketing).
• Documentation needs to clearly say that the data will only be used for research and not marketing.
• Concerned about harms not just to them, but also their children.
• Not sharing is a mechanism to protect themselves. Stigma around IVF treatments.
• HFEA data is required by legislation; however, some expressed concern that that the requirement to collect this type of data is not required in fertile couples.
Transparency
Many were not sure what they had already agreed to in respect to sharing data.
Variation in the understanding of anonymisation and identifiable data.
Trust
Many already thought that data was already shared for research purposes.
Trust in partners, clinics, hospitals, and wider institutions was noted.
Misconception about the data being shared, some believed that it was NHS data which is generally seen as a trustworthy data custodian.
• This trust was not universal as some had lots trust after recent data beaches by this organisation.
Trust in the fertility clinic was reduced as they were seen as businesses.
0.9
[34], Scotland (UK), May to June 2009 Focus groups, thematic analysis General medical/general public 19 Age, years
1 (5), <60
15 (79), 60–74
3 (16), ≥75
Numbers taken part in medical research
6 (32)
Numbers with chronic health condition
13 (68)
Numbers with loyalty cards
15 (79)
Sex, male
6 (32)
Privacy
Trust
Privacy
• Self-worth was articulated as a question of rights (i.e. ‘Isn’t there a right to privacy though?’).
• Beliefs that an individual has a ‘natural right to privacy’ were balanced with a genuine commitment to supporting medical research.
• AS belief that the institutions and researchers to keep their medical records private and confidential, was associated with a decreased requirement for consent.
Trust
• Respondents acutely aware of previous information security breaches, however continued to display a high level of trust in the organisations staff.
• Trust was highest for clinicians involved in a person’s care but was extended to researchers more generally.
• Concerns about control and access and a generalised scepticism and mistrust of the government and large commercial and insurance organisations.
0.85
[35], USA, March 1996 to February 2000 A single structured interview, Pearson’s chi-square test for independence, logistic regression models (binary responses) and ordinal logistic regression General medical/individuals with genetic or chronic health condition* (or a family member with condition) 602 Disease
Participants were equally divided (approximately) into the six diseases. BC and CC each comprised of 50 participants with a personal history of the disease and 50 with a family member with the disease.
Privacy
Trust
Privacy
• 2% thought computerised records were a negative due to privacy violations.
• Those who agreed with anonymised computer records, believed that it would advance medical research without violating privacy.
Trust
• Some did not trust that computer databases set up anonymously for research would be secure.
• If individuals trust the entity asking to use the data, they may better trust that the records will remain confidential and will be used for worthwhile purposes.
• Important that the integrity of medical care and research enterprise is maintained, and patients trust their physicians and medical institutions.
• Institutions have a responsibility to take trust seriously, and never assume a simple right to conduct research with private, identifiable data.
1
(28), Australia, February to December 2006 Focus groups, thematic analysis
Survey, chi-square test of independence
General medical/general public 723 (23, focus group
700, survey)
Age, years (survey population)
35 (5), 18–19
138 (19.7), 20–34
141 (20), 35–44
208 (29.7), 45–59
178 (25.4), ≥60 years
Education (survey population)
66 (9.4), not finished HS
159 (22.7), finished HS but no HSC
131 (18.7), finished HS and HSC
17 (2.4), some technical or commercial/ TAFE
24 (3.4), finished technical or commercial/ TAFE
13 (1.8), some university/ C.A.E.
85 (12.1), tertiary diploma
15 (2.1), now at University/ C.A.E.
145 (20.7), university/C.A.E. degree
40 (5.7), post-graduate degree
Privacy Note: Results from survey population
Privacy
• 98% supportive of general medical research; 73% would be happy to share their health data for research; 12% would not share their data; 14% were not sure.
• 37% concerned about sharing their health information for research; 33% were not concerned.
• The youngest and oldest age groups were less concerned about privacy (51.4% and 53.4% respectively) compared to the other age groups (range between 71% and 76%).
• Those with poorer health were less concerned about privacy compared to those in good health (63.8% vs 67.7%). Of those who did not comment on health status 93.3% had concerns about privacy.
• Even with additional security measures and anonymised data, 25% remained concerned about privacy.
• Those not employed were less privacy concerned (60%) than respondents who were employed (range 66–74%).
• Most concerns about data sharing related to: sexually transmitted diseases; issues of abortion, infertility; family medical history/genetic disorders; drug/alcohol incidents; mental illness; list of previous operations/procedures/dates; and current medications.
• For cancer: 12% were very concerned, 15.7% were concerned, 9.7% were slightly concerned, while 62.3% were not concerned.
• Most want to be asked for their permission before their health information is used for any purpose other than medical treatment (92%), and they would like to know the organisation and details of the research before allowing the use of their health records (83%).
• Many not aware that removing names from medical records does not guarantee confidentiality.
• Insurances that security measures protect confidentiality of personal health information are in place are important, as are reassurances that this will be done consistently and reliably.
0.95
[36], USA, not reported Focus groups, grounded theory approach Arthritis and other chronic conditions/hospital 23 Age, years, mean
59 (SD ±13), range 36–84
Sex, male
5 (21)
Chronic Illness
10 (43.5)
Privacy
Trust
Privacy
• Confidentiality was noted as a concern generally for patients.
Trust
• Trust, distrust, and confidentiality were influential and a consideration in patients’ views towards research registry participation.
• A trusting doctor-patient relationship might be an important factor influencing registry participation.
0.95
[37], USA, not reported Focus groups, emergent content analysis General medicine/general health 30 Age, years
1 (3), 18–30
4 (13, 31–40
4 (13), 41–50
8 (27), 51–60
4 (13), 61–70
6 (20), 71–80
1 (3), ≥80
Sex, male
14 (47)
Education
11 (37), some HS
7 (23), HS
7 (23), some college
3 (10), college
Ethnicity
4 (13), white
5 (17), black
20 (67), Latino
2 (7), other
Privacy
Transparency
Trust
Privacy
• Some respondents were concerned about the loss of privacy.
• Respondents preferred that their electronic data be accessed over paper-based records.
• Concerns regarding privacy violations revealing highly personal information and third-party access to data were expressed.
• If no permission to use data sought, some considered it an invasion of their privacy.
• Using the data to support research recruitment was seen a violation of privacy.
Transparency
Development of transparent policies and practices will continue to support the secondary use of health data.
Trust
• There is a psychological component of uncertainty and mistrust.
• Lack of trust regarding volunteering for research.
• Participants wanted to have face to face contact with researchers during the recruitment process to increase trustworthiness.
• Research organisations and institutional review boards need to develop outreach programmes to engage communities and build trust.
1
[38], USA, 2006 and 2008 Interview (telephone and enhanced face to face), multilevel random effects logistic regression General medicine/health and retirement study 6384 Age, by birth cohort
747 (11.7), <1923
428 (6.7), 1923–1930
3543 (55.5), 1931–1941
792 (12.4), 1942–1947
875 (13.7), 1948–1953
Sex, male
2522 (39.5)
Ethnicity
5235 (82.0), white
875 (13.7), black
275 (4.3), other
Education
1481 (23.2), 0–11 years
2190 (34.3), 12 years
1334 (20.9), 13–15 years
1379 (21.6), ≥16 years
Privacy Privacy
• Concerns regarding privacy and confidentiality were reflected in rates of consent to data linkage (LR 43.48, p < .01)
• As the rate of concerns regarding privacy and confidentiality increases, lower rates of consent are seen.
• Where respondents refused to answer questions regarding their finances, consent for data linkage decreases.
The hypothesis that privacy and confidentiality concerns are negatively related to consent was supported.
1
[39], Australia, not reported Interviews, framework approach General medicine/general public 26 Age, years
Between 24 and 41
Education
3 (12), ≤ Year 12
6 (23), TAFE
16 (62), tertiary
1 (4), post-graduate
Sex, male
6 (23)
Privacy
Trust
Privacy
• The protection of privacy was reflected in the need for consent, without which privacy might be breached.
• Some believed de-identified information does not breach privacy.
• Many not concerned about use of identifiable data to create the linkage key. This may indicate that views on privacy are changing.
• Conflicting values, notably between privacy protection and public benefits.
Trust
• Concerns about identifiability when the linkage being done by researchers; not a lack of trust in researchers. Some concerns about the potential for a person known to them to find out private information.
• Lack of trust that information would remain anonymous.
0.9
Mixed methods
[40], USA, November 2003 to June 2004 Deliberative sessions and surveys
Quantitative - chi-square for categorical data and ANOVA for continuous variables
Qualitative-content analysis
General medical/veterans 217 Characteristics of deliberators provided
Age, years—mean (SD)
65 (12)
Education
80 (37), BS or BA or higher
Sex, male
206 (95)
Privacy
Transparency
Trust
Note: Results from deliberators provided
Privacy
• Compared to university researchers (75%), participants were less inclined to give permission for a local hospital to use their medical records for a preventive health programme (61%) and even fewer (51%) were inclined to give permission to a drug company for marketing purposes.
• Concern regarding the protection of privacy, particularly if enough was being done to protect their privacy.
• Many conformable with using their records for research if their information stayed within the VA.
• Participants wanted to know what data was being used and for what purposes; particularly how this information would be used to help other veterans.
• 75% were unaware that in the US medical records could be used without permission.
• Concerns regarding access to information about stigmatising conditions were raised, particularly HIV/ AIDS or mental health illnesses.
• Concerned about the potential of their data being sold.
Transparency
• Even those with a high level of trust in the VA, want to be fully informed about how their records were being used for research and any conclusions from this research.
• Ensuring medical records are being kept private and confidential in a way that patients can see is important.
Trust
• At follow up survey (4–6 weeks after baseline): 32% believed that medical researchers at a VA hospital would always keep their information confidential and private (change from 37% at baseline); compared to 8% for health insurance company researchers and 9% for pharmaceutical company researchers.
• Respondents who trust the VA were likely to recommend a less-stringent process for obtaining consent.
0.9
[41], England, June to July 2016 Surveys and interviews, not described Cancer registry/cancer patients and non-cancer patients, cancer 2033 (1033 with cancer, 1000 general public) Age, years, cancer group
31 (3), 18–34
155 (15), 35–54
847 (82), ≥55
Age, years, general public
290 (29), 18–34
350 (35), 35–54
350 (35), ≥55
Cancer status, cancer group only
186 (18), localised/stable
31 (3), advanced
671 (65), remission/ cancer free
Cancer type, cancer group only
52 (5), bladder
93 (9), bowel/colorectal
258 (25), breast
134 (13), prostate
62 (6), cervical/womb
155 (15), skin
300 (29), all others
Family or friend who has/had cancer, general public group only
640 (64), yes
Sex, male
475 (46), cancer group
490 (49), general public
Privacy
Trust
Privacy
• Privacy concerns: 12% in the cancer group and 9% in the general public group.
• Practical aspects of privacy: identifiable information being included (6% in the cancer group; 2% in the general public group) and concern over third parties having access to data (6% in the cancer group and 2% of general public).
• Respondents with cancer who oppose the current method of collection, but that support collection of cancer data in general were mostly being put off by the lack of consent and lack of information rather than privacy concerns.
• The trade-off between data collection for improved cancer services and treatment versus no data collection to maintain privacy and security; support for this trade-off was high across both groups.
Trust
• Concern regarding trust in organisations to maintain data security was noted in a small group of respondents.
0.6
[42], Australia, not reported Focus groups and semi-structured interviews, open coding and NVivo analysis Epidemiological research/general public and expert stakeholders 45 (calculated based on the below)
(4 focus groups with general public (4 to 8 persons per group)
2 focus groups with Aboriginal and Torres Strait Islander peoples (4 to 8 persons per group)
5 people from diverse cultural backgrounds
20 expert stakeholders)
Not reported Privacy
Transparency
Trust
Privacy
• Respondents wanted to know where their names and contact details were sourced for studies.
Transparency
• Wanted to know the source of funds for research, indicating a desire for transparency and the ability to judge the merits and motives for the research, to know who has vested interests in its findings.
• Concern about a lack of transparency from research undertaken by pharmaceutical companies (for example not publishing adverse results).
Trust
• Prepared to participate in epidemiological research, particularly if it is conducted by a trusted public institution (government health departments, charities, universities).
• Trust is critical to the conduct of research and it is important that research institutions do not act in ways that betray trust.
• Widespread community distrust of research conducted or sponsored by pharmaceutical companies and private companies.
• Pharmaceutical companies were repeatedly singled out by participants – concerns regarding their motivations were raised (i.e. profits).
0.9
[43], England, April to May 2013 Focus groups and interviews not described General medical/general public 50 Age, years
18–70
Privacy
Transparency
Note: Telephone interviewees were defined as the ‘pro-privacy group’ and were respondents who were especially cautious about releasing personal data and actively taking some measures to protect against doing so. The focus group respondents were recruited as owners of products such as a loyalty store card.
Privacy
• Respondents from the telephone interview group were more fearful of ‘what ifs’ and were cautious in releasing personal data because they worked in industries responsible for handling personal data (e.g. banking, insurance, selling databases).
• Concerns regarding the potential for data to be lost, stolen, hacked, or leaked, and shared without consent.
• Invasion of privacy, with a sense of Big Brother watching; incorrect or inaccurate data collection, which would be hard to correct and undo; potential discrimination (e.g. data falling into the hands of an employer).
• Strong feeling that personal health data are confidential, private, and sensitive, and should not be shared outside secure, authorised bodies, and especially not with private companies such as employers, insurance providers and drug manufacturers.
• Mental health data was sometimes regarded as particularly personal and sensitive.
• Some concern regarding the potential for future discrimination being introduced, or was already being practised, within the NHS (e.g. low priority on waiting list; being refused treatment until lifestyle changes are made).
• Concerns regarding potential privatisation; health data may be vulnerable to outside parties.
• Possibility of individual identification was a cause for concern.
• Fears about research/clinical trial data were low and related to anonymity being lost and possible unwanted media attention.
• Data linkage was more acceptable at aggregate level rather than individual level.
Transparency
• Clarity, transparency, and reassurance required when addressing issues of linking and use of personal data.
0.9
[44], Great Britain, November to December 2015 Deliberative workshops and face to face interview, not reported Commercial access to health data/general public, doctors, individuals with chronic or rare disease 2263 (246 focus groups
2017 interviews)
Not reported Privacy
Transparency
Trust
Privacy
• Clear benefit both to individuals and to wider society was the only ‘good’ rationale for breaching privacy.
• Different data types came have different privacy expectations.
• New ways of collecting and sharing data may give rise to conflicting expectations around data privacy.
• Concepts of privacy are in flux.
• Privacy should be the default position and that any sharing would infringe that privacy.
• Data anonymisation was a potential safeguard.
• Permission for a commercial access was noted as a concern some respondents feel that they are somehow losing their privacy.
• Respondents with pessimistic dystopian outlooks were not only concerned about the potential negative effect on themselves but fear large-scale negative impact for all society.
Transparency
• Underlying concerns for equity, transparency, and independent scrutiny of research by bodies free from vested interest. Restricting third-party access, and transparency in sharing results and publishing analysis.
• Transparency was universally important.
Trust
• Motivations of commercial companies were questioned, and the private sector was mistrusted in general.
• When benefits are perceived (and the organisation is trusted) all participants accepted commercial access to health data in principle.
• The nature of the safeguards is not as important as the trust that comes with knowing there is a safeguard in place.
• Education on aggregation and anonymisation is required to build public trust.
• 20% of respondents said commercial organisations cannot be trusted to store the data safely, 18% say that profit should not be made from their NHS health data, even if there are potential societal and health benefits; 13% fear that a commercial organisation might sell the data on to another commercial organisation.
• Some lacked understanding of, or trust in, anonymisation, and also did not know how data is actually held in the health service.
• Access to data by insurance company to adjust premiums was met with universal disapproval.
• If respondents did not trust the organisation conducting the research, they called into question the ultimate public benefit.
• Only allowing named individuals within an organisation to access health data has had little traction – the individual’s may not be trustworthy.
• Some have limited trust in commercial organisations undertaking research and not only fear no public benefit but allowing access to health data will create new public harms.
0.95
[45], Canada, not reported Public dialogues and survey, ANOVA and MANOVA General medicine/general public 98 Age, years
37 (38), 20–39
35 (36), 40–59
26 (27), ≥60
Education
26 (26), HS or less
18 (18.7), some post-secondary
42 (42.7), completed post-secondary
12 (12.5), post-graduate or professional degree
Sex, male
40 (40.8)
Privacy
Trust
Privacy
• Providing information about research allows individuals to feel like they are contributing while respecting privacy.
• Some respondents were less privacy concerned.
Trust
• Accountable systems for managing data can increase trustworthiness.
0.5
[46], Canada, November 2006 to July 2007 and September 2007 Survey and focus groups, regression analysis using generalised estimating equations General medicine//DM, HT, chronic depression, alcoholism, HIV, BC, LC, and general public. 1780 (n = 1137)
Age, mean
54 years
Sex, male
765 (43)
Education
(33), HS or less
Self-described health
587 (33), poor or very poor
712 (40), fair
481 (27), good or excellent
Privacy
Trust
Completed survey n = 403
Privacy
Respondents who were more privacy sensitive were less inclined to participate in the study.
Disclosure concerns differed across health conditions.
Respondents who completed the survey via telephone were less privacy concerned compared to those who completed it online.
Trust
Participants trusted that their information would be used appropriately.
Higher levels of trust were placed in the individual (doctors) (64%), as well as hospitals (43%); this was higher than for university researchers (28%).
Lowest rates of trust were recorded for: pharmaceutical companies (9%), provincial governments (9%), and insurance industries (6%).
Research undertaken for profit or linking of income, education or occupation had lower rates of consent.
Trust is reduced in the event of high-profile data breaches.
0.9
Other
[47], New Zealand, not reported Citizens’ jury, not applicable Pharmaco-epidemiological research/general public 13 Age, years
18–65 years (7 (54) were 45)
Sex, male
6 (46)
Privacy Privacy
• Given appropriate privacy safeguards, an informed public does not always place personal privacy above societal benefits.
• A balance between the public interest and medicine safety is important.
• The use and linkage of medical information for research on medicine safety is warranted given the existing protections and the minimum of identifiable information.
The jury was comfortable with the small loss of privacy to support public good and safety…
1
[48], United Kingdom, not reported Citizens’ jury, not applicable General medicine/general public 34 Age, years
8 (23.5), 18–29
10 (29.4), 30–44
10 (29.4), 45–59
6 (17.6), ≥60
Sex, male
17 (50)
Education
13 (38.2), no qualification
11 (32.4), apprenticeship or other qualification
10 (29.4), degree level or above
Privacy
Transparency
Trust
Privacy
• Public benefit was a key justification for access.
• Where data was used for public benefit (such as improved medical care and treatments, improved public health, or management of public funds) and organisations made a clear and compelling case for why they need these patient records, access should be granted.
• An individual’s right to privacy should not prevent research that can benefit the general public.
Privacy statements:
a. We should share all the data we can because it benefits the services and me—as long as I can opt out if I choose
b. We should not share data as the risks to people’s privacy and security outweigh the benefits
19 (55.9), agree more with a than b.
11 (32.4), agree more with b than with a.
4 (11.8), agree equally with both or don’t agree with either or don’t know.
Transparency
• Transparency about data use and access was important.
• Involving individuals in the decision regarding data use would increase transparency.
Trust
• Important to show a clear, relevant connection between the research question and the information contained in the records. Some organisations had a track record of protecting data and records and could be trusted to maintain control of data.
• Some believed that organisations could not be trusted to maintain records appropriately.
• Organisations may use the data to exploit or manipulate individuals or populations or might manipulate the data to support their own agenda.
• Providing more information on data use does not increase public trust.
0.8
  1. AIDS acquired immune deficiency syndrome, ALSPAC Avon Longitudinal Study of Parents and Children, BC breast cancer, BHPS British Household Panel Survey, CAE Centre for Adult Education, CATI computer assisted telephone interviewing, CF cystic fibrosis, CC colon cancer, DM diabetes mellitus, ED emergency department, EU European Union, GCSES General Certificate of Secondary Education, GED general educational development, HFEA Human Fertilisation and Embryology Authority, HIV human immunodeficiency virus, HKID Hong Kong Identity Card number, HS high school, HSC high school certificate, HT hypertension, LC lung cancer; LR likelihood ratio, MS multiple sclerosis, NHI National Health Index, NHS National Health Service, NILT Northern Island Life and Times, NZ New Zealand, SCD sickle cell disease, PS primary school, QUAGOL Qualitative Analysis Guide of Leuven, SS secondary school, TAFE Technical and Further Education, VA Veterans Affairs, UK United Kingdom, USA United States of America
  2. *Adults or parents of children with CF, or adults or parents of children with SCD, or adults or parents of children with DM, or adults with HIV, or adults with BC, or adults with CC