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“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

“Let’s get the best quality research we can”: public awareness and acceptance of consent to use... Background: Opt-in consent is usually required for research, but is known to introduce selection bias. This is a particular problem for large scale epidemiological studies using only pre-collected health data. Most previous studies have shown that members of the public value opt-in consent and can perceive research without consent as an invasion of privacy. Past research has suggested that people are generally unaware of research processes and existing safeguards, and that education may increase the acceptability of research without prior informed consent, but this recommendation has not been formally evaluated. Our objectives were to determine the range of public opinion about the use of existing medical data for research and to explore views about consent to a secondary review of medical records for research. We also investigated the effect of the provision of detailed information about the potential effect of selection bias on public acceptability of the use of data for research. Methods: We carried out a systematic review of existing literature on public attitudes to secondary use of existing health records identified by searching PubMed (1966-present), Embase (1974-present) and reference lists of identified studies to provide a general overview, followed by a qualitative focus group study with 19 older men recruited from rural and suburban primary care practices in the UK to explore key issues in detail. Results: The systematic review identified twenty-seven relevant papers and the findings suggested that males and older people were more likely to consent to a review of their medical data. Many studies noted participants’ lack of knowledge about research processes and existing safeguards and this was reflected in the focus groups. Focus group participants became more accepting of the use of pre-collected medical data without consent after being given information about selection bias and research processes. All participants were keen to contribute to NHS-related research but some were concerned about data-sharing for commercial gain and the potential misuse of information. Conclusions: Increasing public education about research and specific targeted information provision could promote trust in research processes and safeguards, which in turn could increase the acceptability of research without specific consent where the need for consent would lead to biased findings and impede research necessary to improve public health. Keywords: Medical record, Informed consent, Selection bias, Secondary research, Confidentiality * Correspondence: liz.hill@bristol.ac.uk School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK © 2013 Hill et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 2 of 10 http://www.biomedcentral.com/1471-2288/13/72 Background safeguards, and education was called for to engage par- Secondary use of health data is common in epidemio- ticipants and increase the acceptability of such research logical research and reviews of medical records can be of without consent [24-29]. Engaging the public and in- great benefit in large-scale public health studies due to creasing awareness about research using medical data the wealth of pre-collected data available. The British was a key recommendation in a UK report on the use of government plans to make de-identified National Health personal medical data for public good [30]. Service (NHS) data readily available for re-use by the This study included a systematic literature review and private sector, unless patients actively opt out [1]. Cur- focus group study. The literature review provided an rently in the UK informed consent must be sought from overview of the existing evidence and enabled the find- individuals for any use of their identifiable data, includ- ings from the focus group to be set in a broader context. ing when conducting a secondary review of a medical The focus group study was part of the ongoing CAP record [2]. In exceptional circumstances approval can be (Cluster randomised triAl of testing for Prostate cancer) sought to waive informed consent, but in practice this trial, which is evaluating the population effectiveness of can be difficult to obtain [3-5]. a single prostate specific antigen (PSA) test for prostate Researchers are concerned about selection bias (or “con- cancer [31]. In the focus groups, we elicited views about sent” or “participation” bias) arising from seeking consent, consent for a review of existing medical records in gen- where systematic differences arise between those who con- eral. Participants were provided with information about sent and those who do not. The detrimental effect of se- research processes and selection bias so that we could lection bias on the validity of data has been shown by a investigate whether an understanding of selection bias number of studies [6-10], although not all [11]. As there is would alter views about the necessity of consent for a no effect on the patient or their care from this type of sec- review of medical records. ondary research, some researchers argue that consent for a review of the patient’s record is unnecessary [4,12-14], Methods and that similar audit-based reviews of records are rou- Systematic review tinely undertaken by clinicians, without requiring separate We searched for any qualitative, mixed method or sur- informed consent [15,16]. It is claimed that NHS medical vey design study that mentioned reasons or characteris- records are a comprehensive resource funded by public tics behind different consent preferences for secondary money and therefore should be used to further research review of pre-collected health data. Medical data could for public benefit [1,13,16,17], and that the cost of be held in primary or secondary care, and be electronic consenting is too high and practical obstacles too great or paper-based. Studies requesting consent to any inter- [18-20]. Researchers often note that many participants vention were not included; studies concerned with con- cannot be contacted because their clinician denies access, sent for use of secondary data only were included. There or they do not respond, while few potential participants were no restrictions on publication date or publication actively refuse to take part [4,7,8,19]. type in the search. The search terms were applied in Although researchers may wish for easier access to English only, however, non-English language papers were medical records to reduce potential bias and the cost of not excluded. Conference abstracts were included. the consent process, public opinion may not be so per- missive. Members of the public hold a wide range of Search strategy views about the necessity of consent for a review of their Studies were identified by searching electronic databases, medical records [21-23]. Some would like to be offered and by reviewing the reference lists of included articles an opportunity to consent for each use of their data; for for any further studies that met the inclusion criteria. th others one-off consent would be acceptable to cover all We searched PubMed (including Medline) (1966-16 th future research, and some are happy for such research to January 2012) and Embase (1974-16 January 2012). go ahead without informed consent. A number of stud- We used the following electronic search strategy for ies have suggested that members of the public are more all database searches: willing to waive consent when they understand the is- ((consent OR authorization OR authorisation) AND bias sues involved in carrying out such studies. Two large- [title + abstract only]) OR ((confidentiality OR privacy) scale UK surveys concluded that the public has low AND (medical record OR health record OR health infor- awareness of how their medical data are used, and if mation) [title + abstract only]). they are informed about what research entails they are generally more positive about it [22,23]. In other studies Study selection where the public were asked about consent for second- The flow diagram in Figure 1 shows the papers retrieved ary uses of medical data, participants were found to be and excluded at each stage of the systematic review. Ti- poorly informed about research processes and existing tles and abstracts of all articles were reviewed by EH. Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 3 of 10 http://www.biomedcentral.com/1471-2288/13/72 two primary care practices. To increase the generalisability Records identified Records identified of focus groups we approached primary care practices lo- via Embase via PubMed cated within an area of some deprivation (higher search n=1663 search n=1449 deprivation quintile) and a more affluent area (lower Duplicates removed deprivation quintile), as ranked by the UK Index of Mul- n=1352 tiple Deprivation [33]. Patients who were considered to Records after have terminal illness or who the General Practitioner (GP) Records excluded after duplicates removed deemed unsuitable to participate in the focus groups for initial screening of title n=1760 and abstract n=1682 other reasons, for example learning difficulties, were excluded. Records included Records excluded after after initial screening full paper screening Methods of title and abstract n=62 n=78 The focus group study received research ethics commit- Full paper unavailable, tee approval from Dorset Research Ethics Committee no reply from author n=1 (ref: 07/H0201/108). Participants meeting the inclusion Records included after full paper criteria were sent an initial invitation letter outlining the Additional studies screening n=15 study and requesting they return a reply slip if they were identified from hand interested in receiving further information. Interested searching reference lists of included studies n=12 men were sent an information sheet, consent form and Total studies identified n=27 short questionnaire, which asked for information about their general health using the 12-item Short Form Figure 1 Flow diagram of included studies. Health Survey (SF-12) [34], and demographic informa- tion to allow us to balance the participants in each Any articles potentially fitting the criteria, or where this group according to age and general health status. Men was unclear from the title and abstract, were retrieved and indicated whether they had worked for the NHS or had the full text articles were reviewed. Data from papers in- ever taken part in health research so we could gauge the cluded in the full review were abstracted to a standardised extent of their prior knowledge about health research. form. Data included type of study (e.g. survey, focus A total of 19 participants attended three focus groups, group), sample size, participant characteristics including with between 5 and 9 in each group. The number of age, gender and any health condition or status. The main focus groups was limited due to time constraints. All findings from each paper were summarised. As this review groups were facilitated by EH, with a note taker and sec- sought both qualitative and quantitative research, a sum- ond researcher present, and followed the same topic mary statistical analysis was not performed. guide, each lasting approximately 90 minutes. Following initial questions about the contents of hospital medical Focus groups records, intended to relax the participants and initiate We used qualitative methods to explore the views and discussion, the men were then asked how they would opinions of members of the public about data from a re- react to a letter asking them to take part in a study that view of their hospital medical records being extracted wished to review their hospital records. They were asked and used for research purposes. The focus group meth- if they would be willing to let a researcher have access to odology was chosen as this allowed exploration of the their records for research purposes. We provided infor- opinions of participants in general before presenting mation about different methods of consent: opt-in, in- them with information about selection bias and noting formed consent and opt-out, or presumed consent, and the ways in which their understanding and opinions asked whether they would approve of their records being changed in relation to the information provided. Focus reviewed without prior consent being sought. groups are considered especially useful where the issues In order to ensure that participants understood the under discussion are new to people, allowing exploration processes and some of the issues faced when undertak- of ideas they may not have considered before [32]. ing such research, a presentation was then given about possible selection bias arising from having to obtain in- Participants formed consent; that is, by obtaining consent, certain Focus group participants were men potentially eligible groups of people would be more or less likely to agree to for the CAP study, aged between 50 and 69 years, but participate, which might alter the findings. Information who were not recruited to the study because of their lo- was presented verbally along with text and diagrams, cation away from the study areas. Participants for the and was given in general and then in the context of a focus groups were identified at random from the lists of real-life scenario. There were opportunities for questions Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 4 of 10 http://www.biomedcentral.com/1471-2288/13/72 throughout and we checked understanding of selection being reported by two papers each [25,47], and [26,27]. Of bias by monitoring their response, and providing further the two review papers, one sought only studies from the clarification if necessary. UK [10], while the other included papers from Canada, The participants were then asked whether the possibil- UK, USA, Ireland, Japan, Taiwan, and Australia [6]. ity of selection bias changed their opinion about a re- view of their records without informed consent. To Characteristics of consenters and non-consenters: survey conclude, we discussed whether any safeguards could be results put in place that would reduce any individual’s require- Of the twelve quantitative surveys looking at differences ment or preference for informed consent. Throughout, between those who consented to a review of their medical participants were requested not to talk about their own records or not, two reported no significant differences be- medical conditions or experiences. tween consenters and non-consenters [11,50], seven pa- pers reported that males were more likely to consent than Analysis females [24,36,37,40,41,43,48], four reported older respon- All focus groups were audio recorded with each partici- dents more likely to consent [36,37,40,43], while three pant’s permission, transcribed verbatim and anonymised. noted that those with less sensitive or stigmatising infor- At least two researchers (EH and JD) undertook iterative mation were more likely to consent [24,37,38]. The un- thematic analysis of the transcripts using the method of employed [24] or those not paying for their healthcare in constant comparison to generate a list of themes. the US were more likely to consent [38]. Those in poorer Themes were compared within and across focus groups health [40] and people with cancer were more likely to and participants, and the coding and themes were consent than the general public [35]. One online survey of discussed until all researchers (EH, JD, RM and ET) the general public found the reverse: that those younger, agreed with the final list. in better health and of white ethnicity were more likely to consent [39]. Results The systematic review of seven UK surveys found that Systematic review overall those with the symptom under investigation were The flow diagram in Figure 1 shows the papers retrieved most likely to consent and consent rates fell in the over and excluded at each stage of the systematic review. 50 age groups, especially for women [10]; however, an- Seventy-eight papers were identified as potentially other systematic review found no clear patterns across relevant from the title and abstract of the 1760 unique 17 international studies on any of variables age, sex, in- papers found by the literature search. Of these, 68 were come, education or health status [6]. excluded on review of the full article. One potentially Patterns of consent were similar in the quantitative as- relevant conference abstract was also identified and the pects of the six mixed methods papers that reported dif- author was contacted for further information but did ferences in consent rates between groups: male gender not reply; this abstract was excluded as it did not con- [21,22,45], older age [23,45,46], having a less sensitive con- tain enough information to meet the inclusion criteria. dition [22], being of non-white ethnicity [22], long term After full review, 15 papers met the review criteria. Hand disability [23] and having breast cancer or sickle cell dis- search of the reference lists of these 15 papers, and those ease (versus other conditions such as cystic fibrosis or papers identified from the reference lists, produced an- colon cancer [28]) were factors associated with being more other 12 papers. The resulting 27 papers included three likely to consent. Participants rating themselves as having papers using qualitative methods, 12 surveys and two sys- a greater knowledge of the NHS were more likely to con- tematic reviews of surveys that contained information on sent in one study [45]. Higher socioeconomic status was the differences between consenters and non-consenters, associated with higher consent rates in two studies and 10 papers using mixed methods. The characteristics [23,45], although another study questioning patients with of the included studies are shown in additional files for various conditions including cancer and diabetes found both quantitative aspects (Additional file 1a, studies those on a lower income more likely to consent [28]. reporting response rates; and Additional file 1b, studies reporting perspectives of respondents) and qualitative as- Themes arising from previous qualitative research pects (Additional file 2). Three papers were identified reporting qualitative results Of the twenty-seven included studies, nine were only. There were also ten mixed methods papers that in- conducted in the USA [28,35-42] with one of these fea- cluded a qualitative aspect. The papers focused on five turing US veterans only [42]. Six studies were carried major themes. The key findings are listed below: out in the UK [11,22,23,43-45], one in Eire [46] and one Eleven of the 13 studies noted the lack of current in New Zealand [11]. Eight studies originated from knowledge that many participants had about how their Canada [21,24-27,47-49], with two research projects medical data may be used for research and the existing Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 5 of 10 http://www.biomedcentral.com/1471-2288/13/72 safeguards to protect their data [22,23,25-27,42,44-47,49]. Approached via primary care There were widespread calls from both the patients and (n=320 approx; exact number researchers for increased public education about research excluded by General Practitioner unknown) processes and safeguards. Participants were reported as recognising the benefit Returned initial reply slip (n=85) of research for the population in nine of the studies [23,25-27,42,44-47]. The time and effort involved in Not selected for focus group due Consent (n=59) to time constraints (n=36) obtaining consent was often balanced against the public benefit of the research during discussions. Allocated to focus group (n=23) Did not attend focus group (n=4) In ten of the studies, participants wished to be informed about how their data were being used and by whom Attended focus group (n=19) [22,23,25-27,42,44-47]. Information about the user of the data was seen as more important than the intended use in Figure 2 Focus group response figures. determining whether to offer consent in some studies [22,45], while others noted that the planned use of the data was an important determinant of whether partici- one participant had some knowledge of health research pants would consent to its use [26,42,47]. having sat on a local research ethics committee. Different consent models were discussed in ten papers [22,23,25,26,42,44-47,49]. There was no consensus on a Consent for medical record review preferred model either within or across studies, although All participants accepted the need for research and participants often considered the balance of obtaining understood that this was an important aspect of the consent against the public benefit incurred by unre- NHS. A few expressed surprise that this sort of research stricted research. Despite this recognition, many partici- was not happening as a matter of course. All would con- pants maintained that informed consent should always sent to a review of their medical records if asked: be sought, out of respect for the individual. “Definitely if it was going to benefit somebody else All 13 studies mentioned areas of concern held by par- then yeah.” (Participant 2, group 2) ticipants about data sharing. Data and database security When asked about the use of records without their [22,28,46,49], and whether the data were anonymous was prior informed consent, opinions were split equally a concern, with participants being less restrictive when Table 1 Sociodemographic characteristics of focus group data were anonymous or unidentifiable [22,26,28]. There participants (n=19) was apprehension in many studies that data would be sold n% for commercial profit, and this was generally seen as less Mean age in years (SD) 61 (4.84) acceptable, commanding a higher requirement for in- Age range 54-69 formed consent [21,23,25-27,42,44,45,47]. Release of data to insurance companies or pharmaceutical companies was Marital status often mentioned as a concern, again leading to a more re- Married / living as couple 16 84 strictive consent requirement [23,26,27,42,44,45,47]. Single 1 5 Divorced 2 11 Focus groups Ethnicity Figure 2 shows the focus group response figures. Ap- White British 18 95 proximately 320 men were invited (exact number of men excluded by GP unknown), 85 were sent informa- White other 1 5 tion about the study at their request and 59 consented Employment status to take part. Twenty-three men were scheduled to take Employed 11 58 part in a focus group, with four of these failing to attend. Retired 5 26 Nineteen men (mean age 61 years) took part in our Unemployed seeking work 1 5 focus groups; age, occupational and health status were Unemployed due to illness or disability 2 11 balanced across groups (Table 1). The characteristics of the men who consented to be involved and returned a Mean SF-12 score* questionnaire (n = 58) were very similar to those who Physical health component (score*) (52.06) attended the groups. Mental health component (score*) (51.32) One participant reported having formerly worked for SD standard deviation. the NHS (not in a clinical role). No participants reported *Range from 0 to 100, with scores below 50 indicating poorer than taking part in any health research previously; however, average health. Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 6 of 10 http://www.biomedcentral.com/1471-2288/13/72 between those that saw the “greater good” of public Interestingly, no participants spontaneously mentioned benefit and those who thought it was courtesy that they ethics committees, NHS research governance procedures were informed: or legislation when considering potential safeguards. “I’m saying yes because I think there’s a greater good.” Throughout the discussion many questions were asked (Participant 1, group 2) about how research was carried out, suggesting that par- “I think it’s just etiquette to ask people to do such ticipants were unaware of how their data could currently things.” (Participant 5, group 3) be used, and needed to be able to trust that their data were secure: Understanding of selection bias “How do we know that you just don’t go to the hos- Following presentation of information about selection bias pital and say “can I have a look at these records” and we and discussion of issues surrounding the consent process, don’t know anything about it?” (Participant 8, group 3) participants could understand the difficulties faced by re- searchers. They recognised the increased cost and time Potential misuse of information that the process took and how a low response rate might The fear of data being misused by companies for their bias the findings: own gain was very apparent in all groups. Concerns were “Well I’d sympathise with the researcher and I think if mainly around insurance companies obtaining health in- you’re setting yourself up to do research which is going formation which may affect their premiums or cover, or to be skewed by the nature of consent then let’s try and companies using the information for targeted advertising: avoid the issue of going for consent. Let’s get the best “What I don’t like is any information being passed quality research we can do.” (Participant 1, group 2) on to a third party, for promotion purposes. Say you’ve We asked if knowing this changed their opinion on got a particular problem then it goes to a drugs sup- the use of their medical records without their prior con- plier or something like that, that I would object to.” sent. Many were already positive about the use of re- (Participant 4, group 1) cords without their prior permission and clarified this, Despite the information collected from medical records but for those who were more reluctant in the first in- being anonymised, the men had the same concerns over stance, their opinion did change. However, when asked, their personal information being disclosed inappropriately a few men still preferred informed consent. This was by the researchers as by commercial companies: more to do with an interest or curiosity in the kind of “I think we can forget security because let’s face it, it research that they were contributing to. Although they isn’t there anymore so if you don’t want it to be given would like to be informed, participants were still likely out then you say so…” (Participant 2, group 2) to consent but felt the need to know details of the Although some men seemed resigned to the fact that research: there was a lack of security, they were still willing to “My own personal opinion, as much as I under- consent and would accept the security risk as part of the stand the maths of it, is I would still like to be asked.” process. (Participant 8, group 3) Among those who preferred to be informed about re- Acceptable & unacceptable types of research search, opt-out consent was considered to be acceptable, In all groups there was discussion around acceptable as it satisfied their curiosity and offered a chance for re- and unacceptable types of research. This dichotomy was fusal, with less of an impact on the validity of the results. based on who profited from the research, rather than the study design or ethical aspects. Research undertaken Safeguards by the NHS was seen as acceptable and for public good, We asked if there were any safeguards that could be put whereas pharmaceutical companies who gained finan- into place that would make the men more likely to cially from the altruistic sharing of records were seen as accept the scenario of no prior consent. Common less acceptable: safeguards suggested were anonymisation and data “If there was a large commercial company… [that] had encryption: free and easy access to people’s medical records I don’t “I think I’d be happy as long it is stays within the area, think that would be right. It would further their research it didn’t find its way into a laptop, and it was all into the particular drug or treatment, but it’d also fur- encrypted.” (Participant 1, group 1) ther their profits that would be wrong. But if it was for A minority of participants said there could be no safe- medical research for everybody then that would be dif- guards that would make them happy with the no con- ferent.” (Participant 6, group 3) sent scenario: “Financial gain comes into it then so why should you “I don’t want any safeguards, end of story, so I want then let them look at your records? They’re going to prior consultation.” (Participant 5, group 3) gain out of it and you’re not…” (Participant 2, group 2) Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 7 of 10 http://www.biomedcentral.com/1471-2288/13/72 University researchers were considered to be some- in a number of countries, each with different health care where in the middle, and it was the funder of the re- systems and governing laws, the themes were very simi- search and their financial gain that was considered when lar, suggesting that there are common issues which need making a judgement about the acceptability of the to be addressed if increasing numbers of members of the research: public are to agree to a review of their existing medical “The question would be who are the researchers work- data. ing for? Are they researching for medical companies, or Our focus group research explored men’s views about universities who are attached to medical companies and consent for a review of medical records in the context of getting funded [by them]?” (Participant 8, group 3). selection bias and the findings reflected the themes aris- There was an apparent dichotomy between acceptable ing from the systematic review. All the men involved research, seen as being undertaken for the public good, agreed that they would consent to a review of their re- and less acceptable research, for commercial gain. cords when asked. However, opinion was split when in- formed consent was not to be sought for such research. The impact of the provision of information Some were happy to be able to help the “greater good”, Men became more accepting of research without specific yet others, while understanding this opinion, felt that it individual consent following the provision of informa- was only courteous to be informed about the research tion about bias and research processes, for example the and that the data should not be taken without the pa- time and cost of obtaining consent: tient’s knowledge. This accords with previous research “If you’re putting money into a charity for them to re- that has shown a wide range of public opinion regarding search something, you want that research done, not for consent to review of medical records [21-23]. Following it to be spent on the administration to enable the re- discussion about selection bias, participants’ views about search to be done.” (Participant 5, group 2) research without consent became more favourable, with Where concerns remained in the minority, on the some men changing their opinion and no longer stating whole these related to the potential misuse of their per- the need for specific informed consent. However a small sonal data, or a wish to be informed about the use of minority remained adamant that they always want an their data. Participants questioned how the processes opportunity to consent or at least to have an opt-out would work, and their need to trust that the data would consent option. The increasing acceptance following in- be secure was implicit: formation provision seen in the focus groups was in con- “How would it happen, how would you do it, how trast to two similar studies (reported in three papers) would you keep it secure?” (Participant 3, group 1) that provided information and research scenarios to aid understanding and found that although individual opin- Discussion ions altered throughout the course of the dialogue, ag- The systematic review identified twenty-seven relevant gregated opinion showed little change [25,42,47]. Focus studies. From the quantitative literature, males and those on selection bias specifically could perhaps influence the who were older seemed more likely to consent to a re- opinions of the participants to a greater extent than view of their medical records, although this was not con- more general consent scenarios and future research firmed in a meta analysis of 17 international studies [6]. should investigate whether this is seen in other demo- Similar themes arose in the qualitative studies. Partici- graphic groups, and the best way to present this infor- pants recognised the benefit of sharing their records for mation to ensure a wide public understanding. research, but the majority wanted to know how their When safeguards were mentioned by the facilitator, data were being used. The systematic review found that the participants did not seem to value them as tangible participants shared many of the same concerns about and asked many questions. There was a lack of know- ledge about current safeguards and there was no spon- disclosing their health data, although the focus on cer- tain issues reflected the context of each study. Concerns taneous mention of ethical approval, hospital research over data security, data being used by insurance or governance procedures or the contractual obligations of the researchers by the participants. In one group there pharmaceutical companies and data being sold for com- mercial gain were common. The UK government’s plans were questions about data protection laws, but on the to allow commercial access to NHS data [1] may be un- whole participants failed to recognise these existing safe- guards. The discussion and questions generated showed acceptable to the public unless a benefit for the majority can be demonstrated. Nearly all the identified studies that the participants were interested in this and wanted noted that participants were ill-informed about current a greater understanding of the processes involved. Previ- ous research has also suggested that the public feel practices and use of their health data and that educating the public may increase the acceptability of the use of poorly informed and would like more information about data for research. Despite the research being carried out how research is carried out [22-29]; eleven of the Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 8 of 10 http://www.biomedcentral.com/1471-2288/13/72 thirteen qualitative studies identified in this systematic noted that during interviews about consent for medical review also noted their participants’ lack of knowledge. record reviews participants were still formulating their There were concerns from these focus group partici- thoughts and did not have mature opinions [26]. The pants about possible misuses of health information such focus group format allowed our participants to develop as passing on health status information to insurance com- their opinions in an area that was new to them, gaining panies or to target advertising for certain treatments. insight from the views of others [32]. Our focus groups Older men in another study also feared that records could concentrated on the provision of specific consent for be shared with outside agencies [42], and these concerns each project, however it is possible that participants may were highlighted in other research [23,51]. In the focus have found broad consent for a number of similar pro- groups, the dichotomy between acceptable and less ac- jects to be satisfactory. Opt-out consent rather than opt- ceptable types of research was based on who profited from in consent may also be acceptable and future research the research, rather than the study design or ethical as- should explore this further. Women and younger males pects, with NHS research for the benefit of the public seen were not included in our focus groups, and all partici- as an example of good research and pharmaceutical com- pants described themselves as of white ethnicity, so panies acting to gain financially seen as less acceptable. these are limitations. The systematic review identified Scepticism about research for commercial profit was a males and older people as more likely to consent to a re- common theme and a number of studies noted that par- view of their medical records and, as is true with all re- ticipants wanted more restrictions on their data where search, those who agree to take part are often those who commercial profit could be made from their information are more positive about research. Therefore the opinions [21-23,25-27,29,50]. If altruistic sharing of data resulted in generated by the focus group may be more accepting of profits that did not benefit the NHS, participants would such research without consent than the general popula- have strong reservations about allowing access to their re- tion. Despite this, our focus groups found that there cords. Public education about current research legislation were still a number of concerns to be allayed about the and data security measures is needed to allay misconcep- research process and that information provision may be tions about the use and safety of patient data, and this will useful to reduce concerns in all groups, not just in those be of paramount importance if the proposed access to data who are positive about research in general. by private industry is to be acceptable. Many similar themes have been found in the related Conclusions area of secondary use of tissue samples for research. A The majority of men in our focus groups were happy for review of 30 studies reporting views on consent for re- medical record reviews to go ahead without consent, search using biological samples [52] found a high level and even more so when their understandings of selec- of willingness to donate leftover samples for research tion bias and appropriate safeguards were enhanced. In- (83-99 %), with marginally less support for commercial creasing public education about research is likely to rather than academic research. Nine of the studies noted benefit research, as a greater understanding of the safe- that people would like information on how their samples guards and legislation that governs research should in- were used. A recent review of 18 qualitative research pa- crease public trust and reduce misconceptions. This pers also noted comparable themes to those reported could improve consent rates or, as found here, the ac- here [53]. Reasons given for allowing excess tissue to be ceptability of research without informed consent for “the used for research were for both individual gain and for greater good” of the National Health Service. public good, but most patients agreed that tissue should not be used without the patient’s consent. Trust in re- Additional files search institutions that data would be secure and tissue not exploited was a common theme, with similar con- Additional file 1: Characteristics of included studies – Quantitative cerns about commercial access to samples as seen in our aspects (1a, studies reporting response rates; 1b, studies reporting research. perspectives of respondents). This study was the first to obtain qualitative opinions Additional file 2: Characteristics of included studies – Qualitative aspects. about medical record review both before and after provision of detailed information about selection bias and research processes. By providing information about Competing interests The authors declare that they have no competing interests. the problems of selection bias, we were able to explore how opinions changed in the context of this knowledge. Authors’ contributions We were also able to answer the many questions that EH, ET, RM and JD conceived and designed the study. EH performed the arose, which helped to increase understanding of re- systematic review and designed the focus group guide and facilitated all search amongst our participants. Previous work has groups with JD, ET or RM also present. EH and JD analysed the focus group Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 9 of 10 http://www.biomedcentral.com/1471-2288/13/72 data. EH drafted the manuscript and all authors reviewed and approved the Do people with potentially stigmatizing health conditions and the final manuscript. general public differ in their opinions? BMC Med Ethics 2009, 10:10. 22. NHS Information Authority in conjunction with The Consumers' Association and Health Which?: Share with care! People's views on consent and Acknowledgments confidentiality of patient information. UK: Crown Copyright; 2002. We would like to thank the men who took part in the focus groups and the 23. Medical Research Council, Ipsos MORI: The Use of Personal Health general practices who allowed us to approach the potential participants. We Information in Medical Research. UK; 2007. would also like to acknowledge assistance from Genevieve Hatton-Brown 24. Page S, Mitchell I: Patients' opinions on privacy, consent and the and Marta Tazewell for transcribing the groups. disclosure of health information for medical research. Chronic Dis Can 2006, 27:60–67. Funding 25. Willison D, Swinton M, Schwartz L, Abelson J, Charles C, Northrup D, Cheng The CAP trial is funded by Cancer Research UK and the UK Department of J, Thabane L: Alternatives to project-specific consent for access to Health (C11043/A4286, C18281/A8145, C18281/A11326, and C18281/A15064). personal information for health research: Insights from a public dialogue. BMC Med Ethics 2008, 9:18. Received: 23 July 2012 Accepted: 29 May 2013 26. Nair K, Willison D, Holbrook A, Keshavjee K: Patients' consent preferences Published: 4 June 2013 regarding the use of their health information for research purposes: a qualitative study. J Health Serv Res Policy 2004, 9:22–27. References 27. Willison DJ, Keshavjee K, Nair K, Goldsmith C, Holbrook AM: Patients' 1. Hawkes N: Cameron promotes new partnership between research, consent preferences for research uses of information in electronic industry, and the NHS. BMJ 2011, 343:1179. medical records: interview and survey data. BMJ 2003, 326:373. 2. Nicholas N, Nicholas S: Understanding confidentiality and the law on 28. Kass NE, Natowicz MR, Hull SC, Faden RR, Plantinga L, Gostin LO, Slutsman J: access to medical records. Obstet Gynaecol Reprod Med 2010, 20:161–163. The Use of Medical Records in Research: What Do Patients Want. J Law 3. Metcalfe C, Martin RM, Noble S, Lane JA, Hamdy FC, Neal DE, Donovan JL: Med Ethics 2003, 31:429–433. Low risk research using routinely collected identifiable health 29. Armstrong V, Barnett J, Cooper H, Monkman M, Moran-Ellis J, Shepherd R: information without informed consent: encounters with the Patient Public perspectives on the governance of biomedical research: a qualitative Information Advisory Group. J Med Ethics 2008, 34:37–40. study in a deliberatve context. London: The Wellcome Trust; 2007. 4. Iversen A, Liddell K, Fear N, Hotopf M, Wessely S: Consent, confidentiality, 30. The Academy of Medical Sciences: Personal data for public good: using and the Data Protection Act. BMJ 2006, 332:165–169. health information in medical research. London; 2006. 5. Hansson MG: Need for a wider view of autonomy in epidemiological 31. Lane JA, Hamdy FC, Martin RM, Turner EL, Neal DE, Donovan JL: Latest research. BMJ 2010, 340:1172–1174. results from the UK trials evaluating prostate cancer screening and 6. Kho ME, Duffett M, Willison DJ, Cook DJ, Brouwers MC: Written informed treatment: The CAP and ProtecT studies. Eur J Cancer 2010, 46:3095–3101. consent and selection bias in observational studies using medical 32. Kitzinger J: Qualitative Research: Introducing focus groups. BMJ 1995, records: systematic review. BMJ 2009, 338:b866. 311:299–302. 7. Macleod U, Watt G: The impact of consent on observational research: a 33. UK Network of Public Health Observatories: Health Profiles. 2011. http://www. comparison of outcomes from consenters and non consenters to an apho.org.uk/default.aspx?QN=P_HEALTH_PROFILES. observational study. BMC Med Res Methodol 2008, 8:15. 34. Ware JE, Kosinski M, Keller SD: A 12-item short-form health survey - 8. Al-Shahi R, Vousden C, Warlow C, for the Scottish Intracranial Vascular Construction of scales and preliminary tests of reliability and validity. Malformation Study (SIVMS) Steering Committee: Bias from requiring Medical Care 1996, 34:220–233. explicit consent from all participants in observational research: 35. Beckjord EBR: What do people affected by cancer think about electronic prospective, population based study. BMJ 2005, 331:942–944. health information exchange? Results from the 2010 LIVESTRONG 9. Barber J, Muller S, Whitehurst T, Hay E: Measuring morbidity: self-report or Electronic Health Information Exchange Survey and the 2008 Health health care records? Fam Pract 2010, 27:25–30. Information National Trends Survey. J Oncol Pract 2011, 7:237–241. 10. Dunn KM, Jordan K, Lacey RJ, Shapley M, Jinks C: Patterns of Consent in 36. Bolcic-Jankovic D, Clarridge BR, Fowler FJ Jr, Weissman JS: Do Epidemiologic Research: Evidence from Over 25,000 Responders. Am J characteristics of HIPAA consent forms affect the response rate. Med Epidemiol 2004, 159:1087–1094. Care 2007, 45:100–103. 11. Baker R, Shiels C, Stevenson K, Fraser R, Stone M: What proportion of 37. Jacobsen SJ, Xia Z, Campion ME, Darby CH, Plevak MF, Seltman KD, Melton patients refuse consent to data collection from their records for research LJ: Potential effect of authorization bias on medical record research. purposes. Br J Gen Pract 2000, 50:655–656. Mayo Clin Proc 1999, 74:330–338. 12. Peto J, Fletcher O, Gilham C: Data protection, informed consent, and 38. Merz JF, Spina BJ, Sankar P: Patient consent for release of sensitive research. BMJ 2004, 328:1029–1030. information from their medical records: an exploratory study. Behav Sci 13. Cassell J, Young A: Why we should not seek individual informed consent Law 1999, 17:445–454. for participation in health services research. J Med Ethics 2002, 28:313–317. 39. Westin AF: How the public views privacy and health research. Results of a 14. Al-Shahi R, Warlow C: Using patient-identifiable data for observational national survey commissioned by the Institute of Medicine Committee on research and audit. BMJ 2000, 321:1031–1032. "Health research and the privacy of health information: The HIPPA Privacy 15. Campbell B, Thomson H, Slater J, Coward C, Wyatt K, Sweeney K: Extracting Rule". USA: Institute of Medicine; 2007. information from hospital records: what patients think about consent. 40. Woolf SH, Rothemich SF, Johnson RE, Marsland DW: Selection Bias From Qual Saf Health Care 2007, 16:404–408. Requiring Patients to Give Consent to Examine Data for Health Services 16. The Academy of Medical Sciences: A new pathway for the regulation and Research. 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Ward HJT, Cousens SN, Smith-Bathgate B, Leitch M, Everington D, Will RG, effect of seeking consent on the representativeness of patient cohorts: Smith PG: Obstacles to conducting epidemiological research in the UK iron-deficiency anaemia and colorectal cancer. Colorectal Dis 2011, general population. BMJ 2004, 329:277–279. 13:e366–e373. 20. Singleton P, Wadsworth M: Consent for the use of personal medical data in research. BMJ 2006, 333:255–258. 44. Robling MR, Hood K, Houston H, Pill R, Fay J, Evans HM: Public attitudes 21. Willison D, Steeves V, Charles C, Schwartz L, Ranford J, Agarwal G, Cheng J, towards the use of primary care patient record data in medical research Thabane L: Consent for use of personal information for health research: without consent: a qualitative study. J Med Ethics 2004, 30:104–109. Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 10 of 10 http://www.biomedcentral.com/1471-2288/13/72 45. Shickle D, Carlisle J, Wallace S: Patient Electronic Record, Information and Consent (PERIC)-Public Attitudes to Protection and Use of Personal Health Information. Sheffield: School of Health and Related Research, University of Sheffield; 2002. 46. Buckley BS, Murphy AW, MacFarlane AE: Public attitudes to the use in research of personal health information from general practitioners' records: a survey of the Irish general public. J Med Ethics 2011, 37:50–55. 47. MacKinnon MP, Saxena N, Swinton M, Watling J, Willison D: Understanding Canadians' Attitudes and Expectations: Citizens' Dialogue on Privacy and the Use of Personal Information for Health Research in Canada. Ottawa, ON: Canadian Policy Research Networks; 2006. 48. Perera G, Holbrook A, Thabane L, Foster G, Willison DJ: Views on health information sharing and privacy from primary care practices using electronic medical records. Int J Med Inform 2011, 80:94–101. 49. Tracy CS, Dantas GC, Upshur RE: Feasibility of a patient decision aid regarding disclosure of personal health information: qualitative evaluation of the Health Care Information Directive. BMC Med Inform Decis Mak 2004, 4:13. 50. Whiddett R, Hunter I, Engelbrecht J, Handy J: Patients' attitudes towards sharing their health information. Int J Med Inform 2006, 75:530–541. 51. Sankar P, Mora S, Merz JF, Jones NL: Patient Perspectives of Medical Confidentiality. J Gen Intern Med 2003, 18:659–669. 52. Wendler D: One-time general consent for research on biological samples. BMJ 2006, 332:544–547. 53. Chan TW, Mackey S, Hegney DG: Patients' experiences on donation of their residual biological samples and the impact of these experiences on the type of consent given for the future research use of the tissue: a systematic review. Int J Evid Based Healthc 2012, 10:9–26. doi:10.1186/1471-2288-13-72 Cite this article as: Hill et al.: “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 2013 13:72. Submit your next manuscript to BioMed Central and take full advantage of: • Convenient online submission • Thorough peer review • No space constraints or color figure charges • Immediate publication on acceptance • Inclusion in PubMed, CAS, Scopus and Google Scholar • Research which is freely available for redistribution Submit your manuscript at www.biomedcentral.com/submit http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png BMC Medical Research Methodology Springer Journals

“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

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Springer Journals
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Copyright © 2013 by Hill et al.; licensee BioMed Central Ltd.
Subject
Medicine & Public Health; Theory of Medicine/Bioethics; Statistical Theory and Methods; Statistics for Life Sciences, Medicine, Health Sciences
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1471-2288
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10.1186/1471-2288-13-72
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23734773
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Abstract

Background: Opt-in consent is usually required for research, but is known to introduce selection bias. This is a particular problem for large scale epidemiological studies using only pre-collected health data. Most previous studies have shown that members of the public value opt-in consent and can perceive research without consent as an invasion of privacy. Past research has suggested that people are generally unaware of research processes and existing safeguards, and that education may increase the acceptability of research without prior informed consent, but this recommendation has not been formally evaluated. Our objectives were to determine the range of public opinion about the use of existing medical data for research and to explore views about consent to a secondary review of medical records for research. We also investigated the effect of the provision of detailed information about the potential effect of selection bias on public acceptability of the use of data for research. Methods: We carried out a systematic review of existing literature on public attitudes to secondary use of existing health records identified by searching PubMed (1966-present), Embase (1974-present) and reference lists of identified studies to provide a general overview, followed by a qualitative focus group study with 19 older men recruited from rural and suburban primary care practices in the UK to explore key issues in detail. Results: The systematic review identified twenty-seven relevant papers and the findings suggested that males and older people were more likely to consent to a review of their medical data. Many studies noted participants’ lack of knowledge about research processes and existing safeguards and this was reflected in the focus groups. Focus group participants became more accepting of the use of pre-collected medical data without consent after being given information about selection bias and research processes. All participants were keen to contribute to NHS-related research but some were concerned about data-sharing for commercial gain and the potential misuse of information. Conclusions: Increasing public education about research and specific targeted information provision could promote trust in research processes and safeguards, which in turn could increase the acceptability of research without specific consent where the need for consent would lead to biased findings and impede research necessary to improve public health. Keywords: Medical record, Informed consent, Selection bias, Secondary research, Confidentiality * Correspondence: liz.hill@bristol.ac.uk School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK © 2013 Hill et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 2 of 10 http://www.biomedcentral.com/1471-2288/13/72 Background safeguards, and education was called for to engage par- Secondary use of health data is common in epidemio- ticipants and increase the acceptability of such research logical research and reviews of medical records can be of without consent [24-29]. Engaging the public and in- great benefit in large-scale public health studies due to creasing awareness about research using medical data the wealth of pre-collected data available. The British was a key recommendation in a UK report on the use of government plans to make de-identified National Health personal medical data for public good [30]. Service (NHS) data readily available for re-use by the This study included a systematic literature review and private sector, unless patients actively opt out [1]. Cur- focus group study. The literature review provided an rently in the UK informed consent must be sought from overview of the existing evidence and enabled the find- individuals for any use of their identifiable data, includ- ings from the focus group to be set in a broader context. ing when conducting a secondary review of a medical The focus group study was part of the ongoing CAP record [2]. In exceptional circumstances approval can be (Cluster randomised triAl of testing for Prostate cancer) sought to waive informed consent, but in practice this trial, which is evaluating the population effectiveness of can be difficult to obtain [3-5]. a single prostate specific antigen (PSA) test for prostate Researchers are concerned about selection bias (or “con- cancer [31]. In the focus groups, we elicited views about sent” or “participation” bias) arising from seeking consent, consent for a review of existing medical records in gen- where systematic differences arise between those who con- eral. Participants were provided with information about sent and those who do not. The detrimental effect of se- research processes and selection bias so that we could lection bias on the validity of data has been shown by a investigate whether an understanding of selection bias number of studies [6-10], although not all [11]. As there is would alter views about the necessity of consent for a no effect on the patient or their care from this type of sec- review of medical records. ondary research, some researchers argue that consent for a review of the patient’s record is unnecessary [4,12-14], Methods and that similar audit-based reviews of records are rou- Systematic review tinely undertaken by clinicians, without requiring separate We searched for any qualitative, mixed method or sur- informed consent [15,16]. It is claimed that NHS medical vey design study that mentioned reasons or characteris- records are a comprehensive resource funded by public tics behind different consent preferences for secondary money and therefore should be used to further research review of pre-collected health data. Medical data could for public benefit [1,13,16,17], and that the cost of be held in primary or secondary care, and be electronic consenting is too high and practical obstacles too great or paper-based. Studies requesting consent to any inter- [18-20]. Researchers often note that many participants vention were not included; studies concerned with con- cannot be contacted because their clinician denies access, sent for use of secondary data only were included. There or they do not respond, while few potential participants were no restrictions on publication date or publication actively refuse to take part [4,7,8,19]. type in the search. The search terms were applied in Although researchers may wish for easier access to English only, however, non-English language papers were medical records to reduce potential bias and the cost of not excluded. Conference abstracts were included. the consent process, public opinion may not be so per- missive. Members of the public hold a wide range of Search strategy views about the necessity of consent for a review of their Studies were identified by searching electronic databases, medical records [21-23]. Some would like to be offered and by reviewing the reference lists of included articles an opportunity to consent for each use of their data; for for any further studies that met the inclusion criteria. th others one-off consent would be acceptable to cover all We searched PubMed (including Medline) (1966-16 th future research, and some are happy for such research to January 2012) and Embase (1974-16 January 2012). go ahead without informed consent. A number of stud- We used the following electronic search strategy for ies have suggested that members of the public are more all database searches: willing to waive consent when they understand the is- ((consent OR authorization OR authorisation) AND bias sues involved in carrying out such studies. Two large- [title + abstract only]) OR ((confidentiality OR privacy) scale UK surveys concluded that the public has low AND (medical record OR health record OR health infor- awareness of how their medical data are used, and if mation) [title + abstract only]). they are informed about what research entails they are generally more positive about it [22,23]. In other studies Study selection where the public were asked about consent for second- The flow diagram in Figure 1 shows the papers retrieved ary uses of medical data, participants were found to be and excluded at each stage of the systematic review. Ti- poorly informed about research processes and existing tles and abstracts of all articles were reviewed by EH. Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 3 of 10 http://www.biomedcentral.com/1471-2288/13/72 two primary care practices. To increase the generalisability Records identified Records identified of focus groups we approached primary care practices lo- via Embase via PubMed cated within an area of some deprivation (higher search n=1663 search n=1449 deprivation quintile) and a more affluent area (lower Duplicates removed deprivation quintile), as ranked by the UK Index of Mul- n=1352 tiple Deprivation [33]. Patients who were considered to Records after have terminal illness or who the General Practitioner (GP) Records excluded after duplicates removed deemed unsuitable to participate in the focus groups for initial screening of title n=1760 and abstract n=1682 other reasons, for example learning difficulties, were excluded. Records included Records excluded after after initial screening full paper screening Methods of title and abstract n=62 n=78 The focus group study received research ethics commit- Full paper unavailable, tee approval from Dorset Research Ethics Committee no reply from author n=1 (ref: 07/H0201/108). Participants meeting the inclusion Records included after full paper criteria were sent an initial invitation letter outlining the Additional studies screening n=15 study and requesting they return a reply slip if they were identified from hand interested in receiving further information. Interested searching reference lists of included studies n=12 men were sent an information sheet, consent form and Total studies identified n=27 short questionnaire, which asked for information about their general health using the 12-item Short Form Figure 1 Flow diagram of included studies. Health Survey (SF-12) [34], and demographic informa- tion to allow us to balance the participants in each Any articles potentially fitting the criteria, or where this group according to age and general health status. Men was unclear from the title and abstract, were retrieved and indicated whether they had worked for the NHS or had the full text articles were reviewed. Data from papers in- ever taken part in health research so we could gauge the cluded in the full review were abstracted to a standardised extent of their prior knowledge about health research. form. Data included type of study (e.g. survey, focus A total of 19 participants attended three focus groups, group), sample size, participant characteristics including with between 5 and 9 in each group. The number of age, gender and any health condition or status. The main focus groups was limited due to time constraints. All findings from each paper were summarised. As this review groups were facilitated by EH, with a note taker and sec- sought both qualitative and quantitative research, a sum- ond researcher present, and followed the same topic mary statistical analysis was not performed. guide, each lasting approximately 90 minutes. Following initial questions about the contents of hospital medical Focus groups records, intended to relax the participants and initiate We used qualitative methods to explore the views and discussion, the men were then asked how they would opinions of members of the public about data from a re- react to a letter asking them to take part in a study that view of their hospital medical records being extracted wished to review their hospital records. They were asked and used for research purposes. The focus group meth- if they would be willing to let a researcher have access to odology was chosen as this allowed exploration of the their records for research purposes. We provided infor- opinions of participants in general before presenting mation about different methods of consent: opt-in, in- them with information about selection bias and noting formed consent and opt-out, or presumed consent, and the ways in which their understanding and opinions asked whether they would approve of their records being changed in relation to the information provided. Focus reviewed without prior consent being sought. groups are considered especially useful where the issues In order to ensure that participants understood the under discussion are new to people, allowing exploration processes and some of the issues faced when undertak- of ideas they may not have considered before [32]. ing such research, a presentation was then given about possible selection bias arising from having to obtain in- Participants formed consent; that is, by obtaining consent, certain Focus group participants were men potentially eligible groups of people would be more or less likely to agree to for the CAP study, aged between 50 and 69 years, but participate, which might alter the findings. Information who were not recruited to the study because of their lo- was presented verbally along with text and diagrams, cation away from the study areas. Participants for the and was given in general and then in the context of a focus groups were identified at random from the lists of real-life scenario. There were opportunities for questions Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 4 of 10 http://www.biomedcentral.com/1471-2288/13/72 throughout and we checked understanding of selection being reported by two papers each [25,47], and [26,27]. Of bias by monitoring their response, and providing further the two review papers, one sought only studies from the clarification if necessary. UK [10], while the other included papers from Canada, The participants were then asked whether the possibil- UK, USA, Ireland, Japan, Taiwan, and Australia [6]. ity of selection bias changed their opinion about a re- view of their records without informed consent. To Characteristics of consenters and non-consenters: survey conclude, we discussed whether any safeguards could be results put in place that would reduce any individual’s require- Of the twelve quantitative surveys looking at differences ment or preference for informed consent. Throughout, between those who consented to a review of their medical participants were requested not to talk about their own records or not, two reported no significant differences be- medical conditions or experiences. tween consenters and non-consenters [11,50], seven pa- pers reported that males were more likely to consent than Analysis females [24,36,37,40,41,43,48], four reported older respon- All focus groups were audio recorded with each partici- dents more likely to consent [36,37,40,43], while three pant’s permission, transcribed verbatim and anonymised. noted that those with less sensitive or stigmatising infor- At least two researchers (EH and JD) undertook iterative mation were more likely to consent [24,37,38]. The un- thematic analysis of the transcripts using the method of employed [24] or those not paying for their healthcare in constant comparison to generate a list of themes. the US were more likely to consent [38]. Those in poorer Themes were compared within and across focus groups health [40] and people with cancer were more likely to and participants, and the coding and themes were consent than the general public [35]. One online survey of discussed until all researchers (EH, JD, RM and ET) the general public found the reverse: that those younger, agreed with the final list. in better health and of white ethnicity were more likely to consent [39]. Results The systematic review of seven UK surveys found that Systematic review overall those with the symptom under investigation were The flow diagram in Figure 1 shows the papers retrieved most likely to consent and consent rates fell in the over and excluded at each stage of the systematic review. 50 age groups, especially for women [10]; however, an- Seventy-eight papers were identified as potentially other systematic review found no clear patterns across relevant from the title and abstract of the 1760 unique 17 international studies on any of variables age, sex, in- papers found by the literature search. Of these, 68 were come, education or health status [6]. excluded on review of the full article. One potentially Patterns of consent were similar in the quantitative as- relevant conference abstract was also identified and the pects of the six mixed methods papers that reported dif- author was contacted for further information but did ferences in consent rates between groups: male gender not reply; this abstract was excluded as it did not con- [21,22,45], older age [23,45,46], having a less sensitive con- tain enough information to meet the inclusion criteria. dition [22], being of non-white ethnicity [22], long term After full review, 15 papers met the review criteria. Hand disability [23] and having breast cancer or sickle cell dis- search of the reference lists of these 15 papers, and those ease (versus other conditions such as cystic fibrosis or papers identified from the reference lists, produced an- colon cancer [28]) were factors associated with being more other 12 papers. The resulting 27 papers included three likely to consent. Participants rating themselves as having papers using qualitative methods, 12 surveys and two sys- a greater knowledge of the NHS were more likely to con- tematic reviews of surveys that contained information on sent in one study [45]. Higher socioeconomic status was the differences between consenters and non-consenters, associated with higher consent rates in two studies and 10 papers using mixed methods. The characteristics [23,45], although another study questioning patients with of the included studies are shown in additional files for various conditions including cancer and diabetes found both quantitative aspects (Additional file 1a, studies those on a lower income more likely to consent [28]. reporting response rates; and Additional file 1b, studies reporting perspectives of respondents) and qualitative as- Themes arising from previous qualitative research pects (Additional file 2). Three papers were identified reporting qualitative results Of the twenty-seven included studies, nine were only. There were also ten mixed methods papers that in- conducted in the USA [28,35-42] with one of these fea- cluded a qualitative aspect. The papers focused on five turing US veterans only [42]. Six studies were carried major themes. The key findings are listed below: out in the UK [11,22,23,43-45], one in Eire [46] and one Eleven of the 13 studies noted the lack of current in New Zealand [11]. Eight studies originated from knowledge that many participants had about how their Canada [21,24-27,47-49], with two research projects medical data may be used for research and the existing Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 5 of 10 http://www.biomedcentral.com/1471-2288/13/72 safeguards to protect their data [22,23,25-27,42,44-47,49]. Approached via primary care There were widespread calls from both the patients and (n=320 approx; exact number researchers for increased public education about research excluded by General Practitioner unknown) processes and safeguards. Participants were reported as recognising the benefit Returned initial reply slip (n=85) of research for the population in nine of the studies [23,25-27,42,44-47]. The time and effort involved in Not selected for focus group due Consent (n=59) to time constraints (n=36) obtaining consent was often balanced against the public benefit of the research during discussions. Allocated to focus group (n=23) Did not attend focus group (n=4) In ten of the studies, participants wished to be informed about how their data were being used and by whom Attended focus group (n=19) [22,23,25-27,42,44-47]. Information about the user of the data was seen as more important than the intended use in Figure 2 Focus group response figures. determining whether to offer consent in some studies [22,45], while others noted that the planned use of the data was an important determinant of whether partici- one participant had some knowledge of health research pants would consent to its use [26,42,47]. having sat on a local research ethics committee. Different consent models were discussed in ten papers [22,23,25,26,42,44-47,49]. There was no consensus on a Consent for medical record review preferred model either within or across studies, although All participants accepted the need for research and participants often considered the balance of obtaining understood that this was an important aspect of the consent against the public benefit incurred by unre- NHS. A few expressed surprise that this sort of research stricted research. Despite this recognition, many partici- was not happening as a matter of course. All would con- pants maintained that informed consent should always sent to a review of their medical records if asked: be sought, out of respect for the individual. “Definitely if it was going to benefit somebody else All 13 studies mentioned areas of concern held by par- then yeah.” (Participant 2, group 2) ticipants about data sharing. Data and database security When asked about the use of records without their [22,28,46,49], and whether the data were anonymous was prior informed consent, opinions were split equally a concern, with participants being less restrictive when Table 1 Sociodemographic characteristics of focus group data were anonymous or unidentifiable [22,26,28]. There participants (n=19) was apprehension in many studies that data would be sold n% for commercial profit, and this was generally seen as less Mean age in years (SD) 61 (4.84) acceptable, commanding a higher requirement for in- Age range 54-69 formed consent [21,23,25-27,42,44,45,47]. Release of data to insurance companies or pharmaceutical companies was Marital status often mentioned as a concern, again leading to a more re- Married / living as couple 16 84 strictive consent requirement [23,26,27,42,44,45,47]. Single 1 5 Divorced 2 11 Focus groups Ethnicity Figure 2 shows the focus group response figures. Ap- White British 18 95 proximately 320 men were invited (exact number of men excluded by GP unknown), 85 were sent informa- White other 1 5 tion about the study at their request and 59 consented Employment status to take part. Twenty-three men were scheduled to take Employed 11 58 part in a focus group, with four of these failing to attend. Retired 5 26 Nineteen men (mean age 61 years) took part in our Unemployed seeking work 1 5 focus groups; age, occupational and health status were Unemployed due to illness or disability 2 11 balanced across groups (Table 1). The characteristics of the men who consented to be involved and returned a Mean SF-12 score* questionnaire (n = 58) were very similar to those who Physical health component (score*) (52.06) attended the groups. Mental health component (score*) (51.32) One participant reported having formerly worked for SD standard deviation. the NHS (not in a clinical role). No participants reported *Range from 0 to 100, with scores below 50 indicating poorer than taking part in any health research previously; however, average health. Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 6 of 10 http://www.biomedcentral.com/1471-2288/13/72 between those that saw the “greater good” of public Interestingly, no participants spontaneously mentioned benefit and those who thought it was courtesy that they ethics committees, NHS research governance procedures were informed: or legislation when considering potential safeguards. “I’m saying yes because I think there’s a greater good.” Throughout the discussion many questions were asked (Participant 1, group 2) about how research was carried out, suggesting that par- “I think it’s just etiquette to ask people to do such ticipants were unaware of how their data could currently things.” (Participant 5, group 3) be used, and needed to be able to trust that their data were secure: Understanding of selection bias “How do we know that you just don’t go to the hos- Following presentation of information about selection bias pital and say “can I have a look at these records” and we and discussion of issues surrounding the consent process, don’t know anything about it?” (Participant 8, group 3) participants could understand the difficulties faced by re- searchers. They recognised the increased cost and time Potential misuse of information that the process took and how a low response rate might The fear of data being misused by companies for their bias the findings: own gain was very apparent in all groups. Concerns were “Well I’d sympathise with the researcher and I think if mainly around insurance companies obtaining health in- you’re setting yourself up to do research which is going formation which may affect their premiums or cover, or to be skewed by the nature of consent then let’s try and companies using the information for targeted advertising: avoid the issue of going for consent. Let’s get the best “What I don’t like is any information being passed quality research we can do.” (Participant 1, group 2) on to a third party, for promotion purposes. Say you’ve We asked if knowing this changed their opinion on got a particular problem then it goes to a drugs sup- the use of their medical records without their prior con- plier or something like that, that I would object to.” sent. Many were already positive about the use of re- (Participant 4, group 1) cords without their prior permission and clarified this, Despite the information collected from medical records but for those who were more reluctant in the first in- being anonymised, the men had the same concerns over stance, their opinion did change. However, when asked, their personal information being disclosed inappropriately a few men still preferred informed consent. This was by the researchers as by commercial companies: more to do with an interest or curiosity in the kind of “I think we can forget security because let’s face it, it research that they were contributing to. Although they isn’t there anymore so if you don’t want it to be given would like to be informed, participants were still likely out then you say so…” (Participant 2, group 2) to consent but felt the need to know details of the Although some men seemed resigned to the fact that research: there was a lack of security, they were still willing to “My own personal opinion, as much as I under- consent and would accept the security risk as part of the stand the maths of it, is I would still like to be asked.” process. (Participant 8, group 3) Among those who preferred to be informed about re- Acceptable & unacceptable types of research search, opt-out consent was considered to be acceptable, In all groups there was discussion around acceptable as it satisfied their curiosity and offered a chance for re- and unacceptable types of research. This dichotomy was fusal, with less of an impact on the validity of the results. based on who profited from the research, rather than the study design or ethical aspects. Research undertaken Safeguards by the NHS was seen as acceptable and for public good, We asked if there were any safeguards that could be put whereas pharmaceutical companies who gained finan- into place that would make the men more likely to cially from the altruistic sharing of records were seen as accept the scenario of no prior consent. Common less acceptable: safeguards suggested were anonymisation and data “If there was a large commercial company… [that] had encryption: free and easy access to people’s medical records I don’t “I think I’d be happy as long it is stays within the area, think that would be right. It would further their research it didn’t find its way into a laptop, and it was all into the particular drug or treatment, but it’d also fur- encrypted.” (Participant 1, group 1) ther their profits that would be wrong. But if it was for A minority of participants said there could be no safe- medical research for everybody then that would be dif- guards that would make them happy with the no con- ferent.” (Participant 6, group 3) sent scenario: “Financial gain comes into it then so why should you “I don’t want any safeguards, end of story, so I want then let them look at your records? They’re going to prior consultation.” (Participant 5, group 3) gain out of it and you’re not…” (Participant 2, group 2) Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 7 of 10 http://www.biomedcentral.com/1471-2288/13/72 University researchers were considered to be some- in a number of countries, each with different health care where in the middle, and it was the funder of the re- systems and governing laws, the themes were very simi- search and their financial gain that was considered when lar, suggesting that there are common issues which need making a judgement about the acceptability of the to be addressed if increasing numbers of members of the research: public are to agree to a review of their existing medical “The question would be who are the researchers work- data. ing for? Are they researching for medical companies, or Our focus group research explored men’s views about universities who are attached to medical companies and consent for a review of medical records in the context of getting funded [by them]?” (Participant 8, group 3). selection bias and the findings reflected the themes aris- There was an apparent dichotomy between acceptable ing from the systematic review. All the men involved research, seen as being undertaken for the public good, agreed that they would consent to a review of their re- and less acceptable research, for commercial gain. cords when asked. However, opinion was split when in- formed consent was not to be sought for such research. The impact of the provision of information Some were happy to be able to help the “greater good”, Men became more accepting of research without specific yet others, while understanding this opinion, felt that it individual consent following the provision of informa- was only courteous to be informed about the research tion about bias and research processes, for example the and that the data should not be taken without the pa- time and cost of obtaining consent: tient’s knowledge. This accords with previous research “If you’re putting money into a charity for them to re- that has shown a wide range of public opinion regarding search something, you want that research done, not for consent to review of medical records [21-23]. Following it to be spent on the administration to enable the re- discussion about selection bias, participants’ views about search to be done.” (Participant 5, group 2) research without consent became more favourable, with Where concerns remained in the minority, on the some men changing their opinion and no longer stating whole these related to the potential misuse of their per- the need for specific informed consent. However a small sonal data, or a wish to be informed about the use of minority remained adamant that they always want an their data. Participants questioned how the processes opportunity to consent or at least to have an opt-out would work, and their need to trust that the data would consent option. The increasing acceptance following in- be secure was implicit: formation provision seen in the focus groups was in con- “How would it happen, how would you do it, how trast to two similar studies (reported in three papers) would you keep it secure?” (Participant 3, group 1) that provided information and research scenarios to aid understanding and found that although individual opin- Discussion ions altered throughout the course of the dialogue, ag- The systematic review identified twenty-seven relevant gregated opinion showed little change [25,42,47]. Focus studies. From the quantitative literature, males and those on selection bias specifically could perhaps influence the who were older seemed more likely to consent to a re- opinions of the participants to a greater extent than view of their medical records, although this was not con- more general consent scenarios and future research firmed in a meta analysis of 17 international studies [6]. should investigate whether this is seen in other demo- Similar themes arose in the qualitative studies. Partici- graphic groups, and the best way to present this infor- pants recognised the benefit of sharing their records for mation to ensure a wide public understanding. research, but the majority wanted to know how their When safeguards were mentioned by the facilitator, data were being used. The systematic review found that the participants did not seem to value them as tangible participants shared many of the same concerns about and asked many questions. There was a lack of know- ledge about current safeguards and there was no spon- disclosing their health data, although the focus on cer- tain issues reflected the context of each study. Concerns taneous mention of ethical approval, hospital research over data security, data being used by insurance or governance procedures or the contractual obligations of the researchers by the participants. In one group there pharmaceutical companies and data being sold for com- mercial gain were common. The UK government’s plans were questions about data protection laws, but on the to allow commercial access to NHS data [1] may be un- whole participants failed to recognise these existing safe- guards. The discussion and questions generated showed acceptable to the public unless a benefit for the majority can be demonstrated. Nearly all the identified studies that the participants were interested in this and wanted noted that participants were ill-informed about current a greater understanding of the processes involved. Previ- ous research has also suggested that the public feel practices and use of their health data and that educating the public may increase the acceptability of the use of poorly informed and would like more information about data for research. Despite the research being carried out how research is carried out [22-29]; eleven of the Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 8 of 10 http://www.biomedcentral.com/1471-2288/13/72 thirteen qualitative studies identified in this systematic noted that during interviews about consent for medical review also noted their participants’ lack of knowledge. record reviews participants were still formulating their There were concerns from these focus group partici- thoughts and did not have mature opinions [26]. The pants about possible misuses of health information such focus group format allowed our participants to develop as passing on health status information to insurance com- their opinions in an area that was new to them, gaining panies or to target advertising for certain treatments. insight from the views of others [32]. Our focus groups Older men in another study also feared that records could concentrated on the provision of specific consent for be shared with outside agencies [42], and these concerns each project, however it is possible that participants may were highlighted in other research [23,51]. In the focus have found broad consent for a number of similar pro- groups, the dichotomy between acceptable and less ac- jects to be satisfactory. Opt-out consent rather than opt- ceptable types of research was based on who profited from in consent may also be acceptable and future research the research, rather than the study design or ethical as- should explore this further. Women and younger males pects, with NHS research for the benefit of the public seen were not included in our focus groups, and all partici- as an example of good research and pharmaceutical com- pants described themselves as of white ethnicity, so panies acting to gain financially seen as less acceptable. these are limitations. The systematic review identified Scepticism about research for commercial profit was a males and older people as more likely to consent to a re- common theme and a number of studies noted that par- view of their medical records and, as is true with all re- ticipants wanted more restrictions on their data where search, those who agree to take part are often those who commercial profit could be made from their information are more positive about research. Therefore the opinions [21-23,25-27,29,50]. If altruistic sharing of data resulted in generated by the focus group may be more accepting of profits that did not benefit the NHS, participants would such research without consent than the general popula- have strong reservations about allowing access to their re- tion. Despite this, our focus groups found that there cords. Public education about current research legislation were still a number of concerns to be allayed about the and data security measures is needed to allay misconcep- research process and that information provision may be tions about the use and safety of patient data, and this will useful to reduce concerns in all groups, not just in those be of paramount importance if the proposed access to data who are positive about research in general. by private industry is to be acceptable. Many similar themes have been found in the related Conclusions area of secondary use of tissue samples for research. A The majority of men in our focus groups were happy for review of 30 studies reporting views on consent for re- medical record reviews to go ahead without consent, search using biological samples [52] found a high level and even more so when their understandings of selec- of willingness to donate leftover samples for research tion bias and appropriate safeguards were enhanced. In- (83-99 %), with marginally less support for commercial creasing public education about research is likely to rather than academic research. Nine of the studies noted benefit research, as a greater understanding of the safe- that people would like information on how their samples guards and legislation that governs research should in- were used. A recent review of 18 qualitative research pa- crease public trust and reduce misconceptions. This pers also noted comparable themes to those reported could improve consent rates or, as found here, the ac- here [53]. Reasons given for allowing excess tissue to be ceptability of research without informed consent for “the used for research were for both individual gain and for greater good” of the National Health Service. public good, but most patients agreed that tissue should not be used without the patient’s consent. Trust in re- Additional files search institutions that data would be secure and tissue not exploited was a common theme, with similar con- Additional file 1: Characteristics of included studies – Quantitative cerns about commercial access to samples as seen in our aspects (1a, studies reporting response rates; 1b, studies reporting research. perspectives of respondents). This study was the first to obtain qualitative opinions Additional file 2: Characteristics of included studies – Qualitative aspects. about medical record review both before and after provision of detailed information about selection bias and research processes. By providing information about Competing interests The authors declare that they have no competing interests. the problems of selection bias, we were able to explore how opinions changed in the context of this knowledge. Authors’ contributions We were also able to answer the many questions that EH, ET, RM and JD conceived and designed the study. EH performed the arose, which helped to increase understanding of re- systematic review and designed the focus group guide and facilitated all search amongst our participants. Previous work has groups with JD, ET or RM also present. EH and JD analysed the focus group Hill et al. BMC Medical Research Methodology 2013, 13:72 Page 9 of 10 http://www.biomedcentral.com/1471-2288/13/72 data. EH drafted the manuscript and all authors reviewed and approved the Do people with potentially stigmatizing health conditions and the final manuscript. general public differ in their opinions? BMC Med Ethics 2009, 10:10. 22. 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Int J Evid Based Healthc 2012, 10:9–26. doi:10.1186/1471-2288-13-72 Cite this article as: Hill et al.: “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 2013 13:72. Submit your next manuscript to BioMed Central and take full advantage of: • Convenient online submission • Thorough peer review • No space constraints or color figure charges • Immediate publication on acceptance • Inclusion in PubMed, CAS, Scopus and Google Scholar • Research which is freely available for redistribution Submit your manuscript at www.biomedcentral.com/submit

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