The European Journal of Public Health Advance Access originally published online on October 5, 2005
The European Journal of Public Health 2006 16(4):433-440; doi:10.1093/eurpub/cki198
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Miscellaneous |
Genetic research and donation of tissue samples to biobanks. What do potential sample donors in the Swedish general public think?
Åsa Kettis-Lindblad1, Lena Ring1,2, Eva Viberth1 and Mats G. Hansson3
1 Department of Pharmacy, Uppsala University, PO Box 580, SE-751 23 Uppsala, Sweden
2 Health Services Research Centre, Department of Psychology, Royal College of Surgeons in Ireland, Ireland
3 Center for Bioethics at Karolinska Institutet and Uppsala University, Department of Public Health and Caring Sciences, Uppsala University, Sweden
Correspondence: Åsa Kettis-Lindblad, PhD, Department of Pharmacy, Uppsala University, PO Box 580, SE-751 23 Uppsala, Sweden, tel: +46 18 471 41 32, fax: +46 18 471 42 23, e-mail: asa.kettis{at}farmaci.uu.se
Received February 14, 2005, accepted September 5, 2005
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Abstract |
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Background: The aim of this study was to identify perceptions of the general public regarding research involving human tissues; to assess the public's willingness to donate samples to biobanks; and to identify factors associated with the willingness to donate samples. Methods: Cross-sectional survey. Postal questionnaires to a random sample of the general public in Sweden, 18–80 years of age (n = 6000) in October 2002 (response rate 49.4%; n = 2928). Results: A majority of the respondents had a positive attitude towards genetic research. Their trust in authorities' capability to evaluate the risks and benefits of genetic research varied. Individual university/hospital-based researchers received the greatest trust, while the county councils (health care providers), and the Swedish Parliament received the lowest trust. Most respondents (86.0%) would donate a linked blood sample for research purposes. Another 3.0% would provide an anonymous sample. In total, 78% of the respondents would agree to both donation and storage. The most common motive was benefit of future patients. The majority was indifferent to the funding source for the research and would delegate this judgment to the research ethics committee. After adjusting for covariates, those more likely to donate a sample were middle-aged, had children, had personal experience of genetic disease, were blood donors, had a positive attitude toward genetic research, and had trust in experts/institutions. Conclusions: The majority of the general public is willing to donate a sample to a biobank. The willingness is mainly driven by altruism, and depends on the public being well-informed and having trust in experts and institutions.
Keywords: cross-sectional studies, public opinion, tissue banks, tissue donors, trust
The rapid development of biotechnological research has stimulated the use of biobanks, i.e. stored biological samples.1 Biobanks allows for identification of disease genes, which is hoped to lead to personalized prevention programmes and treatments. Combining health and genetic data from large populations also means that the complex relationships between genes, environment, and disease can be explored.1 Although biobanks are important resources for biomedical research, and ultimately public health, there are also concerns about the ethical, legal, and social aspects of them, e.g. the privacy and confidentiality of the donors, the use of genetic technologies, and commercialization of genetic products.2
Biobanks depend on people's willingness to contribute samples for both research and storage. Public support is thus essential in securing the long-term viability of biobanks and rests on the assumption that the complex issues surrounding biobanks are managed appropriately by the responsible authorities.3 In this process, different stakeholders have to be consulted, not least the general public.2 Knowledge of the public perspective, and of factors that influence their willingness to donate tissue samples, may inform the governance of biobanks and the design of information and consent procedures.
The public's willingness to contribute to genetic research is relatively high according to some American4–7 and Asian8 studies. Characteristics of those in favour of donation include high age,7 higher education, a positive family history of a genetic disorder, a belief that genetic research will benefit people, a willingness to participate in governmental research on health,6,8 a belief in genetic determinism,6 having no fear of blood, injections or needles, and non-concern about the loss of confidentiality.8
Swedish researchers have also found that peoples' readiness to contribute to genetic research is high.9–12 However, the willingness of the pool of potential sample donors in the Swedish general public has not yet been explored. To our knowledge, there is only one national survey of the general public in the literature based on a representative sample of the US population.4 However, while that study controlled for the impact of demographic factors on the willingness to donate tissue samples, it did not assess the impact of attitudinal factors.
The objectives of this study were (i) to identify perceptions of the general public regarding research involving storage and use of human tissues from which genetic information may be derived; (ii) to assess the public's willingness to donate tissue samples to biobanks; and (iii) to identify demographic and attitudinal factors associated with the willingness to donate tissue samples.
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Methods |
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The study design was cross-sectional. Data were collected in October 2002–February 2003 using a self-administrated questionnaire that was mailed to a random sample of 6000 members of the general public in Sweden between 18–80 years of age. Of the 6000 questionnaires, 70 were returned unopened. After three reminders, the response rate was 49.4% (n = 2928/5930). The research ethics committee at Uppsala University approved the study.
Questionnaire development
The initial development of the questionnaire was informed by the literature. The content validity and the feasibility were ensured by employing a cyclical procedure, where experts (researchers, physicians, ethicists) and members of the public repeatedly reviewed new versions of the questionnaire and suggested the revision, addition, or deletion of questions. To further evaluate the questionnaire, a pilot study was carried out on a random sample of 500 members of the Swedish general public.9
The final questionnaire contained 29 questions about the respondent's willingness to donate blood samples, preferences for information and consent procedures, and questions about background information that we hypothesized would have an impact on (i) the willingness to donate and (ii) the preference for information and consent procedures. Data related to information and consent procedures are presented elsewhere.
Outcome variable
The main outcome variable in this study was the willingness to donate a blood sample. The question was based on a hypothetical scenario, presenting donation where the data could be linked to an individual. The respondent was asked to picture that a blood sample was taken during a regular doctor visit (box 1). The respondent was asked whether he/she would give an extra blood sample for research, if the scenario had really happened. The respondents were directed to different follow-up questions depending on their answer. In the analysis, those answering ‘yes’ were categorized as willing, while those answering ‘no’ or ‘do not know’ were categorized as not willing.
| Box 1 Scenario presented to the respondent in the questionnaire. The respondent was asked whether he/she would give a sample if the situation was for real Picture that a blood sample is taken from you during a regular doctor visit. In addition to this, the health care personnel ask for permission to take an extra sample from you for research purposes. It will be possible to link the sample to personal information, but the linking procedure will be rigorously secured. Data will be analysed at group level only and nobody who hears or reads about the study will be able to identify individual donors. The purpose of the study is to generate knowledge about how genes and other factors affect our health.
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Background variables
The background variables included sociodemographic factors (i.e. age, gender, having children, education level), experience of working in the health care sector, health status, and positive history of genetic diseases in the family or among close friends. The attitudinal factors included are as follows: experiences of health care (either as a patient or relative); trust in health care personnel; ever having been a blood donor; attitudes towards genetic research; and trust in the ability of different authorities to evaluate the risks and benefits of genetic research. Finally, the respondents evaluated the questionnaire itself by answering a few questions at the end.
Analysis
All data were coded and analysed with the SPSS software program. Sociodemographic data were compared between the study sample and the entire Swedish population. Descriptive analyses were carried out to establish the distribution of perceptions of genetic research, trust in authorities, and willingness to donate and allow storage of tissue samples. A univariate analysis was carried out to analyse the willingness to donate tissue samples according to different background characteristics. Logistic regression analysis13 was used to identify factors associated with the willingness to donate a tissue sample while adjusting for covariates. Two logistic regression models are presented: model 1, including sociodemographic factors only, and model 2, including sociodemographic and attitudinal/behavioural factors combined.
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Population characteristics
The mean age of the respondents was 48 years and the majority (83.3%) considered their health as excellent, very good, or good. Compared with the Swedish general public (table 1), women and respondents between 45 and 74 years of age were slightly over-represented in the sample, while younger people (18–44 years) were slightly under-represented. Respondents with the lowest and the highest education were slightly over-represented.
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Respondents' evaluation of the questionnaire
The majority of the respondents (79.0%) thought that it was important that the public is listened to in matters like this. Most thought that the questions were easy to understand (93.8%) and that the number of questions was about right (86.4%). The majority (89.3%) felt that the questions were relevant.
Attitudes towards genetic research and trust in authorities regulating or conducting genetic research
The majority of the respondents had a mostly positive attitude towards genetic research concerning the mapping of the genome (77.2%) and the development of disease risk assessment tools (85.3%), diagnostics (91.0%), and new treatments (92.5%). The proportion that was mostly negative varied between 3.9% (regarding the mapping of the genome) and 0.9% (regarding new treatments). Consequently, the proportion of respondents who were undecided was relatively large, and varied between 18.9 and 6.6% depending on the purpose of the research.
The respondents' trust in different authorities' capability to evaluate the risks and benefits of genetic research is presented in table 2. University/hospital-based researchers received the highest ratings, followed by research ethics committees and health care personnel, and then industry-based researchers. Governmental agencies received slightly lower ratings than industry-based researchers. The county councils (responsible for providing health care services) and the Swedish Parliament received the lowest ratings, scoring less than the midpoint on the scale.
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The willingness to donate tissue samples
When presented the linked scenario, a majority of the respondents (86.0%) would donate an extra blood sample for research purposes (figure 1). Some (18.7%) said that their decision would be influenced by whether the funding was public/independent or provided by private companies. However, the majority (68.2%) was indifferent to the financial source and would delegate this judgment to the research ethics committee, or was undecided (13.1%).
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Of those who said no, or were undecided about donating in the linked scenario, about one-fourth would consent if the sample would be unlinked, i.e. anonymous (figure 1). This means that a total of 89.0% (n = 2520/2830) would provide a sample (linked/unlinked). As seen in figure 1, a vast majority of these potential donors also approved of their sample being stored for future research. Therefore, 78.4% (2220/2830) of the donors would agree to both donation and storage. Of the potential donors, 13.2% reported that there were types of samples that they would not donate. The most common examples were brain tissue, heart tissue, and germ cells.
The most common motives for donating a sample was for the benefit of future patients (89%) and for the benefit of ‘myself or my family’ (61%) (table 3). A sense of duty motivated one-third of the respondents. Less than 1% of the respondents would feel pressured to consent to maintain a good relationship to the health care personnel.
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Factors associated with the willingness to donate a sample
The proportion of respondents who were willing to donate tissue samples varied according to different background factors (table 4). The highest proportion of potential donors was found among those with high trust in authorities' ability to assess the risks and benefits of genetic research (96%), and among blood donors (93%) and people with a university degree (93%), while those who had a negative attitude toward genetic research had the lowest proportion (41%). According to the univariate analysis in table 5, all listed factors except gender were significantly associated with the willingness to donate a tissue sample.
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When assessing all sociodemographic characteristics in a multivariate logistic regression, adjusting for covariates (model 1, table 5), the following associations remained statistically significant: having children; higher education; good self-reported health; and a positive history of genetic disease in the family or among friends. When also including attitudinal/behavioural factors (model 2, table 5), the impact of education and self-reported health was not statistically significant. However, age achieved statistical significance and the association between having children and being willing to donate was stronger. Among the attitudinal/behavioural factors, the attitude toward genetic research and trust in authorities' ability to assess the benefits and risks of genetic research had the most pronounced association with the willingness to donate a sample. Being a blood donor was also significantly associated with a willingness to donate for research purposes.
In summary, after adjusting for all covariates (model 2) those more likely to donate a sample were middle-aged, had children, had genetic disease in the family or among close friends, were blood donors, had a positive attitude toward genetic research, and had high trust in experts and institutions.
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Methodological considerations
The use of personal identification numbers is mandatory in Sweden, thus it is likely that the random sample really covers the entire Swedish population. The response rate, however, was 49.4%, meaning that the results might be affected by selection bias, although the demographic profile of the study sample and the Swedish population was fairly similar. Other surveys on the willingness to donate samples have had response rates between 20%5,14 and 70%,8 or have employed supplemental sampling procedures.6 In surveys carried out in relation to actual collection of samples from a population, the response rate has been higher, 80% when first collecting the sample4,11 and 95% when recontacting eligible donors.11
The evaluation of the questionnaire showed that it was well accepted by the respondents with regard to its relevance, readability, and length. This is satisfactory given the complexity of the topic. However, 51% of the sample chose not to respond, maybe because the questionnaire was too difficult, long, or irrelevant to them.
It could be argued that many people are unaware of the concepts of genetic research and biobanking, or only have a vague perception of them.15 Since the respondents only received a brief background in relation to the donation scenario, it can be questioned whether the respondents provided truly informed views. Still, according to the Eurobarometer on public attitudes towards biotechnology, Sweden has one of the most well-informed groups of citizens in the European Union.15 It is suggested that a strong education system and extensive media debates contributes to this awareness. Consequently, the data provided by the respondents in this study probably reflect opinions held by reasonably well-informed potential donors when first being approached. No specific information about potential risks for the donor was included in the scenario. Information about the hypothetical risk of future denial of access to health insurance and employment has been found to be a cause for non-consent,16 and might have given a lower degree of willingness if included.
Although these data provide useful information on the current climate regarding biobanking in Sweden, there may be a discrepancy between the respondents standpoints based on hypothetical scenarios and their actual behaviour. The degree of willingness might be overestimated due to the social desirability effect, i.e. people might be reluctant to admit that they rather would not make a contribution to the common good. Nonetheless, data on the actual donation of tissue samples, following the establishment of biobanks, mean that the willingness is as high as, or even higher than that found in our study.4,7,11
When considering the relationship between different background factors and the willingness to donate a blood sample, it is important to bear in mind that the temporal relationship cannot be established in a cross-sectional survey.
Willingness to contribute
We found that the Swedish general public's willingness to contribute to genetic research is high. Approximately 86% agreed potentially to donate a blood sample for research purposes and a total of 78% agreed to both potential donation and storage. When collecting actual samples for a biobank in the northern part of Sweden, 79% of a randomly selected population sample provided samples, and 10 years later 93% of those still eligible approved of their samples being used for a new purpose.11 These consent rates are in the higher range in comparison with studies from other countries, which vary between 42 and 90%. In an American study of the general public, only 42% reported that they would consent to storage of specimens for future research.6 In another American study, 60% of prospective jury members would donate a tissue sample to a DNA bank,5 while 60–90% of a Jewish-American population would consent depending on the purpose.14 In a national survey that collected biological specimens from a representative sample of the US population, 85% consented.4 In a Singaporean population, 49% would be willing to donate blood for genetic research.8
It was evident that the decision potentially to donate a sample primarily was based on altruistic motives. Other studies confirm that people are often motivated by benevolence,12 and appear to be willing to donate even though they gain nothing personal from it.5 However, participants are also concerned about the storage of the samples and the right to be informed about the results.12
Patients may voice strong concern about contributing to research sponsored by private companies, as opposed to research sponsored by foundations,17 but in a study of actual donors, only 1% refused to allow their tissue to be used for commercial research.18 In our study, a minority of the respondents said that their decision to donate a sample would be influenced by the financial support for the research. Most chose to delegate this judgment to the ethics committee. Another Swedish study confirms that the majority of the public are willing to delegate some decisions on the use of their biological samples to the ethics committees.10
Factors associated with the willingness to contribute—the importance of attitudes towards genetic research and trust in authorities
Attitudes towards genetic research and trust in authorities seems to be crucial for the willingness to donate, and explains differences due to education and self-reported health. An indirect relationship between the education and the willingness to donate tissue samples has been found elsewhere.6 Education might be used as an indicator of having general knowledge and insights, and being informed about biotechnology issues is a predictor of perceptions of benefits from biotechnology applications.15 Other studies confirm the importance of attitudinal factors, including a belief that genetic research will benefit people and willingness to participate in other governmental research on health.6,8 In our study, being a blood donor was associated with the willingness to donate a blood sample for research purposes. Those who are willing to contribute personally to health care in one way may be likely to do it in other ways, although the specific purpose might differ.
Gender did not influence the willingness to donate, which is in line with findings from other studies.6,8 The impact of age is ambiguous. Those being 45–64 were slightly more prone to donate than other age groups. A study focusing on medical research in general also found that middle-aged people were more prone to participate.19 Biobank-specific studies have either found no differences,6,8 or higher assent rates for patients aged at least 65 years versus those being younger.7 Differences according to age might either be truly age dependent, or reflect differences between generations. The fact that higher age tend to be associated with a higher willingness to donate tissue samples might be explained by Erikson's theory of generativity, i.e. an increasing concern with age for guiding and caring for the next generation.20 Empirical data confirm higher levels of generativity in midlife than in early adulthood.21 Generativity might also explain why having children was associated with a willingness to donate a tissue sample. Being a parent seems to encourage a readiness to provide for good health care opportunities for the children, now and in the future.12
Personal experience of genetic disease in the family, or among close friends, also had a positive impact on the willingness to donate a sample. Such experience of genetic disease might raise the awareness of the importance of gaining new knowledge in this field. An indirect relationship between personal experience of genetic disease and willingness to donate/store blood samples has been found elsewhere, and was explained by positive attitudes towards genetic research.6
Obviously, positive attitudes toward genetic research and trust in authorities are vital for the future of genetic research. It was also evident that highly educated people were more likely to have positive attitudes. Altogether, this suggests that public dissemination of knowledge is important to increase the awareness of genetic research and achieve a climate where people choose to donate and allow storage of tissue samples.
Although an informed public is vital, there will probably always be people who do not wish to or cannot inform themselves by using the information provided.22 Also, the risk and benefits associated with medical treatments is often misunderstood.23 In these cases, peoples' decisions to donate are not based on an informed, rational assessment of the purpose22 and the risks and benefits of specific research projects.5 Rather, the decision is based on a general trust that those responsible for the collection of samples do it for a good cause and have made an appropriate risk assessment.24 Trust has an impact on the acceptance of new technologies.24 Consequently, maintaining or improving the publics' trust is as important as having informed citizens. There should, therefore, be much effort to avoid adverse publicity about biobanks. Even small incidents will be covered by the media and can change the public's perception of both biobanks and the accompanying research.24 For example, in Sweden there was a recent criminal case, in which the police got access to a medical biobank to enable the identification of a murderer. This incident led to an intense debate in the media regarding whether the public can rely on samples not being used in the wrong way.25 In parallel, the number of withdrawals of samples from that biobank increased. Our findings suggest that Swedish government authorities should be more sensitive to the issue of public trust. Individual researchers were relatively well trusted, but trust is something that must be built and, if necessary, regained for each new generation.
In conclusion, since there was a marked willingness among the general public to donate a blood sample for research and storage, a necessary condition for realizing the potential of biobanks was satisfied. The willingness to contribute samples was mostly driven by altruistic motives, but also depended on the public being well-informed and/or having trust in both experts and authorities.
Key points
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Acknowledgments |
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This research project was funded by the Swedish Foundation for Strategic Research (through the ELSA programme), the Swedish Agency for Innovation Systems (VINNOVA), the Federation of County Councils, The Swedish National Board of Health and Welfare and the Knut and Alice Wallenberg Foundation (through the National Biobank Platform of SweGene and Wallenberg Concortium North).
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