The large majority of subjects who were asked to participate in the survey gave consent. Moreover, people who decided not to participate provided reasons more related to logistics than to ideological issues. This large participation is an initial demonstration of laypersons’ wish to take an active part in the construction of knowledge. It also assures that our sample’s opinion is representative of the target population, i.e. family members of patients suffering from dementia or cognitive impairment.
The percentage of participants who expressed the willingness to provide biological materials for the constitution of a biobank is among the highest registered in attitude surveys [10]. The study was related to a hypothetical willingness of participating in a biobank: a request for real involvement in a biobank constitution could provide a different, but not necessarily lower, rate. Studies suggest factual willingness to participate in biobank research may be greater than hypothetical, in particular when donors are recruited in health care facilities and are possibly motivated by factors that are less influential in the hypothetical context, such as altruism, trust and sense of duty [10]. In our study, the aspect of hypothetical participation and the element of motivation due to subjects’ specific situation are combined.
The willingness to participate in the constitution of a biobank was modulated by subjects’ years of schooling, as other surveys found [11], confirming the common, although controversial, idea that higher education contributes to giving people more confidence in science.
Results show that subjects’ attitudes towards biomedical research can predict their attitudes towards participation in the constitution of a biobank, with people expressing a more positive feeling on biomedical research, and particularly on the safety of research, being more available to personally take part in a biobank. The result is also true regardless of the subject’s years of schooling, suggesting that not only education but also individual feeling, i.e., something not necessarily related to formal education or scientific knowledge, counts in expressing this choice.
The attitude towards genetics research on dementia was the strongest predictor of subjects’ participation in a biobank, even taking into account subjects’ education and feelings about biomedical research as expressed in the first questionnaire. These data support the intuitive perception that personal proximity to a disease and the suffering it causes the patients and their relatives makes people more aware and sensitive to the need for research and is the strongest motivation to accept direct involvement in research. The active promotion of research by patients and family members’ associations confirms this point [12].
People who were not available for genetic research manifested a fear of discovering a genetic predisposition to certain diseases, particularly to dementia. This indicates a potential conflict among the family members of people affected by a disorder: on the one hand, there is an increased motivation in contributing to the advancement of knowledge and the possibility of cure and, on the other hand, there is an increased fear of discovering a personal predisposition to the disease. We believe that the fact that psychiatric disorders and dementia are very often the object of social stigma [13] contributes to the worry that genetic information may be used for discriminatory purposes.
The percentage of people who were not available for genetic research but expressed willingness to take part in the constitution of a biobank may perhaps be explained by the idea that giving a sample to a biobank is less demanding than being actively involved in research. Anyway, a misunderstanding of the typical type of research carried out in a biobank cannot be excluded.
Our work was also designed to collect lay subjects’ opinion on the ethical and legal aspects of the management of biobanks and to compare their views with experts’ view, namely, with ethics committees’ opinions. The results showed that on several issues the Italian ECs and our sample of the public did not share the same view, even though the ECs are made up of members with different expertise, including patients’ representatives [14], and may be regarded, at least from an ideal perspective, as an expression of civic participation in the scientific enterprise.
The most relevant result concerns the model of IC and the pertinent information chosen by the ECs and the public. Informed consent is the most crucial and discussed element in the constitution of biobanks [15], where biological samples are collected at a certain point in time and then used for a long period of time, with research methods and opportunities rapidly evolving, which makes it difficult to give the subjects full information at the time of sample collection. The marked difference between the type of IC for research on biological materials that ECs regard as suitable and the type of IC that family members are willing to give may be partially due to a different awareness of the complexity of the ethical and legal issues related to IC among lay people and ECs. This interpretation seems to be confirmed by lay people’s tendency not to choose the more complex model of IC, namely, multi-layered consent. Nevertheless, public’s preferences cannot be simply ascribed to a lack of knowledge and awareness or to the desire not to be too much involved in demanding activities. On the contrary, the public seems to be more in line with researchers’ common idea that broad consent is essential to facilitate research opportunities and therefore scientific advancement. Other studies investigating different consent options found that most people are willing to provide one-time general consent for research [16], but different opinions were also registered [17]. The findings of the Eurobarometer survey EB 73.1 ‘Life Sciences and Biotechnology’, which took place in 2010 and contained questions on biobanks [18], showed that the option of broad consent appears not to be supported by the general public in Europe. People were invited to say which kind of permission they thought was needed when a scientist does research on data in a biobank among: not need to ask for permission (unrestricted consent), ask for permission only once (broad consent), ask for permission for every new piece of research (specific consent), don’t know. Data related to Italy show that 7% of the public thinks there is no need to ask for permission, 21% is in favour of giving permission only once, while 58% is in favour of giving permission for every new piece of research. Interestingly, attitudes in Europe towards broad consent are also shaped by the levels of information, with people who know more about biobanks being more willing to give broad forms of consent [11]. Moreover, those who say they will definitely participate in a biobank are much more likely to say researchers don’t need to ask for permission (16%) or permission granted once only (28%). We did not assess subjects’ level of information on biobanks, but it cannot be excluded that people attending hospitals and who are involved in patients’ caregiving know more than the general public about research on biological materials. In addition, our data on IC preferences refer only to people who expressed willingness to participate in a biobank.
Public and ECs opinions also differ to some extent regarding the key information to be provided to the subjects [Table 3], with the public showing a tendency toward a greater interest in the aspects related to the relationship between researchers and donors, i.e., the authorisation to be re-contacted and to contact family members as well as the communication of research results. Subjects’ interest in the communication of research results is reiterated by almost all subjects’ desire to receive both individual results and research results of general value, while only around fifty per cent of ECs require results communication [Table 4]. This subjects’ expectation is confirmed in other surveys [19], returning research results is regarded as an influential factor in subjects’ decision to become biobank donors [20], and researchers endorse the obligation of communicating with research participants [21]. Anyway, there are a wide-ranging views and practices regarding the return of individual research results to participants [22]. Our participants’ request is in line with the ethical duty to return genetic research results of significance for the individual subject stated in international regulations [23], and with the subjects’ right to ask for their results of any type and to obtain them if they wish [24]. While ECs position may reflect the worry that the communication of research results that may be not informative enough for the individual subject and for which interpretation is difficult may generate misunderstanding and confusion for the subjects.
Family members are not really interested in information regarding sample property and IPR; in fact, around 70% of the subjects believe that the sponsor should be the owner of samples and IPR. On the contrary, those interviewed are greatly interested in having information about the sponsor’s prohibition on commercialising the samples and related data, which in addition they think should be given for free by the donors. Moreover, the large majority of the public regards the access of samples by not-for-profit organisations as acceptable, but only a minority agrees with access by for-profit organisations; on the contrary, ECs did not express a difference in opinion between the possibility of access from for-profit and not-for-profit organisations, both regarded as acceptable by around 70% of ECs. All these data converge in supporting a subjects’ disinterested view on their possible personal economic profit, that they ask be repaid with a similar approach by research promoters. The fact that people do not expect economic gain from participation in biobanks does not mean that they do not have an expectation of getting something in return [25]. From our sample’s responses, the desired reward seems to be primarily a good relationship with researchers who are asked to look at donors as active speakers who contribute to increasing present knowledge and the possibility of cure in the future and who are entitled to be informed of the research results and to be protected against discrimination.
Limitations
The questionnaire on the attitudes towards genetic research was developed and used for the first time in this study, thus it was not validated in a previous and independent sample.
We did not formally check the participants’ level of knowledge and information on biobank. Therefore we could not evaluate if this influenced family members’ willingness to participate in a biobank constitution and their opinion on the ethical aspects of biobank management.
Participants were family members of patients attending a geriatric or neurological visit. At this stage of the project, patients were not involved in the survey. To investigate possible differences between the attitudes of patients and those of family members would be interesting, to evaluate how being affected by a disorders can shape willingness and opinions. Alternatively, a comparison among the attitudes of family members of patients affected from different kind of disorders could help to understand if different pathologies (affecting the brain or the body, with or without a possible treatment, for which we have or not knowledge of the causes) might influence people’s responses.
Finally, we acknowledge that our sample cannot be regarded as representative of the general public because it consists of the family members of patients suffering from a specific disturbance, and they were interviewed in an outpatient medical department. Both of these circumstances could influence their answers.
