What Potential Donors in Research Biobanking Want to Know: A Large Population Study of the Italian Twin Registry

Abstract

Donation of human tissues for research and ELSI (ethical, legal, and social issues) of biobanking are increasingly debated issues. While several studies have highlighted patients' concerns, little is known about opinions and preferences of healthy potential donors. Further investigations in this respect may allow communication procedures tailored to participants' needs. Based on the Italian Twin Registry, a cross-sectional survey was conducted among twins who had not yet donated biological samples for research. The objective was to assess the importance these potential donors attributed to specific procedures and pieces of communication related to research biobanking. A self-administered questionnaire was constructed and validated. Items were as follows: potential agreement on use of biological samples for research; knowledge of biobanks; and importance given to privacy protection and to communication of general and individual tests results, study objectives, type and amount of participant involvement, location and duration of sample storage, and benefits and potential risks. Multivariate analysis was performed to estimate the association of these items with sociodemographic factors as well as with perceived health status and chronic or long-term diseases. The questionnaire was mailed to 4894 twins aged 18–65 (response rate 34%). One-third of subjects already knew about biobanks, 52% had some knowledge, and 20% were uninformed. A majority expressed unconditional agreement to sample use for research. Only 6% of respondents considered privacy protection not important in research biobanking. Knowledge of biobanks predicted attention to most of the issues. Higher education was associated with more frequent concern about type and amount of involvement, but less frequent concern about place and time of storage, and presence of benefits. Women were more attentive to research biobanking. This study supports the need of procedures tailored on different donors' concerns and highlights the social value of population biobanks. Furthermore, the results call for greater efforts in the promotion of research biobanking.

Introduction

The importance of population biobanks as effective infrastructures for life course epidemiology is well documented.¹ In this context, twin registries are valuable tools to create large-scale collections of human biological specimens² for the study of genetic and environmental determinants of health. While new research strategies are developing, the donation of human tissues and the ELSI (ethical, legal, and social issues) of biobanking activities are increasingly addressed within the international debate.^3–5 In this framework, detecting concerns and preferences of potential donors among the general population may contribute to the establishment of biobanking communication procedures tailored to the different needs and concerns of participants, easing the pathway to an effective biobanking. Several studies have already highlighted patients' concerns in the context of disease-oriented biobanking,^6–8 whereas opinions and preferences of healthy donors involved in population-based biobanks deserve further investigations. The Italian Twin Registry (ITR) research enterprise has recently addressed this need. Since 2006, the ITR has established a biobank⁹ in use at the Centre for Epidemiology, Surveillance, and Health Promotion (CNESPS) of the Italian National Institute of Health (Istituto Superiore di Sanità, ISS). To date, the ITR Biobank stores different types of specimens (whole blood, serum, buffy coats, saliva) from ∼2000 twins who have donated their samples for several epidemiological research projects.

In this study, a cross-sectional survey was carried out among the twins enrolled in the Registry, who had not yet donated biological samples for research, to examine what issues these potential donors consider of importance and, consequently, really want to know in the context of a research study in which human biological samples are collected, used, and stored for further epidemiological or biomedical research.

The main objective of the survey was to shed light on the degree of importance potential donors attributed to privacy protection, communication of research objectives and general study results, feedback on individual test results, information about time and amount of involvement of participants, details on sample storage, and communication of risks and benefits. Furthermore, our study investigated the role of sociodemographic and educational factors in modulating preferences and concerns about donation.

There is a lack of studies comparing twin and general population data on the specific issues of this work. However, it is noteworthy that no significant differences between twins and nontwin subjects have been previously detected for several complex traits, including social and behavioral characteristics.¹⁰ We are aware that these characteristics may be only weak proxies for the endpoints in this study and twins might be particularly inclined toward research. Nevertheless, we think that this survey may provide approximate, yet useful, indications on general population concerns and preferences when participating in epidemiological cohort studies and biobanking activities; furthermore, it may provide evidence for discussion on the need of procedures tailored on different donors' concerns and, in the general interest, for debate on the social value of population biobanks.

Materials and Methods

Development, content validity, and reliability of the questionnaire

The survey was designed to be conducted using a self-administered questionnaire.

Questionnaire preliminary version

To develop the questionnaire, we followed a structured procedure. First, we performed a literature review focusing on individuals' attitude and willingness to donate biological samples for research purposes^7,11–15 and constructed a preliminary version of the questionnaire using the questions that were deemed important based on the review. To assess content validity,¹⁶ we submitted this preliminary version to a group of experts, including three psychiatrists working at the Mental Health Unit and one ethicist working at the Genetic Epidemiology Unit of the CNESPS, at the ISS. They were asked to provide their opinion on the clarity of each question and grade items by relevance and importance. The four experts agreed that the questionnaire was a useful measure of people's concerns and preferences about information they want to receive when involved in a research biobank. Although the experts considered all the questions relevant and important, they suggested shortening the questionnaire for maximizing its acceptability and increasing the response rate and also rephrased some questions to make them more understandable.

Questionnaire final version

The final version of the questionnaire included 16 questions, plus sociodemographic characteristics of respondents (i.e., age, sex, education, occupation, region of residence) and one filter question to exclude subjects who had previously donated biological samples for research in other contexts. The 16 questions were chosen based on those questions the experts most often ranked highest in terms of the level of importance. They cover the following issues: individual potential agreement on the use of his/her biological samples for research; individual previous knowledge of biobanks; and degree of importance given by potential participants to privacy protection and the communication of (i) general scientific study results, (ii) individual tests results, (iii) objectives of the study, (iv) type and amount of involvement required to participants, (v) place and (vi) length of storage of the biological material, (vii) presence of benefits, and (viii) potential risks. Subjects were also asked about self-perceived health and presence of chronic or long-term diseases.

The questionnaire also contained one item addressing the individual attitude to donation for research and another one investigating the potential donors' agreement on the access and use for research of their medical data recorded in healthcare settings (e.g., emergency wards) without a specific informed consent. Results on these further questions have already been published.^17,18

The questionnaire is shown in Table 1.

Table 1.

Questionnaire

1.	Have you ever donated biological material (blood, saliva, urine, or other tissues) for research purposes?
	Yes ◯ No ◯
2.	Do you know what a “Research biobank” is?
	◯ Yes, I definitely know what it is.
	◯ Yes, I have some information, but I do not know exactly what it is.
	◯ No, I don't know.
3.	Would you agree, at the present time, to donate a sample of your blood (or saliva, etc.) for epidemiological or biomedical research use?
	◯ Yes, I would definitively agree.
	◯ Yes, I would agree, but only if results regarding my health or predisposition to diseases will be given to me.
	◯ Yes, I would agree, but only if results regarding my health or predisposition to diseases will not be given to me.
	◯ No, I would not agree.
	◯ I don't know.
4.	Would you agree that your medical data, available from previous checkups and/or hospital admissions, could be accessed and used for research purposes without your explicit informed consent?
	Yes ◯ No ◯ I don't know ◯
	Please, indicate how important would the following issues be for you if you had to decide to participate in an epidemiological or biomedical research study in which biological material were collected and stored for future research use.
5.	Having my privacy protected.
	Very important ◯ Important ◯ Slightly important ◯ Not important ◯
6.	Receiving information about the overall research results.
	Very important ◯ Important ◯ Slightly important ◯ Not important ◯
7.	Receiving information about my individual tests results.
	Very important ◯ Important ◯ Slightly important ◯ Not important ◯
8.	Having the objectives of the study explained to me.
	Very important ◯ Important ◯ Slightly important ◯ Not important ◯
9.	Knowing what is expected from my participation in terms of type and amount of involvement.
	Very important ◯ Important ◯ Slightly important ◯ Not important ◯
10.	Receiving information about the location of storage of the biological material.
	Very important ◯ Important ◯ Slightly important ◯ Not important ◯
11.	Receiving information about the length of time the biological material will be stored for future use.
	Very important ◯ Important ◯ Slightly important ◯ Not important ◯
12.	Knowing if my participation would warrant me any benefits (e.g., free of charge medical tests, money etc).
	Very important ◯ Important ◯ Slightly important ◯ Not important ◯
13.	Receiving information about any potential risks related to my participation
	Very important ◯ Important ◯ Slightly important ◯ Not important ◯
14.	Please choose among the following statements the one that best reflects your reasons for participating in a research study and donating biological material.
	◯ “I think we have to donate to help others.”
	◯ “I think donation is a way to personally contribute to medical research, while doctors/researchers give their contribution and expertise.”
	◯ “I think donation is a natural and spontaneous act to help others.”
	◯ “I think donating is not interesting.”
	◯ “I don't know, at present I do not have a clear opinion.”
15.	How do you consider your overall health?
	Very good ◯ Good ◯ Neither good nor bad ◯ Poor ◯ Very Poor ◯
16.	Have you ever been diagnosed with any chronic disease or have you suffered from a long-lasting health problem (6 months or more)?
	Yes ◯ No ◯

Test–retest reliability

To assess test–retest reliability¹⁹ of the final questionnaire, we involved a convenient (nonprobabilistic) sample of students and workers, recruited without any a priori selection strategies for specific individual features such as gender and age. The sample included 34 individuals (18 university students—5 males and 13 females, mean age 21 years, range 20–23 years; 16 workers—nurses and blue collars; 7 males and 9 females, mean age 45 years, range 30–68 years) living in two Italian cities (Rome and Bologna) to whom we administered the questionnaire twice.

The two questionnaire completions took place 14 days apart, a time interval long enough to avoid the issue that the second measure could be affected by the recall of the first one, but not so long to be influenced by intervening changes in participants lives (e.g., health status variation or new biobanking experiences). The questionnaire was presented by two university students. Confidentiality was assured.

Test–retest reliability was measured by Cohen's kappa to estimate agreement beyond chance for nominal variables and Cohen's weighted kappa²⁰ for the question on self-perceived health (a five-point Likert scale) and questions on the degree of importance given to specific aspects of research conduction and biobanking (four-point Likert scales).

Most of the variables showed at least moderate agreement between the two time points, with kappa values ranging from 0.50 to 0.83.

Study population and questionnaire administration

The final version of the questionnaire was mailed, between June and October 2012, to an overall total of 4894 adult twins (aged 18–65) enrolled in the ITR, with a brief letter explaining the aims of the study and the instructions to complete the questionnaire. A written informed consent was required, which the respondents returned separately, to safeguard questionnaires' anonymity.

All data were read using an Optical Character Recognition (OCR) system; they were stored in the ITR database and analyzed using the statistical software STATA (v. 13).

Statistical analysis

The questions rating the degree of importance (on a four-point Likert scale: “not important,” “slightly important,” “important,” “very important”) given to specific issues regarding research biobanking (questionnaire items: 5–13) were first analyzed in a univariate framework; then they were considered in relation to the sociodemographic variables, as well as to perceived health status and presence of chronic or long-term diseases. Pearson's chi-square test was used to compare frequencies between groups, with a p-value <0.05 indicating significant differences. Subsequently, the questions that resulted associated to any of the covariates were analyzed by a multivariate approach using a logit model with two categories for the dependent variable (“very important”/“important” vs. “not important”/“slightly important”); in this model, we used robust standard errors to take into account the nonindependence of data within twin pairs. Covariates that entered the model were as follows: gender, age, education, area of residence, and knowledge of biobanks. Again, we considered significant all the associations with a p-value <0.05.

Education was categorized as “less than high school,” “high school,” and “at least bachelor degree.” Age classes were defined based on the following quartiles: 18–26, 27–38, 39–49, and 50–65 years. Geographical area was categorized as “North,” “Centre,” and “South and Islands” according to the place of residence.

Results

Study sample recruitment

Out of the 4894 questionnaires sent by mail, 1677 were returned, giving a response rate of more than 34%. Three subjects withdrew their consent to the study and their data were not included in the analysis according to ethical and legal requirements; 1674 sample units were then analyzed. One-hundred and eighty-eight individuals were excluded as they declared they had already donated biological samples for research (in contexts other than the ITR Biobank), leaving 1486 questionnaires for the analyses.

Study sample characteristics

Table 2 summarizes the sociodemographic characteristics of the respondents. More than 60% of them were women, the mean age was 38.6 years (standard deviation [SD] = 14 years), and more than half were from Northern Italy; furthermore, about 37% had a college degree and 60% were employed.

Table 2.

Description of the Study Sample

	N (%^a)
Number of questionnaires mailed	4894
Number of questionnaires examined	1674
Number of subjects excluded because they have already donated biological samples	188
Number of subjects in this study	1486 (100.0)
Gender
Males	576 (38.8)
Females	910 (61.2)
Area of residence in Italy
North	796 (54.1)
Center	504 (34.3)
South and Islands	170 (11.6)
Missing data	16
Occupation
Employed	888 (60.0)
Unemployed	110 (7.4)
Housewife/student	372 (25.2)
Retired or unable to work	109 (7.4)
Missing data	7
Education level
Less than high school	339 (22.9)
High school	599 (40.5)
At least bachelor degree	541 (36.6)
Missing data	7
Age (years)
18–26	409 (27.6)
27–38	371 (25.0)
39–49	335 (2.6)
50–65	368 (24.8)
Missing data	3

Percentages are computed on the available (missing excluded) data for each variable.

No significant differences were detected between respondents and nonrespondents with respect to age, gender, and education level, providing at least partial reassurance against major selection biases.

Willingness, awareness, concerns, and preferences among respondents

In our sample, 28% of subjects responded that they already know what a biobank is, 52% had some knowledge, but were lacking complete information, and 20% had no knowledge of biobanks. With regard to the agreement of respondents on the potential access and use of their biological samples for research, only 4% expressed disagreement, while 72% expressed an unconditional agreement to the use of their samples, 11% expressed a conditional agreement (they would give access to their samples only if individual results useful for their own health were communicated to them), and 3% of respondents expressed an opposite conditional agreement (they would give access to their samples only if the individual test results were never communicated to them); 10% had no definite opinion about this issue.

Concerning privacy protection, only about 6% of respondents considered privacy an unimportant issue in research biobanking, while 26% declared it was an important topic to be informed about, and nearly 68% identified privacy to be of major importance.

Moreover, very high percentages of respondents considered “important” or “very important” communication to participants of the following: individual results (94%), general results (97%), study objectives (97%), type and degree of involvement (95%), and presence of risks for participants (99%), while slightly lower percentages of respondents gave importance to practical aspects of biobanking such as place (68%) and length of storage (61%), and the presence of direct benefits (82%).

The influence of sociodemographic and educational factors on concerns: the multivariate analysis

Table 3 summarizes the multivariate results.

Table 3.

Importance of Specific Issues in Research Biobanking

Covariates	Privacy OR (95% CI)	Communication of overall results OR (95% CI)	Communication of individual results OR (95% CI)	Communication of research objectives OR (95% CI)	Communication of type and amount of involvement OR (95% CI)	Communication of place of samples' storage OR (95% CI)	Communication of time of samples' storage OR (95% CI)	Communication of benefits from the study OR (95% CI)
Previous knowledge of biobanks
No (Ref. category)	1	1	1	1	1	1	1	1
Little	1.5 (0.8–2.6)	1.7 (0.9–3.4)	1.4 (0.8–2.4)	1.5 (0.7–3.2)	1.9^a (1.1–3.5)	1.2 (0.9–1.6)	1.3^b (1.0–1.8)	0.9 (0.6–1.3)
Yes	1.9^b (1.0–3.6)	5.7^c (1.9–17.3)	2.3^a (1.2–4.6)	4.3^c (1.4–13.3)	1.8^b (0.9–3.8)	1.8^c (1.2–2.6)	1.8^c (1.3–2.5)	0.8 (0.5–1.3)
Education
<High school (Ref. category)	1	1	1	1	1	1	1	1
High school	0.9 (0.5–1.6)	1.2 (0.5–2.7)	1.1 (0.6–2.1)	2.5^a (1.04–6.2)	1.3 (0.7–2.3)	0.7^a (0.5–0.97)	0.7^a (0.5–0.9)	0.6^a (0.4–0.9)
≥Bachelor's degree	0.6^b (0.3–1.0)	1.3 (0.5–2.8)	0.7 (0.4–1.3)	0.8 (0.4–1.7)	2.7^c (1.3–5.6)	0.4^c (0.2–0.5)	0.4^c (0.3–0.6)	0.4^c (0.3–0.6)
Area of residence
North (Ref. category)	1	1	1	1	1	1	1	1
Center	1.0 (0.6–1.6)	1.5 (0.7–3.3)	1.1 (0.7–1.9)	1.2 (0.5–2.8)	1.3 (0.7–2.4)	1.4^a (1.1–1.8)	1.4^a (1.1–1.8)	1.3 (0.9–1.8)
South	1.6 (0.7–3.8)	1.5 (0.5–4.7)	2.9^a (1.04–8.1)	1.2 (0.4–4.1)	1.3 (0.6–3.1)	2.0^c (1.3–3.1)	2.4^c (1.6–3.6)	1.9^a (1.04–3.5)
Age
1 Quart 26 (Ref. category)	1	1	1	1	1	1	1	1
2 Quart 38	1.4 (0.6–3.4)	0.7 (0.2–2.0)	1.1 (0.6–2.1)	1.5 (0.4–5.6)	1.2 (0.6–2.7)	1.6^a (1.01–2.4)	1.9^c (1.3–2.9)	1.1 (0.7–1.7)
3 Quart 49	1.5 (0.6–3.7)	0.9 (0.3–3.1)	1.5 (0.7–3.2)	1.5 (0.4–5.5)	1.2 (0.5–2.8)	1.7^a (1.1–2.6)	1.9^c (1.3–3.0)	0.9 (0.5–1.4)
4 Quart 65	0.5 (0.2–1.1)	0.3^c (0.1–0.7)	0.9 (0.5–1.7)	0.5 (0.2–1.5)	2.2^b (0.9–4.5)	1.3 (0.8–1.9)	1.2 (0.8–1.8)	0.7 (0.4–1.2)
Gender
Male (Ref. category)	1	1	1	1	1	1	1	1
Female	1.3 (0.8–2.0)	2.0^a (1.02–3.8)	1.6^b (1.0–2.5)	2.8^c (1.3–5.9)	0.7 (0.4–1.3)	1.4^a (1.1–1.8)	1.2 (0.9–1.6)	1.3 (0.9–1.7)

For each questionnaire item, the reference category is “Not important/Slightly important” and the outcome category is “Important”/Very important.” The ORs in the models were also adjusted for occupation according to the following categories: “employed,” “unemployed,” “housewife,” “student,” “retired,” and “unable to work.”

p < 0.05; ^bp < 0.10; ^cp < 0.01.

CI, confidence interval; OR, odds ratio.

Health-related covariates not reported in Table 3 had not shown significant associations in the unadjusted analysis and were not considered in the final model because their inclusion changed the estimates only slightly.

Moreover, none of the unadjusted associations regarding the importance of being informed about possible risks was confirmed in the multivariate model.

Preexisting knowledge about research biobanks is among the main factors, if not the most relevant one, to drive potential donors' preferences and concerns. Knowing in advance about biobanks for research makes individuals more interested in all the investigated issues—except for the presence of direct benefits—than people without any previous knowledge or with little knowledge about these research infrastructures. Informed individuals are more likely to consider privacy an important issue and express the need for adequate communication of the research objectives as well as of the overall and individual study results. Furthermore, they probably attribute higher importance to the location and time length of the storage of their biological material compared to individuals without any prior knowledge. Interestingly, the proportion of subjects who give attention to each research aspect increases with the increasing knowledge of biobanks.

Potential donors with a higher education (at least high school) are more often concerned about the type and amount of involvement, but less often concerned about the place and time length of storage, as well as about the benefits they could receive from donating for research (tests of linear trend: p < 0.01). In particular, the attention toward the communication of the study objectives is more common among individuals with a “high school” level and less common among University-educated individuals, with the latter being more frequently concerned about the type and amount of involvement.

The results involving the geographical area of residence are specific to the Italian context. There are no differences among the geographical areas regarding being informed about research objectives and overall study results, while individuals living in Central and Southern areas of the country seem to be more often concerned about practical aspects of biobanking, such as the knowledge of place and time length of storage of the biospecimens. Moreover, people living in the South seem to be more frequently interested in the feedback on individual results, and benefits are more often expected among them.

With regard to age, we found that participants aged 27–49 years expressed more concerns about the location and time length of the storage of their biological material compared to younger participants. Moreover, the oldest age group (50–65 years) is less likely to be interested in the communication of the overall study results than the youngest age group (18–26 years).

Gender differences in attitudes are suggested, with women appearing generally more thoughtful with respect to research biobanking. Concerns about most of the issues, with the exception of type and amount of involvement, seem to be more common among females, although some estimates are only borderline significant. Being female resulted in an increase of at least 60% of the probability to be concerned about the communication of individual and general results, while this probability is almost threefold for research objectives; furthermore, women seem to pay more attention to the “destiny” of the biological material in terms of place and time length of storage.

Discussion

We conducted this survey to gather knowledge about what potential donors for population-based biobanking and life course epidemiology want to know when participating in research. Our ultimate goal was to spread light on the major concerns that might hinder participation and donation of biological material. The study was also influenced by the conclusion of a relatively recent systematic review of Kirkby et al.,²¹ which focuses on the limited empirical evidence on what potential participants want to know about research and the evidence of nonhomogeneous needs among them.

There are, in fact, few previous empirical investigations on the willingness to donate and awareness of research biobanking. Most studies were conducted in other countries^{6,11,14,22,23} and, apart from our survey, only one was conducted in Italy²⁴ and involved patients' family members, in line with a widespread interest on disease-oriented biobanks. As far as we know, our survey is the first one conducted on twins from a national, population-based registry. It is important to underline that, while in Northern European countries there is a long lasting tradition of large-scale health data collections and research biobanking, whose potential has already been thoroughly framed,²⁵ there are still many gaps to be filled concerning these topics in Italy, as well as in other European countries.

Given these premises, comparisons with other studies need to be made with caution because of a high heterogeneity in terms of targeted populations, cultures, and methodologies.

It is noteworthy that a widespread willingness, quite similar to that recorded in our study, emerged in the relatively recent survey by Porteri et al.,²⁴ in which a high percentage of family members (86%) of geriatric patients expressed willingness to donate specimens for a research biobank. It should be considered that both studies investigated specific subgroups of the general population. If, on one hand, our results may have been affected by the specific “positive feeling” of twins toward research, on the other hand, Porteri's results may have been influenced by the interest of relatives of patients toward possible treatment advancements for the specific disease. In any case, these are the current Italian compliance rates that can be compared with the only national statistics available on these topics, namely that of the Eurobarometer survey in 2010.²⁶ In this survey, 25% of the Italian respondents expressed concerns about “blood donation” for a research biobank. This percentage is somewhat comparable to a 14% of our respondents who would not donate or were uncertain about biological material donation. Such a difference between the general population and the twin subgroup is expected due to the already mentioned twins' “positive feeling” toward medical research.

Another interesting issue for between-studies comparison is the importance given to the feedback in terms of individual and general results. Almost all the respondents in both Porteri et al.²⁴ and our survey are willing to receive individual and general results. In this regard, to cite another study in a completely different cultural setting, Ahram et al.²³ detected the key role of individual and general results availability as positive factors favoring donation in a sample drawn from the Jordanian population. In Germany, Starkbaum et al.²² recorded a high level of attention toward possible “personal follow-up” addressing the health of participants in cohort studies with biobanking. This result may parallel, in some way, our observation on the interest toward the communication of individual test results.

Further comparisons about the role of sociodemographic and educational factors are not allowed because previous studies have variously investigated their direct role in modulating willingness to donate, while our study investigated their role in modulating preferences and concerns about donation, which do not necessarily affect willingness. And this is one of the two key novel aspects of our survey. The second is the focus we made on the well-known need to evaluate, before any inferences, the level of knowledge of potential donors for what concerns research biobanks. This knowledge can be an important modulator of opinions when individuals are involved in biobanking activities.

In our survey, sociodemographic and educational factors mitigated in different ways individuals' concerns and the importance they attributed to specific biobanking actions and communication issues. Our findings show that potential twin donors do not seem to blindly trust research groups or, in other words, they do not seem to be inclined to opt for surrogacy when research biobanking is at stake.

In particular, the results confirmed our underlying hypothesis that a good previous knowledge of biobanks for research or, at least, the idea of having a good knowledge is the main predictor of a high degree of importance attributed to many of the aspects investigated. We can suppose that well-informed individuals might have capitalized on the information they gathered, and knowledge makes them more aware when involved in research biobanking.

Education seems to affect the balance between what is important to know when participating and what can be left to researchers: the higher the level of education, the stronger the attention paid to time spending and amount of involvement, while high school-educated individuals seem to express lower reliance on researchers' choice of objectives compared to less-educated respondents.

Gender differences emerged in this study, somewhat in line with the results of two previous reports by our group, which focused on a different endpoint, the attitude toward research biobanking. The first one was a pilot study²⁷ on a smaller twin sample, which had already donated for research, while the second one was performed on the same data set used in this study.¹⁷ In both these studies, women showed a significantly different attitude toward research compared to men. Gender differences have already been detected in other prosocial behaviors studies and would deserve, in our opinion, further investigations in the field of research biobank donation.

Concerning the generational differences which emerged in our study, results suggest that it is worth discussing specific pieces of information in details with potential donors according to age.

Area of residence seems to come out as a proxy of different donors' profiles. This finding was expected, given the differences in cultures and values among different geographical areas in our country. Although this result cannot be used for comparisons, it indirectly highlights the importance of taking into account the role of social and historical factors in shaping differences among individual groups when a variety of prosocial activities are at stake.

With regard to the privacy issue, we draw attention to the high percentage of our potential donors who consider this as an important aspect when participating in population-based research and biobanks. At present, this is a hot topic all around Europe and health researchers are waiting for provisions of the new forthcoming EU privacy regulation (http://ec.europa.eu/justice/data-protection/reform/index_en.htm). It is of interest to compare between our study and two previous reports. The study by Starkbaum et al.²² was based on focus groups with individuals living in four different regions in Germany, a country where legislation and public attitude toward privacy protection are even narrower than in Italy.²⁶ The other study was conducted by Kaufman et al.²⁸ in a representative sample of citizens from the United States, another country where the attention to privacy protection in research has continuously increased during the last decades. Starkbaum et al.²² underlined that privacy protection is a basic prerequisite for potential participants in research, and further acceptance of research biobanking may intervene (in terms of breach risks) if individual results are communicated and benefits can be expected. Kaufman et al.'s²⁸ results are in the same direction. In our study, we found a high percentage of potential donors who considered it “important” or even “very important” to receive information about privacy protection and feedbacks on individual test results. However, the percentage of individuals considering the presence of benefits as an indispensable component is much lower. We are willing to further investigate these differences to verify whether our potential twin participants are less prone to accept data breach risks when benefits or remuneration are expected. Further considerations about privacy findings regarding this survey can be found in another work by our group.¹⁸

Finally, we want to detail a few further limitations of the study. Even if the response rate obtained is in line with and actually higher than the average rate of the surveys conducted among ITR-enrolled twins, it is not possible to completely exclude a different distribution of opinions among nonrespondents. In any case, this would not be due to the main sociodemographic characteristics analyzed in this work, given that they do not differ between respondents and nonrespondents. Furthermore, given the already mentioned specific inclination of twins toward research, our results should be confirmed in other subgroups of the general population. On the other hand, this specific positive attitude does not seem to diminish the significance of our study because it implies that concerns of potential twin donors are likely to be conservative estimates of the general population concerns about research and biobanking participation.

From this perspective, in line with the investigations started more than a decade ago,¹¹ gathering more knowledge on potential donors' opinions in the field of population-based biobanking will be valuable to foster fruitful interactions among different stakeholders. This will help to establish more efficient and ethically sound collaborations among different countries, which are now increasingly involved in data and samples sharing.

In conclusion, the need for national campaigns promoting epidemiological and biomedical research and population-based biobanks seems to be emerging. In the light of the high rate of potential agreement to donation expressed in our sample, as well as in other studies on different targeted populations, we think that such campaigns are likely to be extremely successful. Educational needs are also underlined by other studies²¹ as well as by former relevant experiences in population biobanking strategy such as that of the UK Biobank.²⁹ Informative campaigns and other educational initiatives would increase the compliance to population-based biobanks both in terms of improved participation rates and individuals' positive awareness. Moreover, procedures carefully tailored to different donors' subgroups would be desirable and valuable from the ethical and social perspectives. What is more, it has recently been envisaged at the European level^30,31 that socioempirical evidence on biobanking is central for planning future strategies in which donors might be assigned to play more active roles, also as citizens, in shaping research projects.

Footnotes

Acknowledgments

We want to thank all the twins enrolled in the Italian Twin Registry and, in particular, those who made this survey possible. We are also grateful to Luigina Ferrigno for her expert reading of our work and suggestions in interpreting the data.

Author Disclosure Statement

No conflicting financial interests exist.

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