This study was conducted in Australia between 2017 and 2018. Here we present the results of two phases of the project: a computer assisted telephone interview (CATI) survey and follow-up semi-structured interviews with members of the Australian public. Ethics approval for the CATI survey and interviews were granted by Swinburne University and The University of Sydney ethics committees respectively.
A total of 750 Australians over the age of 18 years who could speak English participated in the CATI survey which ran for three weeks in November 2017. Telephone numbers (61.3% mobile, 38.7% landline) were randomly generated by Samplworx, and were designed to represent the proportion of residents residing in each Australian State and Territory. The margin of error was 3.5% at the 95% confidence interval where responses are assumed to be evenly split (i.e., 50%), and response rates according to the American Association for Public Opinion Research (AAPOR)’s (2009) definitions and calculations (i.e., RR1 – RR4) ranged from 6.0% - 9.0% with a cooperation rate of between 13.8% - 15.4%. The sample was representative of the Australian population in relation to state and territory, gender (52.4%) and employment status, but was overrepresented by older people (M = 50.85, SD = 18.01, Range = 18 - 91) and those with a university education (48.3%). 82.1% described their ethnicity as Australian.
The survey consisted of 48 forced choice questions, meaning that participants were required to choose an option out of the available responses for each question. The questions were designed to explore issues relating to participation in and support for Australian and international biobanks including: overall willingness to donate/participate, identifiability of samples, ethics, consent preferences, participant engagement, withdrawal, funding, payment for participation, perceived benefits and governance.
Prior to completing the CATI survey, all survey respondents were read a definition of biobanks. This was important given that only 26.4% indicated that they “know enough about medical research involving biobanks?” (71.3% answered ‘No’ and 2.3% ‘Unsure’).
Willingness to donate/participate: immediately after the definition was read, survey respondents were asked whether they would be willing to participate in four biobanks with varying levels of globalisation:
- A biobank that was located entirely within Australia and used only by Australian researchers
- An Australian biobank that allows its samples to be used by researchers located overseas
- An Australian biobank that sent some of its samples to be stored in a biobank overseas
- A biobank located overseas (i.e. a bank that is located entirely overseas and used by researchers located overseas)
To avoid order effects, the order of the four responses was randomly presented throughout the survey.
Willingness to store tissue according to identifiability: six questions were designed to assess respondents’ willingness to allow coded, anonymous and identifiable samples to be stored and used by Australian and foreign biobanks. The three different sample categories were defined to all participants as follows (and in order of presentation):
Coded: ‘Biological samples (like DNA, blood, cancer specimens and so forth) are usually given a code so that researchers do not know who you are, but can link back to other information about you for research purposes. While protections are put in place, a small risk of loss of confidentiality still remains.’
Anonymous: ‘Biobanks can also store samples anonymously. Anonymous samples are samples that have been de-identified so that no one is able to work out who had donated the sample.’
Identifiable: ‘Sometimes biological samples can be completely identifiable (i.e. the researchers and anyone else who accesses the sample would know who you are).’
After each definition, respondents were asked two questions, “Would you be willing to have a coded/anonymous/identifiable sample stored and used by an Australian biobank” and “Would you be willing to have a coded/anonymous/identifiable sample used and stored by biobank researchers located overseas”. The response options were ‘Yes’, ‘No’ or ‘Unsure’, and the order of the two questions was randomly presented.
Consent preferences: participants were asked six questions about their preferences for consent under different conditions. Four different kinds of permission or consent were defined for all participants as follows, including the option of refusal of consent:
None. ‘I would not give consent for my sample to be used for any research study.’
Specific consent: ‘I would like to be asked permission before each new study that uses my tissue.’
Conditional consent: ‘I would want to give consent on the basis that it was used for certain studies and not others.’
Broad consent: ‘I would want to give consent so that my sample could be used for any project.’
Survey respondents were asked what kind of consent they preferred, depending on whether they were donating tissue to an Australian biobank used only by Australian researchers, an Australian biobank that allows its samples to be used by overseas researchers (with samples stored either in Australia or overseas), and if they were donating to a foreign biobank. They were also asked about their consent preferences depending on whether or not future proposed research using their sample would be approved by a Human Research Ethics Committee.
In order to gain a more comprehensive and nuanced understanding of the attitudes and beliefs that motivated participants’ responses to the survey, semi-structured interviews were conducted with 16 participants recruited from the survey. These 16 participants were drawn from a random subset of the CATI survey categorised into four groups according to their age and willingness to donate to an international biobank: Younger supporters (YS), Older supporters (OS), Younger opposers (YO) and Older opposers (OO). Four people were interviewed from each sub-group.
An interview schedule was developed in consultation with expert members of the research team, drawing upon topics covered in the CATI survey—including participants’ willingness to donate to local and international biobanks, attitudes towards the storage and sharing of samples and data, as well as preferences for different kinds of permission or consent. In addition to the four types of consent described in the survey, qualitative interviews introduced the concept of dynamic consent, which uses a technology platform to allow donors to change their consent preferences over time.
Two members of the research team (MW and LD) were responsible for recruiting participants drawn from a random sample of survey respondents across different categories, and conducting the interviews. Interviews took place between May and July 2018, approximately 8 months after the CATI survey, and lasted between 20 and 45 minutes. All interviews took place via telephone, and verbal or written consent was obtained from all participants prior to the interview. All interviews were digitally recorded and transcribed.
Transcripts were entered into NVIVO 11 and were coded by MW and LD. The coding procedure was informed by Morse’s outline of the cognitive basis of qualitative research, (11) and Charmaz’s outline of data analysis in grounded theory (12). This process involved initial line-by-line coding and gerunding to encode process and action. The codes were then synthesised into categories, and subsequently abstracted into concepts. A process of constant comparison was applied throughout the data analysis, with codes, categories and concepts refined and reorganised, as new codes, categories and concepts emerged.
 The script for the definition of biobanks was: “I'd like to begin by giving you a little information about biobanks. Biobanks are collections of biological samples, such as DNA, blood, cancer specimens, etc. that are stored for multiple purposes. In some cases, people are asked to donate their samples for medical research. Biobanks once used to be localised in one place. Today, however, biobanks are going global, which means that tissue collected in one location may be stored and/or used by researchers all over the world.”