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1.  Public’s attitudes on participation in a biobank for research: an Italian survey 
BMC Medical Ethics  2014;15(1):81.
The creation of biobanks depends upon people’s willingness to donate their samples for research purposes and to agree to sample storage. Moreover, biobanks are a public good that requires active participation by all interested stakeholders at every stage of development. Therefore, knowing public’s attitudes towards participation in a biobank and biobank management is important and deserves investigation.
A survey was conducted among family members of patients attending the outpatient department of our institute for a geriatric or neurological visit, documenting their willingness to participate in a biobank and their views on the legal-ethical aspects of biobank management. Information regarding subjects’ attitudes on biomedical research in general and genetic research in particular was also collected. Participants’ data on biobanks were compared with data previously collected from the Italian ethics committees (ECs) to evaluate the extent to which lay people and ethics committees share views and concerns regarding biobanks.
One hundred forty-five subjects took part in the survey. The willingness to give biological samples for the constitution of a biobank set up for research purposes was declared by 86% of subjects and was modulated by subjects’ education. People in favour of providing biological samples for a biobank expressed a more positive view on biomedical research than did people who were not in favour; attitude towards genetic research in dementia was the strongest predictor of participation. Different from ECs that prefer specific consent (52%) and do not choose the option of broad consent (8%) for samples collection in a biobank, participants show a clear preference for broad consent (57%), followed by partially restricted consent (16%), specific consent (15%), and multi-layered consent (12%). Almost all of the subjects available to contribute to a biobank desire to receive both individual research results and research results of general value, while around fifty per cent of ECs require results communication.
Family members showed willingness to participate in a biobank for research and expressed a view on the ethical aspects of a biobank management that differ on several issues from the Italian ECs’ opinion. Laypersons’ views should be taken into account in developing biobank regulations.
Electronic supplementary material
The online version of this article (doi:10.1186/1472-6939-15-81) contains supplementary material, which is available to authorized users.
PMCID: PMC4258254  PMID: 25425352
Public attitudes; Biobanks; Genetic research; Bioethics; Ethical policy
2.  A biobank management model applicable to biomedical research 
BMC Medical Ethics  2006;7:4.
The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information.
We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants.
The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking.
Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment.
PMCID: PMC1475589  PMID: 16600040
3.  Who's minding the shop? The role of Canadian research ethics boards in the creation and uses of registries and biobanks 
BMC Medical Ethics  2008;9:17.
The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks.
Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank.
There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied.
Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.
PMCID: PMC2636819  PMID: 19014594
4.  Development and Progress of Ireland's Biobank Network: Ethical, Legal, and Social Implications (ELSI), Standardized Documentation, Sample and Data Release, and International Perspective 
Biobank Ireland Trust (BIT) was established in 2004 to promote and develop an Irish biobank network to benefit patients, researchers, industry, and the economy. The network commenced in 2008 with two hospital biobanks and currently consists of biobanks in the four main cancer hospitals in Ireland. The St. James's Hospital (SJH) Biobank coordinates the network. Procedures, based on ISBER and NCI guidelines, are standardized across the network. Policies and documents—Patient Consent Policy, Patient Information Sheet, Biobank Consent Form, Sample and Data Access Policy (SAP), and Sample Application Form have been agreed upon (after robust discussion) for use in each hospital. An optimum sequence for document preparation and submission for review is outlined. Once consensus is reached among the participating biobanks, the SJH biobank liaises with the Research and Ethics Committees, the Office of the Data Protection Commissioner, The National Cancer Registry (NCR), patient advocate groups, researchers, and other stakeholders. The NCR provides de-identified data from its database for researchers via unique biobank codes. ELSI issues discussed include the introduction of prospective consent across the network and the return of significant research results to patients. Only 4 of 363 patients opted to be re-contacted and re-consented on each occasion that their samples are included in a new project. It was decided, after multidisciplinary discussion, that results will not be returned to patients. The SAP is modeled on those of several international networks. Biobank Ireland is affiliated with international biobanking groups—Marble Arch International Working Group, ISBER, and ESBB. The Irish government continues to deliberate on how to fund and implement biobanking nationally. Meanwhile BIT uses every opportunity to promote awareness of the benefits of biobanking in events and in the media.
PMCID: PMC4076973  PMID: 24845249
5.  Biobank Participation and Returning Research Results: Perspectives from a Deliberative Engagement in South Side Chicago 
To be respectful of the public, biobank guiding principles and operations should be responsive to and inclusive of the values and beliefs of their participants. In an effort to increase knowledge and inform institutional policies, we conducted a deliberative engagement of individuals from two healthcare facilities in South Side Chicago that serve different socioeconomic communities to consider biobank policies regarding return of research results. We recruited primary caregivers of children receiving care at either a Federally Qualified Health Center or a university-based practice to attend two full-day deliberative engagement sessions, which included four educational presentations followed by focus group discussions. Surveys were administered to assess attitudes before and after the engagement, and an evaluation was conducted to assess the deliberative engagement process. All 45 participants self-identified as African American. Focus group themes included: 1) overall interest in biobank participation, broad consent, and recontact; 2) root causes of distrust and potential biobank strategies to facilitate trust; 3) perceived positive and negative aspects of receiving research results; and 4) strong interest in receiving and managing their children’s research results. Survey data indicated the same degree of interest in receiving results about themselves as about their children. Pre- and post-session findings showed mainly non-significant attitudinal changes in level of interest in biobank participation and return of research results, although there was a decrease in level of concern regarding identification from research data. Our findings reveal shared community insights important in facilitating relationships and policy discussions between biobank researchers and research participants.
PMCID: PMC3331902  PMID: 22438108
biobank; deliberative engagement; research results; research participant; ethics; policy; trust; return of results
6.  Biobanking for research: a survey of patient population attitudes and understanding 
Journal of Community Genetics  2013;4(4):445-450.
Population-based biobanks are a critical resource for genetic research. It is important to know what potential participants understand about the risks and benefits of providing samples in order to ensure adequate informed consent. Kaiser Permanente Colorado (KPCO) is currently planning a biobank where adult members would be asked to contribute an additional tube of blood during a routine blood draw. Adult KPCO members in clinic waiting rooms were asked to read an informational brochure and informed consent form. Respondents then completed a survey to evaluate their understanding of the materials, willingness to provide a blood sample to a biobank, and facilitators and barriers to participation. Two hundred three members participated in the survey, of whom 69 % indicated willingness to contribute to a biobank. Nearly all understood that they would not be paid for any products resulting from the use of their blood and would not receive results from their samples (91 and 84 %, respectively). Seventy-four percent would donate a sample because, “it is important to contribute to research,” and over half the participants (56 %) said they had no concerns about contributing to a biobank. Of those with concerns, 35 % said information security was a reason. In multivariate models, older age and trust in KPCO were significant predictors of willingness to participate (p = 0.03 and p < 0.0001, respectively). Data from this survey indicate an overall willingness to participate in a biobank, provide possible barriers to participation, and identify ways to improve informational materials to ensure adequate informed consent.
PMCID: PMC3773315  PMID: 23605056
Biobanks; Genetics; Public attitudes; Participation; Understanding; Consent
7.  The IgA nephropathy Biobank. An important starting point for the genetic dissection of a complex trait 
BMC Nephrology  2005;6:14.
IgA nephropathy (IgAN) or Berger's disease, is the most common glomerulonephritis in the world diagnosed in renal biopsied patients. The involvement of genetic factors in the pathogenesis of the IgAN is evidenced by ethnic and geographic variations in prevalence, familial clustering in isolated populations, familial aggregation and by the identification of a genetic linkage to locus IGAN1 mapped on 6q22–23. This study seems to imply a single major locus, but the hypothesis of multiple interacting loci or genetic heterogeneity cannot be ruled out. The organization of a multi-centre Biobank for the collection of biological samples and clinical data from IgAN patients and relatives is an important starting point for the identification of the disease susceptibility genes.
The IgAN Consortium organized a Biobank, recruiting IgAN patients and relatives following a common protocol. A website was constructed to allow scientific information to be shared between partners and to divulge obtained data (URL: ). The electronic database, the core of the website includes data concerning the subjects enrolled. A search page gives open access to the database and allows groups of patients to be selected according to their clinical characteristics. DNA samples of IgAN patients and relatives belonging to 72 multiplex extended pedigrees were collected. Moreover, 159 trios (sons/daughters affected and healthy parents), 1068 patients with biopsy-proven IgAN and 1040 healthy subjects were included in the IgAN Consortium Biobank. Some valuable and statistically productive genetic studies have been launched within the 5th Framework Programme 1998–2002 of the European project No. QLG1-2000-00464 and preliminary data have been published in "Technology Marketplace" website: .
The first world IgAN Biobank with a readily accessible database has been constituted. The knowledge gained from the study of Mendelian diseases has shown that the genetic dissection of a complex trait is more powerful when combined linkage-based, association-based, and sequence-based approaches are performed. This Biobank continuously expanded contains a sample size of adequately matched IgAN patients and healthy subjects, extended multiplex pedigrees, parent-child trios, thus permitting the combined genetic approaches with collaborative studies.
PMCID: PMC1318455  PMID: 16329758
8.  Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks & Archived Datasets 
Biobanks and archived datasets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to manage incidental findings (IFs) and individual research results (IRRs) of potential health, reproductive, or personal importance to individual contributors (using “biobank” here to refer to both collections of samples and collections of data). This paper reports recommendations from a 2-year, NIH-funded project. The authors analyze responsibilities to manage return of IFs and IRRs in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). They suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When re-identification of individual contributors is possible, the biobank should work to enable the biobank research system to discharge four core responsibilities: to (1) clarify the criteria for evaluating findings and roster of returnable findings, (2) analyze a particular finding in relation to this, (3) re-identify the individual contributor, and (4) recontact the contributor to offer the finding. The authors suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and that are clinically actionable should generally be offered to consenting contributors. The paper specifies 10 concrete recommendations, addressing new biobanks and biobanks already in existence.
PMCID: PMC3597341  PMID: 22436882
incidental findings; return of results; biobanks; research ethics; bioethics; genetics; genomics
9.  Practice variation across consent templates for biobank research. a survey of German biobanks 
Frontiers in Genetics  2013;4:240.
Introduction: Informed, voluntary, and valid consent from biomaterial donors is a precondition for biobank research. Valid consent protects donors’ rights and helps maintain public trust in biobank research. Harmonization of consent procedures in biobank research is needed, because of the widely shared vision on national and international networking of biobanks including data and sample sharing. So far, no study has assessed and compared the content of current consent forms especially for biobank research. The objective of this study was to perform a content analysis of consent forms in German biobanks.
Methods: Based on ten guidelines for biomedical research, we developed an assessment matrix with 41 content issues that are potentially relevant for consent forms in biobank research. This assessment matrix was applied in a thematic text analysis to 30 consent documents of German biobanks identified via the German Biobank Registry in July 2012.
Results: Coverage of the 41 items in the assessed consent forms varied widely. For example, the items “Right to withdraw consent (without disadvantage),” “Policy for genetic information/consent to genetic analyzes” and “International cooperation/transborder use” were addressed in 97, 40, and 23% of all 30 consent forms respectively. The number of items covered by a single consent form ranged from 9 to 36 (22–88% out of 41 items).
Discussion: Our findings serve as a starting point to reflect upon the spectrum of consent issues that must be addressed in biobank research. The findings show that the majority of consent forms for German biobanks, if not all, should be improved and harmonized to better support an informed and balanced choice of potential donors and to facilitate networking of biobanks. Best practice models for consent forms in biobank research should be developed and biobank operators need to be more aware of relevant consent issues.
PMCID: PMC3827716  PMID: 24294219
biobank; tissue bank; broad consent; informed consent; survey; thematic text analysis; research ethics
10.  A Strategic Plan for the Second Phase (2013–2015) of the Korea Biobank Project 
The Korea Biobank Project (KBP) was led by the Ministry of Health and Welfare to establish a network between the National Biobank of Korea and biobanks run by university-affiliated general hospitals (regional biobanks). The Ministry of Health and Welfare started the project to enhance medical and health technology by collecting, managing, and providing researchers with high-quality human bioresources. The National Biobank of Korea, under the leadership of the Ministry of Health and Welfare, collects specimens through various cohorts and regional biobanks within university hospitals gather specimens from patients. The project began in 2008, and the first phase ended in 2012, which meant that there needed to be a plan for the second phase that begins in 2013. Consequently, professionals from within and outside the project were gathered to develop a plan for the second phase. Under the leadership of the planning committee, six working groups were formed to formulate a practical plan. By conducting two workshops with experts in the six working groups and the planning committee and three forums in 2011 and 2012, they have developed a strategic plan for the second phase of the KBP. This document presents a brief report of the second phase of the project based on a discussion with them.
During the first phase of the project (2008–2012), a network was set up between the National Biobank of Korea and 17 biobanks at university-affiliated hospitals in an effort to unify informatics and governance among the participating biobanks. The biobanks within the network manage data on their biospecimens with a unified Biobank Information Management System. Continuous efforts are being made to develop a common standard operating procedure for resource collection, management, distribution, and personal information security, and currently, management of these data is carried out in a somewhat unified manner. In addition, the KBP has trained and educated professionals to work within the biobanks, and has also carried out various publicity promotions to the public and researchers. During the first phase, biospecimens from more than 300,000 participants through various cohorts and biospecimens from more than 200,000 patients from hospitals were collected, which were distributed to approximately 600 research projects.
The planning committee for the second phase evaluated that the first phase of the KBP was successful. However, the first phase of the project was meant to allow autonomy to the individual biobanks. The biobanks were able to choose the kind of specimens they were going to collect and the amount of specimen they would set as a goal, as well as being allowed to choose their own methods to manage their biobanks (autonomy). Therefore, some biobanks collected resources that were easy to collect and the resources needed by researchers were not strategically collected. In addition, there was also a low distribution rate to researchers outside of hospitals, who do not have as much access to specimens and cases as those in hospitals. There were also many cases in which researchers were not aware of the KBP, and the distribution processes were not set up to be convenient to the demands of researchers.
Accordingly, the second phase of the KBP will be focused on increasing the integration and cooperation between the biobanks within the network. The KBP plans to set goals for the strategic collection of the needed human bioresources. Although the main principle of the first phase was to establish infrastructure and resource collection, the key objective of the second phase is the efficient utilization of gathered resources. In order to fully utilize the gathered resources in an efficient way, distribution systems and policies must be improved. Vitalization of distribution, securing of high-value resource and related clinical and laboratory information, international standardization of resource management systems, and establishment of a virtuous cycle between research and development (R&D) and biobanks are the four main strategies. Based on these strategies, 12 related objectives have been set and are planned to be executed.
PMCID: PMC3767092  PMID: 24159540
biobank; biobank network; biospecimen; Korea Biobank Project; National Biobank of Korea
11.  Characterizing biobank organizations in the U.S.: results from a national survey 
Genome Medicine  2013;5(1):3.
Effective translational biomedical research hinges on the operation of 'biobanks,' repositories that assemble, store, and manage collections of human specimens and related data. Some are established intentionally to address particular research needs; many, however, have arisen opportunistically, in a variety of settings and with a variety of expectations regarding their functions and longevity. Despite their rising prominence, little is known about how biobanks are organized and function beyond simple classification systems (government, academia, industry).
In 2012, we conducted the first national survey of biobanks in the U.S., collecting information on their origins, specimen collections, organizational structures, and market contexts and sustainability. From a list of 636 biobanks assembled through a multi-faceted search strategy, representatives from 456 U.S. biobanks were successfully recruited for a 30-minute online survey (72% response rate). Both closed and open-ended responses were analyzed using descriptive statistics.
While nearly two-thirds of biobanks were established within the last decade, 17% have been in existence for over 20 years. Fifty-three percent listed research on a particular disease as the most important reason for establishment; 29% listed research generally. Other reasons included response to a grant or gift, and intent to centralize, integrate, or harmonize existing research structures. Biobank collections are extraordinarily diverse in number and types of specimens and in sources (often multiple) from which they are obtained, including from individuals, clinics or hospitals, public health programs, and research studies. Forty-four percent of biobanks store pediatric specimens, and 36% include postmortem specimens. Most biobanks are affiliated in one or multiple ways with other entities: 88% are part of at least one or more larger organizations (67% of these are academic, 23% hospitals, 13% research institutes). The majority of biobanks seem to fill a particular 'niche' within a larger organization or research area; a minority are concerned about competition for services, although many are worried about underutilization of specimens and long-term funding.
Effective utilization of biobank collections and effective policies to govern their use will require understanding of the immense diversity found in organizational features, including the very different history and primary goals that many biobanks have.
PMCID: PMC3706795  PMID: 23351549
Biobank; biorepository; governance; survey
12.  Reasons for participating and genetic information needs among racially and ethnically diverse biobank participants: a focus group study 
Journal of community genetics  2011;2(3):153-163.
In order for DNA biobanks to be a valuable reservoir of genetic information, large numbers of participants from all racial and ethnic backgrounds need to be recruited. This study explored reasons for participating in a new biobank among primarily Hispanic and African American individuals, as well as their general attitudes towards genetic research, and their views on obtaining genetic tests. Focus groups were conducted with Mount Sinai Biobank participants recruited from predominantly lower income, minority communities. The topic guide included questions on The Mount Sinai Biobank, genetic research, and genetic testing. All focus groups were audio recorded, transcribed, and analyzed using thematic analysis. The six focus groups comprised 43 participants: 39 females and four males, aged 27–76 years, with a median household income category of $20,000–$39,999. Twenty-one participants were Hispanic, 20 African American, one Asian, and one White. Participants’ reasons for participating in the biobank included altruism, personal and family benefit, and general curiosity. Although there was evidence of conflation between genetic research and genetic testing, most participants held positive views of genetic research and expressed interest in receiving personal genetic test results. Participants wanted to learn more about genetic research and suggested various venues such as health fairs for disseminating information. Participation in biobanks by racial and ethnic minorities is apparently driven by altruism, and desire for personal or collective health benefits. Participants had generally positive attitudes, limited understanding of genetics and genetic research, and made useful suggestions regarding information dissemination mechanisms.
PMCID: PMC3186034  PMID: 22109822
African American; DNA biobank; Focus groups; Hispanics; Motives
13.  A Data Standard for Sourcing Fit-for-Purpose Biological Samples in an Integrated Virtual Network of Biobanks 
Biopreservation and Biobanking  2014;12(3):184-191.
Human tissue biobanks are at the epicenter of clinical research, responsible for providing both clinical samples and annotated data. There is a need for large numbers of samples to provide statistical power to research studies, especially since treatment and diagnosis are becoming ever more personalized. A single biobank cannot provide sufficient numbers of samples to capture the full spectrum of any disease. Currently there is no infrastructure in the United Kingdom (UK) to integrate biobanks. Therefore the National Cancer Research Institute (NCRI) Confederation of Cancer Biobanks (CCB) Working Group 3 looked to establish a data standard to enable biobanks to communicate about the samples they hold and so facilitate the formation of an integrated national network of biobanks. The Working Group examined the existing data standards available to biobanks, such as the MIABIS standard, and compared these to the aims of the working group. The CCB-developed data standard has brought many improvements: (1) Where existing data standards have been developed, these have been incorporated, ensuring compatibility with other initiatives; (2) the standard was written with the expectation that it will be extended for specific disease areas, such as the Breast Cancer Campaign Tissue Bank (BCCTB) and the Strategic Tissue Repository Alliances Through Unified Methods (STRATUM) project; and (3) biobanks will be able to communicate about specific samples, as well as aggregated statistics.
The development of this data standard will allow all biobanks to integrate and share information about the samples they hold, facilitating the possibility of a national portal for researchers to find suitable samples for research. In addition, the data standard will allow other clinical services, such as disease registries, to communicate with biobanks in a standardized format allowing for greater cross-discipline data sharing.
PMCID: PMC4066222  PMID: 24785371
14.  Potential Bias in the Bank: What Distinguishes Refusers, Non-responders and Participants in a Clinic-based Biobank? 
Public health genomics  2013;16(3):10.1159/000349924.
Biobanks are an important resource for genetic and epidemiologic research, but bias may be introduced if those who accept the recruitment invitation differ systematically from those who do not in attributes important to health-related investigations. To understand potential bias in a clinic-based biobank of biological samples, including genetic data linked to Electronic Medical Record information, we compared patient characteristics and self-reported information among participants, non-responders, and refusers. We also compared reasons for non-participation between refusers and non-responders to elucidate potential pathways to reduce non-participation and any uncovered bias.
We mailed recruitment packets to 1600 adult patients with upcoming appointments at Mayo Clinic (Rochester, MN) and recorded their participation status. Administrative data were used to compare characteristics across groups. We used phone interviews with 26 non-responders and 26 refusers to collect self-reported information, including reasons for non-participation. Participants were asked to complete a mailed questionnaire.
We achieved 26.2% participation (n=419) with 12.1% refusing (n=193) and 61.8% non-response (n=988). In multivariate analyses, sex, age, region of residence, and race/ethnicity were significantly associated with participation. The groups differed in information-seeking behaviors and research experience. Refusers more often cited privacy concerns while non-responders more often identified time constraints as the reason for non-participation.
For genomic medicine to advance, large, representative biobanks are required. Significant associations between patient characteristics and nonresponse, as well as systematic differences between refusers and nonresponders, could introduce bias. Oversampling or recruitment changes, including heightened attention to privacy protection and participation burden, may be necessary to increase participation among less-represented groups.
PMCID: PMC3821039  PMID: 23595106
biobank; non-response; research participation; informed consent
15.  Research understanding, attitude and awareness towards biobanking: a survey among Italian twin participants to a genetic epidemiological study 
BMC Medical Ethics  2009;10:4.
The Italian Twin Registry (ITR) has been carrying out several genetic-epidemiological studies. Collection and storage of biological material from study participants has recently increased in the light of biobanking development. Within this scenario, we aimed at investigating understanding, awareness and attitude towards blood/DNA donation of research participants. About these quite unknown dimensions more knowledge is needed from ethical and social perspectives.
Cross-sectional mail survey to explore three dimensions: (i) understanding of aims and method of a specific study, (ii) attitude (three ideas for donation: "moral duty", "pragmatism", "spontaneity") and (iii) awareness (i.e. the recall of having been asked to donate) towards blood/DNA donation for research, among all the Italian twins who had participated in Euroclot (n = 181), a large international genetic-epidemiological study. Multivariate models were applied to investigate the association of sex, age, education and modality of Euroclot recruitment (twins enrolled in the ITR and volunteers) with the targeted dimensions. Pair-wise twin concordance for the "pragmatic" attitude was estimated in monozygotic and dizygotic pairs.
Response rate was 56% (99 subjects); 75.8% understood the Euroclot method, only 33.3% correctly answered about the study aim. A significantly better understanding of aim and method was detected in "volunteers". Graduated subjects were more likely to understand study aim. In the overall sample, the "pragmatic" attitude to blood donation reached 76.8%, and biobanking awareness 89.9%. The latter was significantly higher among women. Monozygotic twins were more concordant than dizygotic twins for the "pragmatic" attitude towards blood/DNA donation for research.
Level of understanding of aims and methods of a specific research project seems to vary in relation to modalities of approaching research; most of the twins are well aware of having been asked to donate blood for biobanking activities, and seem to be motivated by a "pragmatic" attitude to blood/DNA donation. Genetic influences on this attitude were suggested. The framing of interests and concerns of healthy participants to genetic-epidemiological studies should be further pursued, since research, particularly for "common diseases", is increasingly relying on population surveys and biobanking.
PMCID: PMC2703640  PMID: 19531243
16.  Developing a semantically rich ontology for the biobank-administration domain 
Biobanks are a critical resource for translational science. Recently, semantic web technologies such as ontologies have been found useful in retrieving research data from biobanks. However, recent research has also shown that there is a lack of data about the administrative aspects of biobanks. These data would be helpful to answer research-relevant questions such as what is the scope of specimens collected in a biobank, what is the curation status of the specimens, and what is the contact information for curators of biobanks. Our use cases include giving researchers the ability to retrieve key administrative data (e.g. contact information, contact's affiliation, etc.) about the biobanks where specific specimens of interest are stored. Thus, our goal is to provide an ontology that represents the administrative entities in biobanking and their relations. We base our ontology development on a set of 53 data attributes called MIABIS, which were in part the result of semantic integration efforts of the European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI). The previous work on MIABIS provided the domain analysis for our ontology. We report on a test of our ontology against competency questions that we derived from the initial BBMRI use cases. Future work includes additional ontology development to answer additional competency questions from these use cases.
We created an open-source ontology of biobank administration called Ontologized MIABIS (OMIABIS) coded in OWL 2.0 and developed according to the principles of the OBO Foundry. It re-uses pre-existing ontologies when possible in cooperation with developers of other ontologies in related domains, such as the Ontology of Biomedical Investigation. OMIABIS provides a formalized representation of biobanks and their administration. Using the ontology and a set of Description Logic queries derived from the competency questions that we identified, we were able to retrieve test data with perfect accuracy. In addition, we began development of a mapping from the ontology to pre-existing biobank data structures commonly used in the U.S.
In conclusion, we created OMIABIS, an ontology of biobank administration. We found that basing its development on pre-existing resources to meet the BBMRI use cases resulted in a biobanking ontology that is re-useable in environments other than BBMRI. Our ontology retrieved all true positives and no false positives when queried according to the competency questions we derived from the BBMRI use cases. Mapping OMIABIS to a data structure used for biospecimen collections in a medical center in Little Rock, AR showed adequate coverage of our ontology.
PMCID: PMC4021870  PMID: 24103726
17.  Telethon Network of Genetic Biobanks: a key service for diagnosis and research on rare diseases 
Several examples have always illustrated how access to large numbers of biospecimens and associated data plays a pivotal role in the identification of disease genes and the development of pharmaceuticals. Hence, allowing researchers to access to significant numbers of quality samples and data, genetic biobanks are a powerful tool in basic, translational and clinical research into rare diseases. Recently demand for well-annotated and properly-preserved specimens is growing at a high rate, and is expected to grow for years to come. The best effective solution to this issue is to enhance the potentialities of well-managed biobanks by building a network.
Here we report a 5-year experience of the Telethon Network of Genetic Biobanks (TNGB), a non-profit association of Italian repositories created in 2008 to form a virtually unique catalogue of biospecimens and associated data, which presently lists more than 750 rare genetic defects. The process of TNGB harmonisation has been mainly achieved through the adoption of a unique, centrally coordinated, IT infrastructure, which has enabled (i) standardisation of all the TNGB procedures and activities; (ii) creation of an updated TNGB online catalogue, based on minimal data set and controlled terminologies; (iii) sample access policy managed via a shared request control panel at web portal. TNGB has been engaged in disseminating information on its services into both scientific/biomedical - national and international - contexts, as well as associations of patients and families. Indeed, during the last 5-years national and international scientists extensively used the TNGB with different purposes resulting in more than 250 scientific publications. In addition, since its inception the TNGB is an associated member of the Biobanking and Biomolecular Resources Research Infrastructure and recently joined the EuroBioBank network. Moreover, the involvement of patients and families, leading to the formalization of various agreements between TNGB and Patients’ Associations, has demonstrated how promoting Biobank services can be instrumental in gaining a critical mass of samples essential for research, as well as, raising awareness, trust and interest of the general public in Biobanks. This article focuses on some fundamental aspects of networking and demonstrates how the translational research benefits from a sustained infrastructure.
PMCID: PMC3766640  PMID: 24004821
Biobanking; Networking; Biological resources centre; IT infrastructure; Biological material; Biospecimens; Cryopreservation; Rare diseases; Patients’ associations
18.  Establishing a Southern Swedish Malignant Melanoma OMICS and biobank clinical capability 
The objectives and goals of the Southern Swedish Malignant Melanoma (SSMM) are to develop, build and utilize cutting edge biobanks and OMICS platforms to better understand disease pathology and drug mechanisms. The SSMM research team is a truly cross-functional group with members from oncology, surgery, bioinformatics, proteomics, and genomics initiatives. Within the research team there are members who daily diagnose patients with suspect melanomas, do follow-ups on malignant melanoma patients and remove primary or metastatic lesions by surgery. This inter-disciplinary clinical patient care ensures a competence build as well as a best practice procedure where the patient benefits.
Clinical materials from patients before, during and after treatments with clinical end points are being collected. Tissue samples as well as bio-fluid samples such as blood fractions, plasma, serum and whole blood will be archived in 384-high density sample tube formats. Standardized approaches for patient selections, patient sampling, sample-processing and analysis platforms with dedicated protein assays and genomics platforms that will hold value for the research community are used. The patient biobank archives are fully automated with novel ultralow temperature biobank storage units and used as clinical resources.
An IT-infrastructure using a laboratory information management system (LIMS) has been established, that is the key interface for the research teams in order to share and explore data generated within the project. The cross-site data repository in Lund forms the basis for sample processing, together with biological samples in southern Sweden, including blood fractions and tumor tissues. Clinical registries are associated with the biobank materials, including pathology reports on disease diagnosis on the malignant melanoma (MM) patients.
We provide data on the developments of protein profiling and targeted protein assays on isolated melanoma tumors, as well as reference blood standards that is used by the team members in the respective laboratories. These pilot data show biobank access and feasibility of performing quantitative proteomics in MM biobank repositories collected in southern Sweden. The scientific outcomes further strengthen the build of healthcare benefit in the complex challenges of malignant melanoma pathophysiology that is addressed by the novel personalized medicines entering the market.
PMCID: PMC3599425  PMID: 23445834
Malignant melanoma; Protein sequencing; Proteomics; Genes; Antibodies; mRNA; Mass spectrometry; Bioinformatics
19.  Biobanking: The Melding of Research with Clinical Care 
Current genetic medicine reports  2013;1(2):122-128.
The number of biobanks around the world has increased dramatically, owing in part, to the need for researchers to have access to large numbers of samples for genomic research. Policies for enrolling participants, returning research results and obtaining samples and data can have a far reaching impact on the type of research that can be performed with each biobank. Research using biobank samples includes studies of the impact of environmental and other risk exposures on health, understanding genetic risks for common disease, identification of biomarkers in disease progression and prognosis, and implementation of personalized medicine projects. This research has been instrumental in the progress of genetic and genomic research and translational medicine. This article will highlight some of the controversies and recent research associated with biobanking over the past year.
PMCID: PMC3804314  PMID: 24159428
Biobank; Biobanking; Translational Medicine; Genetic; Genetic Research; Research Results; Genomics
20.  Qualitative study of knowledge and attitudes to biobanking among lay persons in Nigeria 
BMC Medical Ethics  2012;13:27.
Interest in biobanking for collection of specimens for non-communicable diseases research has grown in recent times. This paper explores the perspectives of Nigerians on donation of specimen for the biobanking research.
We conducted 16 Focus Group Discussions (FGD) with individuals from different ethnic, age and socio-economic groups in Kano (North), Enugu (Southeast), Oyo States (Southwest) and Abuja, the Federal Capital Territory (Central) of Nigeria. We used topic guides and prompt statements to explore the knowledge and understanding of interviewees to general issues about biobanking of biospecimens, their use and specifically about role of biobanking in non-communicable diseases research.
A total of 123 individuals participated in 16 focus group discussions in 2011. Our participants had limited knowledge of the concept of biobanking but accepted it once they were educated about it and saw it as a worthwhile venture. Half of our study participants supported use of broad consent, a quarter supported restricted consent while the remaining quarter were in favour of tiered consent. Most discussants support shipment of their samples to other countries for further research, but they prefer those collaborations to be done only with competent, ethical researchers and they would like to receive feedback about such projects. The majority preferred health care as a benefit from participation, particularly for any unexpected condition that may be discovered during the course of the research instead of financial compensation. Participants emphasized the need to ensure that donated samples were not used for research that contradicts their religious beliefs.
Our study demonstrates that our participants accepted biobanking once they understand it but there were different attitudes to elements of biobanking such as type of consent. Our study highlights the need to carefully document population attitudes to elements of modern scientific research and the consenting process.
PMCID: PMC3507723  PMID: 23072321
Biobanking; Non-communicable diseases; Public perspectives; Nigeria
21.  Developing a policy for paediatric biobanks: principles for good practice 
The participation of minors in biobank research can offer great benefits for science and health care. However, as minors are a vulnerable population they are also in need of adequate protective measures when they are enrolled in research. Research using biobanked biological samples from children poses additional ethical issues to those raised by research using adult biobanks. For example, small children have only limited capacity, if any, to understand the meaning and implications of the research and to give a documented agreement to it. Older minors are gradually acquiring this capacity. We describe principles for good practice related to the inclusion of minors in biobank research, focusing on issues related to benefits and subsidiarity, consent, proportionality and return of results. Some of these issues are currently heavily debated, and we conclude by providing principles for good practice for policy makers of biobanks, researchers and anyone involved in dealing with stored tissue samples from children. Actual implementation of the principles will vary according to different jurisdictions.
PMCID: PMC3533257  PMID: 22713814
22.  Biobanks for Genomics and Genomics for Biobanks 
Biobanks include biological samples and attached databases. Human biobanks occur in research, technological development and medical activities. Population genomics is highly dependent on the availability of large biobanks. Ethical issues must be considered: protecting the rights of those people whose samples or data are in biobanks (information, autonomy, confidentiality, protection of private life), assuring the non-commercial use of human body elements and the optimal use of samples and data. They balance other issues, such as protecting the rights of researchers and companies, allowing long-term use of biobanks while detailed information on future uses is not available. At the level of populations, the traditional form of informed consent is challenged. Other dimensions relate to the rights of a group as such, in addition to individual rights. Conditions of return of results and/or benefit to a population need to be defined. With ‘large-scale biobanking’ a marked trend in genomics, new societal dimensions appear, regarding communication, debate, regulation, societal control and valorization of such large biobanks. Exploring how genomics can help health sector biobanks to become more rationally constituted and exploited is an interesting perspective. For example, evaluating how genomic approaches can help in optimizing haematopoietic stem cell donor registries using new markers and high-throughput techniques to increase immunogenetic variability in such registries is a challenge currently being addressed. Ethical issues in such contexts are important, as not only individual decisions or projects are concerned, but also national policies in the international arena and organization of democratic debate about science, medicine and society.
PMCID: PMC2447308  PMID: 18629026
23.  Current Status, Challenges, Policies, and Bioethics of Biobanks 
Genomics & Informatics  2013;11(4):211-217.
Many biobanks were established as biorepositories for biomedical research, and a number of biobanks were founded in the 1990s. The main aim of the biobank is to store and to maintain biomaterials for studying chronic disease, identifying risk factors of specific diseases, and applying personalized drug therapies. This report provides a review of biobanks, including Korean biobanks and an analysis of sample volumes, regulations, policies, and ethical issues of the biobank. Until now, the top 6 countries according to the number of large-scale biobanks are the United Kingdom, United States, Sweden, France, the Netherlands, and Italy, and there is one major National Biobank of Korea (NBK) and 17 regional biobanks in Korea. Many countries have regulations and guidelines for the biobanks, and the importance of good management of biobanks is increasing. Meanwhile, according to a first survey of 456 biobank managers in the United States, biobankers are concerned with the underuse of the samples in their repositories, which need to be advertised for researchers. Korea Biobank Network (KBN) project phase II (2013-2015) was also planned for the promotion to use biospecimens in the KBN. The KBN is continuously introducing for researchers to use biospecimens in the biobank. An accreditation process can also be introduced for biobanks to harmonize collections and encourage use of biospecimens in the biobanks. KBN is preparing an on-line application system for the distribution of biospecimens and a biobank accreditation program and is trying to harmonize the biobanks.
PMCID: PMC3897848  PMID: 24465232
biobank; bioethics; biospecimens; safety
24.  Characteristics of Australian cohort study participants who do and do not take up an additional invitation to join a long-term biobank: The 45 and Up Study 
BMC Research Notes  2012;5:655.
Large-scale population biobanks are critical for future research integrating epidemiology, genetic, biomarker and other factors. Little is known about the factors influencing participation in biobanks. This study compares the characteristics of biobank participants with those of non-participants, among members of an existing cohort study.
Individuals aged 45 and over participating in The 45 and Up Study and living ≤20km from central Wagga Wagga, New South Wales (NSW), Australia (rural/regional area) or ≤10km from central Parramatta, NSW (urban area) (n=2340) were invited to join a biobank, giving a blood sample and having additional measures taken, including height, weight, waist circumference, heart rate and blood pressure.
The overall uptake of the invitation to participate was 33% (762/2340). The response rate was 41% (410/1002) among participants resident in the regional area, and 26% (352/1338) among those resident in the urban area. Characteristics associated with significantly decreased participation were being aged 80 and over versus being aged 45–64 (participation rate ratio: RR = 0.45, 95%CI 0.34-0.60), not being born in Australia versus being born in Australia (0.69, 0.59-0.81), having versus not having a major disability (0.54, 0.38-0.76), having full-time caregiving responsibilities versus not being a full-time carer (0.62, 0.42-0.93) and being a current smoker versus never having smoked (0.66, 0.50-0.89). Factors associated with increased participation were being in part-time work versus not being in paid work (1.24, 1.07-1.44) and having an annual household income of ≥$50,000 versus <$20,000 (1.50, 1.26-1.80).
A range of socio-economic, health and lifestyle factors are associated with biobank participation among members of an existing cohort study, with factors relating to health-seeking behaviours and access difficulties or time limitations being particularly important. If more widespread participation in biobanking is desired, particularly to ensure sufficient numbers among those most affected by these issues, specific efforts may be required to increase participation in certain groups such as migrants, the elderly, and those in poor health. Whilst caution should be exercised when generalising estimates of absolute prevalence from biobanks, estimates for many internal comparisons are likely to remain valid.
PMCID: PMC3536556  PMID: 23181586
25.  Newspaper coverage of biobanks 
PeerJ  2014;2:e500.
Background. Biobanks are an important research resource that provides researchers with biological samples, tools and data, but have also been associated with a range of ethical, legal and policy issues and concerns. Although there have been studies examining the views of different stakeholders, such as donors, researchers and the general public, the media portrayal of biobanks has been absent from this body of research. This study therefore examines how biobanking has been represented in major print newspapers from Australia, Canada, the United Kingdom and the United States to identify the issues and concerns surrounding biobanks that have featured most prominently in the print media discourse.
Methods. Using Factiva, articles published in major broadsheet newspapers in Canada, the US, the UK, and Australia were identified using specified search terms. The final sample size consisted of 163 articles.
Results. Majority of articles mentioned or discussed the benefits of biobanking, with medical research being the most prevalent benefit mentioned. Fewer articles discussed risks associated with biobanking. Researchers were the group of people most quoted in the articles, followed by biobank employees. Biobanking was portrayed as mostly neutral or positive, with few articles portraying biobanking in a negative manner.
Conclusion. Reporting on biobanks in the print media heavily favours discussions of related benefits over risks. Members of the scientific research community appear to be a primary source of this positive tone. Under-reporting of risks and a downtrend in reporting on legal and regulatory issues suggests that the print media views such matters as less newsworthy than perceived benefits of biobanking.
PMCID: PMC4121587  PMID: 25101229
Biobanks; Media representations; Public perceptions; ELSI; Consent; Privacy; Evidence-based policy

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