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.
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.
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.
incidental findings; return of results; biobanks; research ethics; bioethics; genetics; genomics
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.
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.
Biobanks; Genetics; Public attitudes; Participation; Understanding; Consent
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.
African American; DNA biobank; Focus groups; Hispanics; Motives
The ethical-legal framework of research biobanking activities is still scarcely defined in Italy, and this constitutes a major obstacle to exploit the potential benefits of existing bioresource patrimony at the national and international levels.
Biobanking and Biomolecular Resources Research Infrastructure (BBMRI), which aims to become a major interface between biological samples and data and top-level biological and medical research, is undertaking the crucial transformation to the ERIC (European Research Infrastructure Consortium) legal entity. In this scenario, there is a need to address the national legal and ethical concerns that are strictly correlated with the use of human biosources in research across European countries participating (and not) in BBMRI. In this perspective, this article aims to review the legal framework applying to research biobanking in Italy, including both “soft” nonbinding instruments and binding regulations. Since ethical and societal aspects impact biobanking research activities, the article discusses both the critical ethical and legal open issues that need to be implemented at the national level.
Advances in genomic technologies and the promise of “personalised medicine” have spurred the interest of researchers, healthcare systems, and the general public. However, the success of population-based genetic studies depends on the willingness of large numbers of individuals and diverse communities to grant researchers access to detailed medical and genetic information. Certain features of this kind of research – such as the establishment of biobanks and prospective data collection from participants’ electronic medical records – make the potential risks and benefits to participants difficult to specify in advance. Therefore, community input into biobank processes is essential. In this report, we describe community engagement efforts undertaken by six United States biobanks, various outcomes from these engagements, and lessons learned. Our aim is to provide useful insights and potential strategies for the various disciplines that work with communities involved in biobank-based genomic research.
Pediatric biobanks are an indispensible resource for the research that will be needed to bring advances in personalized medicine into pediatric medical care. Investigators developing pediatric biobanks have struggled with the ethical and legal challenges that arise in pediatric research. This article explores how one biobank model, the ‘human nonsubjects models’, is able to respond to such common challenges as the role of the parent and the child in agreeing to research participation, reconsent at the age of majority, data sharing and return of research results. Although this approach does not involve formal informed consent, it is well-suited to pediatric biobanking owing to its potential to reduce risk to children through a combination of advanced deidentification techniques and extensive oversight.
biobanking; data sharing; genomic research; pediatric research; research regulation; responsible conduct of research; return of research results
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.
Population biobanks offer new opportunities for public health, are rudimentary for the development of its new branch called Public Health Genomics, and are important for translational research. This article presents organizational models of population biobanks in selected European countries. Review of bibliography and websites of European population biobanks (UK, Spain, Estonia). Some countries establish national genomic biobanks (DNA banks) in order to conduct research on new methods of prevention, diagnosis and treatment of the genetic and lifestyle diseases and on pharmacogenetic research. Individual countries have developed different organizational models of these institutions and specific legal regulations regarding various ways of obtaining genetic data from the inhabitants, donors’ rights, organizational and legal aspects. Population biobanks in European countries were funded in different manners. In light of these solutions, the authors discuss prospects of establishing a Polish national genomic biobank for research purpose. They propose the creation of such an institution based on the existing network of blood-donation centres and clinical biobanks in Poland.
DNA banking; Genetic epidemiology; Population biobanks; Public health genomics; Life Sciences; Human Genetics; Plant Genetics & Genomics; Animal Genetics and Genomics; Microbial Genetics and Genomics; Life Sciences, general
During the past decade, various guidelines that imply a duty for researchers to disclose information obtained through research to participants have emerged. The character and extent of this obligation have been debated extensively, with much attention devoted to the decisiveness of the validity and utility of the results in question. The aim of this paper is to argue that individual results from research on materials stored in large-scale biobanks, consisting of samples taken within the healthcare system or of altruistically donated materials, should not be returned. We will defend the thesis that medical research on these biobanks should be viewed as a collective project to improve public health, and that available resources should be utilized to pursue this goal. We argue that there is a need for a change of perspectives. Medical research should not primarily be viewed as a danger that individuals must be protected from, but rather be recognized as constituting a necessary defense against current and future diseases. Research that bears the prospect of advancing medicine and that can be carried out at no risk to individuals should be endorsed and facilitated. This calls for a shift of focus from autonomy and individual rights toward collective responsibility and solidarity.
biobanks; returning results; solidarity; public health; altruism
Progress in the debate over returning incidental findings (IFs) and individual research results (IRRs) to research participants who provide specimens and data to biobanks in genetic and genomic research requires a new tool to allow comparison across heterogeneous biobank research systems and in-depth analysis of the sources and types of findings generated for potential return. This paper presents a new visual mapping tool to allow systematic and standardized depiction of (1) the specimens initially collected, (2) the materials and datasets then created (3) the analyses then performed, and finally (4) the genetic and genomic results generated, including potential IFs and IRRs. For any individual biobank research system, this sequence of four maps can be created to anticipate the sources and types of IFs and IRRs to be generated, to plan how to handle them, and then to manage them responsibly over time. The authors show how this 4-map tool was created, then apply this tool to 4 national biobank systems, demonstrating that this tool can provide a common platform to visualize biobank content, anticipate how IFs and IRRs will arise in a biobank research context, and inform policy development.
incidental findings; return of results; genetics; genomics; biobank; biorepository; human subjects research; bioethics; research ethics
There is limited information about what African Americans think about biobanks and the ethical questions surrounding them. Likewise, there is a gap in capacity to successfully enroll African Americans as biobank donors. The purposes of this community-based participatory study were to: (a) explore African Americans’ perspectives on genetics/genomic research, (b) understand facilitators and barriers to participation in such studies, and (c) enlist their ideas about how to attract and sustain engagement of African Americans in genetics initiatives. As the first phase in a mixed methods study, we conducted four focus groups with 21 African American community leaders in one US Midwest city. The sample consisted of executive directors of community organizations and prominent community activists. Data were analyzed thematically. Skepticism about biomedical research and lack of trust characterized discussions about biomedical research and biobanks. The Tuskegee Untreated Syphilis Study and the Henrietta Lacks case influenced their desire to protect their community from harm and exploitation. Connections between genetics and family history made genetics/genomics research personal, pitting intrusion into private affairs against solutions. Participants also expressed concerns about ethical issues involved in genomics research, calling attention to how research had previously been conducted in their community. Participants hoped personalized medicine might bring health benefits to their people and proposed African American communities have a “seat at the table.” They called for basic respect, authentic collaboration, bidirectional education, transparency and prerogative, and meaningful benefits and remuneration. Key to building trust and overcoming African Americans’ trepidation and resistance to participation in biobanks are early and persistent engagement with the community, partnerships with community stakeholders to map research priorities, ethical conduct of research, and a guarantee of equitable distribution of benefits from genomics discoveries.
African American leaders; Community engagement in research; Genetics; Genomics; Biobanks; Health disparities; Research ethics
Eighty Dutch investigators (response 41%) involved in biobank research responded to a web-based survey addressing communication of results of biobank research to individual participants. Questions addressed their opinion towards an obligation to communicate results and related issues such as ownership of blood samples, privacy, therapeutic relationship, costs and implications for participants. Most researchers (74%) indicated that participants only have to be informed when results have implications for treatment or prevention. Researchers were generally not inclined to provide more feedback to patients as compared with healthy participants, nor were they inclined to provide feedback in return for participants' contribution to the biobank. Our results demonstrate major and significant differences in opinion about the feedback of individual results within the community of biobank researchers.
biobanks; genetic databases; disclosing results; researchers' opinions
The development of genomics has dramatically expanded the scope of genetic research, and collections of genetic biosamples have proliferated in countries with active genomics research programs. In this essay, we consider a particular kind of collection, national biobanks. National biobanks are often presented by advocates as an economic “resource” that will be used by both basic researchers and academic biologists, as well as by pharmaceutical diagnostic and clinical genomics companies. Although national biobanks have been the subject of intense interest in recent social science literature, most prior work on this topic focuses either on bioethical issues related to biobanks, such as the question of informed consent, or on the possibilities for scientific citizenship that they make possible. We emphasize, by contrast, the economic aspect of biobanks, focusing specifically on the way in which national biobanks create biovalue. Our emphasis on the economic aspect of biobanks allows us to recognize the importance of what we call clinical labor—that is, the regularized, embodied work that members of the national population are expected to perform in their role as biobank participants—in the creation of biovalue through biobanks. Moreover, it allows us to understand how the technical way in which national biobanks link clinical labor to databases alters both medical and popular understandings of risk for common diseases and conditions.
biobank; clinical labor; database; risk; biovalue
The authors define a DNA biobank as a repository of genetic information correlated with patient medical records. DNA biobanks may assist in the research and identification of genetic factors influencing disease and drug interactions, but may raise ethical issues. How healthcare providers perceive DNA biobanks is unknown.
To determine how useful healthcare professionals believe DNA biobanks will be and whether these attitudes differ between private and socialized healthcare systems.
The authors surveyed 200 healthcare professionals, including research and non-research focused doctors, nurses and other staff from medical centers and independent practice in both the United States and Scotland. The survey included fifteen items evaluated for general receptiveness toward biobanks, presumed usefulness of biobanks and perceived attitudes in recruiting patients for a biobank.
A total of 81 (45%) of 179 eligible participants responded: 41 from the U.S. and 40 from Scotland. Of these respondents, most (70%) were from academic centers.
Results indicate that there is a broadly favorable attitude in both locations toward the creation of a DNA biobank (83%) and its perceived benefit (75%). This enthusiasm is tempered in Scotland when respondents evaluated their comfort in consenting patients for entry into a biobank; 16 of 40 respondents (40%) were uncomfortable doing so, representing a significant difference from those in the U.S. (p=0.001).
Despite systematic differences in healthcare practice between the U.S. and Scotland, health care professionals in both nations believe DNA biobanks will be useful in curing disease. This finding appears to support further development of such a research tool.
Biobanks are essential tools in diagnostics and therapeutics research and development related to personalized medicine. Several
international recommendations, standards and guidelines exist that discuss the legal, ethical, technological, and management
requirements of biobanks. Today's biobanks are much more than just collections of biospecimens. They also store a huge amount of
data related to biological samples which can be either clinical data or data coming from biochemical experiments. A well-designed
biobank software system also provides the possibility of finding associations between stored elements. Modern research biobanks
are able to manage multicenter sample collections while fulfilling all requirements of data protection and security. While
developing several biobanks and analyzing the data stored in them, our research group recognized the need for a well-organized,
easy-to-check requirements guideline that can be used to develop biobank software systems. International best practices along with
relevant ICT standards were integrated into a comprehensive guideline: The Model Requirements for the Management of Biological
Repositories (BioReq), which covers the full range of activities related to biobank development. The guideline is freely available on
the Internet for the research community.
The database is available for free at http://bioreq.astridbio.com/bioreq_v2.0.pdf
Biobank Software System; guideline; model requirement; personalized medicine
In the endeavour of biobank research there is dispute concerning what type of consent and which form of donor–biobank relationship meet high ethical standards. Up until now, a ‘broad consent' model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top–down governance. Recently, an approach termed ‘dynamic consent' has been proposed to meet such challenges. Dynamic consent uses modern communication strategies to inform, involve, offer choices and last but not the least obtain consent for every research projects based on biobank resources. At first glance dynamic consent seems appealing, and we have identified six claims of superiority of this model; claims pertaining to autonomy, information, increased engagement, control, social robustness and reciprocity. However, after closer examination, there seems to be several weaknesses with a dynamic consent approach; among others the risk of inviting people into the therapeutic misconception as well as individualizing the ethical review of research projects. When comparing the two models, broad consent still holds and can be deemed a good ethical solution for longitudinal biobank research. Nevertheless, there is potential for improvement in the broad model, and criticism can be met by adapting some of the modern communication strategies proposed in the dynamic consent approach.
broad consent; dynamic consent; biobank; research participation; ethics
The aim of the overview is to give a perspective of global biobank development is given in a view of positioning biobanking as a key resource for healthcare to identify new potential markers that can be used in patient diagnosis and complement the targeted personalized drug treatment. The fast progression of biobanks around the world is becoming an important resource for society where the patient benefit is in the focus, with a high degree of personal integrity and ethical standard. Biobanks are providing patient benefits by large scale screening studies, generating large database repositories. It is envisioned by all participating stakeholders that the biobank initiatives will become the future gateway to discover new frontiers within life science and patient care. There is a great importance of biobank establishment globally, as biobanks has been identified as a key area for development in order to speed up the discovery and development of new drugs and protein biomarker diagnostics. One of the major objectives in Europe is to establish concerted actions, where biobank networks are being developed in order to combine and have the opportunity to share and build new science and understanding from complex disease biology. These networks are currently building bridges to facilitate the establishments of best practice and standardizations.
Although issues involved in offering individual results to participants in genomic research have received considerable attention, communication of aggregate results has been the subject of relatively little ethical analysis. Offering participants aggregate results is typically assumed to be a good thing, and studies have found that a significant majority of biobank research participants, when asked about their interest in aggregate results, say that access to such information would be important. Even so, return of aggregate results remains a relatively uncommon practice.
In this paper, we explore the opportunities involved in communicating aggregate results to participants in genomic research, including affirming the value of research participation, informing participants about research being conducted based on broad consent for future unspecified research, educating participants and the public about the research process, and building trust in the research enterprise. We also explore some of the challenges, including the complex intersection between individual and aggregate results, as well as practical hurdles. We conclude by offering our preliminary recommendations concerning the provision of aggregate results and an agenda for much-needed future research.
Research results; aggregate results; research participants; trust; education; informed consent
The tissue biobanking of specific biological residual materials, which constitutes a useful resource for medical/scientific research, has raised some ethical issues, such as the need to define which kind of consent is applicable for biological residual materials biobanks.
Biobank research cannot be conducted without considering arguments for obtaining the donors’ consent: in this paper we discuss to what extent consent in biobank research on oncological residual materials has to be required, and what type of consent would be appropriate in this context, considering the ethical principles of donation, solidarity, protection of the donors’ rights and the requirements of scientific progress. Regarding the relationship between informed consent and tissue collection, storage and research, we have focused on two possible choices related to the treatment of data and samples in the biobank: irreversible and reversible anonymization of the samples, distinguishing between biobank research on residual materials for which obtaining consent is necessary and justified, and biobank research for which it is not. The procedures involve different approaches and possible solutions that we will seek to define. The consent for clinical research reported in the Helsinki Declaration regards research involving human beings and for this reason it is subordinate to specific and detailed information on the research projects.
An important ethical aspect in regard to the role of Biobanks is encouraging sample donation. For donors, seeing human samples being kept rather than discarded, and seeing them become useful for research highlights the importance of the human body and improves the attitude towards donation. This process might also facilitate the giving of informed consent more willingly, and with greater trust.
Biobanks; Consent; Oncological residual material; Cancer biobanks; Residual materials biobanks; Informed consent; Ethics; Research; Solidarity
An increasing portion of biomedical research relies on the use of biobanks and databases. Sharing of such resources is essential for optimizing knowledge production. A major obstacle for sharing bioresources is the lack of recognition for the efforts involved in establishing, maintaining and sharing them, due to, in particular, the absence of adequate tools. Increasing demands on biobanks and databases to improve access should be complemented with efforts of end-users to recognize and acknowledge these resources. An appropriate set of tools must be developed and implemented to measure this impact.
To address this issue we propose to measure the use in research of such bioresources as a value of their impact, leading to create an indicator: Bioresource Research Impact Factor (BRIF). Key elements to be assessed are: defining obstacles to sharing samples and data, choosing adequate identifier for bioresources, identifying and weighing parameters to be considered in the metrics, analyzing the role of journal guidelines and policies for resource citing and referencing, assessing policies for resource access and sharing and their influence on bioresource use. This work allows us to propose a framework and foundations for the operational development of BRIF that still requires input from stakeholders within the biomedical community.
Data sharing; Bioresource; Biobank; Identifier; Metrics; Traceability; Impact factor; Biology; Science policy; Open data
The dynamic development of biobanks causes some ethical, social, and legal problems. The most discussed problems are obtaining informed consent, especially for future research, from minors and from deceased people. The aim of this article is to present the current standards held by Polish biobanks concerning obtaining a participant's informed consent in some aspects.
Material and methods
Survey was carried out by anonymous questionnaire among 59 institutions which deal with the collecting and storage of human cells and tissues in the year 2008. Twenty four filled-in copies of the questionnaires were sent back (return=41%).
Almost every institution (92%) obtains written consent, but a third of the surveyed institutions (29%) do not obtain consent for the future use of the samples. The majority of the respondents (83%) support the idea of using biological materials for research purposes of a donor who died if he did not leave any written objection to such practices and 46% of respondents stated that biobanks should obtain the consent from the already mature donor who gave their samples as a child.
The practice and rules for obtaining informed consent for the scientific research require improvement. The possibility to use the human materials in the future, conditions for getting access to the data, the possibility of their withdrawal from the database and using the materials and data after the death of the donor should be clearly determined when the informed consent to collect the material is obtained.
biobanks; research ethics; informed consent; genetic collection; management
Increasing the size of prospective cohorts and biobanks is one approach to discovering previously unknown contributors to complex diseases, but it may come at the price of concealing contributors that are less common across all the participants in those larger studies and of limiting hypothesis generation. Prospective cohorts and biobanks constitute significant, long-term investments in research infrastructure that will have ongoing consequences for opportunities in biomedical research for the foreseeable future. Thus, it is important to think about how these major additions to research infrastructure can be designed to be more productive in generating hypotheses for novel environmental contributors to complex diseases and to help identify genetic and environmental contributors that may not be common across the larger samples but are more frequent within local or ancestral subsets. Incorporating open-ended inquiries and qualitative information about local communal and ecologic contexts and the political, economic, and other social structures that affect health status and outcome will enable qualitative hypothesis generation in those localized contexts, as well as the collection of more detailed genealogic and family health history information that may be useful in designing future studies. Using communities as building blocks for larger cohorts and biobanks presents some practical and ethical challenges but also enhances opportunities for interdisciplinary, multilevel investigations of the multifactorial contributors to complex diseases.
biobanks; communities; complex disease; gene–environment interaction; prospective cohorts; qualitative methods; research design