A comparative review of human milk banking and national tissue banking programs.

This paper explores the legislative and operational commonalities and differences in Medical Products of Human Origin (MPHO) programs, including blood, hematopoietic cells, tissues and reproductive cells and human milk banking. The analysis includes ethical principles in donation and utilization, policies and legislation, public awareness and education, registries, guidelines in donor selection, safety and quality assurance, operational models and funding, infrastructure and human resources and biovigilance and evaluation of outcomes. Unlike other MPHO, the need for donor human milk (DHM) may be greatly reduced, that is, by ensuring optimal support for maternal lactation and breastfeeding. This should not be lost in the drive for wider and improved service provision. Nevertheless, increased overall demand for DHM is expected as a result of forthcoming international recommendations and also its increased use as the first-choice supplement to a mother's own milk both within and beyond preterm, low-birthweight and sick infant populations. Insight into current human milk banking highlights differences and gaps in practices that can benefit from further exploration and harmonization. Strong similarities with the ethical and operational principles underpinning donation and processing of the diverse MPHO suggest that legislating human milk banks within similar MPHO frameworks may bring additional safety and facilitate improved product quality. Moreover, that MPHO-inspired models operating within attainable regulatory requirements may contribute to sustainable human milk banking activity and growth.

Legal and ethical framework for global health information and biospecimen exchange - an international perspective.

BACKGROUND: The progress of electronic health technologies and biobanks holds enormous promise for efficient research. Evidence shows that studies based on sharing and secondary use of data/samples have the potential to significantly advance medical knowledge. However, sharing of such resources for international collaboration is hampered by the lack of clarity about ethical and legal requirements for transfer of data and samples across international borders. MAIN TEXT: Here, the International Clinical Trial Center Network (ICN) reports the legal and ethical requirements governing data and sample exchange (DSE) across four continents. The most recurring requirement is ethical approval, whereas only in specific conditions approval of national health authorities is required. Informed consent is not required in all sharing situations. However, waiver of informed consent is only allowed in certain countries/regions and under certain circumstances. The current legal and ethical landscape appears to be very complex and under constant evolution. Regulations differ between countries/regions and are often incomplete, leading to uncertainty. CONCLUSION: With this work, ICN illuminates the unmet need for a single international collaborative framework to facilitate DSE. Harmonising requirements for global DSE will reduce inefficiency and waste in research. There are many challenges to realising this ambitious vision, including inconsistent terminology and definitions, and heterogeneous and dynamic legal constraints. Here, we identify areas of agreement and significant difference as a necessary first step towards facilitating international collaboration. We propose the establishment of a working group to continue the comparison across jurisdictions, create a standardised glossary and define a set of basic principles and fundamental requirements for DSE.

Human bone and amniotic membrane banking in Bangladesh for grafting: the impact of the international atomic energy agency (IAEA) programme.

The idea of establishing a human tissue bank in Bangladesh was started in 1985. However, in 2003, with the active cooperation of international atomic energy agency (IAEA) and Bangladesh Atomic Energy Commission, a tissue bank laboratory was upgraded as a unit for tissue banking and research. Due to increasing demand of allograft, this unit was transformed as an independent institute "Institute of Tissue Banking and Biomaterial Research (ITBBR)" in 2016. This is the only human tissue bank in Bangladesh, which processes human bone and amniotic membrane to provide safe and cost-effective allografts for transplantation. Importantly, banking of human cranial bone as autograft has also started at ITBBR. These processed grafts are sterilized using gamma radiation according to the IAEA Code of Practice for the radiation sterilization of tissues allografts. The amount of grafts produced by the ITBBR from 2007 to 2018 were 120,800 cc of bone chips, 45,420 cm2 of amniotic membranes, 277 vials of de-mineralized bone granules (DMB), 95 pieces of massive bones, and 134 pieces of cranial bones. Overall, 112,748 cc of bone chips, 40,339 cm2 of amniotic membranes, 174 vials of DMB, 44 pieces of massive bones, and 64 pieces of cranial bones were transplanted successfully. Nevertheless, to cope up with the modern advanced concepts of cell and tissue banking for therapeutic purpose, ITBBR is working to set up facilities for skin banking, stem cells banking including amniotic and cord blood derived stem cells and scaffold designing. To ensure the quality, safety, ethical and regulatory issues are sustainable in cell and tissue banking practices, ITBBR always works with the Government of Bangladesh for enhancing the national tissue transplantation programme within the contemporary facilities.

Stakeholders views on the ethical aspects of oocyte banking for third-party assisted reproduction: a qualitative interview study with donors, recipients and professionals.

STUDY QUESTION: What are the moral considerations held by donors, recipients and professionals towards the ethical aspects of the intake and distribution of donor bank oocytes for third-party assisted reproduction? SUMMARY ANSWER: Interviews with oocyte donors, oocyte recipients and professionals demonstrate a protective attitude towards the welfare of the donor and the future child. WHAT IS KNOWN ALREADY: The scarcity of donor oocytes challenges the approach towards the many ethical aspects that arise in establishing and operating an oocyte bank for third-party assisted reproduction. Including experiences and moral considerations originating from practice provides useful insight on how to overcome these challenges. STUDY DESIGN, SIZE, DURATION: The project was set-up as a qualitative interview study and took place between October 2016 and August 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS: We conducted 25 semi-structured interviews with professionals engaged in the practice of oocyte banking (n = 10), recipients of donor oocytes (n = 7) and oocyte donors (n = 8). Key themes were formulated by means of a thematic analysis. MAIN RESULTS AND THE ROLE OF CHANCE: Based on the interviews, we formulated four main themes describing stakeholders' views regarding the ethical aspects of the intake and distribution of donor bank oocytes. First, respondents articulated that when selecting donors and recipients, healthcare workers should prevent donors from making a wrong decision and safeguard the future child's well-being by minimizing health risks and selecting recipients based on their parental capabilities. Second, they proposed to provide a reasonable compensation and to increase societal awareness on the scarcity of donor oocytes to diminish barriers for donors. Third, respondents considered the prioritization of recipients in case of scarcity a difficult choice, because they are all dependent on donor oocytes to fulfil their wish for a child. They emphasized that treatment attempts should be limited, but at least include one embryo transfer. Fourth and finally, the importance of good governance of oocyte banks was mentioned, including a homogenous policy and the facilitation of exchange of experiences between oocyte banks. LIMITATIONS, REASONS FOR CAUTION: The possibility of selection bias exists, because we interviewed donors and recipients who were selected according to the criteria currently employed in the clinics. WIDER IMPLICATIONS OF THE FINDINGS: Respondents' moral considerations regarding the ethical aspects of the intake and distribution of donor oocytes demonstrate a protective attitude towards the welfare of the donor and the future child. At the same time, respondents also questioned whether such a (highly) protective attitude was justified. This finding may indicate there is room for reconsidering strategies for the collection and distribution of donor bank oocytes. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by ZonMw: The Dutch Organization for Health Research and Development (Grant number 70-73000-98-200). A.M.E.B. and B.C.J.M.F. are the initiators of the UMC Utrecht oocyte bank. J.J.P.M.P. is the director of the MCK Fertility Centre. IMC is working as a gynaecologist at the AMC Amsterdam oocyte bank. During the most recent 5-year period, BCJM Fauser has received fees or grant support from the following organizations (in alphabetic order): Actavis/Watson/Uteron, Controversies in Obstetrics & Gynaecologist (COGI), Dutch Heart Foundation, Dutch Medical Research Counsel (ZonMW), Euroscreen/Ogeda, Ferring, London Womens Clinic (LWC), Merck Serono (GFI), Myovant, Netherland Genomic Initiative (NGI), OvaScience, Pantharei Bioscience, PregLem/Gedeon Richter/Finox, Reproductive Biomedicine Online (RBMO), Roche, Teva and World Health Organization (WHO). The authors have no further competing interests to declare. TRIAL REGISTRATION NUMBER: N/A.

Genetic databases and the future of donor anonymity.

Anonymity is a multifaceted term. Anonymity is rarely eternal or absolute. The use of genetic databases increases the risk of identification of previously anonymous donors. Searches through genetic databases jeopardize the privacy of people who did and did not register on them. Three types of searches can be distinguished in the context of gamete donation: offspring looking for their donor, offspring looking for donor siblings and donors looking for their donor offspring. All three types of searches violate the rights of recipients and donors. It is argued that despite the existence of genetic databases, anonymity maintains the same function as it had before: it expresses a wish for distance and privacy by both donors and recipients and, even if not enforceable, should be respected by all parties in good faith.

Consent requirements for research with human tissue: Swiss ethics committee members disagree.

BACKGROUND: In Switzerland, research with identifiable human tissue samples, and/or its accompanying data, must be approved by a research ethics committee (REC) before it can be allowed to take place. However, as the demand for such tissue has rapidly increased in recent years, and biobanks have been created to meet these needs, committees have had to deal with a growing number of such demands. Detailed instructions for evaluating every kind of tissue request are scarce. Committees charged with evaluating research protocols therefore sometimes face uncertainty in their decision-making. METHODS: We examine how a pool of Swiss REC members deal with a number of cases involving human tissue, in order to determine the standards they adhere to, and their understanding and implementation of existing laws and guidelines. RESULTS: There is considerable divergence in the approaches and decisions of Swiss REC members regarding human tissue sample requests, particularly concerning the issue of informed consent. Despite recent trends towards less strict consent requirements for biosample research, many of our respondents continue to employ demanding standards for researchers. The question of informed consent, and the circumstances in which it is required, continues to result in differences of opinion. CONCLUSIONS: While room for local and cultural interpretation is essential to the workings of an REC, misunderstanding of existing guidelines, or an absence of regulation in sensitive areas, will only lead to suboptimal functioning of the REC itself. Our data suggests that there is uncertainty and disagreement on the question of consent for human tissue sample, which existing laws and guidelines may not fully clarify. Methods to address these uncertainties should be implemented in order to ensure efficient and harmonious review of research protocols.

Evidence of broad-based family support for the use of archival childhood tumour samples in future research.

OBJECTIVES: This study aimed to determine the ability to successfully contact past paediatric patients and their families to request participation in research, to assess familial views on the use of previously collected archival clinical samples for research purposes, and to highlight the ethical and practical issues in obtaining this type of retrospective consent. METHODS: To assess familial views on the use of such samples for research, we contacted a cohort of families with children previously diagnosed with a brain tumour to ask for consent to an epigenetic/genetic study. Examining participants' responses allowed us to gauge their opinions on the use of such tissue for research, and whether they would like to receive genetic information uncovered during research. RESULTS: We were able to successfully contact 107 out of 178 families and found a significant positive correlation between year of diagnosis and ability to make contact. Of those families contactable that returned a consent form (75/107), 74 agreed to the use of their/their child's archival tissue in future research, and 70 of 74 requested notification should a gene change of potential clinical relevance be found. There were no differences in opinion between parents of living or deceased children or the patients themselves. CONCLUSIONS: This study highlights the importance of time since diagnosis on the ability to make contact with previous patients and their families. When contactable, our data highlight the altruistic views of families towards the use of archival clinical samples for research purposes, irrespective of the outcome of their child's illness.

Managing Human Tissue Transfer Across National Boundaries - An Approach from an Institution in South Africa.

With biobank research on the increase and the history of exploitation in Africa, it has become necessary to manage the transfer of human tissues across national boundaries. There are many accepted templates of Material Transfer Agreements (MTAs) that currently exist internationally. However, these templates do not address the specific concerns of South Africa and even of Africa as a continent. This article will examine three significantly important ethico-legal concepts that were deliberated and carefully adapted by a South African Institution to suit the transfer of Human Biological Materials (HBMs) and associated data for biobank research, namely: informed consent; benefit sharing arrangements; and ownership together with intellectual property rights in human tissues. The discussion includes an analysis of current practice; the ethico-legal challenges in the South African/African context; the decisions made with regard to how the related ethico-legal challenges were addressed in the MTA; and justifications for implementing these decisions. The processes considered could be of benefit to other developing world countries who consider it necessary to manage the transfer of HBMs across national boundaries.

Sampling populations of humans across the world: ELSI issues.

There are an increasing number of population studies collecting data and samples to illuminate gene-environment contributions to disease risk and health. The rising affordability of innovative technologies capable of generating large amounts of data helps achieve statistical power and has paved the way for new international research collaborations. Most data and sample collections can be grouped into longitudinal, disease-specific, or residual tissue biobanks, with accompanying ethical, legal, and social issues (ELSI). Issues pertaining to consent, confidentiality, and oversight cannot be examined using a one-size-fits-all approach-the particularities of each biobank must be taken into account. It remains to be seen whether current governance approaches will be adequate to handle the impact of next-generation sequencing technologies on communication with participants in population biobanking studies.

The tension between data sharing and the protection of privacy in genomics research.

Next-generation sequencing and global data sharing challenge many of the governance mechanisms currently in place to protect the privacy of research participants. These challenges will make it more difficult to guarantee anonymity for participants, provide information to satisfy the requirements of informed consent, and ensure complete withdrawal from research when requested. To move forward, we need to improve the current governance systems for research so that they are responsive to individual privacy concerns but can also be effective at a global level. We need to develop a system of e-governance that can complement existing governance systems but that places greater reliance on the use of technology to ensure compliance with ethical and legal requirements. These new governance structures must be able to address the concerns of research participants while at the same time ensuring effective data sharing that promotes public trust in genomics research.

Inclusion of residual tissue in biobanks: opt-in or opt-out?

Residual samples are an important source of tissue for biobanks. They refer to leftover tissue that is obtained in the course of clinical care. Residual samples can be included through an opt-in method--that is, a person explicitly expresses consent to include residual tissue--or an opt-out method--that is, the tissue is stored unless a person explicitly refuses. At the moment there is a renewed interest in the appropriate method for the inclusion of residual samples in biobanks. The expansion of biobanks and rapid developments in biomedical research underscore the need to evaluate the proper procedure. In this article we revisit the arguments in favor and against opt-in and opt-out methods for residual tissue research. We conclude firstly that an opt-out method is only justifiable when certain conditions are met: (1) awareness has to be raised, (2) sufficient information has to be provided, and (3) a genuine possibility to object has to be offered. An opt-out procedure that fulfills these conditions can be called a "thick" opt-out method. As a consequence, the dichotomy between opt-in and opt-out is less stark than usually suggested, as both methods require a certain amount of effort. Secondly, we conclude that because of the diversity of tissue and research, not every situation can be treated alike. There are at least four situations that require opt-in procedures: (1) research with higher risks or increased burdens, (2) the use of controversial or high-impact techniques, (3) research on sensitive tissue types, and (4) research involving vulnerable patients. We suggest that further interdisciplinary debate should answer the question when to opt-in or when to opt-out.

Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi.

BACKGROUND: This paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi. DISCUSSION: The current research ethics regulations and guidelines in Malawi do not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes. In conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi.

Report of the clinical donor case workshop of the European Association of Tissue Banks Annual Congress 2013.

The European Association of Tissue Banks (EATB) Donor Case Workshop is a forum held within the program of the EATB Annual Congress. The workshop offers an opportunity to discuss and evaluate approaches taken to challenging donor selection and donation ethics, and it strengthens networking between tissue banking professionals. The workshops actively engage participants from a wide array of international expertise, in an informal, secure and enjoyable setting in which learning from peers and finding potential solutions for submitted cases are facilitated. This report reflects some of the discussion at the Donor Case Workshop during the EATB Annual Congress in Brussels in 2013. The presented cases demonstrate that the findings, their interpretation, the resulting actions and preventive measures in the different tissue facilities are not always predictable. The varied responses from participants and lack of consensus corroborate this and clearly indicate that operating procedures do not comprehensively cover or prepare for all eventualities. For many of the issues raised there is no relevant information in the published literature. By publication of a summary of the discussions we hope to reach a wider audience, to provide information gathered at the workshop and to stimulate individuals and institutions to undertake further literature reviews or to undertake research in order to gather evidence concerning the discussed topics.

Informed consent for human genetic and genomic studies: a systematic review.

As genetic and genomic studies grow in scale, there are ethical concerns related to the collection and use of genetic information. The emergence of large public databases potentially redefine the terms of participation in genetic and genomic research, and suggests the changing application of traditional ethical principles such as privacy or consent. For this study, we wanted to see whether such developments are reflected in the informed consent processes in human genetic and genomic studies. Therefore, we performed a systematic review of the empirical studies that examined informed consent involving large genetic databases in human genetic and genomic studies, grouped the identified issues related to the different stakeholders (including subjects, researchers, and institutional review boards) and discussed the limitations and implications of these findings. Major themes related to the place of bioethical considerations, procured tissues, people involved, process of informed consent and study procedures. Frequently raised issues included confidentiality of participants, documentation of informed consent, public attitudes, future use of participant samples or data, and disclosure of results. Awareness and attention to these bioethical issues as well as assiduousness in managing these concerns in genetic/genomic research would further strengthen and safeguard the rights, safety and well-being of genetic research participants.

"It's my blood": ethical complexities in the use, storage and export of biological samples: perspectives from South African research participants.

BACKGROUND: The use of biological samples in research raises a number of ethical issues in relation to consent, storage, export, benefit sharing and re-use of samples. Participant perspectives have been explored in North America and Europe, with only a few studies reported in Africa. The amount of research being conducted in Africa is growing exponentially with volumes of biological samples being exported from the African continent. In order to investigate the perspectives of African research participants, we conducted a study at research sites in the Western Cape and Gauteng, South Africa. METHODS: Data were collected using a semi-structured questionnaire that captured both quantitative and qualitative information at 6 research sites in South Africa. Interviews were conducted in English and Afrikaans. Data were analysed both quantitatively and qualitatively. RESULTS: Our study indicates that while the majority of participants were supportive of providing samples for research, serious concerns were voiced about future use, benefit sharing and export of samples. While researchers view the provision of biosamples as a donation, participants believe that they still have ownership rights and are therefore in favour of benefit sharing. Almost half of the participants expressed a desire to be re-contacted for consent for future use of their samples. Interesting opinions were expressed with respect to export of samples. CONCLUSIONS: Eliciting participant perspectives is an important part of community engagement in research involving biological sample collection, export, storage and future use. A tiered consent process appears to be more acceptable to participants in this study. Eliciting opinions of researchers and research ethics committee (REC) members would contribute multiple perspectives. Further research is required to interrogate the concept of ownership and the consent process in research involving biological samples.

Alternatives of informed consent for storage and use of human biological material for research purposes: Brazilian regulation.

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms - Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 - state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher.

Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.

UNLABELLED: Human Biological Materials (HBMs) are an invaluable resource in biomedical research. OBJECTIVE: To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. STUDY DESIGN: Ethically approved retrospective cross-sectional descriptive audit. RESULTS: Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively. CONCLUSIONS: Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research.

Use of human surplus biospecimens in research: a survey from a cancer centre.

Little is known about the public's views on the use of human biospecimens for research in the Eastern Mediterranean Region. A study at a cancer centre in Amman, Jordan, assessed patients' perceptions about the use of blood and tissue samples obtained during clinical care and the use of these in research. A self-administered questionnaire was distributed to a sample of 205 adult cancer patients. Almost all patients (98.0%) accepted the use of their surplus blood samples and archived tissue in research if they consented, with about one-third requesting a specific opt-in consent. Most patients (82.9%) also agreed to donate a blood sample for research purposes only, 84.9% were interested to know the results of that research, but with a specific opt-in consent, and 81.0% accepted sending their samples to research laboratories abroad, even without specific consent. Patients' views on the potential use of the surplus biospecimens in research were largely concordant with the international literature.

An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank.

BACKGROUND: Efforts to improve patients' understanding of their own medical treatments or research in which they are involved are progressing, especially with regard to informed consent procedures. We aimed to design a multisource informed consent procedure that is easily adaptable to both clinical and research applications, and to evaluate its effectiveness in terms of understanding and awareness, even in less educated patients. METHODS: We designed a multisource informed consent procedure for patients' enrolment in a Cancer Institute Biobank (CRO-Biobank). From October 2009 to July 2011, a total of 550 cancer patients admitted to the Centro di Riferimento Oncologico IRCCS Aviano, who agreed to contribute to its biobank, were consecutively enrolled. Participants were asked to answer a self-administered questionnaire aim at exploring their understanding of biobanks and their needs for information on this topic, before and after study participation. Chi-square tests were performed on the questionnaire answers, according to gender or education. RESULTS: Of the 430 patients who returned the questionnaire, only 36.5% knew what a biobank was before participating in the study. Patients with less formal education were less informed by some sources (the Internet, newspapers, magazines, and our Institute). The final assessment test, taken after the multisource informed consent procedure, showed more than 95% correct answers. The information received was judged to be very or fairly understandable in almost all cases. More than 95% of patients were aware of participating in a biobank project, and gave helping cancer research (67.5%), moral obligation, and supporting cancer care as main reasons for their involvement. CONCLUSIONS: Our multisource informed consent information system allowed a high rate of understanding and awareness of study participation, even among less-educated participants, and could be an effective and easy-to-apply model for others to consider to contribute to a well-informed decision making process in several fields, from clinical practice to research.Further studies are needed to explore the effects on the study comprehension by each source of information, and by other sources suggested by participants in the questionnaire.

Respecting donors to biobank research.

The most common way for people to consent to research with their banked biological material is through signing a blanket consent, which allows any future use, giving the donor no information or control. This does not respect the donor or the philosophy if donation.