A review of the key issues associated with the commercialization of biobanks

Caulfield, Timothy; Burningham, Sarah; Joly, Yann; Master, Zubin; Shabani, Mahsa; Borry, Pascal; Becker, Allan B.; Burgess, Michael; Calder, Kathryn; Critchley, Christine; Edwards, Kelly; Fullerton, Stephanie M.; Gottweis, Herbert; Hyde-Lay, Robyn; Illes, Judy; Isasi, Rosario; Kato, Kazuto; Kaye, Jane; Knoppers, Bartha Maria; Lynch, John; McGuire, Amy L.; Meslin, Eric M.; Nicol, Dianne; O’Doherty, Kieran C.; Ogbogu, Ubaka; Otlowski, Margaret; Pullman, Daryl; Ries, Nola M.; Scott, Chris; Sears, Malcolm R.; Wallace, Helen M.; Zawati, Ma’n H.

doi:10.1093/jlb/lst004

Cited by 100 publications

(91 citation statements)

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“…This study found that other than the original researcher, participants were most comfortable sharing their pooled data and information with other researchers at the same university and non-profit organizations, followed by researchers at other universities in the USA. Also consistent with others (Hoeyer 2012;Steinsbekk et al 2013;Caulfield et al 2014), research participants were least comfortable having their information shared with for-profit, private organizations. Possible reasons for this varying level of comfort with data sharing may be due to a mismatch participants feel between their altruistic motivations and the financial incentives of the private organizations (Trinidad et al 2010), they feel that for-profit companies are not interested in the public good and they question if the for-profit company may use their data in a morally problematic manner (Lemke et al 2010).…”

Section: Discussionsupporting

confidence: 80%

De-identified genomic data sharing: the research participant perspective

et al. 2017

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Combining datasets into larger and separate datasets is becoming increasingly common, and personal identifiers are often removed in order to maintain participant anonymity. Views of research participants on the use of deidentified data in large research datasets are important for future projects, such as the Precision Medicine Initiative and Cancer Moonshot Initiative. This quantitative study set in the USA examines participant preferences and evaluates differences by demographics and cancer history. Study participants were recruited from the Northwest Cancer Genetics Registry and included cancer patients, their relatives, and controls. A secure online survey was administered to 450 participants. While the majority participants were not concerned about personal identification when participating in a genetic study using de-identified data, they expressed their concern that researchers protect their privacy and information. Most participants expressed a desire that their data should be available for as many research studies as possible, and in doing so, they would increase their chance of receiving personal health information. About 20% of participants felt that a link should not be maintained between the participant and their de-identified data. Reasons to maintain a link included an ability to return individual health results and an ability to support further research. Knowledge of participants' attitudes regarding the use of data into a research repository and the maintenance of a link to de-identified data is critical to the success of recruitment into future genomic research projects.

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Section: Discussionsupporting

confidence: 80%

De-identified genomic data sharing: the research participant perspective

et al. 2017

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“…Biobanking research involves multiple players with different interests, including donors, those related to the donor, biobankers (scientists involved in the collection and storage of samples and information), the end users of biobanked material (ie, private or publically funded researchers and others working in institutions including law enforcement or government), and, possibly clinicians who must interpret findings. Despite the worldwide growth of biobanks, there are many unresolved research ethics challenges, including those associated with participant withdrawal, 1 ownership and control of samples and information, 2,3 commercialization, 4 and the return of results and incidental findings. 5 Yet none have received as much ethics discourse and policy debate than informed consent.…”

Section: Introductionmentioning

confidence: 99%

Scientists’ perspectives on consent in the context of biobanking research

2014

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Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking.

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“…39 Kamuya ait biyobankalar, özel şirketler, kar amacı gütmeyen kuruluşlar, ilaç veya tıbbi cihaz şirketleri ile ortaklık kurmakta ya da bu şirketlerden fon kabul etmektedir. 38 Hem önceden toplanmış örneklere erişimde, hem de özel şirketler tarafından klinik araştırma-larda kullanılmak üzere, örneklerin ve bunlarla iliş-kili verilerin prospektif olarak toplanmasında kullanılmaktadır. Karşılıklılık ilkesi gereğince, akademik araştırmacılar da şirket tarafından toplanan ve depolanan örnekleri kullanmalıdır.…”

Section: Toplumsal Ve İnsan Haklarina Dayali Bi̇r Yaklaşimunclassified

“…Dolaylı olarak kazanç elde edilmesinde örneklerden elde edilen sonuçlar veya geliştirilen ürünler satılırken; doğrudan kazanç eldesinde örneklere erişim hakkı ya da örneklerin kendisi satılmaktadır. 37,38 Araştırma sonuçlarının satılarak maddi kazanç elde edilmesi, sadece biyobanka temelli araştırma-larda bir sorun olarak görülmemekte, çeşitli endişe-ler tüm ticari tıbbi araştırmalar için söz konusu olmaktadır. Bununla beraber, biyobankaların dolaylı olarak ticarileştirilmesi çeşitlilik göstermekte-dir.…”

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The Concept of Biobanking in Terms of Ethics: Review

Kurtoğlu¹,

Arda²

2015

Turkiye Klinikleri J Med Ethics

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Ö ÖZ ZE ET T En temel tanımı ile biyobankalar, insan biyolojik örnekleri ile bu örneklerle ilişkili tıbbi, soya ait, çevresel ve yaşam tarzı verilerini içeren yapılandırılmış kaynaklardır. Bu kaynaklar, katı-lımcılara ait DNA, kan ve doku gibi çok çeşitli biyolojik örnekler ile bu örneklerle ilişkili, yaş, cinsiyet, yaşam tarzı gibi kişisel bilgileri içermektedir. İnsan Genom Projesi'nin tamamlanmasıyla birlikte, biyobankalar, hem biyoteknoloji, hem de genomik alanlarında önemli bir konu haline gelmiştir. Var oldukları süre, içerdiği örnek sayısı ve ölçeği, içerisinde depolanan örneklerin türü, depolanan örneklerin kullanım amaçları, verilerin ve örneklerin prospektif ya da retrospektif olarak kullanılması, örnekleri saklama koşulları, devlet kuruluşu ya da kar amaçlı olup olmaması, mali olarak nasıl desteklendiği, kullanılan gizlilik yöntemleri ve faaliyet gösterdikleri siyasi ve hukuki ortam gibi özellikleri göz önüne alındığında, biyobankalar arasında farklı sınıflandırmalar yapmak müm-kündür. Biyomedikal araştırmalar ve ilaç gelişimi için yeni ve önemli bir alt yapı ile kaynak oluş-turması bakımından son yıllarda pek çok ülkenin dikkatini çekmeye başlayan biyobankaların dünya genelindeki faaliyetlerinin artmasıyla birlikte, konu ile ilgili etik ve yasal tartışmalar da gündeme gelmiştir. Bu alandaki temel etik sorunlar, başta aydınlatılmış onam olmak üzere, katılımcıların gizliliğinin ve mahremiyetinin korunması, yarar paylaşımı, ticarileşme ve verilerin üçüncü kişiler tarafından kullanımıdır. Makale kapsamında bu sorunlar; aydınlatılmış onam, gizlilik ve mahremiyetin korunması ile toplumsal ve insan haklarına dayalı bir yaklaşım olmak üzere üç ana başlıkta işlenmiştir.A An na ah h t ta ar r K Ke e l li i m me e l le er r: : Biyolojik örnek bankaları; etik; bilgilendirilmiş onam, aydınlatılmış onam; mahremiyet; gizlilik A AB BS S T TR RA AC CT T In common definition, the biobanks are, structured resources which are about human biological materials and associated data including clinical, genealogical, lifestyle and environmental data. These resources contain biological materials like DNA, blood and tissue that are related to participants, and associated data like age, gender and lifestyle. The biobanks have become an important issue both in biotechnology and genomics when Human Genome Project was completed. It is possible to make various classifications between biobanks consider to the period of time they have been existence, the size of the biobank, the type of samples being collected, the intended usage of materials, whether data and samples are prospective or retrospective, whether they are public organization or private institution, how they are financially supported, the method used for privacy and the political and legal environment where they active etc. The biobanks are a new and important infrastructure as well as an important resource for biomedical research and drug developments. Also, with the increasing of biobanking activities worldwide, ethical and legal debates in this area have brought to the ...

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A review of the key issues associated with the commercialization of biobanks

Cited by 100 publications

References 0 publications

De-identified genomic data sharing: the research participant perspective

De-identified genomic data sharing: the research participant perspective

Scientists’ perspectives on consent in the context of biobanking research

The Concept of Biobanking in Terms of Ethics: Review

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