Uk biobank ethics and governance pdf

In developing the eigf, the authors have drawn on the uk biobank ethics and governance framework and are grateful to jonathan sellors of uk biobank for permission to do so. Egf for uk biobank which lays out explicitly the organisations commitments to participants, the public. As a result, a permanent ethics and governance council egc was formed in 2004. Remit to act as an independent guardian of the uk biobank ethics and governance framework egf and advise on its revision. Members of the scientific steering committee are listed below. Set against the two decades of experience of setup, management and most recently granting access to biobanks to promote advances in human health, it is argued that the boundariesand so the legitimacyof the. Appendix 3 ukcrc tissue directory and coordination centre. Nov 25, 2008 it has been suggested that special governance frameworks should be created to promote public trust caulfield et al, 2003. Role of the uk biobank ethics and governance council. Nov 14, 2009 in their comment sept 12, p 861,1 david jones and calum mckellar misunderstand the role of the uk biobank ethics and governance council egc. The council also advises more generally on the interests of research participants and the general public in relation to the project. Does the audit regimen in place for the biobank include scrutiny of compliance with the ethical approvals that govern its.

Professor peter brocklehurst professor simon burgess professor carol dezateux professor peter elias. The ethics advisory committee replaces the uk biobank ethics and governance council egc which was established by the uk biobank funders, the wellcome trust and the medical research council, when uk biobank began the recruitment of its 500,000 participants in 2006. Shaping the ethics and governance of uk biobank and genetic research practices back to research heather widdows research on genetic ethics and governance, especially biobanking, began in 2000 it includes a monograph, a coedited collection and journal special issue, and over ten single and coauthored journal articles and book chapters. Role of the uk biobank ethics and governance council by graeme laurie download pdf 181 kb.

Uk biobank ethics and governance framework version. The wide consultation, rigorous ethics and governance framework, and ethics and governance council oversight role have been essential in paving the way for uk biobank to accomplish obtaining the multiple ethical and regulatory approvals required for participant recruitment, sample and data storage, linkages to routine health care data. Request pdf on nov 1, 2009, graeme laurie and others published role of the uk biobank ethics and governance council find, read and cite all the research you need on researchgate. Ethical governance uk biobank ethics and governance framework 2 of 2 confirms uk biobanks role as steward of the resource andl l fth d t b dth l ll tid legal owner of the database and the sample collection. The governance structure of biobanks may also change. This article reexamines and fundamentally reassesses the symbiotic relationship between law and ethics in the governance and regulation of biobanks as a global phenomenon. For this, and other, reasons it is important that its ethics and governance framework should be gold standard. Uk biobank is likely to be subject to understandably high levels of public scrutiny. The egc is an independent body set up to advise and monitor uk biobank. Biobanks governance model reveals both strengths and. This was set up by the principal funders of uk biobank the medical research council and the wellcome trust to act as an independent. Committee, so i just wanted to tell you a little bit about the changes that have been in ethics governance at uk biobank.

Ethics governance of biobank ryuichi ida member, council on bioethics, japan medical association distinguished visiting professor, doshisha university, japan expert conference on the revision of the declaration of helsinki world medical association 2802 1020, imperial hotel tokyo. On the value of policy led approaches and the need to recognise the limits of law. The expiry problem of broad consent for biobank research. Physical activity, sedentary behaviour and colorectal.

Are the access policy, procedures and decisionmaking process outlined in the biobanks research ethics protocol. Joint response from the academy of medical sciences, medical research council and wellcome trust on regulations to implement the human fertilisation and embryology act 2008. Uk biobank ethics and governance council terms of reference the uk biobank ethics and governance council egc is an independent committee established by the medical research council and the wellcome trust. She will be joined by dr eric meslin, who takes on the role of vice chair. Biobanks comprise organized collections of human biological samples, usually. Jun 01, 2016 the uk biobank has a comprehensive access policy, governed by principles enshrined in the biobank s selfregulatory ethics and governance framework and monitored by the specifically created uk biobank ethics and governance council.

Physical activity, sedentary behaviour and colorectal cancer. Uk biobank ethics and governance framework version 3. The egc does not decide on uses of uk biobank, as suggested by jones and mckellar, but rather recommends action as the project develops. Uk biobanks board of directors, which is accountable to the members of the company. Jan 06, 2009 it has been suggested that special governance frameworks should be created to promote public trust caulfield et al, 2003. This document sets out policies and guidelines for the uk10k project that specifically relate to the ethical and regulatory issues with regard to participant involvement.

Baroness helene hayman has been appointed as chair of the uk biobank ethics and governance council. In conclusion the council was established in direct response to the broad model of consent adopted by uk biobank and to the long term nature of the resource recognising that there will be both foreseen and unforeseen challenges. The aim of uk biobank is to elucidate the complex interplay of genetic and environmental factors involved in the aetiology of common diseases, which could lead to new diagnostics and therapies. We sought to describe community recommendations for biorepository. Dec 04, 2015 new appointments at the uk biobank ethics and governance council. From being tasked with acting as an independent guardian of the uk biobank ethics and governance. Uk biobank has approval from the north west multicentre research ethics committee mrec, which covers the uk. Engaging with the pressing issues of privacy, consent, access to data, and benefit sharing, principles and practice in biobank governance draws together the latest empirical research from the uk, europe, america, australia and asia to focus on these challenges. Principles and practice in biobank governance 1st edition. Cambonthomsen et al, 2007 and the uk biobank established accordingly a separate ethics and governance council with this end in mind. Governance arrangements also extend to the use of contracts material transfer agreements to articulate the conditions that apply to the use of samples and data by collaborator researchers and third parties chalmers et al. Partnership in uk biobank university of california, berkeley.

Its purposes are to act as an independent guardian of the uk biobank ethics and governance framework egf and advise on its revision. The uk biobank ethics and governance council egc is an independent committee established by the wellcome trust and the medical research council. Biobank uk is currently consulting on its ethics and governance framework on. Medical research council and wellcome trust, will act as charity. New appointments at the uk biobank ethics and governance. The ethics and governance framework and the council itself. Uk biobank ethics and governance framework internet. The uk biobank funders the department of health, medical research council and the. Recognising the potential for reputation risk to uk biobank and being mindful not to overburden participants, we are of a view that uk biobank should carefully vet requests of this kind and require a very high standard of the researcher. No major political or parliamentary debate about the development of a national biobank in the uk has taken place. David jones and calum mckellar misunderstand the role of the uk biobank ethics and governance council egc. Sep 22, 2011 the author was previously a member of uk biobank interim ethics and governance advisory group and is a member of the home officeimperial college airwave project ethical advisory group.

Cambonthomsen et al, 2007 and the uk biobank established accordingly a. Role of the uk biobank ethics and governance council core. From ethics and governance council to ethics advisory. Ukbiobankethicsandgovernancecounciluk biobank ethics and. Dec 20, 2019 the study used data and genetic information from a number of sources, including uk biobank. Shaping the ethics and governance of uk biobank and genetic. Aug 26, 2014 find out more about the uk biobank ethics and governance council egc in this interview between andrew trehearne uk biobank and professor roger brownsword of the egc, which took place at the. Wellcome trust would like to thank the individuals and organisations. United statesbased biorepositories are on the cusp of substantial change in regulatory oversight at the same time that they are increasingly including samples and data from large populations, e. Professor roger brownswordchair, professor martin richards, dr roger moore, mr andrew russell, ms tracey phillips, mrs margaret shotter, dr sheelagh. Public trust is also believed to require different participatory approaches so that. Uk biobank participants gave broad consent between 2006 and 2010 to the use of their data, health records, and bodily materials for healthrelated research purposes 1, 2. The uk biobank ethics and governance council is one example of such a body uk biobank, 2008.

It is appropriate to engage stakeholders from these populations in new governance arrangements. Recently the ethics and governance council of biobank uk was superseded by the uk biobank ethics advisory committee. Does the biobank produce an annual report of its activities to satisfy the requirements of its ethical approval. Biobanks, bioethics and concepts of donated blood in the uk. Role of the uk biobank ethics and governance council the lancet. In addition, an independent ethics and governance council was formed in 2004 to oversee uk biobanks continuous adherence to the ethics and governance framework, which were developed for the. It must be emphasized that all opinions here expressed are solely the personal views of the author. Uk biobank ethics and governance framework wellcome. An independent ethics and governance council egc was formed in november 2004 to oversee uk biobank s adherence to the framework. The independent uk biobank ethics and governance council provides advice to the project and monitors its conformity with the framework. The ethics governance council was established by the funders when uk biobank began its recruitment back in 2006 and that very much acted as an independent guardian of the uk biobank ethics and. An ethical governance framework has been drafted by the ethical advisory group of the uk10k project. P uk biobank funders will be aware of the importance of ensuring that the ethics and governance.