{"id":4045,"date":"2017-01-20T15:15:53","date_gmt":"2017-01-20T15:15:53","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Clark-WMA-Declaration-on-Health-Databanks-BRJC-v2-16-09-2015.pdf"},"modified":"2017-01-20T15:15:53","modified_gmt":"2017-01-20T15:15:53","slug":"clark-wma-declaration-on-health-databanks-brjc-v2-16-09-2015-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/clark-wma-declaration-on-health-databanks-brjc-v2-16-09-2015-2\/","title":{"rendered":"Clark-WMA-Declaration-on-Health-Databanks-BRJC-v2-16-09-2015"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Clark-WMA-Declaration-on-Health-Databanks-BRJC-v2-16-09-2015<\/a><\/p>\n

Comments on the
\nWMA Declaration on
\nHealth Databanks
\nand Biobanks
\nDr Brian J Clark
\nGlobal Head of Biobanking
\nNovo Nordisk A\/S
\nChair, ISBER Publications Committee
\nAdvisor, ISBER Science Policy Committee
\n\u2022 Global healthcare company
\n\u2022 Headquartered in Denmark
\n\u2022 90 years innovation and leadership in
\ndiabetes care
\n\u2022 Leading positions in haemophilia, growth
\nhormone and hormone replacement
\n\u2022 39,000 staff in 75 countries
\n\u2022 Products used in >180 countries
\n\u2022 Bioethics central to the Novo Nordisk Way
\n\u2022 Uses human biosamples and data daily in
\nour R&D
\nAbout Novo Nordisk
\nWMA Declaration on Ethical Considerations regarding Health Databases
\nand Biobanks
\n14th September 2015 2
\n\u2022 Creates a bioethics framework that can act as the foundation for
\ninternationally harmonised policies and legislation relating to
\nbiobanks and databanks
\n\u2022 Recognises that biobanks and databanks are distinct from regular
\nclinical research
\n\u2022 Addresses that the Declaration of Helsinki alone does not cover all
\nthe issues
\n\u2022 Can address the impact of local, varying, inconsistent and often
\nincompatible policies and legislation that exists from country-to-
\ncountry
\nThe positives
\nWMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 3
\n\u2022 Could afford citizens across the world a consistent level of protection
\nand opportunity to participate in, and benefit from, research using
\ndonated biosamples and\/or health data
\n\u2022 Could facilitate research collaboration beyond national borders \u2013
\nlarger more powerful studies, better uses of resources, broader
\napplicability of research findings, \u2026
\n\u2022 Recognises the validity of \u201cbroad consent\u201d
\n\u2022 The document provides flexibility and scope of interpretation
\nThe positives
\nWMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 4
\n\u2022 The document lacks specificity and is too open to interpretation
\n\u2022 Potential to diverge policy and legislation rather than converge and harmonise
\n\u2022 Definitions required
\n\u2022 Accompanying commentary or interpretation guide required
\n\u2022 May over limit research whilst aiming to address \u201cmajor risk scenarios\u201d
\nof \u201ccommercial, administrative or political use\u2026\u201d
\n\u2022 The scope of applicability is not clear
\n\u2022 What types of biobanks and databanks are in scope?
\n\u2022 Secondary uses of primary health data and biosamples?
\n\u2022 Databanks and biobanks primarily created for research?
\n\u2022 Only databanks and biobanks where the data\/biosamples are identifiable?
\nSome negatives
\nWMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 5
\n\u2022 Anonymous \u2013 non-identifiable \u2013 pseudo-anonymous – identifiable \u2013
\nlinked-anonymous \u2013 de-identified \u2013 identified
\n\u2022 Which are covered?
\n\u2022 How defined?
\n\u2022 Consent \u2013 specific \u2013 broad \u2013 conditional broad \u2013 blanket \u2013 open
\n\u2022 Information is the key and autonomy should allow donors to agree to
\nwhatever they wish
\n\u2022 Information + opt out maybe as valid
\n\u2022 Where concerns about provision of adequate information, can be
\ncounterbalanced by the need for ethics review of the intended uses
\nSome negatives
\nWMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 6
\n\u2022 Emphasis on the need for consent and autonomy overbalanced in
\ncomparison with other bioethics principles of beneficence and justice
\n\u2022 The narrow waiver of consent provision could close the door on
\nbeneficial research using legacy healthcare data and biosample
\ncollections
\n\u2022 Retrospective consent can be impracticable, unwarranted, unnecessarily
\ndistressing, not affordable\u2026\u2026
\n\u2022 Routine \u201cfront-door consent\u201d – neither warranted nor affordable and
\nprovides a false promise scenario
\n\u2022 Prevention of research will necessitate accumulating equivalent data \/
\nbiosamples prospectively with consent, which may take many years if even
\npossible, delaying or preventing benefit
\nSome negatives
\nWMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 7
\n\u2022 A balance between consent and donor protection by ethics
\nreview\/approval can be better achieved
\n\u2022 Declaration of Helsinki, para 32 \u2013 \u201c\u2026 situations where consent would be
\nimpossible or impracticable to obtain for such research. In such situations
\nthe research may be done only after consideration and approval of a
\nresearch ethics committee.\u201d
\n\u2022 Maintenance of this position is strongly recommended
\nSome negatives
\nWMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 8
\nBiosamples are data
\n\u2022 In governance terms, management of samples should be similar to
\nmanagement of sensitive personal (health) data.
\n\u2022 Biobanking is a form of Data Processing.
\n\u2022 Biobanks are Databanks.
\n9Biobanks and Data Protection
\n= =
\n\u2022 Potential impact
\n\u2022 With regard to research for the benefit of the public
\n\u2022 Beneficence
\n\u2022 Non-maleficence
\n\u2022 Justice
\n\u2022 Autonomy
\n\u2022 Clarity, proportionality, practicality and affordability
\nConcluding remarks
\nWMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 10
\nDisseminate information on repository management
\nissues
\nEducate and share information and tools within
\nthe society and with stakeholders
\nAct as the voice for repositories to influence regulations
\nand policy
\nDevelop best practice guidelines
\nProvide centralized information about existing
\nrepositories
\nBring members together to work on emerging issues
\nISBER: Goals of the Society
\nThrough its ISBER Science Policy Committee,ISBER serves as the
\ninternational voice for repositories on science policy issues by:
\n\u2022 Communicatingwith and soliciting input from ISBER members on
\nemerging science policy issues that may affect the biorepository
\ncommunity
\n\u2022 Providing input on numerous national and international policy
\ndocuments
\n\u2022 Submitted comments on WMA Draft Declaration on Ethical
\nConsiderations Regarding Health Databases and Biobanks
\n\u2022 See:
\nhttp:\/\/c.ymcdn.com\/sites\/www.isber.org\/resource\/resmgr\/documents\/20
\n15.06.11_ISBER_Comments-WM.pdf
\nISBER: The International Voice for Repositories on
\nScience Policy Issues<\/p>\n"},"caption":{"rendered":"

Clark-WMA-Declaration-on-Health-Databanks-BRJC-v2-16-09-2015 Comments on the WMA Declaration on Health Databanks and Biobanks Dr Brian J Clark Global Head of Biobanking Novo Nordisk A\/S Chair, ISBER Publications Committee Advisor, ISBER Science Policy Committee \u2022 Global healthcare company \u2022 Headquartered in Denmark \u2022 90 years innovation and leadership in diabetes care \u2022 Leading positions in haemophilia, growth hormone […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Clark-WMA-Declaration-on-Health-Databanks-BRJC-v2-16-09-2015.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/4045"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=4045"}]}}