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
• Global healthcare company
• Headquartered in Denmark
• 90 years innovation and leadership in
diabetes care
• Leading positions in haemophilia, growth
hormone and hormone replacement
• 39,000 staff in 75 countries
• Products used in >180 countries
• Bioethics central to the Novo Nordisk Way
• Uses human biosamples and data daily in
our R&D
About Novo Nordisk
WMA Declaration on Ethical Considerations regarding Health Databases
and Biobanks
14th September 2015 2
• Creates a bioethics framework that can act as the foundation for
internationally harmonised policies and legislation relating to
biobanks and databanks
• Recognises that biobanks and databanks are distinct from regular
clinical research
• Addresses that the Declaration of Helsinki alone does not cover all
the issues
• Can address the impact of local, varying, inconsistent and often
incompatible policies and legislation that exists from country-to-
country
The positives
WMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 3
• Could afford citizens across the world a consistent level of protection
and opportunity to participate in, and benefit from, research using
donated biosamples and/or health data
• Could facilitate research collaboration beyond national borders –
larger more powerful studies, better uses of resources, broader
applicability of research findings, …
• Recognises the validity of “broad consent”
• The document provides flexibility and scope of interpretation
The positives
WMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 4
• The document lacks specificity and is too open to interpretation
• Potential to diverge policy and legislation rather than converge and harmonise
• Definitions required
• Accompanying commentary or interpretation guide required
• May over limit research whilst aiming to address “major risk scenarios”
of “commercial, administrative or political use…”
• The scope of applicability is not clear
• What types of biobanks and databanks are in scope?
• Secondary uses of primary health data and biosamples?
• Databanks and biobanks primarily created for research?
• Only databanks and biobanks where the data/biosamples are identifiable?
Some negatives
WMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 5
• Anonymous – non-identifiable – pseudo-anonymous – identifiable –
linked-anonymous – de-identified – identified
• Which are covered?
• How defined?
• Consent – specific – broad – conditional broad – blanket – open
• Information is the key and autonomy should allow donors to agree to
whatever they wish
• Information + opt out maybe as valid
• Where concerns about provision of adequate information, can be
counterbalanced by the need for ethics review of the intended uses
Some negatives
WMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 6
• Emphasis on the need for consent and autonomy overbalanced in
comparison with other bioethics principles of beneficence and justice
• The narrow waiver of consent provision could close the door on
beneficial research using legacy healthcare data and biosample
collections
• Retrospective consent can be impracticable, unwarranted, unnecessarily
distressing, not affordable……
• Routine “front-door consent” – neither warranted nor affordable and
provides a false promise scenario
• Prevention of research will necessitate accumulating equivalent data /
biosamples prospectively with consent, which may take many years if even
possible, delaying or preventing benefit
Some negatives
WMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 7
• A balance between consent and donor protection by ethics
review/approval can be better achieved
• Declaration of Helsinki, para 32 – “… situations where consent would be
impossible or impracticable to obtain for such research. In such situations
the research may be done only after consideration and approval of a
research ethics committee.”
• Maintenance of this position is strongly recommended
Some negatives
WMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 8
Biosamples are data
• In governance terms, management of samples should be similar to
management of sensitive personal (health) data.
• Biobanking is a form of Data Processing.
• Biobanks are Databanks.
9Biobanks and Data Protection
= =
• Potential impact
• With regard to research for the benefit of the public
• Beneficence
• Non-maleficence
• Justice
• Autonomy
• Clarity, proportionality, practicality and affordability
Concluding remarks
WMA Declaration on Ethical Considerations regarding Health Databases and Biobanks 14th September 2015 10
Disseminate information on repository management
issues
Educate and share information and tools within
the society and with stakeholders
Act as the voice for repositories to influence regulations
and policy
Develop best practice guidelines
Provide centralized information about existing
repositories
Bring members together to work on emerging issues
ISBER: Goals of the Society
Through its ISBER Science Policy Committee,ISBER serves as the
international voice for repositories on science policy issues by:
• Communicatingwith and soliciting input from ISBER members on
emerging science policy issues that may affect the biorepository
community
• Providing input on numerous national and international policy
documents
• Submitted comments on WMA Draft Declaration on Ethical
Considerations Regarding Health Databases and Biobanks
• See:
http://c.ymcdn.com/sites/www.isber.org/resource/resmgr/documents/20
15.06.11_ISBER_Comments-WM.pdf
ISBER: The International Voice for Repositories on
Science Policy Issues