Ethical Governance Framework (EGF) for BioMedBridges

Ethical Governance Framework
(EGF) for BioMedBridges
Carol Smee
Independent External Ethics Advisor
Governance within terms of the EGF
Ethical Governance Committee
• Monitors compliance of the project with the EGF
• Provides an ethics management report to
Executive Steering Committee
• Supports the External Independent Ethics advisor
in monitoring and reporting on progress with
respect to the requirements of the EGF
• Prepares updates of the EGF to be approved by
Executive Steering Committee
Ethical Governance Committee
• Janet Thornton, Chair
• Ruth Chadwick, University of Cardiff
(nominated by BBMRI)
• Christian Gluud, Copenhagen University Hospital
(nominated by ECRIN)
• Kimmo Pitkanen, Institute for Molecular Medicine
Finland (nominated by EATRIS)
• Maurizio Ribera d’Alcala, Stazione Zoologica Anton
Dohrn (nominated by EMBRC)
EGF requirements
• Only data for which all national
regulatory requirements have been
fulfilled should be made available
• The project establishes data interoperability – it
does not test scientific hypotheses (WP reports to
the EU must reflect this)
• No data will be stored in BMB – data is stored by
the data providers and made accessible/linked
from there
• Novel ways of combining data or datasets can
proceed as long as the data is linked or unlinked
anonymised and an ethics committee has granted
EGF requirements
• Responsibility for all data made
available and linked or accessed via
BMB remains with data providers
• Approval for use of data will be by existing
committees (DACs or, where necessary, ethics
• Research participant consent and/or ethics
committee approval must cover all aspects of
making data available within BMB and/or
accessing it in another country
EGF conditions
• Consider implications of linking with
new and/or different types of data
and what might be discovered
• Direct feedback of research results to research
participants is not planned
• Unlinked anonymised data will be impossible to
remove from the dataset
• EGF stipulates that each data provider should
complete a data provider form (where
appropriate) – intention is to ensure that all
ethical issues re. datasets have been addressed
• Everyone has to agree to sign-up to it!
Data Provision
To enable data sharing, data providers are
responsible for ensuring that the following (where
relevant) have granted approval for the data to be
accessed within BMB prior to data deposition:
• Ethics committees
• Data access committees
• National regulatory authorities
• Or equivalent bodies.
Data providers are responsible for ensuring consent
and/or ethics committee or other authority (where
relevant) approval is in place.
Data Provision
Deposition of data by data providers acts as
assurance to the project that data providers
have obtained all appropriate approvals
required by:
• Relevant national laws
• Relevant national regulations
Ethics Committees – There to help!
• Where there is doubt re. consent for use
in BMB or where consent did not foresee
use of data in BMB
• Where there is doubt consent covers
the combination of datasets
• Where data analyses may confer
non-intentional stigmatisation of population subsets
• Where existing consent does not cover sharing of data
across national boundaries (inc. source country different
from data deposition country)
• Where consents do not allow for an individual’s data not
to be withdrawn when requested by them to do so (and
data may already be accessed by other researchers)
• What to do about communicating findings of clinical
significance (not planned in BMB)
What the Coordinator Needs to Know!
Data Provider Form to be used where there are restrictions on
use imposed by:
• Consent requirements
• Ethics committee (or DAC) approvals (to
include restrictions on combining datasets)
• National regulations
• Agreements, e.g., MTAs, RCAs, DAAs – to include those made with
the original suppliers of the data
• Time-limitations attached to datasets
• Obligations re. communication of findings of clinical significance, inc.
any obligations on data requestors and time-limits.
However, please note that the BMB Coordinator is not responsible
for ensuring that any conditions/restrictions are complied with.
Name of data provider
Name and address of Data Provider’s research institute/university
Name of dataset and URL of dataset or service
Please list the restrictions on use imposed by consent requirements, ethics committee approvals,
national regulations or any agreements, such as, research collaboration agreements, material transfer
agreements, and data access agreements, including those made with other parties who may have
originally supplied the data
Is the data obtained from the research participant in linked or unlinked anonymised?
If linked anonymised, name the person(s) holding the linkage key
If linked anonymised, please give the name and address of the linkage key holder’s research
If applicable, please state if there is a date by when this dataset must be removed from BioMedBridges
Please state any decisions made regarding the management and communication of findings of
individual clinical significance, including any obligations data requestors may have to communicate
findings, and any pre-set time-limits for the feeding-back of results
Please sign to indicate that you have read the BioMedBridges Ethical Governance Framework
document and you agree to abide by the conditions contained therein
Please sign to confirm that the donor consent provisions and/or ethical approval, and national laws
and regulations, allow the use of the data in BioMedBridges
Examples of when a
Data Provider Form is needed
• A dataset in which the consent provisions only
allow the use of the dataset in studies which
are concerned with cardiovascular disease
• A dataset where findings of
individual clinical significance
are to be communicated back
to research participants
Examples of when a
Data Provider Form is not needed
• A dataset uploaded into an existing database
which already allows combination of datasets
• A dataset generated through the
use of model organisms which does
not have restrictions placed upon its use
• A dataset generated from human participant data
where there is broad consent and ethics
committee approval to share the data openly and
indefinitely for any research study
Why the Coordinator and External
Ethics Adviser Need to Know!
• We will use the Data Provider Forms to ‘audit’
selected case-studies in Autumn 2014 to get a
feel for how any restrictions on data use are
being considered, and the project’s compliance
with the Ethical Governance Framework
• We will use information from these case-studies
in our report to the EU in December this year
Thank you for listening
…with thanks to Steffi Suhr for her input and
excellent suggestions re. this presentation.
Contact details:
Carol Smee
[email protected]
+44(0)1223 494968

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