Ethical Governance Framework (EGF) for BioMedBridges

1. Ethical Governance Framework (EGF) for BioMedBridges Carol Smee Independent External Ethics Advisor

2. 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

3. Ethical Governance Committee • Janet Thornton, Chair • Ruth Chadwick, University of Cardiff (nominated by BBMRI) • Christian Gluud, Copenhagen University Hospital (nominated by ECRIN) • KimmoPitkanen, Institute for Molecular Medicine Finland (nominated by EATRIS) • Maurizio Ribera d’Alcala, StazioneZoologica Anton Dohrn (nominated by EMBRC)

4. 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 approval

5. 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 committees) • 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

6. 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!

7. 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.

8. 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

9. 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)

10. 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.

12. 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

13. 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

14. 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

15. Thank you for listening …with thanks to Steffi Suhr for her input and excellent suggestions re. this presentation. Contact details: Carol Smee cs14@sanger.ac.uk +44(0)1223 494968