the ethics of (research) data sharing madeleine murtagh · social system •benefits &...

The Ethics of (Research) Data SharingMadeleine Murtagh

Overview1. Socio-technical – Engaging Stakeholders2. Research Ethics – foundations3. Ethics of (Research) Data Sharing – different?4. General Data Protection Regulation (GDPR) –

May 20185. METADAC: Managing Ethico-social, Technical

and Administrative issues in Data ACcess6. And, back to stakeholder engagement

Social system• Benefits & Performance measures

• Planning

• Engagement and consent

• Governance

• Roles, responsibilities and reporting relationships

• Management structure & style

• Accountability culture

• Outsourcing, procurement and partnering

• Decision making practices

• Information sharing

• Pay appraisal and other personnel practices

• Training needs

• Culture and values

• Job attitudes and expectations

Technical system• Building & Physical layout

• Steps in the core work process

• Task analysis

• Work methods and procedures

• Work instructions

• Quality mgt system

• Technology

• Equipment, materials

• Common problems or variances

• Cycle time/value added

Technicalsystem

Socialsystem

Jointoptimisation

Business strategy & organisation vision

Stakeholder requirements

Ark requires integrated socio-technical approach

Social system

• Benefits & Performance measures

• Planning


• Governance









• Training needs



Patient & Public Facing

• Benefits & Performance measures

• Planning


• Governance









• Training needs




• Benefits & Risks for the Public

• Planning


• Governance









• Training needs





• Planning & Communication


• Governance









• Training needs







• Governance









• Education and training







• Governance











• Attitudes and expectations

Stakeholder engagement




• Governance











• Attitudes and expectations

Human Rights - Bioethics - Research Ethics

Declaration of Human Rights (1948)• Right to

Privacy (Article 8)

• Right to share in the benefits of science (Article 27)

• Duties to the community (Article 29)

Beauchamp and Childress (1979)

• Respect for autonomy

• Non-Maleficence

• Beneficence

• Justice

Helsinki Declaration (1964)

• Trust & Trustworthiness

• Informed consent

• Confidentiality/ protection of identity

• Security

• Right to participate & withdraw

• Safeguards and regulation

Primary, Secondary research and Data Sharing

•Differences between Information Governance and Research Ethics•Research ethics regulatory bodies

• Research Ethics Committees• Data Access Committees

• For ARCHIE, we need an interface that encompasses Information Governance and Research Ethics

GDPR – Conditions for Research Consent (Recital 33) • It is often not possible to fully identify the purpose of personal data

processing for scientific research purposes at the time of data collection.

• Therefore, data subjects should be allowed to give their consent to certain areas of scientific research when in keeping with recognised ethical standards for scientific research.

• Data subjects should have the opportunity to give their consent only to certain areas of research or parts of research projects to the extent allowed by the intended purpose.

GDPR - When is pseudonymisation data NOT pseudonymised (Recital 26)

Personal data which have undergone pseudonymisation, which could be attributed to a natural person by the use of additional information should be considered to be information on an identifiable natural person.

GDPR - Data subject rights: Articles 14-21

• 14. Right to information to be provided to the data subject

• 15. Right of access by the data subject

• 16. Right to rectification

• 17. Right to erasure (“right to be forgotten")

• 18. Right to restriction of processing

• 19. Notification obligation regarding rectification or erasure of personal data or restriction of processing

• 20. Right to data portability

• 21. Right to object

GDPR – Governing data for research (Recital 156)

The processing of personal data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes should be subject to appropriate safeguards for the rights and freedoms of the data subject pursuant to this Regulation. Those safeguards should ensure that technical and organisational measures are in place.

Managing Ethico-social, Technical and Administrative issues in Data ACcess

• Managing access to UK longitudinal research projects • Decades of phenotypic and genotypic data and samples• Consent for sharing• But with constraints and expectations

• METADAC Access Committee reviews and decides • the most sensitive data and samples - algorithms aren’t enough• Human decision making needed

• Committee made up of a multidisciplinary/professional team

• Include study-participants

• Communicates to stakeholders – e.g. plain language summaries of all approved studies

• www.metadac.ac.uk

http://www.metadac.ac.uk/

Managing Ethico-social, Technical and Administrative issues in Data ACcess

1. The application has been submitted by bona fide researchers.

2. The application does not risk producing information that may allow individual study participants to be identified.

3. The application does not violate (or potentially violate) any of the ethical permissions granted to the study and/or any of the consent forms signed by the participants or their guardians.

4. The application addresses topics that fall within the acknowledged remit of the project, as understood by participants.

5. There is no significant risk that the application might upset or alienate study members or of reducing their willingness to continue as active participants.

6. There is no significant risk that the application might harm individuals in the study, or the study as a whole.

7. The application does not require access to a depletable finite resource (whole blood extracted DNA, blood, saliva and urine).

Data sharing for research - Getting it right!

Engaging stakeholders1. Learn what bothers and excites stakeholders✓ Focus Groups✓ Engagement events

2. Work together with stakeholders – co-producing solutions✓ Amy’s page – professionals➢ Amy’s page – patients & publics

3. Maintain a dialogue➢ Communication and outreach➢ ECOUTER – taking engagement to the people – workplaces,

supermarkets, shopping centres, hospitals4. Systems of ethical governance of data sharing that incorporate

stakeholder perspectives and involves them in decision making

Thank you

The Ethics of (Research) Data SharingMadeleine Murtagh

[email protected]

the ethics of (research) data sharing madeleine murtagh · social system •benefits &...

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