1. Phaik Yeong Cheah, B.Pharm, MSc (Bioethics), PhD
Data ethics
Phaik Yeong Cheah, B.Pharm, MSc (Bioethics), PhD
Associate Professor, Oxford University
Head, Bioethics & Engagement, Mahidol Oxford Tropical Medicine Research Unit (MORU)
New York City, 2 Aug 2018

2. From 1st July 2018

3. What do we mean data sharing in research
Individual level health research data
De-identified
Sharing beyond primary research team

4. Quinine vs Artesunate for severe malaria in African children
Illustration
Quinine vs Artesunate for severe malaria in African children
Randomised controlled trial in 11 sites in 9 countries
Quinine vs artesunate 1:1, death is the primary outcome
5425 children with severe malaria enrolled
Artesunate was proven better than quinine
Dondorp et al, Lancet, 2010

5. What are the arguments for sharing data
What are the arguments for sharing data? What are the arguments against sharing data?

6. Why data sharing? Transparency Cost effective
New uses for data already collected
Bigger more powerful datasets
Reanalysis – new findings
Different statistical methods
Better data quality overall
Respecting participants
Improve science
Improve health

7. Why not? Confidentiality Misuse of data Rogue analysis, cherry picking
Extra resources
Data quality
Data curation is expensive
Primary researchers
Exacerbates existing inequality
Ownership issues
Group harms
Any moral objections
Consent issues

8. Types of consent Which do you think works best? Consent type
Description
No consent
Do not obtain donor consent
Blanket consent
Consent to future research with no limitations
Broad consent
Consent to future research with limitations (or governance)
Checklist
Particioant chooses which types of studies/projects allowed
Reconsent
Consent for each specific future study
Which do you think works best?

9. Consent
When data are collected and stored for research purposes, either specific informed consent for a particular use or broad informed consent for unspecified future use must be obtained from the person from whom the data were originally obtained.
The ethical acceptability of broad informed consent relies on proper governance.
CIOMS 2016 Guideline 12 - Data Sharing

10. Challenges around broad consent
Consent for the primary study is challenging enough
Analogy – “I am late for a date….”
Is broad consent considered “informed” consent? (2 opposing views)
What about children?
What aspects of data sharing are considered most important to inform participants?
How to explain data sharing to potential participants?
Little empirical data

11. Thailand study – broad consent
Cheah et al, BMC Med Ethics Submitted

12. Location – Bangkok and Tak Province
Tak Province is an area of convergence Karen and Burmese migrants
Multi resistant malaria, material and child health problems
A typical T-CAB meeting
Lwin KM et al. BMC Med Ethics 2015
Cheah et al, Int Health 2010

14. What information should be provided to participants?
Some findings
What information should be provided to participants?

15. Healthy volunteer study vs very ill e.g. severe malaria

17. Broad consent Broad consent is imperfect, so governance is important
Conclusions from our study
Broad consent
Broad consent is imperfect, so governance is important
Information will have to be tailored per context – or we crowd out important information
Empirical research and *community engagement is important
*More on community engagement if we have time….

18. What does governance mean?
Having a review process eg. data access committee
Who is applying?
What will the data be used for?
Social value - improvement health and science?
How would the primary investigators be credited?
Any potential for group harms
Any moral objections to certain research
Any potential for breach of confidentiality
Data access agreement

19. Many research questions
What are the REAL harms and REAL benefits of data sharing?
Who should be on a data access committee?
What should their roles be?
How do we make it equitable?

20. Quinine vs Artesunate for severe malaria in African children
Illustration
Quinine vs Artesunate for severe malaria in African children
Randomised controlled trial in 11 sites in 9 countries
Quinine vs artesunate 1:1, death is the primary outcome
5425 children with severe malaria enrolled
Artesunate was proven better than quinine
Dondorp et al, Lancet, 2010

21. The study was funded by a charitable UK funder (except for drugs)
The drugs used were donated by a pharmaceutical company
No prior consent for data to be shared with third parties
The trial resulted in change in WHO policy for treatment of malaria
Artesunate registered in many countries
Study can/will never be repeated

22. Time to vote
A pharmaceutical company requests for data for registration of IV artesunate in USA
Researchers in Europe want to merge datasets of severe malaria to find out causes of mortality in severe malaria
Vote:
Should the data be shared with the pharmaceutical company?
Should the data be shared with the European researchers?

23. And if time permits…

24. Ethics guidelines are not enough
Some actions
required
prohibited
encouraged
permissible
Some areas covered by guidance are relatively uncontroversial, others make a judgement in areas of ongoing controversy amongst competing ethical obligations eg new areas like data sharing
What can we do? Community engagement can help address some of these issues
Examples of community engagement…

25. Young Persons Advisory Board – Angkor Hospital for Children, Cambodia
Sremom, Coordinator of YPAG

26. Community Advisory Board (CAB)– on the Thai-Myanmar border
A typical T-CAB meeting

27. Play video – 7 mins

28. Questions?