Slides to introduce the "Ethics, Research & Society" roundtable of the C3BI annual retreat — 2018-05-24

1. Ethics, Research & Society
Guillaume Dumas — 2018-05-24

2. Credit: Center for Bioethics & Human Dignity

3. Flickr/rmdey2000
bioethics.com
Applications
Informed-consent

4. newyorker.com/tech/elements/can-we-patent-life

5. Martin Shkreli, Who Raised Drug Prices from $13.50 to
$750, Arrested in Securities Fraud Probe

6. A second concern held by some is that
a new class of research person will
emerge — people who had nothing to
do with the design and execution of the
study but use another group’s data for
their own ends, possibly stealing from
the research productivity planned by the
data gatherers, or even use the data to
try to disprove what the original
investigators had posited. There is
concern among some front-line re-
searchers that the system will be taken
over by what some researchers have
characterized as “research parasites.”

8. Some motivations :
www.nature.com/articles/sdata201618

10. 7 principles
1. Lawful, fair and transparent processing – this principle emphasizes transparency for all EU data subjects.
When the data is collected, it must be clear as to why that data is being collected and how the data will be
used.
2. Purpose limitation – this principle means that organizations shouldn’t collect any piece of data that doesn’t
have a specific purpose, and those who do can be out of compliance.
3. Data minimization – this principle instructs organizations to ensure the data they capture is adequate,
relevant and limited. Organizations must store the minimum amount of data required for their purpose.
4. Accurate and up-to-date processing – this principle requires data controllers to make sure information
remains accurate, valid and fit for purpose. Organization must have a process and policies to address how
they will maintain the data.
5. Limitation of storage in the form that permits identification – this principle discourages unnecessary
data redundancy and replication. Organizations must have control over the storage and movement of data.
6. Confidential and secure – this principle protects the integrity and privacy of data by making sure it is
secure. Organizations must spend an adequate amount of resources to protect the data from those who are
negligent or malicious.
7. Accountability and liability – this principle ensures that organizations can demonstrate compliance.
Organizations must be able to demonstrate to the governing bodies that they have taken the necessary
steps comparable to the risk their data subjects face.

11. arno.uvt.nl/show.cgi?fid=142885
The Influence of Article 89 GDPR on the Use of Big Data
Analytics for the Purpose of Scientific Research
Danny Koevoets (2017)

13. Research Ethics & Integrity
'Be the change that you wish to see in the world.' Gandhi
1. Truth — The scientist is concerned with the expansion of human Knowledge. S/he
must avoid negligence leading to fabrication of the scientific message, false credit or
emphasis given to a scientist, or distortion of the research process.
2. Freedom — The scientist follow the principles of the democratic system, for the
adequate safeguarding of human life, welfare, dignity, and liberty.
3. Responsibility — The scientist bears full responsibility for every scientific research or
experiment, particularly with regards to its effect on humans and other living forms.
4. Integrity — The scientist follow the scientific method, presenting her data in full,
precisely, frankly, and fairly.
5. Collaboration — The scientific fosters collaboration by maintaining an atmosphere of
openness, mutual assistance, and trust.
6. Professionalism — The scientist makes judicious and continual use of knowledge and
imparts the values and principles of the scientific method.
Adapted from "The Ethics of Scientific Research: Values and Principles” by Asa Kasher et al.

14. References
• Button, K. S., Ioannidis, J. P., Mokrysz, C., Nosek, B. A., Flint, J., Robinson, E. S., &
Munafò, M. R. (2013). Power failure: why small sample size undermines the reliability
of neuroscience. Nature Reviews Neuroscience, 14(5), 365.
• Engelhardt, H. T. (1996). The foundations of bioethics. Oxford University Press
• Ioannidis, J. P. (2005). Why most published research findings are false. PLoS
medicine, 2(8), e124.
• Knoppers, B. M. (2010). Consent to ‘personal’genomics and privacy: Direct-to-
consumer genetic tests and population genome research challenge traditional notions
of privacy and consent. EMBO reports, 11(6), 416-419.
• Koevoets, D. (2017). The Influence of Article 89 GDPR on the Use of Big Data
Analytics for the Purpose of Scientific Research.
• Manson, N. C., & O'Neill, O. (2007). Rethinking informed consent in bioethics.
Cambridge University Press.
• McGuire, A. L., & Burke, W. (2008). An unwelcome side effect of direct-to-consumer
personal genome testing: raiding the medical commons. Jama, 300(22), 2669-2671.
• Mostert, M., Bredenoord, A. L., Biesaart, M. C., & van Delden, J. J. (2016). Big Data in
medical research and EU data protection law: challenges to the consent or anonymise
approach. European Journal of Human Genetics, 24(7), 956.
• Open Science Collaboration. (2015). Estimating the reproducibility of psychological
science. Science, 349(6251), aac4716.
• Rumbold, J. M. M., & Pierscionek, B. (2017). The effect of the General Data Protection
Regulation on medical research. Journal of medical Internet research, 19(2).
Contact: gdumas@pasteur.fr / @introspection / extrospection.eu