Présentation de Rym Benkahlifa, chercheur à l'IPT et point focal national du partenariat allemand en excellence biologique et sécurité sanitaire, durant le symposium organisé conjointement entre le Robert Koch Institute et l'Institut Pasteur de Tunis "Current challenges of Biological Risks and Heealth Security" (22-23 septembre 2016)

1. THE CODE OF CONDUCT
THE IPT INITIATIVE
République Tunisienne
Ministère de la Santé
Rym BENKHALIFA
September, 22- 23, 2016
Ramada Plaza Hotel – Gammarth, Tunisia

2. • Is a researcher responsible for the use of its work?
• What today found the responsibility of the scientist?
• Why is the reflection in new technologies essentially concerned the risk?
IPT- RKI Symposium Gammarth, September, 22-23, 2016

3. “Science cannot stop when ethics go after her - and no one
should expect from scientists to conduct all the reflections
for the country"
Elvin Charles Stackman, American Association for the Advancement of Science, 1949
IPT- RKI Symposium Gammarth,
September, 22-23, 2016

4. Who is, in your opinion, the "scientist who has most
damaged the planet"?
IPT- RKI Symposium Gammarth,
September, 22-23, 2016
James Conant (1893 – 1978)
 produces a toxic gas during the 1st World War
 becomes the President of Harvard University at the age of 40 years as
President of the Scientific Committee for national defense:
 He encouraged the development of the atomic bomb project
Thomas Midgley (1889 – 1944)
 Inventor of the leaded gasoline to remove the rattling of the engine
 Had synthesized the dichlorodifluoromethane: refrigerators and air
conditioners cooling agent, product for maintenance of electronic
equipment and gas for sprayers

5. Many scientific progress in the 20th century has been a source of freedom and
progress in terms of public health:
• penicillin  democratization of health
• Biotechnology continue every day to save lives, previously, sacrificed
A paradox…
IPT- RKI Symposium Gammarth,
September, 22-23, 2016

6. Dual use: an ethical problem
The dual-use dilemma occurs in a context of scientific research
and means that works or results, are likely to be used both for
peaceful purposes and for purposes dangerous for humans,
animals, plants or for the environment.
IPT- RKI Symposium Gammarth,
September, 22-23, 2016

7. IPT- RKI Symposium Gammarth,
September, 22-23, 2016

8. Unexpectedly, the new genetically modified virus has demonstrated a large virulence
to exterminate mice
Originally, the virus was designed to be a contraceptive vaccine for the mouse
Mouse Smallpox Virus
genetically modified
• Unexpected toxicity
• Inefficiency of current
immunization program
Would the use of similar
technics can develop the
ultimate biological weapon?
Human Smallpox Virus
Mechanism analysis
Dual use research??
IPT- RKI Symposium Gammarth,
September, 22-23, 2016

9. The air transmission of H5N1 between mammals by creation of highly
pathogenic strains by mutagenesis.
However, the extrapolation to humans is not so obvious and it should be
considered crossing the species barrier, which can be associated with a new
mutation resulting in a loss of virulence,
• the synthesis de novo of a poliovirus in 2002
• the partial reconstruction of the Spanish flu in 2005,
Need for assessing the "dual use" character of research
projects
IPT- RKI Symposium Gammarth, September, 22-23, 2016
Then….

10. GOFR
IPT- RKI Symposium Gammarth,
September, 22-23, 2016
Gain-of-function (GOF) research involves experimentation that aims or is
expected to increase the transmissibility and/or virulence of pathogens.
responsible scientists
Such research aims to improve understanding of disease causing agents,
their interaction with human hosts, and/or their potential to cause
pandemics.
Despite these important potential benefits, GOF research (GOFR) can pose
risks regarding biosecurity and biosafety.

11. Dual Use Research of Concern : DURC
IPT- RKI Symposium Gammarth,
September, 22-23, 2016
DURC : Dual Use of Research of Concern =
refers to dual-use research for which the consequences of malevolent use would be
exceptionally severe of particular concern in the context of life science research is that
advances in biotechnology may enable development and use of a new generation of
biological weapons of mass destruction.

12. Duties associated with dual-use science
IPT- RKI Symposium Gammarth, September, 22-
23, 2016
• To be “morally”… “ethically” responsible
Scientists must to prevent any damage which:
- Is under their professional responsibilities.
- Is within their skills.
- Presents a potential risk.
- is proportionally greater than the resulting benefits

13. IPT- RKI Symposium Gammarth,
September, 22-23, 2016

14. From Responsible life sciences research for global health
security, WHO guidance document, 2010
Spectrum of biological risks and measures for mitigation
IPT- RKI Symposium Gammarth,
September, 22-23, 2016

15. • Raise awareness around biological threats
• Promote cooperation between the fields of human and animal
health, science, and research communities in charge of safety
programs
• Reduce the impact of biological threats
• Strengthen global security
How combating threats?
IPT- RKI Symposium Gammarth, September,
22-23, 2016

16. WHO: Vision and Objectives
IPT- RKI Symposium Gammarth,
September, 22-23, 2016
"Responsible research in Life Science for a global safety project"
3 pillars supporting the public health:
• Openness and Honesty
Excellency
• Accountability & Responsability
Ethics
• Protection against accidents and/or deliberate misuse
Biosecurity & Biosafety in labs

17. Educating to reinforce the code of conduct
IPT- RKI Symposium Gammarth, September, 22-
23, 2016
Capacity building is needed
Training the Trainers
Education
Inform scientists and policy makers = Efficient B&B and CoC
Code of conduct
Important but prematureImportant but difficult to implement

18. IPT- RKI Symposium Gammarth,
September, 22-23, 2016
a set of rules outlining the social norms and rules and
responsibilities of, or proper practices for, an individual
or organization.
Related concepts include ethical, moral codes and
laws.
What is a code of conduct?

19. IPT code of conduct
IPT- RKI Symposium Gammarth, September, 22-
23, 2016

20. IPT- RKI Symposium Gammarth, September, 22-23,
2016

21. IPT- RKI Symposium Gammarth, September, 22-
23, 2016
 2 workshops in April 2015, then in June 2015
 Developed with the RKI experts, the IPT Committee of Biomedical Ethics
members and IPT B&B experts,
 finalized in July 2015.

22. The IPT CoC
• Code of conduct for handling pathogenic microorganisms and toxins
• Related to research in the areas of IPT activities :
– Public Health Research,
– Production of vaccines and Therapeutic Sera
– as well as other activities (laboratory animals, biostatistics, technical
platform...).
• It defines the procedure to follow for the assessment of possible dual use
for:
– Preserving freedom of benefic research to society,
– Preventing the dissemination of information and research results that
can harm society and environment.
IPT- RKI Symposium Gammarth,
September, 22-23, 2016

23. Consulting
experts
Assessment and risk management
IPT- RKI Symposium Gammarth, September,
22-23, 2016
Evaluation of the dual-use potential
Analysis
Risk / Benefit
No yes
 Completed review
 Research could be
continued Approval by the
CERB
IPT General
Manager
Research
could not be
conducted at
IPT
x
 Completed review
 Research could be
continued
Research
could not be
conducted
x
Risk
Mitigation
Questionnaire
Planning Stage
Final phase of
the project:
unexpected
results
Before the use
of the results:
for exple, a
Publication
Point of time
Supervisor: Head of the lab
for check
Principle of 4 eyes
yes
No

24. IPT- RKI Symposium Gammarth,
September, 22-23, 2016

25. IPT- RKI Symposium Gammarth,
September, 22-23, 2016
Thank you for your attention