the code of conduct the ipt initiative

THE CODE OF CONDUCT THE IPT INITIATIVE

République TunisienneMinistère de la Santé

Rym BENKHALIFA

September, 22- 23, 2016Ramada Plaza Hotel – Gammarth, Tunisia

• 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

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

“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

Who is, in your opinion, the "scientist who has most damaged the planet"?

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

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

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…

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

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

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

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??

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….

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

GOFRGain-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.

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

Dual Use Research of Concern : DURC

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.

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

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

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

From Responsible life sciences research for global health security, WHO guidance document, 2010

Spectrum of biological risks and measures for mitigation

• 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

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

WHO: Vision and Objectives

"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

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 CoCCode of conduct

Important but prematureImportant but difficult to implement

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?

IPT code of conduct

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

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

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.

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

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

Noyes

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

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

Thank you for your attention