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TRANSCRIPT
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H2020 MSCARISE
Ethics Evaluation
Berta Vizcarra-Mir
Adam WalendzikREA.A.3, 2 July 2020
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1. Being an expert
2. Ethics appraisal timeline
3. Ethics appraisal process
4. Main ethics issues
Part I
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Role of the experts
Assess
Responsible
Diligent
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Principles
Independent Impartial
Objective Consistent
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Confidentiality
Discuss
Contact
Disclose
Keep
DONOT
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Conflict of Interest
Inform the REA
Do not evaluate
Do not hide
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Conflict of Interest
• e.g. Involved in proposal
preparation
• Benefits if proposal funded
• Relation to applicants
• Involved in the management
structure of the applicant
organisation
• …
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Ethics in H2020
Described in all proposal
For all scientific domains
Integral part of research
Ethics review
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Timeline
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Process
Scientific evaluation
Ethical screening
Assessment
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Process: Screening
• Ethics clearanceEthical issues well
addressed and documents provided
• Requirements• Conditional ethics clearance
Ethical issues partially addressed
• Assessment neededComplex ethical issues (e.g. hESC)
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Main Ethics Issues - 1
HESC & Human embryos and foetuses
Humans
Human cells/tissues
Personal data
Animals
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Main Ethics Issues - 2
Third countries / Non-EU Countries
Environment & Health and Safety
Dual use
Exclusive Focus on Civil Applications
Misuse
Other issues
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Part II
1. Ethics Self-Assessment
2. Ethics Appraisal Process in RISE
3. SEP – Workflow
4. Key Messages
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Ethics Self Assessment
The Applicants
• Identify
• Handle
• Detail
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Ethics Self Assessment
Part A:
Ethics self-assessment
Part B:
Information can be anywhere
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Ethics Issues Table
Indicate pages in Part B of the proposal
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The Ethics Self Assessment Guidance
http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf
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Appraisal Process in RISE
Likely to be funded
Ethics Flagged
Assess
Give Opinion
Requirements
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Reports Generic Information
EthIR EthCR EthSR
• Clear, Concise, Project Specific
• Identify & address all ethical issues
• Check the entire proposal
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Requirements
• Editable pre-defined text
• GDPR – Use the updated list of requirements
• Indicate WHEN it needs to be addressed:
• Before Grant Signature – clarifications, information
• By month X of the project – documents to be
requested
Indicate which participating organisations must provide
the documents.
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Requirements
• Revised art. 34.2
• For non-sensitive projects, revise the SEP wording with the sentence below,
“the copies of the opinions, notifications or authorisations, must be obtained and kept on file and be submitted upon request”
• Adaptation methodology, if necessary
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Opinion
• Ethics clearance
• Conditional ethics clearance
• Ethics assessment recommended (limited)
• Additional information needed
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Ethics Assessment
- Not part of the current exercise
- Recommended for very limited cases only:
Proposals raising complex ethics issues
- All proposals involving hESC
- Recommend in the EthSR whether the
ASSESSMENT is needed: NO REQUIREMENTS
- Inform the ethics coordinators
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Ethics Check
- Complex and difficult ethics issues
- Documents not satisfactory
- Compliance with Ethics requirements needs
to be checked during the implementation
- If a check is requested: JUSTIFICATION
- Indicate the TIME (Month number X of the project)
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Sensitive Flag
- Normal / High- High: complex and difficult ethics issues- To signal the sensitivity to the EC/REA officers
If the high sensitivity flag is selected,
include a justification
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SEP – EthIR
https://ec.europa.eu/research/participants/evaluation/workflow/tasks/my.ht
ml
https://ec.europa.eu/research/participants/evaluation/workflow/tasks/my.html
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SEP - EthCR
http://ec.europa.eu/research/participants/data/support/expert/expert
_evaluation_user_manual.pdf
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Key Messages
Require-ments
• If not already fulfilled in the proposal
• Conditional clearance
Check
• Completeness & Accuracy of your comments
• Include a justification
EthSR
• Will be sent to the applicants
Sensitive proposals
• Let the REA team know
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Thank you
© European Union 2020
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