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H2020 MSCARISE
Ethics Evaluation
Berta Vizcarra-Mir
Adam WalendzikREA.A.3, 2 July 2020
1. Being an expert
2. Ethics appraisal timeline
3. Ethics appraisal process
4. Main ethics issues
Part I
Role of the experts
Assess
Responsible
Diligent
Principles
Independent Impartial
Objective Consistent
Confidentiality
Discuss
Contact
Disclose
Keep
DONOT
Conflict of Interest
Inform the REA
Do not evaluate
Do not hide
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
• …
Ethics in H2020
Described in all proposal
For all scientific domains
Integral part of research
Ethics review
Timeline
Process
Scientific evaluation
Ethical screening
Assessment
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)
Main Ethics Issues - 1
HESC & Human embryos and foetuses
Humans
Human cells/tissues
Personal data
Animals
Main Ethics Issues - 2
Third countries / Non-EU Countries
Environment & Health and Safety
Dual use
Exclusive Focus on Civil Applications
Misuse
Other issues
Part II
1. Ethics Self-Assessment
2. Ethics Appraisal Process in RISE
3. SEP – Workflow
4. Key Messages
Ethics Self Assessment
The Applicants
• Identify
• Handle
• Detail
Ethics Self Assessment
Part A:
Ethics self-assessment
Part B:
Information can be anywhere
Ethics Issues Table
Indicate pages in Part B of the proposal
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
Appraisal Process in RISE
Likely to be funded
Ethics Flagged
Assess
Give Opinion
Requirements
Reports Generic Information
EthIR EthCR EthSR
• Clear, Concise, Project Specific
• Identify & address all ethical issues
• Check the entire proposal
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.
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
Opinion
• Ethics clearance
• Conditional ethics clearance
• Ethics assessment recommended (limited)
• Additional information needed
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
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)
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
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
SEP - EthCR
http://ec.europa.eu/research/participants/data/support/expert/expert
_evaluation_user_manual.pdf
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
Thank you
© European Union 2020
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