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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