msca rise 2018 coordinators' day 17-18 january, 2019 › info › sites › info › files ›...
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MSCA RISE 2018 Coordinators' Day
17-18 January, 2019Berta VIZCARRA MIR and Frederico MIRANDA
ETHICS & RESEARCH INTEGRITY
#RISE2019Day@MSCActions
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1. Legal Aspects
2. Ethics in the project lifetime
3. Ethics Requirements & Deliverables
4. Nagoya Protocol
5. New General Regulation on Data Protection
6. Misconduct & Integrity
7. Key Messages
OVERVIEW
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ETHICS LEGAL BASIS
Article 34 – Ethics
• 34.1 – Obligation to comply with ethical principles
• 34.2 – Activities raising ethical issues
• 34.3 – Activities involving human embryos or hESC
Article 39 – Processing of Personal Data
Horizon 2020 Grant Agreement
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Submission EvaluationGrant
PreparationProject
Call Deadline
Ranking List
Grant Agreement
ProjectClosure
Self-Assessment Screening Assessment Checks Audit
Ethics Review Ethics Checks & Audits
Ethics Appraisal
ETHICS TIMELINE
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Pre-grant signature
requirements
Post-grant signature
requirements
Ethics Screening
Report
ETHICS REQUIREMENTS
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Ethics Check
Any time during the project or after
Ethics AuditEthics Check Report
ETHICS CHECK / AUDIT
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• Upload confirmations under relevant Deliverables
• If requested send the PO a copy of the Ethics document
• In case of check, provide the PO with the requested documents
• If applicable, submit the Ethics Independent Adviser / Advisory Board report
MAIN ACTIONS DURING IMPLEMENTATION
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Person authorised to submit the declaration via theparticipant portal,
I declare that the following documents needed forimplementing the action tasks described under projectnumber-acronym have been obtained prior to the startof the research activities and kept on file according toarticle 34.2 of the GA:
a)any ethics committee opinion required undernational law
b)any notification or authorisation for activities raisingethical issues required under national and/orEuropean law
CONFIRMATION TEMPLATE
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ETHICS INDEPENDENT ADVISOR
• Expert in research ethics
• Independent of the project
• No CoI with the research project they will advise
• Oversee the project activities, advice on ethics issues and ensure compliance
• Involved in the management structure of the project
• Provide a report at interim and final payment
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• Created to fight biopiracy
• Safeguards benefit sharing to provider countries
• Compliance ensured by Regulation 511/2014 (ABS Regulation)
NAGOYA PROTOCOL
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NAGOYA PROTOCOL & HORIZON 2020
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NAGOYA PROTOCOL DECISION TREE
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Mandatory Data
Protection Officer (DPO)
GENERAL DATA PROTECTION REGULATION
Accountability based
approach
Data Protection by design and by
default
Data Minimisation
Risk Based Approach
Data protection
Impact Assessments
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European Code of Conduct for Research Integrity of ALLEA and ESF:
• Fabrication
• Falsification
• Plagiarism
• Other research misconduct
MISCONDUCT & RESEARCH INTEGRITY
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• Ethics issues Self-Assessment Guidance
• Guidance Note on Ethics and Data
• Ethics in Horizon 2020 Online Manual
• Nagoya Protocol
• Access and Benefit-sharing Clearing-house
• EU Directive on Data Protection (95/46/EC)
• EU Regulation on Data Protection (2016/679)
• European Code of Conduct for Research Integrity
ADDITIONAL INFORMATION
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Ms Helena João Gonçalves
STAB VIDA
RISE-2016 LungCARD 734790
“Blood test for clinical therapy guidance of non-small cell lung cancer patients”
RISE TESTIMONIAL
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KEY MESSAGES
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• Ethics are addressed during entire project
• Comply with legal aspects (Article 34 of GA)
• Complete ethics Deliverables and comply with checks
• If applicable, appoint an Adviser and provide a report
KEY MESSAGES
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• Check the Nagoya Protocol scope
• Keep in mind the new Regulation on Data Protection
• Refrain from Misconduct
• The Coordinator is responsible for informing its consortium
KEY MESSAGES
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Thank you for your attention
More information here
Pictures: ©iStock and ©Getty Images
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