MSCA RISE 2018 Coordinators' Day

17-18 January, 2019Berta VIZCARRA MIR and Frederico MIRANDA

ETHICS & RESEARCH INTEGRITY

#RISE2019Day@MSCActions

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

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

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

Pre-grant signature

requirements

Post-grant signature

requirements

Ethics Screening

Report

ETHICS REQUIREMENTS

Ethics Check

Any time during the project or after

Ethics AuditEthics Check Report

ETHICS CHECK / AUDIT

• 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

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

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

10

• Created to fight biopiracy

• Safeguards benefit sharing to provider countries

• Compliance ensured by Regulation 511/2014 (ABS Regulation)

NAGOYA PROTOCOL

11

NAGOYA PROTOCOL & HORIZON 2020

12

NAGOYA PROTOCOL DECISION TREE

13

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

European Code of Conduct for Research Integrity of ALLEA and ESF:

• Fabrication

• Falsification

• Plagiarism

• Other research misconduct

MISCONDUCT & RESEARCH INTEGRITY

• 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

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

KEY MESSAGES

• 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

• 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

Thank you for your attention

More information here

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