H2020 Ethics
Ethics Appraisal Procedure - Guidance and examples
Horizon 2020 and Ethics
Ethics is an integral part of all research activities funded by the European Union, from beginning to
end at all levels.– reference http://ec.europa.eu/research/participants/docs/h2020-fundingguide/cross-cutting-issues/ethics_en.htm
The broad topic of ethics in research is considered from different aspects:
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Research integrity
„Ethics-ready“ proposals
Ethics monitoring during the implementation of projects
Funding of ethics research
Responsible research and innovation (RRI)
Pointers
! Research ethics is not a one size fits all approach
! It is strongly recommended, when planning your project, that you give yourself enough time
in case it needs to go through screening, assessments and check/audits.
! The Ethics Paragrapgh is not part of the scientific evaluations, but will be evaluated separately
later
Ethical Table
Self assessment.
Self Assessment
New developments
• EU regulation for Protection of Privacy
• Adoption Mid June
• Will have effect on Research esp. concerning
collection personal data and safety of personal
data.
• University Data Protection Officer will become
Obligatory
Box 1 en 3
• Box 1. Human Embryos/ Foetuses
• Box 3. Human Cells and Tissues
• Ethical Committee Medical Research (METC)
(LUMC) Contact: cme@lumc.nl +31 (0)71- 52
63241 / 66963
Box 2 en 4
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•
•
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Box 2. Humans
• A. Psychology in combi with human cells and tissues: METC
• B. Human volunteers is SS&H research Ethical Approval if applicable (
unable to give consent; vulnerable people; children; patients; )
Box 4: protection of Personal data
• Collection en processing personal data; genetic information; tracking
& observation; secondary use of PD
Beschrijven van procedures of informed consent en voorbeelden van te
gebruiken forms. Binnen faculteiten bestaan voorbeelden.
Approval for collecting /processing Personal data:
– Tot de adoptie van de nieuwe europese regelgeving: NL wetgeving van kracht : melding bij
Collge Bescherming persoonsgegevens.
– Na de adoptie van de europese regelgeving: GEEN NL wetgeving meer maar EU: universiteit is
verplicht een DPO aan te stellen . Dit wordt een toezichthouder
– Beschrijving van de procedures met behulp van UB.
Box 5 en 7
• Box 5 : Dieren
– Wet op de dier proeven
– DEC voert ethics toetsing
–
Information on Animal Welfare
http://www.science.leidenuniv.nl/index.php/faculteit/diergebonden_onderzoek/onderzoekslijn
en
• Box 7: Environment & Health and Safety
– Kaderregeling Veiligheid, gezondheid en Milieu
Aptil 2010. schrjft voor dat iedere faculteit een
VGM plan moet hebben, wo bijv. De classificate
Laboratoria, indien met GNO gewerkt wordt etc.
Box 6,8 en 9
• Box 6 Third countries
– Ook third countries approvals nodig indien in die landen data verzameld
worden. ( ethics dumping)
– Export vergunningen voor data (!) Material Transfer Agreements
– Convention on Biodiversity
• Box 8 en 9 Dual use and misuse
– 8:Military en standards military ethics .
– 9: malevolent, criminal/terrorist abuse.
Box 10 Other
• Box 10 Other Ethical issues
• ???
• Cultural Heritage:
– In Europa het verdrag van Valetta.
Ethical experts at Leiden University
Academic Integrity Committee
Contact: Prof. I.M. Tieken-Boon van Ostade, i.m.tieken@hum.leidenuniv.nl 071-5272163
Visiting address: Rapenburg 70 2311 EZ Leiden
Ethics Commission for Social Sciences and Humanities (SSH)
The ethics committee SSH has been established by the deans of the Faculties of Archaeology,
Campus The Hague, Humanities, Law and Social Sciences.
Publication: Regulation Ethics Commission SSH
Committee Secretary: Anne Christine de Haan LL.M. a.m.c.de.haan@cdh.leidenuniv.nl
Ethics Review Board (ERB) Education and Child Studies
Publication: Academic Integrity in the Institute of Education and Child Studies
Committee Secretary: ms. Dr. D.J.G. Arnoldus d.j.g.arnoldus@fsw.leidenuniv.nl
Ethical Committee Psychology (CEP)
Application through: https://uleidenss.eu.qualtrics.com/SE/?SID=SV_4T5vINjCpgyb4Ve
Contact person: mw. drs. M. Leemkuil ethiekpsychologie@fsw.leidenuniv.nl 071-5273725
Ethical experts at Leiden University continued
Ethical Committee Medical Research (METC) (LUMC)
Contact: cme@lumc.nl +31 (0)71- 52 63241 / 66963
Code integriteit wetenschappelijk onderzoek (LUMC)
Publication: Scientific Integrity at the LUMC
Information on Animal Welfare
http://www.science.leidenuniv.nl/index.php/faculteit/diergebonden_onderzoek/onderzoekslijnen
Information Management University Leiden
Secretary: Mw. D.J. (Daphny) Uljé bvsecretariaat@bb.leidenuniv.nl +31 (0)71 527 3144
Contact person: Dhr.drs. M.C. (Marco) Gosselink MA m.gosselink@bb.leidenuniv.nl
Ethics Appraisal Procedure – in 4 steps
To assess and address the ethical dimension of activities funded under Horizon 2020
Step
Activity
Who?
When?
How?
1.
Ethics self-assessment
Applicant
Application/submis
sion phase
Consideration of
ethical issues of the
proposal
2
Ethics Prescreening/Screening
Ethics Experts
Evaluation phase
Review of application
material
3
Ethics Assessment
Ethics Experts
Evaluation/ Grant
preparation phase
Review of application
material
4
Ethics Check/Audit
Ethics Experts
Implementation
phase
Review of project
deliverables/interview
with applicants
(for proposals involving hESC or
raising serious ethical issues:
severe intervention on humans)
Ethics Appraisal procedure – its Life Cycle
Call
Deadline
Submission
Selfassessment
Ranked
Evaluation
Prescreening
Grant preparation
Screening
Project
Closure
GA
Assessment
Ethical Review
Implementation
Checks &
Audits
Audit
Ethics Checks & Audits
Ethical Appraisal
You need to think about ethics as early as possible and throughout the research lifecycle!