FP7 /1 Integrating Ethics in EU Research European Commission Research DG Mary Fitzgerald Unit L 3,...
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Transcript of FP7 /1 Integrating Ethics in EU Research European Commission Research DG Mary Fitzgerald Unit L 3,...
FP7 /1
Integrating Ethics in EU Research
European Commission
Research DG
Mary Fitzgerald
Unit L 3, Governance and Ethics
FP7 /2
European Commission Ethical Reviews - Introduction
■ Why set up Ethical Reviews? Two Major Objectives
Assuring citizens and decision-makers that EU-funded research complies with the highest ethical standards
Facilitating Research Excellence in FP 7
FP7 /3
Legal Basis for Ethical Reviews in FP7 – (1)
■ Seventh Framework Programme (Decision N° 1982/2006/EC), Article 6 (1§):
■ Rules for Participation, Article 10:
« All the research activities carried out under the Seventh Framework Programme shall be carried out in compliance with fundamental ethical principles. »
« A proposal […] which contravenes fundamental ethical principles […] shall not be selected . Such a proposal may be excluded from the evaluation and selection procedures at any time. »
FP7 /4
Legal Basis for Ethical Reviews in FP 7 – (2)
■ Areas excluded from funding under FP 7, Art. 6 (2§):
A) Research activity aiming at human cloning for reproductive purposes
B) Research activity intended to modify the genetic heritage of human beings which could make such changes heritable (Research related to cancer treatment of the gonads can be financed)
C) Research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer
FP7 /5
Legal Basis for Ethical Reviews in FP 7 – (3)
Convention of the Council of Europe on Human Rights and Biomedicine (Oviedo, 4 April 1997)
UN Convention of the Rights of the Child
Universal Declaration on the Human Genome and Human Rights adopted by UNESCO
FP7 /6
Ethical Review in Context – Balance in the Fields of Expertise
Balance in Fields of expertise - Ethical Reviews 2004 (FP6)
Bioethics
Health and Medical Sciences
Biology and Biotechnology
Technological Sciences
Animal Welfare
Humanities and Social Sciences
Law
Balance in fields of expertise: experts from different disciplines such as law, sociology, philosophy and ethics, psychology, IT, medicine, molecular biology, veterinary science
45 % of female experts
FP7 /7
Geographical Balance Geographical Balance in Ethical Reviews 2006 (FP6)
0
5
10
15
20
25
AL BE BG CZ DE DK EE ES FI FR GR HU IE IL IT LT LV MT NL NO PL PT RO RU SE SK TR UK
First Natioanlity
Va
lue
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Series1
Geographical Balance: Experts mainly from the EU Member States, Candidate countries but also from developing countries and emerging economies
FP7 /8
Number of FP6 Research Proposals undergoing Ethical Reviews
FP6 Proposals undergoing ethical reviews
0
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100
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450
1 2 3 4
Years (2003-2006)
Nu
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Series2
FP7 /9
Content of the FP6 Research Proposals undergoing Ethical Reviews
Nanotechnology, 9%
Biomedicine and Genetics; 45%
ICT; 8%
Food and green biotech; 11%
Mobility(Marie Curie); 11%
Other; 18%
Breakdown of projects having undergone ethical review, by research area
11% of all funded FP6 projects have undergone an ethical review
FP7 /10
18 FP6 Proposals involving hESC (Human Embryonic Stem Cells) among 855 Proposals under Ethical Review 2,11%
FP6 Proposals undergoing Ethical Reviews
0
50
100
150
200
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300
350
400
450
1 2 3 4
FP6 Years (2003-2006)
Nu
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Other
hESC Proposals
FP7 /11
Ethical Reviews in Practice: The Project Evaluation Process
■Scientific Evaluation
All proposals submitted to the Commission for funding following a call for proposals are evaluated on their scientific merit.
Scientific evaluators identify the proposals raising ethical issues and needing ethical reviews.
■ Ethical Review (if required)
All proposals for funding involving a research intervention on humans, the use of hESC and/or fœtal issues, and non-human primates will be automatically submitted to an ethical review panel.
FP7 /12
Proposal
Individual evaluation
Consensus
Panel review
Consultation of programme committee (if required)
Commission funding and/or rejection decision
with hearing(optional)
Thresholds
Eligibility
Negotiation
Commission ranking
Commission rejection decision
Ethical Review
(if needed)
Security Scrutiny
(if needed)
Applicants informed of results of expert evaluation*
• invitation to submit second-stage
proposal, when applicable
Submission and evaluation in
FP7
Applicants informed of Commission decision
FP7 /13
Ethical Reviews’ Methodology
Two General Questions asked in ethical reviews
The necessity to use i.e. personal data, animals, human tissue in order to achieve the scientific objectives set forth in the proposal; is there an alternative?
The benefit/burden balance of the research project; what will be the impact of this research not only regarding scientific advance but also in terms of Human dignity as well as social and cultural impact?
FP7 /14
Ethical Review Methodology – (2)
In particular, the Ethical Review Panel discusses the following elements:
The awareness of the applicants on the ethical aspects and the social impact of the research they propose
Whether the researchers respect the FP7 ethical standards
Whether the relevant European Directives are applied
Whether the consortium is seeking the approval of relevant local ethics committees
Whether the relevant international Conventions and Declarations are applied
The balance between the research objectives and the means the applicants intend to use
FP7 /15
Ethical Review Methodology – (3)
MAJOR CHANGES FROM FP6 TO FP7:
The Ethic Review will be carried out on the proposal submitted
No additional information will be requested from the consortium
The Consortium is asked to submit drafts of Information Sheet and Consent Form
The Consortium does not need to submit copies of legislation
TAKE HOME MESSAGE:
GET IT RIGHT FIRST TIME!
FP7 /16
Ethical Review Methodology – (4)
■ COMMON PROBLEMS:
Consistency and context
Insurance
Incidental Findings
Incentives (Financial inducements, etc.)
FP7 /17
Ethical Review Methodology – (5)
■ COMMON PROBLEMS:
Issues related to Children: Minimum Risks? Minimum Burden? Real and Direct Benefit?
Research on Animals: Number; Humane End Points; Checked alternatives?
Developing Countries: Benefit sharing
Conflict of Interest: Treating Doctor; Research Interest
FP7 /18
Typology of Specific Ethical Issues (1)
INFORMED CONSENT (1)
■ Two key issues
Who benefits
What happens to data, samples and animals at end?
■ Who should consent?
Persons able to freely understand and question
Vulnerable persons generally excluded BUT to avoid
- loss of opportunity possibilities exist
FP7 /19
Typology of Specific Ethical Issues (2)
INFORMED CONSENT (2)
■ How to Inform?
Culture, Literacy, use of linguist in preparation of consent forms
■ How to get the approval?
Literacy, Responsible adult, written agreements not always provided (DC)
Notion of Individuality is lacking in some cultures
Gender issues
FP7 /20
Typology of Specific Ethical Issues (3)
DATA PROTECTION (1)
■ Personal Data:
Health Information, Criminal Justice, Financial Information, Genetic Information, Location Information
■ Challenge:
Process data while protecting identity
Processing = Obtaining, Holding, Disclosing
FP7 /21
Typology of Specific Ethical Issues (3)
DATA PROTECTION (2)
■ 8 ENFORCEABLE PRINCIPLES:
Fairly and lawfully processed
Processed for limited purposes
Adequate, relevant and not excessive
Accurate
Not kept longer than is necessary
Processed in accordance with data subject's rights
Secure
Not transferred to countries without adequate data protection
FP7 /22
Typology of Specific Ethical Issues (4)
ANIMAL RESEARCH (1)
■ Convincing Application of the 3Rs
Reduction, Replacement, Refinement
■ To describe and justify:
Species and Numbers
Humane End Points and Pain Suffering
■ To Check for alternatives (cf. the following websites):
http://www.nc3rs.org.uk/category.asp?catID=3
http://www.vet.uu.nl/nca/links/databases_of_3r_models
FP7 /23
Typology of Specific Ethical Issues (4)
DEVELOPING COUNTRIES (1)
■ To justify the involvement of Developing Countries
■ To consider:
Culture and Literacy
Best Interest of the subject
Informed Consent
Benefit sharing
Use of local resources
Avoiding Double Standards
FP7 /24
RESEARCH ON HUMAN EMBRYONIC STEM CELLS
Specific Procedural Modalities:
They are exactly the same as in FP6
Scientific Evaluation:
Independent experts assess the NECESSITY of using hESC for achieving the objectives set forth in the proposal.
All proposals for funding involving the use of hESC and/or fœtal issues will be automatically submitted to an ethical review panel.
Typology of Specific Ethical Issues (5)
FP7 /25
Typology of Specific Ethical Issues (6)
Once the scientific evaluators confirm the necessity of using hESC in the research proposal, the ethical review panel assesses:
That the proposal does not include research activities which destroys embryos including for the procurement of stem cells;
Whether the consortium has taken into account the legislation, regulations, ethical rules and/or codes of conduct in place in the country(ies) where the research using hESC is to take place, including the procedures for obtaining informed consent*
The source of the hESC; The measures taken to protect personal data, including
genetic data, and privacy; The nature of financial inducements, if any
* Cf. Directive 2004/23/EC
FP7 /26
Typology of Specific Ethical Issues (7)
RESEARCH ON HUMAN EMBRYONIC STEM CELLS
In addition, when research proposals involve the use of hESC, the following procedures are required:
A positive opinion from a Regulatory Committee constituted by Member States’ representatives is required .
Participants in research projects must seek the approval of the relevant national or local ethics committees prior to the start of the research activities (General Clause in the contract!)
FP7 /27
Typology of Specific Ethical Issues (8)
RESEARCH ON HUMAN EMBRYONIC STEM CELLS
In conclusion, each research proposal involving the use of hESC, which is supported within FP7, is assessed by at least two independent ethical reviews: one in the country itself where the research will be carried out) and one at the EU level.* No System in the world offers a higher guarantee regarding the respect of fundamental ethical principles.
* If the research raising ethical issues is performed in more than one country (i.e. n countries), it implies that more than two ethical reviews will be performed (i.e. in fact n+1 ethical reviews)