FP7 /1 Integrating Ethics in EU Research European Commission Research DG Mary Fitzgerald Unit L 3, Governance and Ethics

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

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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. »

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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

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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)

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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

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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

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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

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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


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


■ COMMON PROBLEMS:

Consistency and context

Insurance

Incidental Findings

Incentives (Financial inducements, etc.)

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■ 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


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


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

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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


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


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.


FP7 /25


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



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



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)

Documents

FP7 /1 Integrating Ethics in EU Research European Commission Research DG Mary Fitzgerald Unit L 3, Governance and Ethics