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FP7 Health: Ethics Review

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Ethics: Panorama for FP7. Ethical Review Process Evolving ... Very similar to the panorama in FP6. Revision at mid-term for the 2nd part of FP7 (2010-2013) ... – PowerPoint PPT presentation

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Title: FP7 Health: Ethics Review


1
  • FP7 Health Ethics Review What to Do Point
    by Point

Malta 2008

Dr. Joana Namorado Ethics, Gender
Issues Directorate Health- DG RTD European
Commission
September 2008
2
The purpose of ethical review
  • to ensure that FP7 ethical rules are complied
    with and that the European Union is not
    supporting research which would be contrary to
    the fundamental ethical principles of FP7
  • to raise researchers awareness about ethical
    issues in research and ensure that these are
    properly addressed

3
Proposals for ER/year Increase in number of
proposals

4
Relative percentage of Health Proposals ER The
Highest is Health
5
In 2006, 48 proposals undergoing ethics reviews
were from Health (134 Health out of 280)
6
Number of proposals for ethical review FP6 2006
  • Thematic priority 1 Life sciences, genomics and
    biotechnology for health, Calls Lifehealth 2005
    6 and 7
  • Total proposals received 460 355 815
  • Total proposals Ethical review 134 ( ressub)
  • ? 134/815 proposals (16 of all received
    proposals) for ethical review
  • ? 134/279 proposals (i.e.48,0 of all ranked
    proposals)
  • genomics and biotechnology for health 35 12
    16 1 64
  • Combating major diseases 50 8 5 6 69
  • First call FP7, deadline 19 April 2007

7
Legal Basis for Ethical Reviews in FP7
  • Seventh Framework Programme (Decision N
    1982/2006/EC), Article 6 (1)
  • All the research activities carried out under
    the Seventh Framework Programme shall be carried
    out in compliance with fundamental ethical
    principles. 
  • Rules for Participation, Article 10
  • 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. 
  • Areas excluded from funding under FP 7, Art. 6
    (2)

8
Legal Basis for Ethical Reviews in FP7
  • Areas excluded from funding under FP 7, Art. 6
    (2)
  • 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

9
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.

10
Proposal
Submission and evaluation in FP7
Eligibility
Individual evaluation
Ethical Scrutiny (if needed)
Consensus
Thresholds
Applicants informed of results of expert
evaluation
Panel review
with hearing (optional)
Ethical Review (if needed)
Commission ranking
Negotiation
  • invitation to submit second-stage
  • proposal, when applicable

Commission rejection decision
Consultation of programme committee (if required)
Applicants informed of Commission decision
Commission funding and/or rejection decision
11
Ethics Panorama for FP7 The Proposal
  • The Proposal includes a section dedicated to
    ETHICS.
  • The applicant fills out a table of ethics issues
    in the proposal
  • Scientific evaluators are asked to signal any
    ethical issues that arise in a proposal including
    those which have not been highlighted by the
    applicant.

12
Ethical review
  • The Ethical Review is organised and carried out
    by Ethics Review Unit either Remotely or
    Centrally
  • Automatic ethical review - Proposals involving
    interventions on human beings, non-human
    primates, hEmbryos/embryonic stem cells.
  • Where necessary ethical safeguards should be in
    place i.e. in cases of international
    co-operation,in third countries.
  • Based on the screening report may consider that
    no further ethics scrutiny is necessary and the
    project can be followed by PO who may follow-up
    indications in the screening report.

13
Ethics Panorama for FP7
Ethical Review Process Evolving
  • Applicants are first expected to identify key
    ethical issues raised by their proposals and
    explain how they address them. They are
  • Informed Consent
  • Research on Human Embryos/Foetuses
  • Data Protection and Privacy
  • Research on Animals
  • Research involving Developing Countries
  • Dual Use (research that could have a military
    application)

14
Under FP7 Art 6
  • Some areas are excluded from funding Run it by
    your ethics expert
  • Human reproductive cloning
  • Germ line gene therapy (except cancer treatment
    of the gonads)
  • Creation of human embryos solely for the purpose
    of research (or for the purpose of stem cell
    procurement, including by means of somatic cell
    nuclear transfer).

15
Areas of Special Sensitivity
  • Examples of Important ethical issues
  • Research involving intervention on human beings,
    human biological samples, human embryonic stem
    cells,
  • Personal data or genetic information
  • Animal research esp. non-human primates or
    non-typical laboratory animals (e.g. dogs, pigs)
  • Developing countries.

16
Ethics Process for FP7
Novel Ethical Review Process
  • Applicants identify key ethical issues explain
    how they address them then list them.
  • Scientific Evaluation
  • Ethics Review at EC level -2 STEPS 1 Ethics
    Screening- 2 Ethics Review
  • Ethics (Screening or Review) Report
  • Requirements incorporated in Grant Agreement
  • Possibility of Ethics Audit

17
Ethics Process for FP7
Novel Ethical Review Process
  • Applicants identify key ethical issues explain
    how they address them then list them.
  • Scientific Evaluation
  • Ethics Review at EC level -2 STEPS 1 Ethics
    Screening- 2 Ethics Review
  • Ethics (Screening or Review) Report
  • Requirements incorporated in Grant Agreement
  • Possibility of Ethics Audit

18
Applicants identify key ethical issues explain
how they address them then list them
  • The Proposal includes a section dedicated to
    ETHICS. Part 4 of Guide for Proposers
  • The applicant fills out a table of ethics issues
    in the proposaladdresses issues
  • Scientific evaluators signal any ethical issues
    in a proposal, even those missed by the
    applicant.

19
Applicants identify key ethical issues
Novel Ethical Review Process
  • Applicants are expected to identify key ethical
    issues raised by their proposals and explain how
    they address them. They are
  • Intervention on Human beings
  • Informed Consent
  • Research on Human Embryos/Foetuses
  • Data Protection and Privacy
  • Research on Animals
  • Double Standards- research in Developing and
    Third Countries
  • Dual Use (research that could have a military
    application)

20
Ethics Process for FP7
Novel Ethical Review Process
  • Applicants identify key ethical issues explain
    how they address them then list them.
  • Scientific Evaluation
  • Ethics Review at EC level -2 STEPS 1 Ethics
    Screening 2 Ethics Review
  • Ethics Result - Screening or Review Report
  • Requirements incorporated in Grant Agreement
  • Possibility of Ethics Audit

21
PHASE 1) Ethics screening
  • Proposals go to ethical screening.
  • This process, is part of the Ethics Process
  • Identifies proposals for ethical review.
  • Screening by Experts, PO and ScS
  • Screening carried out according to the specific
    requirements of WP
  • The outcome (i.e. which proposals need full
    Ethical Review)
  • Screening seeks to divide proposals into three
    groups
  • - No ethical review required. This decision is
    taken by the relevant PO assisted by the
    screeners experts
  • Those that require only the approval from the
    relevant national or local ethics committees
    (requested before the start of the RTD
    activities)
  • Those that require ethical review
  • Directorate L will be provided with the
    screening report and will decide that the ethics
    review is completed.

22
PHASE 1) Ethics screening
.
Proposals go to ethical screening. as part of the
Ethics Process Identifies proposals for ethical
review
  • Those adequately treated every issue have a
    screening report which may include 'REQUIREMENTS'
  • These will be included in the contract
  • May be additional info or alteration of the
    proposal
  • May be accompanied by info and explanation to
    ensure good ethical practice.
  • Those requiring automatic ER
  • Directorate L will conduct ethics review.
  • Proposals move from ethical screening to ethical
    review which is conducted by an independent panel
    of experts chosen by the Commission
  • These experts may work remotely or in Brussels.  

23
Ethics Process for FP7
Novel Ethical Review Process
  • Applicants identify key ethical issues explain
    how they address them then list them.
  • Scientific Evaluation
  • Ethics Review at EC level -2 STEPS 1 Ethics
    Screening- 2 Ethics Review
  • Ethics (Screening or Review) Report
  • Requirements incorporated in Grant Agreement
  • Possibility of Ethics Audit

24
2) Ethical review
  • The Ethical Review is organised and carried out
    by Directorate L either Remotely or Centrally
  • Automatic ethical review - Proposals involving
    interventions on human beings, non-human
    primates, hEmbryos/embryonic stem cells,
    developing/third countries, dual use.
  • Where necessary ethical safeguards should be in
    place i.e. in cases of international
    co-operation,in third countries.
  • Ethics Review
  • When screening considers that further ethics
    scrutiny is necessary

25
Remote Assessment using IT Tool
  • Expert reads ,writes individual report - Once
    reports completed,
  • Expert communicates with other experts
  • Experts on line, and work towards a consensus,
    assisted by the Chair of the panel.
  • If Consensus results
  • An Ethics report is drafted and the requirements
    will be part of the contract negotiation process
  • If there is NO Consensus
  • A panel will convene in Brussels for face-to-face
    debate mediated by Commission officials.
  • In all cases
  • The panel issues an 'Ethical Review Report'
  • The proposal ethics status will be judged
    'Sufficient' or 'Insufficient'.
  • - 'Sufficient' means that the proposal identifies
    and addresses the relevant ethical issues.
  • - 'Insufficient' means that there remain
    significant weaknesses which should be amended.
  • There may be 'REQUIREMENTS' which will part of
    the contract negotiation process.
  • These may be more information or modifications
    to the proposal itself.

26
Ethics Issues One by One
  • Applicants identify key ethical issues explain
    how they address them then list them.
  • Scientific Evaluation
  • Ethics Review at EC level -2 STEPS 1 Ethics
    Screening- 2 Ethics Review
  • Ethics (Screening or Review) Report
  • Requirements incorporated in Grant Agreement
  • Possibility of Ethics Audit

Or, on How TACKLE Ethics issues
27
Mandatory Ethical review
  • The Ethical Review is organised and carried out
    by Directorate L either Remotely or Centrally
  • Automatic ethical review - Proposals involving
    interventions on human beings, non-human
    primates, hEmbryos/embryonic stem cells,
    developing/third countries, dual use.
  • Where necessary ethical safeguards should be in
    place i.e. in cases of international cooperation
    in third countries.
  • Ethics Review
  • When screening considers that further ethics
    scrutiny is necessary

28
Ethics check list
  • Informed Consent
  • Does the proposal involve children?
  • Does the proposal involve patients or persons not
    able to give consent?
  • Does the proposal involve adult healthy
    volunteers?
  • Does the proposal involve Human Genetic Material?
  • Does the proposal involve Human biological
    samples?
  • Does the proposal involve Human data collection?
  • Research on Human embryos/foetus
  • Does the proposal involve Human Embryos?
  • Does the proposal involve Human Foetal
    Tissue/Cells?
  • Does the proposal involve Human Embryonic Stem
    Cells?
  • Privacy
  • Does the proposal involve processing of genetic
    information or personal data
  • (eg. health, sexual lifestyle, ethnicity,
    political opinion, religious or philosophical
    convinction)?
  • Does the proposal involve tarcking the location
    or observation of people?
  • Research on Animals
  • Does the proposal involve research on animals?
  • Are those animals transgenic small laboratory
    animals?
  • Are those animals transgenic farm animals?

29
Informed Consent
  • When is it needed?
  • When children are involved.
  • Healthy volunteers.
  • Human genetic material.
  • Human biological samples.
  • Human data collection
  • Insurance

30
People Informed Consent
  • What must be in Consent form ? State explain
  • That it is research
  • Purposedurationdescription
  • foreseen risks
  • benefits
  • Alternative
  • confidentiality
  • Treatment/compensation information
  • contact for rights/claims
  • contact for injury to the subject
  • Voluntary participation
  • No penalty or loss on stopping
  • When is it needed?
  • When Children involved
  • Healthy volunteers
  • Human genetic material
  • Human biological samples
  • Human data collection

31
Informed consent 2 crucial Issues
  • How can the subjects contribute to science- How
    will researchers protect their subjects and data.
  • Financial benefit for researcher, promoter,
    humanity What Future use

32
Privacy and Data Protection
  • Refers to relation between tech and the right to
    privacy
  • identifiable data collected and stored,
  • Improper or non-existent disclosure control
  • Data affected by privacy issues
  • Health information.
  • Criminal justice.
  • Financial information.
  • Genetic information.
  • Location information.
  • Data privacy / share data while protecting
    identifiable information.
  • How to Deal with Data Protection and Privacy?
  • describe the procedures for informed consent
    confidentiality
  • inform consent for duration
  • code or anonymised banked biomaterial, security
    for storage and handling
  • Fairly and lawfully processed
  • limited purposes
  • Adequate, relevant sufficient
  • Accurate
  • Timely storage
  • Processed in due form subject's rights
  • Secure
  • Not transferred abroad unprotected

33
Research with Animals/NHP
  • 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?catID3
  • http//www.vet.uu.nl/nca/links/databases_of_3r_mod
    els

34
Third Countries
  • 1. Activities open for International Cooperation
  • International Cooperation Partner Countries
    (ICPCs) can participate in projects and receive
    EC funding (as in FP6)
  • Industrialised countries may be funded if their
    participation is seen as essential for the
    project
  • Minimum number of participants 3 from MS/AS
  • 2. Specific International Cooperation Actions
  • Address specific issues that partner countries
    face or have a global character, on the basis of
    mutual interest and benefit
  • Minimum number of participants 22 (2 from
    MS/AS 2 from ICPCs) BUT
  • Ethics Requirements MUST BE equivalent to those
    applied in MS

35
Research in Developing Countries No DOUBLE
Standards
  • ? Does the research project provide benefit to
    the local community (in terms of access to
    healthcare, education, allocation of property
    rights, capacity to assess and use modern
    technologies while respecting the population 's
    own choices and needs, etc.)?
  • ? Does the research project use local resources
    (genetic resources, animal, and plants)? Result
    in their benefit or?

36
Developing Countries - No Double Standards?
  • what constitutes the best interest of subjects
    with insightful recognition that individual and
    cultural preferences, and what can be achieved in
    any particular context, may differ significantly
  • what distinguishes the truly universal from
    imperialistic notions
  • 3) the relevance of contextual issues that can be
    taken into consideration on moral grounds without
    resorting to ethical relativism
  • The issues requiring special attention
  • Unequal burden of diseases/effort to treat
  • the breadth and depth of poverty and high levels
    of illiteracy
  • disparities in health and in access to health
    care
  • imbalance between resources for research and
    basic health care
  • Poor scientific and ethics infrastructures for
    reviewing
  • disempowerment in personal and communal lives
  • the cultures sense of self versus perceptions
    the classical western notion
  • to be ill in contexts different from researchers
    experience
  • what to expect from those consult for help

37
Dual Use
  • Research that can have military application
  • In the case of health, it has to be carefully
    screened for excesses.

38
Ethical Review in hESC Research
  • Each research proposal involving the use of hESC,
    which is supported within FP7, is assessed by at
    least two independent ethical reviews
  • in the country itself where the research will be
    carried out,
  • 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 n1
    ethical reviews)

39
hESC Research in FP7
  • Very similar to the panorama in FP6
  • Revision at mid-term for the 2nd
    part of FP7 (2010-2013)
  • hESC When involving the use of hESC in their
    research project, researchers should take into
    account and specify that
  • The process does not destroy embryos (including
    to procure stem cells)
  • the consortium has taken into account the
    legislation, regulations, ethics rules and/or
    codes of conduct in place in the countries where
    the research using the hESC will take place,
    including the procedures for obtaining informed
    consent
  • the source of the hESC
  • the protection of personal data (genetic data and
    privacy)
  • the nature of financial inducements, if any
  • positive opinion from a Committee constituted by
    Member States
  • representatives PROGRAMME COMMITTEE assent
  • approval of the relevant national or local ethics
    committee prior to the start of the research
    activities.
  • Please note that hESC lines from commercial
    providers are also subject to these rules

40
Must all Ethics Committees permissions be
presented ?
  • No, but in the the proposal
  • The issues must be recognised
  • The issues must be enumerated
  • The issues must be addressed
  • The solutions must be pondered
  • The permissions mentioned and planned.

41
What are ethics reviewers looking for?
  • Was consideration given to ethical issues such
    as, insurance and incidental problems how are
    they dealt with?
  • When people are involved, is the participant
    aware of the approach taken.
  • Situations leading to conflict of interest is
    the researcher carrying out the research should
    not be the person to inform the subject about the
    pros and cons of the clinical trial.
  • Full disclosure of incentives, financial and
    others money may not be the only incentive.
  • The approach must fit context and nature of the
    research.
  • You must inform the subject that refusing or
    abandoning the study will not have adverse
    consequences.

42
What are ethics reviewers looking for?
  • Does the researcher realise the ethics
    implication of his work
  • The involvement of children (and vulnerable
    people) is sensitive. Identify direct benefit to
    the child. If individual benefit is not present
    and children need to be involved ensure that
    there is a minimum risk and burden to the child.
  • Is the information accurate, complete and
    coherent
  • If animals are involved, numbers, species and
    origin of animals must be specified.
  • What happens at the end of the research project.
  • Are there alternatives to animal experimentation?

43
Main Problems found
  • Consistency and context
  • Insurance
  • Incidental Findings
  • Incentives (Financial inducements, etc.)
  • Issues related to Children Minimum Risk/Burden?
    Real and Direct Benefit?
  • Research on Animals Number End Points
    alternatives?
  • Developing Countries Benefit sharing
  • Conflict of Interest Treating Doctor Research
    Interest

44
Ethics mirrors the clarity of Science
  • The Ethics of a proposal can be a positive
    structuring factor of a proposal
  • Like the budget, it quantifies, clarifies and
    shapes the proposal
  • Clarity of purpose simplifies Transparency
  • Transparency opens the way to accountability
  • Ethics bridges science and application

45
  • Thank You

Dr. Joana Namorado Directorate Health DG RTD
European Commission
FP7 Cooperation theme
46
(No Transcript)
47
How to deal with informed consent in practice?-
Address the issue
  • Who should consent
  • exclude vulnerable persons, prisoners, mentally
    impaired persons, severely-injured patients, very
    young children,
  • But
  • avoid lost opportunities for these persons,
    framework should guarantee their participation
    (notion of surrogate legal/ therapeutic
    representative).
  • How to inform
  • is it understood? How do you check the critical
    part of the process?
  • People rarely able to recall what they have
    agreed upon by signing an inform consent.
  • The following strategies may be of great help
  • Translator participation
  • Presentation of the project using technologies
    (video, power-point, theatre play, etc.)
  • Interviews of the participants to ensure that
    they understand the issues in the research project

48
Ethics in the Health theme
  • Key issues
  • for humans Informed Consent / Data Protection /
    Privacy
  • for animals the 3Rs (Reduce, Replace, Refine)
  • for human embryonic stem cells some restrictions
    conditions

3 areas are excluded from funding - Human
reproductive cloning - Intentional germ line
modification (except research relating to
cancer of the gonads which can be funded) -
Creation of human embryos for research or stem
cell procurement (including by means of
somatic cell nuclear transfer)
NB all ethics issues must be recognised and
addressed in the proposal. - Guide for
Applicants, Annex 4, section 4. - Checklist
http//cordis.europa.eu/fp7/ethics_en.html
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