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FP7 Health: Ethics Review & What to Do : Point by Point
Dr. Joana NamoradoEthics, Gender IssuesDirectorate Health-DG RTD – European Commission
September 2008
Malta 2008
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
Proposals for ER/year: Increase in number of
proposals…
FP6 Proposals undergoing ethics reviews
89
153181
280
0
50
100
150
200
250
300
1 2 3 4
Years (2003, 2004, 2005, 2006)
Valu
es
Relative percentage of
Health Proposals ER The Highest is: Health
Increase in the proportion of Health Proposals undergoing ethics reviews
45%
48,21%
43%
44%
45%
46%
47%
48%
49%
Proportion of Health ProposalsUp to July 2005
Proportion of Health Proposals in2006
Perc
enta
ges
In 2006, 48% proposals undergoing ethics reviews were from Health (134
Health out of 280)
Research Proposals undergoing ethics reviews in 2006 - Proportion of Health Proposals
48%
52%
Percentage of Health Proposals Percentage of Proposals in other areas
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
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§):
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
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.
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)
Ethical 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
• 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.
Ethics: Panorama for FP7
The Proposal
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.
Ethical review
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)
Ethics: Panorama for FP7
Ethical Review Process Evolving
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).
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.
1. Applicants identify key ethical issues explain how they address them then list them.
2. Scientific Evaluation3. Ethics Review at EC level -2 STEPS 1: Ethics
Screening-: 2: Ethics Review4. Ethics (Screening or Review) Report5. Requirements incorporated in Grant
Agreement6. Possibility of Ethics Audit
Ethics: Process for FP7
Novel Ethical Review Process
1. Applicants identify key ethical issues explain how they address them then list them.
2. Scientific Evaluation3. Ethics Review at EC level -2 STEPS 1: Ethics
Screening-: 2: Ethics Review4. Ethics (Screening or Review) Report5. Requirements incorporated in Grant
Agreement6. Possibility of Ethics Audit
Ethics: Process for FP7
Novel Ethical Review Process
• 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 proposal+addresses issues
• Scientific evaluators signal any ethical issues in a proposal, even those missed by the applicant.
Applicants identify key ethical issues explain how they address them then list them
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)
Applicants identify key ethical issues
Novel Ethical Review Process
1. Applicants identify key ethical issues explain how they address them then list them.
2. Scientific Evaluation3. Ethics Review at EC level -2 STEPS 1:
Ethics Screening2: Ethics Review
4. Ethics Result - Screening or Review Report5. Requirements incorporated in Grant
Agreement6. Possibility of Ethics Audit
Ethics: Process for FP7
Novel Ethical Review Process
PHASE 1) Ethics screening
Screening by Experts, PO and Sc&S• 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 reviewDirectorate L will be provided with the screening report and will decide that the ethics review is completed.
Proposals go to ethical screening.
•This process, is part of the Ethics Process•Identifies proposals for ethical review.
PHASE 1) Ethics screening
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.
.Proposals go to ethical screening.as part of the Ethics ProcessIdentifies proposals for ethical review +
1. Applicants identify key ethical issues explain how they address them then list them.
2. Scientific Evaluation3. Ethics Review at EC level -2 STEPS 1: Ethics
Screening-: 2: Ethics Review4. Ethics (Screening or Review) Report5. Requirements incorporated in Grant
Agreement6. Possibility of Ethics Audit
Ethics: Process for FP7
Novel Ethical Review Process
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
2) Ethical review
• 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. They should contain explanation and information to ensure compliance with good ethical practice.
Remote Assessment using IT Tool
1. Applicants identify key ethical issues explain how they address them then list them.
2. Scientific Evaluation3. Ethics Review at EC level -2 STEPS 1: Ethics
Screening-: 2: Ethics Review4. Ethics (Screening or Review) Report5. Requirements incorporated in Grant
Agreement6. Possibility of Ethics Audit
Ethics Issues One by One
Or, on How TACKLE Ethics issues
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
Mandatory Ethical review
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? • Are those animals cloning farm animals? • Are those animals non-human primates? Research Developing countries • Use of local resources (genetic, animal, plant, etc.)? • Benefit to local community (capacity building ie access to healthcare, education, etc. ) Dual Use• Resarch having potential military/terrorist application
* Found in the Science and Society w.page
Informed Consent
• When is it needed?• When children are involved.• Healthy volunteers.• Human genetic material.• Human biological samples.• Human data collection• Insurance
People : Informed Consent
When is it needed?
• When Children involved• Healthy volunteers• Human genetic material• Human biological samples• Human data collection
What must be in Consent form ? State + explain
• That it is research• Purpose+duration+description
• 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
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
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
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?catID=3 http://www.vet.uu.nl/nca/links/databases_of_3r_models
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: 2+2
(2 from MS/AS + 2 from ICPCs) BUT
Ethics Requirements MUST BE equivalent to those applied in MS
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?
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
Dual Use
Research that can have military application
In the case of health, it has to be carefully screened for excesses.
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 n+1 ethical reviews)
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
hESC Research in FP7
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.
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.
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?
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
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
Thank You
Dr. Joana NamoradoDirectorate HealthDG RTD – European Commission
FP7 –Cooperation theme
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
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 &
conditions3 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