Ethics in projects
involving
nanomaterials
2009-2011
Ms. Timea Balogh
Ethics Sector
DG Research and Innovation
European Commission
Compliance of applicants with ethical rules:
a legal obligation (1)
Seventh Framework Programme
(Decision N° 1982/2006/EC)
Article 6:
'All the research activities carried out under the Seventh
Framework Programme shall be in compliance with fundamental
ethical principles’
Fields of research excluded from funding:
-
research activity aiming at human cloning for reproductive
purposes
-
research activity intended to modify the genetic heritage of
human beings which could make such changes heritable
-
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
2
Compliance of applicants with ethical rules:
a legal obligation (2)
Rules for submission of proposals, and the related evaluation,
selection and award procedures
'Ethical and security considerations: Any proposal which
contravenes fundamental ethical principles, or which fails to
comply with the relevant security procedures may be excluded at
any time from the process of evaluation, selection and award'
(Introduction)
'The Commission may reject proposals on ethical grounds
following an ethical review' (Part 4.3)
'Any proposal that contravenes fundamental ethical principles shall
not be selected' (Article 15.2 of the EC Rules for Participation, and
article 14.2 of the equivalent Euratom Rules for Participation)
Ethics Review Procedures
1. Applicants should complete the “Ethical Issues Table” included in the
Guide for Applicants
2. Ethics review procedures
The evaluation is followed by an ethics review of proposals that are in line
for funding and raise ethical issues.
Phase 1: Ethics screening
Objectives:
(a) identifying proposals that fall under EU and Euratom law and require
an approval and/or a positive opinion at the national level
and
(b) identifying proposals that in addition to national approvals, require an
Ethics Review by the Commission due to the nature of ethical issues raised
primarily intervention on humans, use of non-human primates in
research, research on human embryos and human embryonic stem
cells —> Ethics Review undertaken by the Ethics Sector of DG Research
and Innovation
4
Phase 2: Ethics review
After the ethics screening process, the Commission may decide to submit
proposals that fall under category (b) and proposals under category (a)
that raise challenging ethical issues, to an ethics review panel.
Three mandatory categories, plus particular attention to research involving
children, undertaken in developing countries, and security-related
research
Ethics Review Report (ERR)
- includes a list of ethical issues
- is an account on how ethical issues are addressed by the applicants
- includes the requirements and recommendations made by the panel
- may indicate the need to organise an ethics audit at a later stage
- is sent to the applicants without disclosing the identity of the experts
5
Ethics follow-up and audit
- introduced in 2010
- experts can ask for an Ethics follow-up/audit
- conducted by experts specialised in ethical
issues
- on the date of the first reporting period at the
earliest
- the objective is to assist the beneficiaries to
deal with the ethical issues raised and - if
necessary - take preventative and/or corrective
measures
6
Most common ethical issues
in projects involving nanomaterial
YEAR
ETHICAL ISSUES (number of proposals)
2009
1. adults (11)
4. human tissue (7)
5. human intervention (5)
13 proposals 2. data protection (11)
3. privacy (9)
6. animals/genetically modified animals (9)
2010
5 proposals
1. animals/transgenic animals (3) 4. data protection (1)
2. developing countries (3)
5. human samples (1)
3. safety and hazard (4)
6. patients (1)
2011
1. data protection(10)privacy (8) 4. research on humans (6)
14 proposals 2. human biological samples (9) 5. patients (7)
3. safety and hazard (5)
6. animals/transgenic animals (8)
TOTAL
32 proposals
1. data protection
4. safety and hazard
2. animals/transgenic animals
5. research on humans
3. human intervention and biological samples
6. privacy
7
General and domain-specific requirements in ERRs 1.
(most frequent requirements)
Requirements become contractual obligations
General
-
Copies of ethical/legal approvals by the competent local/national
ethics/legal Committees (where the research takes place) and
submission to the EC prior to the commencement of the research
Appointment of independent Ethics Advisor/Ethics Board,
description of their work, submission of reports prepared by them
Rigorous application of ethical standards and guidelines
compatible with, and equivalent to those of FP7, regardless of the
country of the research
Reference to/enlisting the relevant European/national legislation
and ethical guidelines to be observed
Plan/information/protocol on the management of incidental
findings
8
Domain-specific requirements in ERRs 2.
(most frequent requirements)
Data protection and privacy:
-
Detailed information on procedures and measures to be taken for data
collection, storage, protection, retention and destruction, right to access etc.
Information on data security and the proper handling of data, clarification
on the nature of the data to be collected (de-identified or anonymous)
Copies of authorisations from relevant data protection authorities
Compliance with local and EC regulations with regard to confidentiality and
data protection
Detailed information on measures to ensure privacy/confidentiality
Animals:
-
Compliance with the EU guidelines/directives and the 3R principle –
reduction, refinement, replacement
Copies of relevant authorisations for animal experimentation
Clarification on the number of animals used, on the choice of species, on the
nature of the experiments, the procedures and their anticipated impact and
the minimalization of adverse effects. Justification if living animals are used.
Details on ensuring welfare of animals during their lives
9
Domain-specific requirements in ERRS 3.
(most frequent requirement)
Human intervention and use of human biological samples:
-
Information on the source of the samples, the way the samples are collected
and anonymised, the duration of storage
Clarification what will happen to the samples afterwards and their possible
usage for other purposes
Possible commercial applications
Insurance cover for the research
Information on voluntary nature of participation, right to withdraw from the
study and withdraw samples and data at any time
Safety and hazard related to nanotechnology:
-
Clarification on measures ensuring that no health risks are associated with
the handling of the nanodevices by researchers and the way to minimize
potential risks
Thorough risk assessment of the novel technologies for human therapies,
assessment of potential health, safety and environmental risks associated
with nanotechnology101010
10
Domain-specific requirements in ERRs 4.
(most frequent requirements)
Research on humans – informed consent (research on patients, healthy
volunteers, adults, vulnerable people):
-
-
Detailed information on procedures for recruitment of participants, on
inclusion/exclusion criteria, on direct/indirect incentives, on informed
consent procedures, the risk/benefit analysis, the nature of material to be
collected
Submission of copies of all information sheets and informed consent forms
written in the language and terms understandable to the participants
Justification on the participation of children in the research - parents’
consent and children's assent
Information on the voluntary nature of participation, right of withdrawal
Possible commercial exploitation
Ensuring adequate insurance cover for the participant to cover any potential
adverse effects
11
From insufficiency to sufficiency
Overall assessment of proposals (as of 2010)
1. The proposal adequately identifies and addresses the relevant ethical issues.
Specific requirements, if any, are provided in the 'Requirements‘
2. The proposal addresses the ethical issues only in general terms but there are
aspects which require substantial clarification. These are highlighted in the
'Requirements' section
3. The proposal fails to identify and to address the relevant ethical issues. A
supplementary Ethics Review is recommended (resubmission)
To be considered…
1. The description of ethical aspects of the research regarding the objectives
2. The description of ethical aspects of the research regarding the methodology
3. The description of ethical aspects of the research regarding the possible
implication of the results
4. The indication how the proposal meet the national legal and ethical
requirements of the country of the research
5. The indication of timeframe for approval by relevant authority at national
level
12
Some messages from experts
- Besides the dissemination of results among the
scientific audience, dissemination of results to the
general public
- The purpose is to increase the knowledge and
awareness about the potential of nanotechnologies…
- To improve the quality of the research the applicants
should take into account the Recommendation of
07/02/2008 on a Code of Conduct for a Responsible
Nanosciences and Nanotechnologies Research
- Not sufficient preparation might entail delay in
negotiations
13
More information
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Website on Ethics review:
http://cordis.europa.eu/fp7/ethics_en.html
http://ec.europa.eu/research/science-society/index.cfm?fuseaction=public.topic&id=1289
Ethics Review Help Desk:
- all FP7 funded projects can request specific assistance on ethical issues
from the Ethics Review Help Desk:
http://www.cordis.europa.eu/fp7/get-support_en.html
More information
Horizon 2020
http://ec.europa.eu/research/horizon2020/index
_en.cfm
Science in Society Portal (EUROPA)
http://ec.europa.eu/research/sciencesociety/home_en.cfm
European Research Area
http://ec.europa.eu/research/era/index_en.htm
Thank you for your attention!