79C3C34C52B45572883A05D425EB0F82
A Guide for Research Ethics Committees for Biological Research (2008)
http://www.bioethics.gr/images/pdf/ENGLISH/OPINIONS_REPORTS/guide.pdf
http://leaux.net/URLS/ConvertAPI Text Files/6DD73A42A17C12D47BBCA41FAC1E958F.en.txt
Examining the file media/Synopses/6DD73A42A17C12D47BBCA41FAC1E958F.html:
This file was generated: 2020-12-01 05:52:49
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000002: A GUIDE
p.000002: for Research Ethics Committees for Biological Research (RECs)
p.000002:
p.000002:
p.000002: In its effort to promote the creation of Research Ethics Committees for Biological Research Organisations
p.000002: in Greece – according to the model followed internationally for a number of years now – the National
p.000002: Bioethics Commission produced the following Guide which is expected to assist our research organizations
p.000002: (universities and research centres) to act accordingly. Obviously, the guide is intended only as a general framework
p.000002: of guidelines for the creation and operation of RECs. Each research organisation should complete it with more
p.000002: specialized rules depending on its mission and priorities.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Ι. Object of Research Ethics Committees
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1. Which types of research must be subject to an ethical evaluation?
p.000002:
p.000002:
p.000002: An ethics evaluation by a REC is currently recommended for the following types of research:
p.000002: - clinical trials of medicines or other interventional forms of treatment,
p.000002: - epidemiological studies,
p.000002: - research on human behaviour and the behaviour of other primates,
p.000002: - research of vulnerable population groups such as children, prisoners or mentally ill patients,
p.000002: - research of groups with particular racial or cultural characteristics,
p.000002: - research on the human embryo (in vitro or in vivo),
p.000002: - research on human genetic or other biological materials,
p.000002: - research on vertebrate animals,
p.000002: - research in rare biological species (plants or animals),
p.000002: - research on potentially dangerous organisms for humanity and the environment, including
p.000002: genetically modified organisms.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: 2. Why is an ethics evaluation by a REC necessary?
p.000002:
p.000002:
p.000002: The above types of research put at risk fundamental values and social interests enjoying strict
p.000002: protection by international law, internationally recognized ethical rules, the legislation of the European Union
p.000002: and national legislation.
p.000002: These are, in particular, the respect for human dignity, the protection of physical integrity, the respect
...
p.000003: Involving Human Subjects ,
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000003: 4 – 14).
p.000003:
p.000003: II. Population (epidemiological) studies
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 5, 10, 11, 12),
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (only in case of
p.000003: sample processing that can reveal the identity of the person, particularly arts 4 – 14),
p.000003: - UNESCO's Universal Declaration on the Human Genome and Human Rights (particularly arts 5 – 12),
p.000003: - UNESCO's International Declaration on Human Genetic Data (particularly arts 4 – 22 if involving sample
p.000003: processing that can reveal the identity of the person).
p.000003:
p.000003: III. Behavioural studies in humans
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000003: 4 – 14).
p.000003:
p.000003: IV. Research in sensitive population groups such as children, prisoners or mental patients
p.000003: - Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on
p.000003: medicinal products for human use (particularly arts 3, 4, 5, 6),
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Additional protocol to the Oviedo Convention concerning Biomedical Research,
p.000003:
p.000004: 4
p.000004:
p.000004: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000004: Involving Human Subjects ,
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14).
p.000004:
p.000004: V. Research in groups with particular racial or cultural characteristics
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 11, 12).
p.000004:
p.000004: VI. Research in the human embryo
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly art.
p.000004: 18),
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: A GUIDE
p.000002: for Research Ethics Committees for Biological Research (RECs)
p.000002:
p.000002:
p.000002: In its effort to promote the creation of Research Ethics Committees for Biological Research Organisations
p.000002: in Greece – according to the model followed internationally for a number of years now – the National
p.000002: Bioethics Commission produced the following Guide which is expected to assist our research organizations
p.000002: (universities and research centres) to act accordingly. Obviously, the guide is intended only as a general framework
p.000002: of guidelines for the creation and operation of RECs. Each research organisation should complete it with more
p.000002: specialized rules depending on its mission and priorities.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Ι. Object of Research Ethics Committees
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1. Which types of research must be subject to an ethical evaluation?
p.000002:
p.000002:
p.000002: An ethics evaluation by a REC is currently recommended for the following types of research:
p.000002: - clinical trials of medicines or other interventional forms of treatment,
p.000002: - epidemiological studies,
p.000002: - research on human behaviour and the behaviour of other primates,
p.000002: - research of vulnerable population groups such as children, prisoners or mentally ill patients,
p.000002: - research of groups with particular racial or cultural characteristics,
p.000002: - research on the human embryo (in vitro or in vivo),
p.000002: - research on human genetic or other biological materials,
p.000002: - research on vertebrate animals,
p.000002: - research in rare biological species (plants or animals),
p.000002: - research on potentially dangerous organisms for humanity and the environment, including
p.000002: genetically modified organisms.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: 2. Why is an ethics evaluation by a REC necessary?
p.000002:
p.000002:
p.000002: The above types of research put at risk fundamental values and social interests enjoying strict
p.000002: protection by international law, internationally recognized ethical rules, the legislation of the European Union
p.000002: and national legislation.
p.000002: These are, in particular, the respect for human dignity, the protection of physical integrity, the respect
...
Health / Drug Dependence
Searching for indicator dependence:
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p.000006:
p.000006:
p.000006: The composition of a REC must ensure on the one hand a thorough examination of the ethical issues raised by a
p.000006: research proposal and, on the other hand, the independence of relevant deliberations from conflicts of
p.000006: interests.
p.000006:
p.000006:
p.000006: 1. Number of members
p.000006:
p.000006: A relatively small number of members is recommended (e.g. from seven to nine persons)
p.000006:
p.000006: The optimal number of members is to be defined by each organization taking into account the workload of
p.000006: the Committee, especially the number of anticipated research proposals to be evaluated annually and the fact
p.000006: that members will be basically volunteers with another full-time employment.
p.000006: If a big number of research proposals is anticipated, the composition may be enlarged so that evaluations can be
p.000006: performed by subcommittees.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: 2. Composition
p.000007:
p.000007: Committees should include medical and biology experts, specialists from the social sciences (e.g. legal
p.000007: experts, philosophers, theologians, sociologists) and lay persons.
p.000007:
p.000007: The composition of the Committee must ensure impartial evaluation, the capacity to comprehend the questions under
p.000007: consideration and adequate justification of the scope of the proposals so that it is comprehensible by the general
p.000007: public.
p.000007: At least one third of the members should not be involved with biological research. Members should not be in any
p.000007: relation of dependence with the persons submitting the research proposal or have any other vested interests
p.000007: that may interfere with their judgment.
p.000007: It is useful to provide for deputy members to ensure a full composition in the case that members are prevented from
p.000007: attending due to any of the above-mentioned conflicts of interest.
p.000007:
p.000007:
p.000007: 3. Appointment of president and members
p.000007:
p.000007: The president and the members of the REC are appointed by the Rector of the University or the General Director of the
p.000007: Research Centre.
p.000007:
p.000007: Each organization will decide depending on its specificities if members will be appointed directly by the
p.000007: head (rector or general director) of the organization or by decision of the central administrative body (university
p.000007: senate or board of directors).
p.000007:
p.000007:
p.000007: 4. Term of office
p.000007:
p.000007: The suggested term of office is from one (1) to three (3) years.
p.000007:
p.000007: The term of office is to be determined on the basis of the expected workload and in a way that allows as many
p.000007: members of the academic community as possible to gain experience on the ethical evaluation of research
p.000007: proposals.
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: It is important that the term of office allows the acquisition of necessary experience on evaluation but also deters
p.000008: the development of dependence relations between REC members and the researchers who submit proposals.
p.000008:
p.000008: 5. Meetings and quorum
p.000008:
p.000008: A REC meets frequently and at regular intervals depending on the number of submitted proposals. A quorum exists
p.000008: when at any one meeting the present members (indispensably including the president) outnumber the
p.000008: absent members and at least one present member does not come from the biological sciences.
p.000008:
p.000008: RECs must hold frequent meetings to avoid unnecessary delay in the onset of implementation of research
p.000008: proposals. For the efficient operation of the evaluation system, meetings should be held at regular
p.000008: intervals and on prefixed dates and the deadlines for the submission of proposals to be evaluated at each meeting
p.000008: should be determined well in advance. The usual practice internationally is for RECs to publish the schedule of their
p.000008: meetings for a whole academic or calendar year.
p.000008: The authority of RECs decisions is enhanced by the participation of members outside the biological sciences and
p.000008: laypersons outside the scientific community. It is desirable that decisions are made with interdisciplinary
p.000008: participation.
p.000008:
p.000008:
p.000008: 6. Members financial compensation
p.000008:
p.000008: The question of financial compensation is to be decided by individual research organizations.
p.000008:
p.000008: The members of the scientific community should consider their participation in the research organization’s
p.000008: REC as a duty. Especially scientists who submit proposals for evaluation by the REC should consider it as a return of
p.000008: services they have enjoyed and will enjoy in the future.
...
Health / Healthy People
Searching for indicator volunteers:
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p.000005: for experimental and other scientific purposes (particularly art. 4).
p.000005:
p.000005: XI. Research in genetically modified organisms and micro-organisms
p.000005: - UN Convention on Biological Diversity (Rio Convention – preamble),
p.000005: - Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms
p.000005: (particularly art. 4),
p.000005: - Directive 98/81/EC on the contained use of genetically modified micro- organisms (particularly art. 5).
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: ΙΙ. Creation and operation of ECBRs
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: The composition of a REC must ensure on the one hand a thorough examination of the ethical issues raised by a
p.000006: research proposal and, on the other hand, the independence of relevant deliberations from conflicts of
p.000006: interests.
p.000006:
p.000006:
p.000006: 1. Number of members
p.000006:
p.000006: A relatively small number of members is recommended (e.g. from seven to nine persons)
p.000006:
p.000006: The optimal number of members is to be defined by each organization taking into account the workload of
p.000006: the Committee, especially the number of anticipated research proposals to be evaluated annually and the fact
p.000006: that members will be basically volunteers with another full-time employment.
p.000006: If a big number of research proposals is anticipated, the composition may be enlarged so that evaluations can be
p.000006: performed by subcommittees.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: 2. Composition
p.000007:
p.000007: Committees should include medical and biology experts, specialists from the social sciences (e.g. legal
p.000007: experts, philosophers, theologians, sociologists) and lay persons.
p.000007:
p.000007: The composition of the Committee must ensure impartial evaluation, the capacity to comprehend the questions under
p.000007: consideration and adequate justification of the scope of the proposals so that it is comprehensible by the general
p.000007: public.
p.000007: At least one third of the members should not be involved with biological research. Members should not be in any
p.000007: relation of dependence with the persons submitting the research proposal or have any other vested interests
p.000007: that may interfere with their judgment.
p.000007: It is useful to provide for deputy members to ensure a full composition in the case that members are prevented from
p.000007: attending due to any of the above-mentioned conflicts of interest.
p.000007:
p.000007:
p.000007: 3. Appointment of president and members
p.000007:
p.000007: The president and the members of the REC are appointed by the Rector of the University or the General Director of the
p.000007: Research Centre.
p.000007:
p.000007: Each organization will decide depending on its specificities if members will be appointed directly by the
...
Health / Mentally Disabled
Searching for indicator mentally:
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p.000002:
p.000002:
p.000002: In its effort to promote the creation of Research Ethics Committees for Biological Research Organisations
p.000002: in Greece – according to the model followed internationally for a number of years now – the National
p.000002: Bioethics Commission produced the following Guide which is expected to assist our research organizations
p.000002: (universities and research centres) to act accordingly. Obviously, the guide is intended only as a general framework
p.000002: of guidelines for the creation and operation of RECs. Each research organisation should complete it with more
p.000002: specialized rules depending on its mission and priorities.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Ι. Object of Research Ethics Committees
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1. Which types of research must be subject to an ethical evaluation?
p.000002:
p.000002:
p.000002: An ethics evaluation by a REC is currently recommended for the following types of research:
p.000002: - clinical trials of medicines or other interventional forms of treatment,
p.000002: - epidemiological studies,
p.000002: - research on human behaviour and the behaviour of other primates,
p.000002: - research of vulnerable population groups such as children, prisoners or mentally ill patients,
p.000002: - research of groups with particular racial or cultural characteristics,
p.000002: - research on the human embryo (in vitro or in vivo),
p.000002: - research on human genetic or other biological materials,
p.000002: - research on vertebrate animals,
p.000002: - research in rare biological species (plants or animals),
p.000002: - research on potentially dangerous organisms for humanity and the environment, including
p.000002: genetically modified organisms.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: 2. Why is an ethics evaluation by a REC necessary?
p.000002:
p.000002:
p.000002: The above types of research put at risk fundamental values and social interests enjoying strict
p.000002: protection by international law, internationally recognized ethical rules, the legislation of the European Union
p.000002: and national legislation.
p.000002: These are, in particular, the respect for human dignity, the protection of physical integrity, the respect
p.000002: for privacy, the right to health, the protection of personal data, the protection of the environment and of
p.000002: biodiversity, etc.
...
Health / ill
Searching for indicator ill:
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p.000002:
p.000002:
p.000002: In its effort to promote the creation of Research Ethics Committees for Biological Research Organisations
p.000002: in Greece – according to the model followed internationally for a number of years now – the National
p.000002: Bioethics Commission produced the following Guide which is expected to assist our research organizations
p.000002: (universities and research centres) to act accordingly. Obviously, the guide is intended only as a general framework
p.000002: of guidelines for the creation and operation of RECs. Each research organisation should complete it with more
p.000002: specialized rules depending on its mission and priorities.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Ι. Object of Research Ethics Committees
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1. Which types of research must be subject to an ethical evaluation?
p.000002:
p.000002:
p.000002: An ethics evaluation by a REC is currently recommended for the following types of research:
p.000002: - clinical trials of medicines or other interventional forms of treatment,
p.000002: - epidemiological studies,
p.000002: - research on human behaviour and the behaviour of other primates,
p.000002: - research of vulnerable population groups such as children, prisoners or mentally ill patients,
p.000002: - research of groups with particular racial or cultural characteristics,
p.000002: - research on the human embryo (in vitro or in vivo),
p.000002: - research on human genetic or other biological materials,
p.000002: - research on vertebrate animals,
p.000002: - research in rare biological species (plants or animals),
p.000002: - research on potentially dangerous organisms for humanity and the environment, including
p.000002: genetically modified organisms.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: 2. Why is an ethics evaluation by a REC necessary?
p.000002:
p.000002:
p.000002: The above types of research put at risk fundamental values and social interests enjoying strict
p.000002: protection by international law, internationally recognized ethical rules, the legislation of the European Union
p.000002: and national legislation.
p.000002: These are, in particular, the respect for human dignity, the protection of physical integrity, the respect
p.000002: for privacy, the right to health, the protection of personal data, the protection of the environment and of
p.000002: biodiversity, etc.
...
Social / Access to Social Goods
Searching for indicator access:
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p.000003:
p.000004: 4
p.000004:
p.000004: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000004: Involving Human Subjects ,
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14).
p.000004:
p.000004: V. Research in groups with particular racial or cultural characteristics
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 11, 12).
p.000004:
p.000004: VI. Research in the human embryo
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly art.
p.000004: 18),
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly art.
p.000004: 7 on sensitive data of gamete donors),
p.000004: - Act 3089/2002 on assisted reproduction (particularly art. 1459 of the Civil Code),
p.000004: - Act 3305/2005 on assisted reproduction (particularly arts 11, 12).
p.000004:
p.000004:
p.000004: VII. Research on human genetic or other biological materials and research involving access to sensitive personal data
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 10, 21, 22),
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14 if involving sample processing that can reveal the identity of the person),
p.000004:
p.000004: - Presidential decree 26/2008, transferring Directive 2004/23/EC on setting standards of quality and
p.000004: safety for the donation, procurement, testing, processing, preservation, storage and distribution of
p.000004: human tissues and cells (particularly arts 12 – 14).
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: VIII. Research in vertebrates
p.000005: - Presidential decree 160/1991 transferring Directive 86/609/EC on the protection of animals used
p.000005: for experimental and other scientific purposes, (particularly arts 3 - 11),
p.000005: - Act 2015/1992 on the protection of vertebrates used for experimental and other scientific purposes
p.000005: (particularly arts 5 – 12).
p.000005:
p.000005: IX. Behavioural studies in primates other than humans
p.000005: - Presidential decree 160/1991 transferring Directive 86/609/EC on the protection of animals used
p.000005: for experimental and other scientific purposes (particularly arts 5, 6, 7, 10),
...
p.000009:
p.000009: To achieve transparency, the REC members who participate in the evaluation should expressly declare (in writing) at
p.000009: each meeting that they do not stand to gain any benefit whatsoever and are in no way involved in the
p.000009: proposals under consideration.
p.000009:
p.000009:
p.000009: 8. Obligations of RECs
p.000009:
p.000009: a) Justification of decisions
p.000009:
p.000009: The REC must justify its decisions and the justification must be communicated in writing to the researchers concerned.
p.000009:
p.000009: Decisions and evaluation procedures must be transparent and justified to ensure good cooperation between the ethics
p.000009: committee and researchers.
p.000009:
p.000009: b) Records – monitoring of proposals
p.000009:
p.000009: RECs must keep records of research applications and corresponding decisions and monitor the course of approved
p.000009: proposals.
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: To monitor the progress of proposals, RECs may ask the research team to submit progress reports and may
p.000010: evaluate the project anew if they think there is cause to do so.
p.000010: For the sake of transparency and the provision of information to the scientific community, RECs should
p.000010: produce annual reports including the categorization of the main ethical problems they encountered with and the
p.000010: solutions they offered. These reports will be submitted to the head of the research organization, communicated to
p.000010: the National Bioethics Commission, which may suggest ways of improvement on the operation of the institution, and
p.000010: publicized (e.g. on the website of the organization). The National Bioethics Commission may have access to the
p.000010: records if the REC so decides.
p.000010:
p.000010: c) The educational role of RECs
p.000010:
p.000010: RECs organize seminars and debates on ethical issues on their own initiative in order to provide information to and
p.000010: stimulate awareness amongst the staff of the research organizations in which they operate.
p.000010:
p.000010: Compliance with ethical principles in biological research depends above all on proper information and training of
p.000010: researchers.
p.000010: For this reason, RECs play a crucial educational role by providing constant information to the
p.000010: scientific personnel of research organizations on the ethics of research and the practical aspects of
p.000010: submission of research proposals for evaluation.
p.000010:
p.000010:
p.000010: 9. Funding of RECs
p.000010:
p.000010: The expenses of RECs are expected to be covered by the research account or another similar fund of the
p.000010: research organization.
p.000010:
p.000010: RECs have operating expenses as they require support by full-time or part-time staff (depending on the conditions
p.000010: of each research organization) to collect applications, organize meetings, keep records, coordinate and promote
p.000010: training actions and to meet their other obligations. Therefore, when a REC is created, the necessary funds for its
p.000010: unhindered operation must be ensured. Since the operation of RECs supports research, the necessary
p.000010: funds should at best originate from the research account.
p.000010:
p.000011: 11
p.000011:
p.000011: References
p.000011:
...
Social / Child
Searching for indicator children:
(return to top)
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: A GUIDE
p.000002: for Research Ethics Committees for Biological Research (RECs)
p.000002:
p.000002:
p.000002: In its effort to promote the creation of Research Ethics Committees for Biological Research Organisations
p.000002: in Greece – according to the model followed internationally for a number of years now – the National
p.000002: Bioethics Commission produced the following Guide which is expected to assist our research organizations
p.000002: (universities and research centres) to act accordingly. Obviously, the guide is intended only as a general framework
p.000002: of guidelines for the creation and operation of RECs. Each research organisation should complete it with more
p.000002: specialized rules depending on its mission and priorities.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Ι. Object of Research Ethics Committees
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1. Which types of research must be subject to an ethical evaluation?
p.000002:
p.000002:
p.000002: An ethics evaluation by a REC is currently recommended for the following types of research:
p.000002: - clinical trials of medicines or other interventional forms of treatment,
p.000002: - epidemiological studies,
p.000002: - research on human behaviour and the behaviour of other primates,
p.000002: - research of vulnerable population groups such as children, prisoners or mentally ill patients,
p.000002: - research of groups with particular racial or cultural characteristics,
p.000002: - research on the human embryo (in vitro or in vivo),
p.000002: - research on human genetic or other biological materials,
p.000002: - research on vertebrate animals,
p.000002: - research in rare biological species (plants or animals),
p.000002: - research on potentially dangerous organisms for humanity and the environment, including
p.000002: genetically modified organisms.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: 2. Why is an ethics evaluation by a REC necessary?
p.000002:
p.000002:
p.000002: The above types of research put at risk fundamental values and social interests enjoying strict
p.000002: protection by international law, internationally recognized ethical rules, the legislation of the European Union
p.000002: and national legislation.
p.000002: These are, in particular, the respect for human dignity, the protection of physical integrity, the respect
...
p.000003: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000003: Involving Human Subjects ,
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000003: 4 – 14).
p.000003:
p.000003: II. Population (epidemiological) studies
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 5, 10, 11, 12),
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (only in case of
p.000003: sample processing that can reveal the identity of the person, particularly arts 4 – 14),
p.000003: - UNESCO's Universal Declaration on the Human Genome and Human Rights (particularly arts 5 – 12),
p.000003: - UNESCO's International Declaration on Human Genetic Data (particularly arts 4 – 22 if involving sample
p.000003: processing that can reveal the identity of the person).
p.000003:
p.000003: III. Behavioural studies in humans
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000003: 4 – 14).
p.000003:
p.000003: IV. Research in sensitive population groups such as children, prisoners or mental patients
p.000003: - Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on
p.000003: medicinal products for human use (particularly arts 3, 4, 5, 6),
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Additional protocol to the Oviedo Convention concerning Biomedical Research,
p.000003:
p.000004: 4
p.000004:
p.000004: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000004: Involving Human Subjects ,
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14).
p.000004:
p.000004: V. Research in groups with particular racial or cultural characteristics
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 11, 12).
p.000004:
p.000004: VI. Research in the human embryo
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly art.
p.000004: 18),
...
Social / Racial Minority
Searching for indicator racial:
(return to top)
p.000002: in Greece – according to the model followed internationally for a number of years now – the National
p.000002: Bioethics Commission produced the following Guide which is expected to assist our research organizations
p.000002: (universities and research centres) to act accordingly. Obviously, the guide is intended only as a general framework
p.000002: of guidelines for the creation and operation of RECs. Each research organisation should complete it with more
p.000002: specialized rules depending on its mission and priorities.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Ι. Object of Research Ethics Committees
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1. Which types of research must be subject to an ethical evaluation?
p.000002:
p.000002:
p.000002: An ethics evaluation by a REC is currently recommended for the following types of research:
p.000002: - clinical trials of medicines or other interventional forms of treatment,
p.000002: - epidemiological studies,
p.000002: - research on human behaviour and the behaviour of other primates,
p.000002: - research of vulnerable population groups such as children, prisoners or mentally ill patients,
p.000002: - research of groups with particular racial or cultural characteristics,
p.000002: - research on the human embryo (in vitro or in vivo),
p.000002: - research on human genetic or other biological materials,
p.000002: - research on vertebrate animals,
p.000002: - research in rare biological species (plants or animals),
p.000002: - research on potentially dangerous organisms for humanity and the environment, including
p.000002: genetically modified organisms.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: 2. Why is an ethics evaluation by a REC necessary?
p.000002:
p.000002:
p.000002: The above types of research put at risk fundamental values and social interests enjoying strict
p.000002: protection by international law, internationally recognized ethical rules, the legislation of the European Union
p.000002: and national legislation.
p.000002: These are, in particular, the respect for human dignity, the protection of physical integrity, the respect
p.000002: for privacy, the right to health, the protection of personal data, the protection of the environment and of
p.000002: biodiversity, etc.
p.000002: RECs must examine whether a research project – in addition to its scientific adequacy which is evaluated by other
...
p.000003:
p.000003: III. Behavioural studies in humans
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000003: 4 – 14).
p.000003:
p.000003: IV. Research in sensitive population groups such as children, prisoners or mental patients
p.000003: - Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on
p.000003: medicinal products for human use (particularly arts 3, 4, 5, 6),
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Additional protocol to the Oviedo Convention concerning Biomedical Research,
p.000003:
p.000004: 4
p.000004:
p.000004: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000004: Involving Human Subjects ,
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14).
p.000004:
p.000004: V. Research in groups with particular racial or cultural characteristics
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 11, 12).
p.000004:
p.000004: VI. Research in the human embryo
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly art.
p.000004: 18),
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly art.
p.000004: 7 on sensitive data of gamete donors),
p.000004: - Act 3089/2002 on assisted reproduction (particularly art. 1459 of the Civil Code),
p.000004: - Act 3305/2005 on assisted reproduction (particularly arts 11, 12).
p.000004:
p.000004:
p.000004: VII. Research on human genetic or other biological materials and research involving access to sensitive personal data
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 10, 21, 22),
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14 if involving sample processing that can reveal the identity of the person),
p.000004:
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000002: - epidemiological studies,
p.000002: - research on human behaviour and the behaviour of other primates,
p.000002: - research of vulnerable population groups such as children, prisoners or mentally ill patients,
p.000002: - research of groups with particular racial or cultural characteristics,
p.000002: - research on the human embryo (in vitro or in vivo),
p.000002: - research on human genetic or other biological materials,
p.000002: - research on vertebrate animals,
p.000002: - research in rare biological species (plants or animals),
p.000002: - research on potentially dangerous organisms for humanity and the environment, including
p.000002: genetically modified organisms.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: 2. Why is an ethics evaluation by a REC necessary?
p.000002:
p.000002:
p.000002: The above types of research put at risk fundamental values and social interests enjoying strict
p.000002: protection by international law, internationally recognized ethical rules, the legislation of the European Union
p.000002: and national legislation.
p.000002: These are, in particular, the respect for human dignity, the protection of physical integrity, the respect
p.000002: for privacy, the right to health, the protection of personal data, the protection of the environment and of
p.000002: biodiversity, etc.
p.000002: RECs must examine whether a research project – in addition to its scientific adequacy which is evaluated by other
p.000002: responsible bodies – includes sufficient safeguards to ensure that the above values and interests are respected.
p.000002:
p.000002: 3. What is the practical importance of an ethics evaluation?
p.000002:
p.000002:
p.000002: At least for research funded by the European Union, a research proposal must pass the test of both, scientific and
p.000002: ethical evaluation.
p.000002: Ethical evaluation, however, has become the standard practice for any respectable contemporary research
p.000002: organization – irrespective of the source of funding – because it is an essential safeguard of reliability and a
p.000002: prerequisite for its acceptance by the public.
p.000002:
p.000002: 4. What are the main legal instruments governing this evaluation?
p.000002:
p.000002:
p.000002: A REC examines the specific compliance measures described in research proposals based mainly on the following
p.000002: instruments (laws and ethics codes):
p.000002:
p.000002: I. Clinical trials of medicines or other aggressive forms of treatment
p.000002:
p.000002: - Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on
p.000002: medicinal products for human use (particularly arts 3, 4, 5, 6),
p.000002: - European Convention on Human Rights and Biomedicine (Oviedo Convention, Act 2619/1998)
p.000002: (particularly arts 15, 16, 17),
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: - Additional protocol to the Oviedo Convention concerning Biomedical Research,
p.000003: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000003: Involving Human Subjects ,
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000003: 4 – 14).
p.000003:
...
Social / education
Searching for indicator educational:
(return to top)
p.000009: each meeting that they do not stand to gain any benefit whatsoever and are in no way involved in the
p.000009: proposals under consideration.
p.000009:
p.000009:
p.000009: 8. Obligations of RECs
p.000009:
p.000009: a) Justification of decisions
p.000009:
p.000009: The REC must justify its decisions and the justification must be communicated in writing to the researchers concerned.
p.000009:
p.000009: Decisions and evaluation procedures must be transparent and justified to ensure good cooperation between the ethics
p.000009: committee and researchers.
p.000009:
p.000009: b) Records – monitoring of proposals
p.000009:
p.000009: RECs must keep records of research applications and corresponding decisions and monitor the course of approved
p.000009: proposals.
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: To monitor the progress of proposals, RECs may ask the research team to submit progress reports and may
p.000010: evaluate the project anew if they think there is cause to do so.
p.000010: For the sake of transparency and the provision of information to the scientific community, RECs should
p.000010: produce annual reports including the categorization of the main ethical problems they encountered with and the
p.000010: solutions they offered. These reports will be submitted to the head of the research organization, communicated to
p.000010: the National Bioethics Commission, which may suggest ways of improvement on the operation of the institution, and
p.000010: publicized (e.g. on the website of the organization). The National Bioethics Commission may have access to the
p.000010: records if the REC so decides.
p.000010:
p.000010: c) The educational role of RECs
p.000010:
p.000010: RECs organize seminars and debates on ethical issues on their own initiative in order to provide information to and
p.000010: stimulate awareness amongst the staff of the research organizations in which they operate.
p.000010:
p.000010: Compliance with ethical principles in biological research depends above all on proper information and training of
p.000010: researchers.
p.000010: For this reason, RECs play a crucial educational role by providing constant information to the
p.000010: scientific personnel of research organizations on the ethics of research and the practical aspects of
p.000010: submission of research proposals for evaluation.
p.000010:
p.000010:
p.000010: 9. Funding of RECs
p.000010:
p.000010: The expenses of RECs are expected to be covered by the research account or another similar fund of the
p.000010: research organization.
p.000010:
p.000010: RECs have operating expenses as they require support by full-time or part-time staff (depending on the conditions
p.000010: of each research organization) to collect applications, organize meetings, keep records, coordinate and promote
p.000010: training actions and to meet their other obligations. Therefore, when a REC is created, the necessary funds for its
p.000010: unhindered operation must be ensured. Since the operation of RECs supports research, the necessary
p.000010: funds should at best originate from the research account.
p.000010:
p.000011: 11
p.000011:
p.000011: References
p.000011:
p.000011: Glasa J. (ed): Ethics Committees in Central and Eastern Europe, Proceedings of the International Bioethics
p.000011: Conferenece, Ethics Committees in Central and Eastern Europe - Present State and Perspectives for the
p.000011: 21st Century, Bratislava, Slovak Republic, October 26-27, Council of Europe, 2000, 266 pp. ISBN 80-88743-40-0
p.000011:
p.000011: Eckstein, Sue (ed.): Manual for Research Ethics Committees (Centre of Medical Law and Ethics, King’s College London),
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000002: Bioethics Commission produced the following Guide which is expected to assist our research organizations
p.000002: (universities and research centres) to act accordingly. Obviously, the guide is intended only as a general framework
p.000002: of guidelines for the creation and operation of RECs. Each research organisation should complete it with more
p.000002: specialized rules depending on its mission and priorities.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Ι. Object of Research Ethics Committees
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1. Which types of research must be subject to an ethical evaluation?
p.000002:
p.000002:
p.000002: An ethics evaluation by a REC is currently recommended for the following types of research:
p.000002: - clinical trials of medicines or other interventional forms of treatment,
p.000002: - epidemiological studies,
p.000002: - research on human behaviour and the behaviour of other primates,
p.000002: - research of vulnerable population groups such as children, prisoners or mentally ill patients,
p.000002: - research of groups with particular racial or cultural characteristics,
p.000002: - research on the human embryo (in vitro or in vivo),
p.000002: - research on human genetic or other biological materials,
p.000002: - research on vertebrate animals,
p.000002: - research in rare biological species (plants or animals),
p.000002: - research on potentially dangerous organisms for humanity and the environment, including
p.000002: genetically modified organisms.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: 2. Why is an ethics evaluation by a REC necessary?
p.000002:
p.000002:
p.000002: The above types of research put at risk fundamental values and social interests enjoying strict
p.000002: protection by international law, internationally recognized ethical rules, the legislation of the European Union
p.000002: and national legislation.
p.000002: These are, in particular, the respect for human dignity, the protection of physical integrity, the respect
p.000002: for privacy, the right to health, the protection of personal data, the protection of the environment and of
p.000002: biodiversity, etc.
p.000002: RECs must examine whether a research project – in addition to its scientific adequacy which is evaluated by other
p.000002: responsible bodies – includes sufficient safeguards to ensure that the above values and interests are respected.
p.000002:
p.000002: 3. What is the practical importance of an ethics evaluation?
...
p.000003: 4 – 14).
p.000003:
p.000003: IV. Research in sensitive population groups such as children, prisoners or mental patients
p.000003: - Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on
p.000003: medicinal products for human use (particularly arts 3, 4, 5, 6),
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Additional protocol to the Oviedo Convention concerning Biomedical Research,
p.000003:
p.000004: 4
p.000004:
p.000004: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000004: Involving Human Subjects ,
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14).
p.000004:
p.000004: V. Research in groups with particular racial or cultural characteristics
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 11, 12).
p.000004:
p.000004: VI. Research in the human embryo
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly art.
p.000004: 18),
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly art.
p.000004: 7 on sensitive data of gamete donors),
p.000004: - Act 3089/2002 on assisted reproduction (particularly art. 1459 of the Civil Code),
p.000004: - Act 3305/2005 on assisted reproduction (particularly arts 11, 12).
p.000004:
p.000004:
p.000004: VII. Research on human genetic or other biological materials and research involving access to sensitive personal data
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 10, 21, 22),
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14 if involving sample processing that can reveal the identity of the person),
p.000004:
p.000004: - Presidential decree 26/2008, transferring Directive 2004/23/EC on setting standards of quality and
p.000004: safety for the donation, procurement, testing, processing, preservation, storage and distribution of
p.000004: human tissues and cells (particularly arts 12 – 14).
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: VIII. Research in vertebrates
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000007: senate or board of directors).
p.000007:
p.000007:
p.000007: 4. Term of office
p.000007:
p.000007: The suggested term of office is from one (1) to three (3) years.
p.000007:
p.000007: The term of office is to be determined on the basis of the expected workload and in a way that allows as many
p.000007: members of the academic community as possible to gain experience on the ethical evaluation of research
p.000007: proposals.
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: It is important that the term of office allows the acquisition of necessary experience on evaluation but also deters
p.000008: the development of dependence relations between REC members and the researchers who submit proposals.
p.000008:
p.000008: 5. Meetings and quorum
p.000008:
p.000008: A REC meets frequently and at regular intervals depending on the number of submitted proposals. A quorum exists
p.000008: when at any one meeting the present members (indispensably including the president) outnumber the
p.000008: absent members and at least one present member does not come from the biological sciences.
p.000008:
p.000008: RECs must hold frequent meetings to avoid unnecessary delay in the onset of implementation of research
p.000008: proposals. For the efficient operation of the evaluation system, meetings should be held at regular
p.000008: intervals and on prefixed dates and the deadlines for the submission of proposals to be evaluated at each meeting
p.000008: should be determined well in advance. The usual practice internationally is for RECs to publish the schedule of their
p.000008: meetings for a whole academic or calendar year.
p.000008: The authority of RECs decisions is enhanced by the participation of members outside the biological sciences and
p.000008: laypersons outside the scientific community. It is desirable that decisions are made with interdisciplinary
p.000008: participation.
p.000008:
p.000008:
p.000008: 6. Members financial compensation
p.000008:
p.000008: The question of financial compensation is to be decided by individual research organizations.
p.000008:
p.000008: The members of the scientific community should consider their participation in the research organization’s
p.000008: REC as a duty. Especially scientists who submit proposals for evaluation by the REC should consider it as a return of
p.000008: services they have enjoyed and will enjoy in the future.
p.000008: At all events, it is at the discretion of the research organization to decide whether the members of the REC
p.000008: (especially those not working for the organization) are to be compensated.
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: 7. Decisions
p.000009:
p.000009: The REC decides if in quorum and provided that all supporting documents have been submitted by the principle
p.000009: investigator. The REC may, if necessary, call in independent experts or the National Bioethics Commission
p.000009: for assistance. Decisions are made without the presence of independent guest experts and, if possible,
p.000009: unanimously. Members with conflict of interest must abstain from the decision-making process and be substituted with
p.000009: deputy members.
p.000009:
p.000009: During the evaluation procedure researchers submitting research proposals are warned of eventual ethical problems
p.000009: so that they may modify the research protocol appropriately.
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000002:
p.000002: 3. What is the practical importance of an ethics evaluation?
p.000002:
p.000002:
p.000002: At least for research funded by the European Union, a research proposal must pass the test of both, scientific and
p.000002: ethical evaluation.
p.000002: Ethical evaluation, however, has become the standard practice for any respectable contemporary research
p.000002: organization – irrespective of the source of funding – because it is an essential safeguard of reliability and a
p.000002: prerequisite for its acceptance by the public.
p.000002:
p.000002: 4. What are the main legal instruments governing this evaluation?
p.000002:
p.000002:
p.000002: A REC examines the specific compliance measures described in research proposals based mainly on the following
p.000002: instruments (laws and ethics codes):
p.000002:
p.000002: I. Clinical trials of medicines or other aggressive forms of treatment
p.000002:
p.000002: - Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on
p.000002: medicinal products for human use (particularly arts 3, 4, 5, 6),
p.000002: - European Convention on Human Rights and Biomedicine (Oviedo Convention, Act 2619/1998)
p.000002: (particularly arts 15, 16, 17),
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: - Additional protocol to the Oviedo Convention concerning Biomedical Research,
p.000003: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000003: Involving Human Subjects ,
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000003: 4 – 14).
p.000003:
p.000003: II. Population (epidemiological) studies
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 5, 10, 11, 12),
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (only in case of
p.000003: sample processing that can reveal the identity of the person, particularly arts 4 – 14),
p.000003: - UNESCO's Universal Declaration on the Human Genome and Human Rights (particularly arts 5 – 12),
p.000003: - UNESCO's International Declaration on Human Genetic Data (particularly arts 4 – 22 if involving sample
p.000003: processing that can reveal the identity of the person).
p.000003:
p.000003: III. Behavioural studies in humans
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000003: 4 – 14).
p.000003:
p.000003: IV. Research in sensitive population groups such as children, prisoners or mental patients
p.000003: - Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on
p.000003: medicinal products for human use (particularly arts 3, 4, 5, 6),
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Additional protocol to the Oviedo Convention concerning Biomedical Research,
p.000003:
p.000004: 4
p.000004:
p.000004: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000004: Involving Human Subjects ,
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14).
p.000004:
p.000004: V. Research in groups with particular racial or cultural characteristics
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 11, 12).
p.000004:
p.000004: VI. Research in the human embryo
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly art.
p.000004: 18),
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly art.
p.000004: 7 on sensitive data of gamete donors),
p.000004: - Act 3089/2002 on assisted reproduction (particularly art. 1459 of the Civil Code),
p.000004: - Act 3305/2005 on assisted reproduction (particularly arts 11, 12).
p.000004:
p.000004:
p.000004: VII. Research on human genetic or other biological materials and research involving access to sensitive personal data
...
General/Other / oviedo
Searching for indicator oviedo:
(return to top)
p.000002: biodiversity, etc.
p.000002: RECs must examine whether a research project – in addition to its scientific adequacy which is evaluated by other
p.000002: responsible bodies – includes sufficient safeguards to ensure that the above values and interests are respected.
p.000002:
p.000002: 3. What is the practical importance of an ethics evaluation?
p.000002:
p.000002:
p.000002: At least for research funded by the European Union, a research proposal must pass the test of both, scientific and
p.000002: ethical evaluation.
p.000002: Ethical evaluation, however, has become the standard practice for any respectable contemporary research
p.000002: organization – irrespective of the source of funding – because it is an essential safeguard of reliability and a
p.000002: prerequisite for its acceptance by the public.
p.000002:
p.000002: 4. What are the main legal instruments governing this evaluation?
p.000002:
p.000002:
p.000002: A REC examines the specific compliance measures described in research proposals based mainly on the following
p.000002: instruments (laws and ethics codes):
p.000002:
p.000002: I. Clinical trials of medicines or other aggressive forms of treatment
p.000002:
p.000002: - Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on
p.000002: medicinal products for human use (particularly arts 3, 4, 5, 6),
p.000002: - European Convention on Human Rights and Biomedicine (Oviedo Convention, Act 2619/1998)
p.000002: (particularly arts 15, 16, 17),
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: - Additional protocol to the Oviedo Convention concerning Biomedical Research,
p.000003: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000003: Involving Human Subjects ,
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000003: 4 – 14).
p.000003:
p.000003: II. Population (epidemiological) studies
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 5, 10, 11, 12),
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (only in case of
p.000003: sample processing that can reveal the identity of the person, particularly arts 4 – 14),
p.000003: - UNESCO's Universal Declaration on the Human Genome and Human Rights (particularly arts 5 – 12),
p.000003: - UNESCO's International Declaration on Human Genetic Data (particularly arts 4 – 22 if involving sample
p.000003: processing that can reveal the identity of the person).
p.000003:
p.000003: III. Behavioural studies in humans
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000003: 4 – 14).
p.000003:
p.000003: IV. Research in sensitive population groups such as children, prisoners or mental patients
p.000003: - Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on
p.000003: medicinal products for human use (particularly arts 3, 4, 5, 6),
p.000003: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000003: 15, 16, 17),
p.000003: - Additional protocol to the Oviedo Convention concerning Biomedical Research,
p.000003:
p.000004: 4
p.000004:
p.000004: - Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research
p.000004: Involving Human Subjects ,
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14).
p.000004:
p.000004: V. Research in groups with particular racial or cultural characteristics
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 11, 12).
p.000004:
p.000004: VI. Research in the human embryo
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly art.
p.000004: 18),
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly art.
p.000004: 7 on sensitive data of gamete donors),
p.000004: - Act 3089/2002 on assisted reproduction (particularly art. 1459 of the Civil Code),
p.000004: - Act 3305/2005 on assisted reproduction (particularly arts 11, 12).
p.000004:
p.000004:
p.000004: VII. Research on human genetic or other biological materials and research involving access to sensitive personal data
p.000004: - European Convention on Human Rights and Biomedicine (Oviedo Convention) (particularly arts
p.000004: 5, 6, 10, 21, 22),
p.000004: - Act 2472/1997 on the Protection of Individuals with regard to the Processing of Personal Data (particularly arts
p.000004: 4 – 14 if involving sample processing that can reveal the identity of the person),
p.000004:
p.000004: - Presidential decree 26/2008, transferring Directive 2004/23/EC on setting standards of quality and
p.000004: safety for the donation, procurement, testing, processing, preservation, storage and distribution of
p.000004: human tissues and cells (particularly arts 12 – 14).
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: VIII. Research in vertebrates
p.000005: - Presidential decree 160/1991 transferring Directive 86/609/EC on the protection of animals used
p.000005: for experimental and other scientific purposes, (particularly arts 3 - 11),
p.000005: - Act 2015/1992 on the protection of vertebrates used for experimental and other scientific purposes
p.000005: (particularly arts 5 – 12).
p.000005:
p.000005: IX. Behavioural studies in primates other than humans
p.000005: - Presidential decree 160/1991 transferring Directive 86/609/EC on the protection of animals used
p.000005: for experimental and other scientific purposes (particularly arts 5, 6, 7, 10),
p.000005: - Act 2015/1992 on the protection of vertebrates used for experimental and other scientific purposes
p.000005: (particularly arts 5, 6, 7, 9, 10).
p.000005:
...
Orphaned Trigger Words
p.000008: laypersons outside the scientific community. It is desirable that decisions are made with interdisciplinary
p.000008: participation.
p.000008:
p.000008:
p.000008: 6. Members financial compensation
p.000008:
p.000008: The question of financial compensation is to be decided by individual research organizations.
p.000008:
p.000008: The members of the scientific community should consider their participation in the research organization’s
p.000008: REC as a duty. Especially scientists who submit proposals for evaluation by the REC should consider it as a return of
p.000008: services they have enjoyed and will enjoy in the future.
p.000008: At all events, it is at the discretion of the research organization to decide whether the members of the REC
p.000008: (especially those not working for the organization) are to be compensated.
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: 7. Decisions
p.000009:
p.000009: The REC decides if in quorum and provided that all supporting documents have been submitted by the principle
p.000009: investigator. The REC may, if necessary, call in independent experts or the National Bioethics Commission
p.000009: for assistance. Decisions are made without the presence of independent guest experts and, if possible,
p.000009: unanimously. Members with conflict of interest must abstain from the decision-making process and be substituted with
p.000009: deputy members.
p.000009:
p.000009: During the evaluation procedure researchers submitting research proposals are warned of eventual ethical problems
p.000009: so that they may modify the research protocol appropriately.
p.000009: At all events, the aim of evaluation should be to improve on the ethics of research proposals and not to
p.000009: raise bureaucratic obstacles. A total rejection of proposals is justified only exceptionally if the ethical
p.000009: problems are insurmountable (e.g. proposals for research in the reproductive cloning of human beings which is against
p.000009: the law).
p.000009:
p.000009: To achieve transparency, the REC members who participate in the evaluation should expressly declare (in writing) at
p.000009: each meeting that they do not stand to gain any benefit whatsoever and are in no way involved in the
p.000009: proposals under consideration.
p.000009:
p.000009:
p.000009: 8. Obligations of RECs
p.000009:
p.000009: a) Justification of decisions
p.000009:
p.000009: The REC must justify its decisions and the justification must be communicated in writing to the researchers concerned.
p.000009:
p.000009: Decisions and evaluation procedures must be transparent and justified to ensure good cooperation between the ethics
p.000009: committee and researchers.
p.000009:
p.000009: b) Records – monitoring of proposals
p.000009:
p.000009: RECs must keep records of research applications and corresponding decisions and monitor the course of approved
p.000009: proposals.
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: To monitor the progress of proposals, RECs may ask the research team to submit progress reports and may
p.000010: evaluate the project anew if they think there is cause to do so.
p.000010: For the sake of transparency and the provision of information to the scientific community, RECs should
p.000010: produce annual reports including the categorization of the main ethical problems they encountered with and the
p.000010: solutions they offered. These reports will be submitted to the head of the research organization, communicated to
...
p.000010: of each research organization) to collect applications, organize meetings, keep records, coordinate and promote
p.000010: training actions and to meet their other obligations. Therefore, when a REC is created, the necessary funds for its
p.000010: unhindered operation must be ensured. Since the operation of RECs supports research, the necessary
p.000010: funds should at best originate from the research account.
p.000010:
p.000011: 11
p.000011:
p.000011: References
p.000011:
p.000011: Glasa J. (ed): Ethics Committees in Central and Eastern Europe, Proceedings of the International Bioethics
p.000011: Conferenece, Ethics Committees in Central and Eastern Europe - Present State and Perspectives for the
p.000011: 21st Century, Bratislava, Slovak Republic, October 26-27, Council of Europe, 2000, 266 pp. ISBN 80-88743-40-0
p.000011:
p.000011: Eckstein, Sue (ed.): Manual for Research Ethics Committees (Centre of Medical Law and Ethics, King’s College London),
p.000011: 6th edition. Cambridge: Cambridge University Press, 2003, 558 pp. ISBN 0-521-81004-3
p.000011:
p.000011: National Research Council: Guide for the Care and Use of Laboratory Animals, National Academy Press,
p.000011: Washington D.C., 1996, 128 pp. ISBN 0-309-05377-3
p.000011:
p.000011: Sieber, Joan E.: Planning Ethically Responsible Research: A Guide for Students and Internal Review Boards, Applied
p.000011: Social Research Methods Series, Vol. 31, Sage Publications, 1992, Newbury Park, CA
p.000011:
p.000011: UNESCO: Establishing Bioethics Committees, Guide No1, 2005, Division of Ethics of Science and Technology, SHS/B
p.000011: 10-2005/01
p.000011:
p.000011: National Bioethics Commission: Ethics Committees in Research, chapter 10, Positions on Contemporary
p.000011: Problems – articles 2000 – 2007, 2007, National Printing House (the full text of the book is available on the
p.000011: Commission’s website at: http://www.bioethics.gr/media/pdf/bioethics2.pdf ).
p.000011:
p.000011: T. Vidalis and K. Manolakou (editor): Documents on Bioethics, National Commission of Bioethics, Eds.
p.000011: Sakkoulas, 2002, p. 493, ISBN 960-15-0716-7.
p.000011:
p.000011: (International documents and Greek Legislation on bioethics, grouped in thematic sections, can be
p.000011: consulted on the website of the Commission at
p.000011: http://www.bioethics.gr/category.php?category_id=63 )
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| children | Child |
| dependence | Drug Dependence |
| educational | education |
| embryo | embryo |
| helsinki | declaration of helsinki |
| ill | ill |
| mentally | Mentally Disabled |
| oviedo | oviedo |
| prisoners | Criminal Convictions |
| racial | Racial Minority |
| union | Trade Union Membership |
| volunteers | Healthy People |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
cultural
ethics
protection
risk
sensitive
Applicable Type / Vulnerability / Indicator Overlay for this Input