lg21 o’reilly institute ethics in h2020 eu proposals · 2019-04-05 · a world leading sfi...
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A World Leading SFI Research Centre
How to deal with Ethical Issues in Career – FIT Marie Curie EU Projects
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My Brief
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All research funded under H2020 must comply with Ethical Principles
The onus is on the Applicant to describe the ethical issues in the proposal and demonstrate that they comply with National, European and International regulations
The applicant is also expected to provide details of how they propose to deal with ALL ethical issues in the proposal
Article 34, originally published in July 2016, titled “Guidance – How to complete your ethics self-assessment” The present version is 6.1, February 2019.
http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf
Introduction
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Research activities directed at human cloning for reproductive purposes
Research activity intended to modify the genetic make-up of human beings that could make such changes heritable (apart from research relating to cancer treatment of the gonads, which may be financed)
Research activities intended to create human embryos solely for the purposes of research or stem cell procurement, including the technique of somatic cell nuclear transfer
Research that leads to the destruction of human embryos.
Research NOT funded (Article 34)
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The General Ethical Issues
The Ethical issues Table in EU Proposals – Part A
Ethics Self-Assessment – Part B
Outline
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Ethics related to:
• Human Rights and the protection of human beings
• Animal welfare and protection
• Data protection (including GDPR) and privacy
• Environmental protection
• Developing Countries
• Dual use
• Research integrity – falsification, plagiarism misrepresentation etc.
Main Focus
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Methodology
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Headings on the Ethical Issues Table are:• Human Embryos/Foetuses
• Humans
• Human Cells/Tissues
• Personal Data
• Animals
• Third Countries
• Environment & Health and Safety
• Dual Use
• Exclusive Focus on Civil Applications
• Misuse
• Other Ethical Issues
There are also sub-headings within the above
There is also a column where the page number identifying where the Ethical Issues are included in the proposal.
Ethical Issues Table – Part A
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Each Ethical Issue identified in the Ethical Issues Table in Part A must be elaborated on in the Ethics Self-Assessment – Part B
The elaboration must contain confirmation that the proposer is fully aware of the ethical issues involved in the proposed research
They must also state that they are familiar with the relevant legislation and ethical standards expected in H2020 proposals
They must confirm that they will comply with above by implementing the necessary procedures
They must state how they will address the various issues
The guidance document on Article 34 should be consulted
Ethics Self-Assessment – Part B
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See Article 19(1) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013
cells were NOT derived from embryos specially created for research or by somatic cell nuclear transfer
the project uses existing cultured cell lines only
cell lines were derived from supernumerary non-implanted embryos resulting from in vitro fertilisation
informed consent has been obtained for using donated embryos for the derivation of the cell lines
personal data and privacy of donors of embryos for the derivation of the cells are protected
NO financial inducements were provided for the donation of embryos used for derivation of the cell lines
Human Embryonic Stem Cells (hESC)
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Any research involving work with humans (‘research or study participants’), regardless of its nature or topic of the work.
Examples: collection of biological samples, personal data, medical interventions, interviews, observations, tracking or the secondary use of information provided for other purposes, e.g. other research projects, officially collected information, social media sites, etc.
Humans
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Volunteers for social or human sciences research –local ethical approval must be got and the participants must be given Information Sheets and then Consent Forms which must be signed.
Persons unable to give informed consent
Vulnerable individuals or groups
Children or minors
Patients
Healthy volunteers for medical studies
For all of the above groups you must identify how each group will be identified and recruited
Justification for using vulnerable and/or children and/or minors and/or patients
Humans
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This refers to research using, invasive techniques producing or collecting human cells or tissues.
You may obtain cells or tissues:
• from commercial sources
• as part of this research project
• from another research project, laboratory or institution
• from a biobank.
Must comply with applicable international, EU and national law in particular, EU Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p.48).
Human cells or tissues
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You need to provide:
Details of the provider (company or other).
Copies of Import licences (if relevant)
Commercial Sources
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In this case you need to provide:
Details of the source of the material, the amount to be collected and the procedure for collection.
Details of the duration of storage and what you will do with the material at the end of the research.
Confirm that informed consent has been obtained.
Copies of Information Sheets and Consent Forms
Obtained in the project
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You need to provide:
Country and Laboratory/Institution where the material is stored.
Details of the legislation under which material is stored.
How long will the material be stored and what will you do with it at the end of the research project?
Confirm that material is fully anonymised or that consent for secondary use has been obtained.
Copies of import licences (if relevant).
Statement of laboratory/institution that informed consent has been obtained.
Obtained from Another Project, Laboratory or Institution
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You will need to supply:
The Name and the Country where the biobank is located.
Details of the legislation under which material is stored.
Confirm that material is fully anonymised or that consent for secondary use has been obtained.
Copies of import licences (if relevant).
Statement from the biobank that informed consent has been obtained.
Biobank
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Cells or Tissues from Clinical Practice (secondary use) for Example:
Waste Material
Additional Material
Future Research
Setting up a Biobank
Genetic Testing – Personal Data
Transfer to or from the EU
Specific Issues
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Maximise the benefits while minimising the risk/harm
General Principle for Invasive Techniques
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Must obtain independent Ethical Approval
Must obtain and document the participants INFORMED consent
For children and/or vulnerable adults or those unable to give consent. “You must obtain informed consent from the legally authorised representative and ensure that they have sufficient information to enable them to provide this on behalf and in the best interests of the participants. Whenever possible, the assent of the participants should be obtained in addition to the consent of the parents or legal representatives. Participants must be asked for consent if they reach the age of majority in the course of the experiment.”
Requirements for Invasive Techniques
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Research involving children (or other persons unable to give consent) — should be carried out only if:
Studies with consenting adults would not be effective
Participants are subject to only a minimal risk and burden
The results of the research will benefit the individual or group represented by the participant.
Children and/or those unable to give consent
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This typically Involves:
Potentially vulnerable groups and people unable to give informed consent
Personal or sensitive topics, which might induce psychological stress, anxiety or humiliation
Deception
Risks to Researcher Safety
Seeking respondents through the internet/social media (e.g. using identifiable visual images or discussing sensitive issues ).
Minimal Risk Research
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Pay particular attention to:
Children
Patients
People subject to discrimination
Minorities
People unable to give consent
People of dissenting opinion
Immigrant or minority communities
Sex workers, etc.
Vulnerable Groups
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‘Personal data’ means information relating to an identified or identifiable natural person.
An identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person (art. 2(a) EU General Data Protection Regulation (GDPR).
Examples: name, address, identification number, pseudonym, occupation, e-mail, CV, location data, Internet Protocol (IP) address, cookie ID, phone number, data provided by smart meters, data held by a hospital or doctor.
Data – Definition of Personal Data
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Research which involves collecting or processing personal data, regardless of the method used (e.g. interviews, questionnaires, direct online retrieval, ICT research, genetic sample collection, tissue storage, personal records (financial, criminal, education, etc.), lifestyle and health information, family histories, physical characteristics, gender and ethnic background, location tracking and domicile information, etc.).
Examples of collecting: name, address, identification number, e-mail, CV, bank account number, phone number, medical records etc.
Examples of Processing: creating a mailing list or a list of participants, managing a database, accounting records on personnel costs, time-sheets, project planning with names.
Personal Data
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Requirements:
Details of the technical and organisational measures to safeguard the rights of the research participants.
For organisations that must appoint a DPO under the GDPR: Involvement of the data protection officer (DPO) and disclosure of the contact details to the research participants.
For all other organisations: Details of the data protection policy for the project (i.e. project-specific, not general).
Details of the informed consent procedures.
Details of the security measures to prevent unauthorised access to personal data.
How is all of the processed data relevant and limited to the purposes of the project (“data minimisation principle”).
Details of the anonymisation /pseudonymisation techniques.
Justification of why research data will not be anonymised/ pseudonymised (if relevant).
Details of the data transfers (type of data transferred and country to which it is transferred – (for both EU and non-EU countries).
Processing of Personal Data
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Examples:
Genetic
Health
Sexual lifestyle
Ethnicity
Political opinion
Religious or philosophical conviction
You need to state:
Justification for the processing of special categories of personal data.
Why can the research objectives not be reached by processing anonymised/ pseudonymised data (if applicable)?
Special Categories of Personal Data
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If the processing involves profiling, systematic monitoring of individuals or processing of large scale of special categories of data, intrusive methods of data processing (such as, tracking, surveillance, audio and video recording, geo-location tracking etc.) or any other data processing operation that may result in high risk to the rights and freedoms of the research participants?
You must consider:
Details of the methods used for tracking, surveillance or observation of participants.
Details of the methods used for profiling.
Risk assessment for the data processing activities.
How will harm be prevented and the rights of the research participants safeguarded?
Details on the procedures for informing the research participants about profiling, and its possible consequences and the protection measures.
Special Categories of Data
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You must consider:
Details of the database used or of the source of the data.
Details of the data processing operations.
How will the rights of the research participants be safeguarded? Explain.
How is all of the processed data relevant and limited to the purposes of the project. ( the data minimisation principle)
Justification of why the research data will not be anonymised/ pseudonymised (if relevant).
Secondary Use of Data
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For import/export of personal data to/from the EU you must say:
Details of the types of personal data to be imported/exported.
How will the rights of the research participants be safeguarded?
Confirmation must also be made that confirming compliance with Chapter V of the GDPR for exporting data and for importing data a Declaration confirming compliance with the laws of the country in which the data was collected.
Import/Export of Personal Data
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Risk and Consent Forms
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Non Human Primates
Why are NHPs the only research subjects suitable for achieving your scientific objectives?
What is the purpose of the animal testing?
Where do the animals come from?
Animals – NHP
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Details of the phenotype and any inherent suffering expected.
What scientific justification is there for producing such animals?
What measures will you take to minimise suffering in breeding, maintaining the colony and using the GM animals?
Animals – GM
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Details of the phenotype and any inherent suffering expected.
What scientific justification is there for producing such animals?
What measures will you take to minimise suffering in breeding, maintaining the colony and using of the GM animals?
Animals – cloned
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Why is there no alternative to using this species?
What is the purpose of the research?
Copies of authorisations for supply of endangered animal species (including CITES). (Convention on International Trade in endangered Species of Wild Fauna and Flora)
Animals – Endangered Species
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Incidental Findings
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Replacement — replacing animal use by an alternative method or testing strategy (without use of live animals).
Examples
• ‘Higher' animals can be replaced by 'lower' animals: microorganisms,
plants, eggs, reptiles, amphibians, and invertebrates may be used in
some studies to replace warm-blooded animals.
• Live animals may be replaced by non-animal models, such as dummies
for an introduction to dissection for teaching the structure of the animal
or the human body, mechanical or computer models, audio-visual aids,
or in vitro modelling.
Reduction — reducing the number of animals used.
Refinement — improving the breeding, accommodation and care of animals and the methods used to minimise pain, suffering, distress or lasting harm to animals.
Animals – the three R’s
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Animals
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research activities are conducted, partially or wholly, in a non-EU country
participants or resources come from a non-EU country
material is imported from or exported to a non-EU country.
Being outside the reach of European laws and standards, such research can raise specific ethical issues (particularly in developing countries), such as:
• exploitation of research participants
• exploitation of local resources
• risks to researchers & staff
• research that is prohibited in the EU.
Non EU Countries
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Identify the Activities and Countries and do a Risk/Benefit Analysis
Copy of all approvals and licences for Import/Export
Details of the benefit sharing measures.
Details of the responsiveness to local research needs.
Details of the procedures to facilitate effective capacity building.
Details of the safety measures you intend to take, including training for staff and insurance cover.
Non EU Countries – Ethical Issues
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Research that may adversely affect:
• the environment or
• the health & safety of the researchers involved.
This may be due to any of the following:
• the experimental design of the research itself
• undesirable side-effects of the technologies used.
The health and safety of all human participants in research – as subjects, investigators or uninvolved third parties, must be a priority in all research studies.
Environment, Health and Safety
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If the research involves the use of elements that may cause harm to the environment, to animals or plants? A full Risk/Benefit Analysis must be carried out.
Show how you apply the precautionary principle (if relevant).
What safety measures will you take?
Safety classification of laboratory.
Copy of GMO and any other specific authorisations
Environment
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The precautionary principle enables decision-makers to adopt precautionary measures when scientific evidence about an environmental or human health hazard is uncertain and the stakes are high.
The Precautionary Principle
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The health and safety of all human participants in research - as subjects, investigators or uninvolved third parties, must be a priority in all research studies.
The kinds of risk to researcher safety vary according to the nature of the discipline, the topic and the research site. All Health and Safety Procedures should be detailed.
However, research in both familiar and unfamiliar settings can involve added safety concerns.
In certain types of research, the risk of harm to the researcher is caused by the topic of study or by the actions of the researchers themselves.
Health and Safety
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Dual-use items are normally used for civilian purposes but may have military applications, or may contribute to the proliferation of weapons of mass destruction.
Only research that has an exclusive focus on civil applications is eligible for funding.
However, this does not rule out the participation of military partners or the development of generic technologies, products or knowledge that may meet the needs of both civil and military end-users (known as 'dual-use' goods or technologies), provided that the research itself has a clear focus on civil applications
Dual Use
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Items are considered as Dual Use items if the research involves goods, software and technologies covered by the EU Export Control Regulation No 482/2009. These dual-use items are normally used for civilian purposes but may have military applications, or may contribute to the proliferation of weapons of mass destruction. If this is the case it must be identified:
What goods and information used and produced in the research will need export licences?
How exactly will compliance be ensured?
How exactly will you negative implications be avoided?
Dealing with Dual Use
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However, this does not rule out the participation of military partners or the development of generic technologies, products or knowledge that may meet the needs of both civil and military end-users (known as 'dual-use' goods or technologies), provided that the research itself has a clear focus on civil applications.
In this case:
Explain the exclusive civilian focus of your research.
Justify inclusion of military partners or military technologies
Exclusive Focus on Civil Applications
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This concerns research involving or generating materials, methods, technologies or knowledge that could be misused for unethical purposes. Although such research is usually carried out with benign intentions, it has the potential to harm humans, animals or the environment.
Could the materials/methods/technologies and knowledge involved or generated harm humans, animals or the environment if they were modified or enhanced?
What would happen if the materials/methods/technologies and knowledge involved or generated ended up in the wrong hands?
Could the materials/methods/technologies and knowledge involved or generated serve purposes other than those intended? If so, would such use be unethical?
You must conduct a risk-assessment and take appropriate steps to avoid misuse.
You must also comply with the numerous international, EU and national laws that address concerns relating to potential misuse of materials, technologies and information
Potential misuse of research results
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Example of Misuse
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Copies of Insurance where relevant
• In the case of medical research this is often a requirement
Confirm approval for secondary use of data
• If data has been collected for a previous research project then consent
must be sought for the re-use of the data, unless it is anonymised.
Under the GDPR (General Data Protection Regulation – 25th May 2018)
consent must be proved by the researcher
How will subjects be recruited – number, children or vulnerable persons
• How many and the statistical justification for them
• All inclusion/exclusion criteria and why
• Level of compensation
• If biological samples what type, how many, storage etc
• Risks and Benefits
• How risks will be handled
Typical types of Requirements
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Animals
• The type of animals
• How many with statistical justification
• Animal welfare
• Relevant licences
• Three R’s (Replacement, Reduction and Refinement )
Handling of risks
• Risks to staff as well as participants
Handling of incidental findings
• In Medical Research
Typical types of Requirements
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Ethics Training
• Ensure that all those involved in the research are trained in ethics
Appoint an external ethics advisor
• Must be totally independent
Appoint an ethics board
• This chair should be external to the project
• Should have independent experts with experience relative to the field of
research
Ethical report with general reports
• An ethical report should be submitted at the same time as other
required reports
Developing Countries
• Ensure that there is fair benefit sharing
Guarding against possible dual use or misuse
Typical types of Requirements
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All activities MUST conform to local/national and international legislation
No matter where in the World the research is carried out it MUST conform strictly to H2020 ethical standards and guidelines
Guarding against possible Dual Use or Misuse
Guard against malevolent/criminal/terrorist abuse
Typical types of requirement
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A proposal will be rejected if it:
• Does not comply with the requirements from the screening or
assessment procedure
• Is in breach of ethical principles or is
• In breach of relevant legislation
Rejection
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Some projects may be asked to include a report on the Ethical Issues at the same time as the regular reports
Some projects may be monitored by audit to ensure that they comply with ethical issues this is rare and only happens where the proposal has had prolonged screening or assessments due to proposers showing that they have limited knowledge of ethical issues and how to handle them
Ethics Monitoring
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An Ethics Check can be carried out at any stage during the project
If the check is found to be in breach of any ethical issues an ethical audit can be carried out
Ethics checks and audits
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The proposers must confirm that the project will be conducted with reference to EU and International legislation
Proposals involving non EU participants
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Self Assessment
http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf
Informed Consent
http://ec.europa.eu/research/participants/data/ref/fp7/89807/informed-consent_en.pdf
Ethnography and Anthropology
http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/ethics-guide-ethnog-anthrop_en.pdf
References (1)
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Refugees and Migrants
http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/guide_research-refugees-migrants_en.pdf
FMRI
http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/ethics-guide-fmri_en.pdf
Endangered Species
https://www.cites.org
References (2)
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Alternative to animal testing
https://ec.europa.eu/jrc/en/eurl/ecvam
Research on animals
http://ec.europa.eu/environment/chemicals/lab_animals/index_en.htm
Developing Countries
http://ec.europa.eu/research/participants/data/ref/fp7/89817/international-cooperation_en.pdf
References (3)
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The Precautionary Principle
http://www.europarl.europa.eu/RegData/etudes/IDAN/2015/573876/EPRS_IDA(2015)573876_EN.pdf
Civil Applications
http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/guide_research-civil-apps_en.pdf
Role of Ethics Advisors
http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/ethics-guide-advisors_en.pdf
References (4)
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FP7: Recommendations on the ethical review of hESC FP7 research projects (Opinion 22), European Group on Ethics in Science and New Technologies.
FP7 guidance: Research on Human embryos/foetus.
EU Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
The ARRIVE Guidelines — Animal Research: Reporting In Vivo Experiments. FestingMFW, Overend P, Gaines Das R, Cortina Borja M, Berdoy M (2002), The design of animal experiments: reducing the number of animals in research through better experimental design, Laboratory Animal Handbooks Series, 14. London: Royal Society of Medicine Press.
Hooijmans C. et al. (2010), A gold standard publication checklist to improve the quality of animal studies, to fully integrate the Three Rs, and to make a systematic review more feasible, ATLA 38: 167-182.
For alternatives to animal testing, refer to the following website: http://ecvam.jrc.it/
More References
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The End of…….!!!!
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Almost and Finally Finally …
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Thank you for your attention
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