LG21 O’Reilly Institute Ethics in H2020 EU proposals · 2019-04-05 · A World Leading SFI Research Centre All research funded under H2020 must comply with Ethical Principles The

Ethics in H2020 EU proposals

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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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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



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)


The General Ethical Issues

The Ethical issues Table in EU Proposals – Part A

Ethics Self-Assessment – Part B

Outline



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



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



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



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)


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


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


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


You need to provide:

Details of the provider (company or other).

Copies of Import licences (if relevant)

Commercial Sources


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


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


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


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


Maximise the benefits while minimising the risk/harm

General Principle for Invasive Techniques


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



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


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


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


‘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


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


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



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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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



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




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




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



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



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



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



The proposers must confirm that the project will be conducted with reference to EU and International legislation

Proposals involving non EU participants





Self Assessment


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)


http://ec.europa.eu/research/participants/data/ref/fp7/89807/informed-consent_en.pdf

http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/ethics-guide-ethnog-anthrop_en.pdf


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)

http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/guide_research-refugees-migrants_en.pdf

http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/ethics-guide-fmri_en.pdf

https://www.cites.org


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)

https://ec.europa.eu/jrc/en/eurl/ecvam

http://ec.europa.eu/environment/chemicals/lab_animals/index_en.htm

http://ec.europa.eu/research/participants/data/ref/fp7/89817/international-cooperation_en.pdf


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)

http://www.europarl.europa.eu/RegData/etudes/IDAN/2015/573876/EPRS_IDA(2015)573876_EN.pdf

http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/guide_research-civil-apps_en.pdf

http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/ethics-guide-advisors_en.pdf


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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LG21 O’Reilly Institute Ethics in H2020 EU proposals · 2019-04-05 · A World Leading SFI Research Centre All research funded under H2020 must comply with Ethical Principles The