Crucial information for the Seventh Framework Programme applicants who have identified ethical issues in the Guide for Proposers checklist

You identified possible ethical issues in your proposed research project by ticking one or more "yes" in the Guide for Proposers checklist. Please examine carefully the following specifications and explanations and ensure that you give sufficient and clear information in your research proposals on the subject(s) identified.

1. Specification of the issues identified:
   
   

   Please indicate whether the proposal involves
   Informed Consent
   Does the proposal involve children?
   Does the proposal involve patients or persons not able to give consent?
   Does the proposal involve adult healthy volunteers?
   Does the proposal involve Human Genetic Material?
   Does the proposal involve Human biological samples?
   Does the proposal involve Human data collection?
   Research on Human embryo/foetus
   Does the proposal involve Human Embryos?
   Does the proposal involve Human Foetal Tissue /Cells?
   Does the proposal involve Human Embryonic Stem Cells?
   Privacy
   Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle, ethnicity, political opinion, religious or philosophical conviction)
   Does the proposal involve tracking the location or observation of people?
   Research on Animals
   Does the proposal involve research on animals?
   Are those animals transgenic small laboratory animals?
   Are those animals transgenic farm animals?
   Are those animals cloned farm animals?
   Are those animals non-human primates?
   Research Involving Developing Countries
   Use of local resources (genetic, animal, plant etc)
   Benefit to local community (capacity building i.e. access to healthcare, education etc)
   Dual Use
   Research having direct military application
   Research having the potential for terrorist abuse
   ICT Implants
   Does the proposal involve clinical trials of ICT implants?

   
   
2. Applicants are requested to confirm that the proposed research does not involve:
   
   • Research activity aimed at human cloning for reproductive purposes,
   • Research activity intended to modify the genetic heritage of human beings which could make such changes heritable *
   • Research activity intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.


3. The applicants are requested to address the ethical issues related to the proposed research:
   
   • Describe the potential ethical aspects of the proposed research regarding its objectives, the methodology and the possible implications of the results;
   • Explain and justify the research design;
   • Indicate the relevant national legislation or requirements of the Member State(s) where the research takes place.


4. The applicants are requested to address the following questions where relevant to their research:
   
   • National regulations and international codes of conduct
     The applicants must indicate which national and international rules are applicable to their proposed research and explain how they will conform to these. When appropriate, they should indicate as well whether the proposal contributes to the implementation of EU and international legislation in the specific field and to the fulfilment of its main objectives. In the cases described in (2) applicants must specify any additional national or local regulation with which any or each of the partners must comply in relation to the use of foetal tissue, human embryos or embryonic stem cells in culture.
   
   
   
   • Use of banked or isolated human embryonic stem (hES) cells in culture, human foetuses, and human foetal tissue
     Read the procedural modalities for research activities involving banked or isolated human embryonic stem cells in culture to be funded under Council Decision 2002/834/EC (PDF - 27Kb).
     The applicant should:
     • justify the use of banked or isolated human embryonic stem cells in culture;
     • give full details about the source of hES cells;
     • specify and justify the number of any foetuses to be used and why the use of such material is necessary;
     • specify the source of human foetal tissue;
     • describe the procedure for obtaining informed consent;
     • describe the arrangements for protecting the confidentiality of personal data of individuals concerned.
   
   
   • Use of other human biological samples
     The applicant should:
     • specify and justify the type, amount and source of human biological samples to be used;
     • describe the procedure for obtaining informed consent of the person(s) from whom the material is obtained;
     • describe the arrangements for protecting the confidentiality of donors' personal data.

   The applicants should also clarify the handling and storage of the samples: duration of the storage, access, ownership, and possible commercial exploitation.

   • Use of personal data in bio-banking (including gene-banking)
     Applicants should describe the procedure for obtaining informed consent of persons and describe the arrangements for protecting the confidentiality of their personal data. Applicants should describe measures taken to encode or anonymise banked biomaterial (including traceability measures). Even where only anonymised data are used, adequate security for storage and handling of such data must be shown.
   
   
   
   • Research involving persons (individuals or populations) in particular children or persons unable to give consent, pregnant women or healthy volunteers for clinical trials
     The applicant should:
     • provide justification for such research in terms of the potential benefits of the research in relation to the possible risks to persons;
     • indicate the number of persons involved and describe the selection criteria;
     • provide details of the arrangements made for providing information to persons and for obtaining informed consent;
     • specify any payments, inducements or other benefits to be given to the persons concerned;
     • describe the compensation and treatment available to subjects for trial-related injuries.

   For persons unable to give a valid consent, applicants should, in addition to the above:

   • indicate the degree of risk and burden involved for the subject;
   • whether and how the persons might benefit from the procedures envisaged;
   • indicate why it is necessary to involve persons unable to give a valid consent;
   • describe what arrangements are made to seek the agreement of the person's parent, guardian or other representative.
     A copy of both the informed consent form and the subject information sheet should be provided.
   
   
   
   • Protection of personal data
     Applicants should describe the procedure for obtaining informed consent of persons and describe the procedures for protecting the confidentiality of such personal data. Where data are to be shared with other stakeholders the persons whose data are collected should give a specific consent. Applicants should also describe the process of encoding or anonymisation used and indicate if the collected data will be used for commercial purposes. Even where only anonymised data are used adequate security measures for storage and handling of such data must be shown.
   
   
   
   • Use of animals
     Applicants should provide details of the species (and strains where appropriate) of animals to be used and explain why these have been chosen. They should explain why the anticipated benefits justify the use of animals and why methods avoiding the use of living animals cannot be used. They should also give details and justify the numbers of animals proposed with reference to statistical advice if applicable.
     Applicants should provide a summary of the main adverse effects for the animals, including any adverse effects due to methods of husbandry and supply of animals as well as the effects of the scientific procedures themselves. They should state what will happen to the animals at the end of the procedures (e.g. sacrifice).
     They should also indicate what steps have been taken to comply with the principles of reduction, refinement and replacement. In particular they should describe the procedures adopted to ensure that the amount of suffering to the animals is minimised and their welfare is protected as far as possible (e.g. improvements in technique, application of humane end-points, environmental enrichment).
     
     
   • Transgenic animals
     Applicants should be aware that the issues and questions relating to the use of animals in general (as above) apply equally to transgenic animals and the same information should be provided. In addition applicants should state what the possible phenotypic effects of transgenesis are and how this may affect animal welfare and biodiversity.
   
   
   
   • Non-human primates
     In the case of non-human primates the applicants must in addition to the information above, specify not only which species are used, but also their origin (i.e. whether they are wild-caught or captive bred, and which breeding centre they were originally obtained from).
     

     Please also state which partner is in charge of the importation or breeding of animals, where the primates are to be housed and which partner is performing the experiments.
     Additional information and justification on any likely restrictions to the animal husbandry and care (e.g. single housing) and on the numbers of animals to be sacrificed should also be provided.

   • Research in co-operation with developing countries
     When research is to be performed in developing countries and/or by partners from developing countries or when the results can be potentially applied in these countries, the applicants should also describe the arrangements for:
     - sharing of benefits and allocation of intellectual property rights;
     - contribution to capacity building in developing countries (i.e. capacity to asses and use modern technologies while respecting their own choices, needs and local conditions).
   
   
   
   • Local ethics committees opinions and authorisations of competent bodies If the relevant authorisation or opinion of local ethics committees has already been obtained, then it should be clearly mentioned and a copy should be included.
     Where the opinion or authorisation cannot be obtained at the time of contract signature, (for instance because preliminary results should be first obtained before considering a clinical trial or experiment), the contract will specify that the applicant has to provide it to the Commission services in due course, and in any case before starting the phase of the project concerned by this authorisation. Ethics Committee approval or authorisation of a competent body should also be specified as a project deliverable.
   
   
   
   • Conflict of interest
     Applicants should declare any potential conflicts of interest that may arise during the project and describe the way they will be addressed.
   
   
   
   • Ethical implication of research results
     Applicants must consider and describe the possible ethical implications of the research results such as the protection of dignity, autonomy, integrity and privacy of persons, biodiversity, protection of the environment, sustainability and animal welfare.

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