EUROPEAN COMMISSION Ethical Issues Report (EIR) FP7
ETHICAL ISSUES REPORT (EIR)
Proposal AcronymProposal Number
The Ethical Issues Report is intended to be part of the Evaluation Summary Report (ESR) in FP7.
It is only to be used for those proposals which are above threshold.
Areas Excluded From Funding Under FP7 (Art. 6)(i) Research activity aiming at human cloning for reproductive purposes
(ii) Research activity intended to modify the genetic heritage of human beings which could make
such changes heritable (Research relating to cancer treatment of the gonads can be financed)
(iii) Research activities intended to create human embryos solely for the purpose of research or for
the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.
***If ANY of the above appears in a proposal above threshold ALERT the moderator immediately ***
STEP 1- Identification of Ethical Issues
(Note: Research involving activities marked with an asterisk *in the left columnin the table below will be referred automatically to Ethical Review)
Research on Human Embryo/ Foetus / YES / NO* / Does the proposed research involve human Embryos?
* / Does the proposed research involve human Foetal Tissues/ Cells?
* / Does the proposed research involve human Embryonic Stem Cells (hESCs)?
* / Does the proposed research on human Embryonic Stem Cells involve cells in culture?
* / Does the proposed research on Human Embryonic Stem Cells involve the derivation of cells from Embryos?
Research on Humans / YES / NO
* / Does the proposed research involve children?
* / Does the proposed research involve patients?
* / Does the proposed research involve persons not able to give consent?
* / Does the proposed research involve adult healthy volunteers?
Does the proposed research involve Human genetic material?
Does the proposed research involve Human biological samples?
Does the proposed research involve Human data collection?
Privacy / YES / NO
Does the proposed research involve processing of genetic information or personal data (e.g. health, sexual lifestyle, ethnicity, political opinion, religious or philosophical conviction)?
Does the proposed research involve tracking the location or observation of people?
Research on Animals / YES / NO
Does the proposed research involve research on animals?
Are those animals transgenic small laboratory animals?
Are those animals transgenic farm animals?
* / Are those animals non-human primates?
Are those animals cloned farm animals?
Research Involving Developing Countries / YES / NO
Does the proposed research involve the use of local resources (genetic, animal, plant, etc)?
Is the proposed research of benefit to local communities(e.g. capacity building, access to healthcare, education, etc)?
Dual Use / YES / NO
Research having direct military use
Research having the potential for terrorist abuse
Other Ethical Issues / YES / NO
Are there OTHER activities that may raise Ethical Issues?
If YES please specify:
Step 2 – Coverage of Ethical Issues
(It is necessary to complete this step onlyif there are 'Yes' replies in STEP 1)
Coverage of Ethical Issues / YES / NOIf the research involves use of human embryos or human Embryonic Stem Cells (hESCs), do you consider that this research methodology is necessary in order to achieve the proposal's scientific objective?
Are the ethical issues raised in STEP 1 above adequately addressed in the proposal?
Do the applicants demonstrate familiarity with the guidelines and established ethical standards?
Have the applicants indicated in which country(s) any research raising ethical issues will be carried out?
Have they indicated which national, EU and/or international regulations will apply?
Step 3 – Conclusion
Conclusion / YES / NOSHOULD THIS PROPOSAL BE REFERRED TO AN ETHICAL REVIEW?
If "yes", please give the main reason(s) for referral:
Moderator's Signature: ______Date: ______
Rapporteur'sSignature: ______
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