Ethical issues

All applicants must disclose any ethical issues in the research plan and how they intend to deal with ethics issues in their research project.

An ethics issues form is available for download at the website in the section Apply and download templates and this must be submitted with the application. If there are no ethical issues to be reported, this should be stated in the form and the form included in the application. Failure to include the obligatory ethical issues form in the application will result in rejection of the application without further notice.

Applicants who disclose an ethical issue must contact the H.C. Ørsted COFUND secretariat in writing for advice on the proper steps to be taken in order to resolve the issue before submission. The Research Department at DTU will be able to help in assessing ethical issues and necessary approvals. The secretariat will be able to assist applicants in obtaining approval from the ethics committee. The research plan should reflect on how applicants intend to deal with ethical issues, if relevant.

Ethical issues that must be reported:

  • Use of human cells or tissue, including human embryonic stem cells (hESCs), embryos or foetal tissue

  • The proposal must be referred to Danish and EU ethical authorities for scrutiny and approval. Projects which involve hESCs must be approved in an European Commission (EC) ethics review and the PEOPLE Programme Committee.

  • Human beings or primates

    If the research involves interventions on human beings, use of human embryonic stem cells or the use of non‐human primates the proposal must be referred to Danish and EU ethical authorities for scrutiny and approval. If the research involves factors that necessitate informed consent the proposal must describe a proper procedure of establishing informed consent.

  • Uniquely identifiable personal data (GDPR)

    If the research involves the collection and storage of uniquely identifiable data the project proposal must describe a proper procedure for establishing data protection and privacy. All research involving personal data is subject to regulation by GDPR.

  • Offensive/military/dual use or misuse (malevolent/criminal/terrorist abuse)

    If it is likely that the proposed research will result in technology which can be used for both peaceful and offensive aims the project proposal must describe a procedure to handle the risk of offensive use.

  • Non-EU countries

    If the research involves non-EU countries the project proposal must describe a procedure to ensure that research is responsive to the needs of the country where research is carried out as well abiding by relevant EU/national legislation and international guidelines.

  • Animals

    If the research involves research on animals the project proposal must present a convincing argument for the use of animals and the non‐availability of alternatives to conducting research on animals.

Projects which involve research in humans, human embryonic stem cells (hESCs), animals and developing countries must strictly follow the guidelines advised by the European Commission for H2020. There are specific procedures for the use of hESCs. The use of hESCs must be justified and necessary for the success of the project. The use of hESCs must be approved in an EC ethics review and the PEOPLE Programme Committee.

Does your research involve non-human genetic material from countries other than Denmark?

Access And Benefit Sharing (ABS) EU Regulation and the Nagoya Protocol must be adhered to by applicants using non-human genetic resources from other sovereign countries and territories. The ABS rules apply when genetic resources, and the traditional knowledge associated with them, are used in research and development for their genetic properties and/or biochemical composition, including through the application of biotechnology.

Projects which include ethics issues that are banned from funding under H2020 will be rejected without further notice. Research areas which cannot be funded and will lead to rejection are:

  • Human cloning for reproductive purposes.

  • Modification of genetic heritage of human beings which could make such changes heritable (research related to cancer treatment of the gonads can be financed).

  • Creation of human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.

Whenever proposals involve ethical issues, a mandatory Statement on Ethics from DTU will be requested. A declaration duly signed by DTU regarding the acknowledgement and observance of ethics under national rules together with ethical approvals (if applicable) will be a prerequisite to sign the contract. Ethical or legal (data protection) approvals by the competent ethics committees in Denmark must be submitted prior to the commencement of the relevant part of the research.

The ethics issues table can be downloaded in the section Apply and download templates.

 

  This project has received Funding from the European Union's Seventh Framework Programme and Horizon 2020 Research and Innovation Programme under Marie Sklodowska-Curie Actions grant no. 713683 (H2020)