Self-declaration for AU’s Research Ethics Committee

Self-declaration for AU's Research Ethics Committee

Study manager
Study information
c) Same limitation as in the Danish Act on Research Ethics Review of Health Sciences Research Projects ( komitéloven om videnskabsetisk behandling af sundhedsvidenskabelige forskningsprojekter), that is to say the medical definition in section 5(1) of the Danish Guardianship Act (værgemålsloven): “a person who is not capable of managing their own affairs on account of mental illness, including severe dementia, or mental retardation or other forms of severe ill health".
Study information (cont.)
The declaration must demonstrate that the beneficial outcome of the study is balanced against the human resources involved in the project and the risks/inconvenineces (including inconveniences of a mental or social nature) that participants may be exposed to in connection with recruitment, study and reporting. The declaration must also demonstrate that the social group represented by the study participants will benefit from the outcome of the study.
The purpose of the question is to clarify whether the evaluation of the study’s ethical viability falls under the remit of the health research ethics committee system governing health research projects.
A health research project is defined as a project involving experiments on live-born human individuals, human gametes intended for fertilisation, fertilised human eggs,embryos and fetuses, tissues, cells and genetic material from humans or deceased persons. Health research projects also include clinical trials of medicines on humans and clinical evaluation of medical devices.
A health data research project is defined as a project involving the use of sensitive bioinformatic data in which there may be a risk of significant secondary health findings, including projects with genome data.
Research design
This is only relevant for BSS employees. Please choose X if you are from another faculty.
Final step before going over and submitting declaration