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.