Practices

Scientific research in the field of health shall be based on respect for the human rights of the participants. Human rights shall not be sacrificed for the interests of science and society. The organization and conduct of scientific research in the field of health shall respect ethical and scientific considerations and protect the privacy of the participants.

The national bioethics committee

The national bioethics committee (VSN) evaluates scientific research in the health field to ensure that it is compatible with scientific and ethical considerations. If there is doubt whether there is a scientific research in the health field, VSN decides. VSN evaluates collaborative projects, multinational research, clinical pharmaceutical research and other programmes for scientific research in the health field that are not within the scope of the ethics committees of health research according to Article 11 of Act No. 44/2014. VSN shall participate in general and theoretical discussions at the level of bioethics, provide advice and publish guidance on issues within the scope of the committee. More details on VSN's tasks are discussed in a regulation. The Minister confirms the rules of procedure of VSN (in progress). Rules of procedure, which are established by VSN pursuant to this Act or regulations established on the basis of the Act, shall also apply to the work of the ethics committees of health research appointed on the basis of this Act.

Other ethics committees

The Minister shall establish ethics committees for health research at certain health institutions following the opinion of the VSN. The regulation provides for the composition and tasks of the ethics committee for health research. Such a committee evaluates scientific research carried out within its own institution or in cooperation with related educational institutions. The ethics committees for health research operate at the National Hospital and the Akureyri Hospital.

Permission from VSN or the Ethical Committee of Health Research.

Scientific research involving intervention shall not be conducted on humans if the same or similar objectives can be achieved without human participation. Before a scientific study on humans is authorized, the VSN or the Ethical Committee for Health Research shall evaluate risks and discomfort and the usefulness for participants or others. In the study of the usefulness of a new treatment, patients must always be guaranteed to receive an approved treatment. The VSN or the Ethical Committee for Health Research shall stop the study if it is found that risks outweigh potential usefulness. Special caution should be exercised when requesting the participation of individuals from vulnerable social groups, i.e. individuals who are not, for any reason, in a position to make an informed or uncoerced decision. A scientific study in the field of health may not be initiated unless the Ethical Committee has granted the study. The Ethical Committee shall evaluate the research programme from the scientific, ethical and human rights perspective and may impose a certain condition on the authorization of a study.

Changes to the research programme

No changes to the nature or scope of a scientific study or other major changes may be made unless they have been authorized before by the Ethical Committee for Health Research, which approved the original research plan. The VSN may decide that minor changes to a scientific study are only subject to notification to the VSN or the Ethical Committee for Health Research under rules set by the VSN.