The Bioethics Committee System

The Act of Law, No. 44/2014, on scientific research within the health sector defines the conditions for biomedical research and the role of the bioethics committees:

Scientific research projects in the health sector shall be based upon a research protocol which provides information on the study and its principal investigator. In the application submitted to the Bioethics Committee or to a Health Research Ethics Committee, (Art. 4)

A scientific research project in the health sector may not be commenced unless it has been approved by the National Bioethics Committee (NBC) or a Health Research Ethics Committee. The NBC or Health Research Ethics Committee shall evaluate the research protocol of a scientific study from the perspectives of science, ethics and human rights. The NBC and Health Research Ethics Committees may attach certain conditions to their approval of a study. (Art 12)

The Minister of Health (Welfare) appoints seven members to a National Bioethics Committee (NBC), for a term of four years, to consider scientific research protocols in the biomedical field. It shall be ensured that on the committee are individuals with expertise in biomedical sciences, ethics of research, human rights and social science. The NBC shall consider collaborative projects, multi-national research projects, clinical pharmaceutical research projects subject to the provisions of the Regulation on Clinical Pharmaceutical Research on Human Beings, No. 443/2004, and other planned scientific studies in the biomedical field, which are not within the mandate of ethics committees ( IRB's, see below). In addition the NBC shall participate in public and scholarly debate on bioethics, and issue guidance on matters within its mandate.

A request for consideration of a research project shall be accompanied by a detailed research protocol, and other information as further determined by the NBC.

Local Health Research Ethics Committees

The following health research ethics committees (HREC's) shall consider protocols for scientific studies in the biomedical field to be carried out within the mandate of the respective ethics committee:

1. The HREC of Landspítali University Hospital assesses and approves studies in the biomedical field to be carried out at the hospital, and research projects in the biomedical field to be carried out in collaboration between Landspítali University Hospital and universities.

2. The HREC of Akureyri Hospital assesses and approves studies in the biomedical field to be carried out at the hospital or the University of Akureyri, or to be carried out in collaboration between Akureyri Hospital and universities

The NBC issues its rules of procedure, which shall be approved by the Minister of Welfare. These rules shall also apply to the procedures of HREC's.

The procedural rules of the bioethics committees shall be accessible to researchers and others who consult the committees. The rules of procedure shall be in accordance with legal provisions, the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, and additional protocols, and the relevant European Union guidelines on bioethics; the World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects; and other relevant international ethical guidelines for scientific research in the biomedical field. In addition the NBC shall take account of new developments of international guidelines in the field of bioethics, and to adapt its rules of procedure as appropriate.

The service of the committees is free of charge.