Scientific research in the health field is a research that is conducted to increase knowledge that, among other things, allows for better diagnosis of diseases, improves the health of participants, relieves suffering and cures diseases.
The national bioethics committee (VSN) has the task of evaluating scientific research in the field of health in order to ensure that it is compatible with scientific and ethical considerations. If there is doubt as to whether a scientific research in the field of health is relevant, VSN decides. There have been cases where it has not been clear whether a research is considered a scientific research in the field of health or a social sciences research. In such cases, VSN has sought to evaluate the research in a comprehensive manner, taking into account, among other things, the background of the researcher, the population, the purpose and the objective of the research. If the purpose and objective of a research is to increase knowledge, which, among other things, makes it possible to improve health and cure diseases, VSN has considered that the relevant research falls within the remit of VSN (or, where appropriate, VSN for health research). Examples of research where health and social sciences overlap are, for example, research on the well-being and health of schoolchildren.
It may be difficult to draw a clear line between health research and social sciences, as it is common for research and surveys in social sciences to also address issues related to health and well-being. When applications for authorization for such research have been submitted to the Scientific Ethics Committee, it has generally considered them, particularly in the case of questions concerning health information on vulnerable groups. It can be assumed that the choice of either side depends largely on the background of the investigator.
If the researchers are considered healthcare professionals, it can be assumed that the research is a scientific study in the field of health.
If the researchers have a background in social sciences, it can also be assumed that a research is considered to be a social sciences research and therefore does not fall within the competence of the national bioethics committee.
The national bioethics committee shall evaluate collaborative projects, multinational studies, clinical pharmaceutical studies and other programmes for scientific research in the field of health that are not within the scope of the Ethical Committees for Health Research under Article 11 of the Law on Scientific Research in the field of Health.
A scientific study in the field of health may not be initiated unless the national bioethics committee or the ethics committee for health research has granted the authorization for the study.
The national bioethics committee or the ethics committee for health research shall evaluate the research programme of a scientific study from the scientific, ethical and human rights perspective. The national bioethics committee and the ethics committee for health research may impose a certain condition on the authorization of a study.
Research based on information on the health/disease history of participants is, as a rule, subject to a permit from the national bioethics committee or the Health Research Ethics Committee. Valid only if information is obtained from the participants themselves (e.g. with questionnaires or interview surveys), from data stored in a healthcare institution (e.g. medical records) or data stored in public databases (e.g. cancer registry). An application to the national bioethics committee contains a special chapter on the treatment of personal data (chapter B). A special application to the Data Protection Authority is not required.
The national bioethics committee's authorization is required for all experiments with new medical devices, medicines, vaccines or preparations on people, changing the use of medicines, as well as other clinical trials conducted to test/improve the treatment of a disease and involve risks for patients or significant interference in or inconvenience to privacy. Equally, a license from the Icelandic Medicines Agency (IMA) is also required. You can read more about clinical pharmaceutical research here.
All genetic research on humans (whether based on new biopsies or samples in bioassays) must be authorized by the national bioethics committee or other ethics committee (see law nr. 44/2014). The bioassay must also be authorized by the responsible body for the bioassay.
Any addition or amendment to the research plan authorized by VSN or the Ethical Committee for Health Research is subject to further approval by the committee that granted the authorization.
If the proposed investigation is not clearly covered by the above and investigators have doubts about the liability of the investigation, they should send a question to the Committee at the following email address: vsn@vsn.is.
The researchers should consider the following points and include the following in their question to the Scientology Ethics Committee:
Does the study concern diseases and/or other health-related issues?
Are participants clients of a healthcare institution? If not, how will they be searched?
Are the research data (e.g. information, samples or results) obtained from a public institution? What kind of data will be collected?
Are investigators employees of a healthcare institution? Is the investigation conducted in their name or the institution?
In general, if one or more of the above points apply to the proposed study, it is liable to a permit from a scientific ethics committee or another ethics committee.
Regulation No. 520/2018, on the organisation of scientific research.
Regulation No. 443/2004, on clinical pharmaceutical research in humans.
Regulation No. 1311/2021, on the clinical trials of medicinal products for human use.
Rules No. 230/2018, on how people can choose and access participation in scientific research in the health field and what education they should receive before seeking their consent.
Procedure No 578/2018, on the processing of applications for access to health data
Rules No. 1117/2022, on minor changes and the obligation to report to the national bioethics Committee or the Ethical Committee for Health Research.
International conventions shape the practices and criteria of VSN to a significant extent. This is normal, among other things, because of the extensive international cooperation involving Icelandic health scientists.
A scientific study in humans is a study where a person is actively involved in a scientific study, aimed at undergoing a study, providing samples or information for the study, e.g. by answering a questionnaire.
Data research is different from a scientific study on humans in that no active participants are part of the study. It is a study using available health data, e.g. that are stored at the Directorate of Health and Landspítali. A person who has the information or data is not actively involved in the study.
