Scientific research in the health field

In order for the scientific ethics committee to consider an application, all necessary supporting documents must be included.

The following data must, where applicable, accompany applications:

• The study's author's CV and publications

• The undersigned undertaking of the responsible party if the application is sent by a non-responsive party.

• Authorisation of the registry holder. The application to the national bioethics committee shall be accompanied by the approval of the responsible person for the health records, biopsy collections and health information collections to which access is requested.

• Informed consent. In the case of a scientific study involving humans, where individuals are active participants, the informed consent form for participants (information text and declaration of consent) must be available. Note, however, that there is no need to sign a separate declaration of consent if participation in the study consists solely in answering a questionnaire, but a form for participants on the study must be attached.

• Questionnaire. A copy of the questionnaire to be submitted to the participants must be submitted to the committee in the form they will be submitted. Final version in Icelandic. The questionnaire must not contain a name and ID number.

• Interview framework. A copy of the interview framework that will be used in the study must be included with the application.

• Advertisement. If the committee is to be invited to participate in a scientific study, it must receive a copy of the ad.

• Copies of signed declarations of cooperation from the partners.

• If the participants are to be offered one interview with a professional because participation in the study may cause them distress, a declaration of cooperation with that person must be submitted to the committee.

• Insurance certificate and insurance terms, if applicable.

Please note that all documents that are submitted to participants must be submitted to the committee in the form that they will be published to participants.

Only scientific research in the field of health is subject to authorization by the Scientific Ethics Committee. Scientific research in the field of health is defined in section 1. Article 3, law no. 44/2014 as research on humans, biological samples and health information where scientific methods are applied to increase knowledge about health and diseases.

If it is unclear whether a study is considered a scientific study in the field of health, which falls under the committee's scope of work, or another type of study, e.g. a study in the field of social sciences or a quality survey that does not fall under the committee's scope of work must submit an application for evaluation by the committee itself. The staff of the office cannot make a decision regarding whether or not it is a scientific study in the field of health, but it is the committee itself that evaluates it, and this is only done in accordance with application and at committee meetings according to law no. 44/2014.

In an application, more complete information is always presented than is presented in an inquiry about the study that is planned to be carried out.

During the evaluation, the committee then strives to evaluate the research holistically based on the information provided in the application and then has, among other things, the background of the researchers, the population (healthy individuals or patients), the purpose and goal of the study have been taken into account. The mere fact that a question is asked about physical or mental health does not necessarily make a study directly a scientific study in the field of health.

You can read more about license obligation by clicking here.

The national bioethics committee meets every other Tuesday. More information on the committee's meeting time can be found here.

It is not permitted to make changes to the nature or scope of research or other major changes unless they have received the permission of the Scientific Ethics Committee. If the application for changes to the approved research plan includes significant deviations, the Scientific Ethics Committee can decide that it is a new study.
The Scientific Ethics Committee may grant permission for changes to scientific research for which it has given approval. The committee is also authorized to decide that minor changes in research are only subject to notification. Does this mean changes to the research plan that are not burdensome for the participants, for example if one researcher leaves and a new one takes his place, changes in the measurements of blood samples, extension of the study by one year, etc.
The person responsible for the research is responsible for notifying changes to the research plan to the scientific ethics committee, and it is the committee that assesses whether it is necessary to seek new consent from the participants. However, this does not apply to minor changes that are only subject to notification.
It can be assumed that a new consent of the participants will need to be obtained if there are major changes to the research plan and if the change has significance for the consent of the participants.

A student can never be guarantor for their own research, but works on it under the guidance of a guarantor. Further information on student research can be found here under additional information.

Only one person is defined as responsible for research, not two or more. However, the responsible person can assign a co-investigator to handle certain aspects of the investigation. A guarantor can therefore e.g. entrusted to a person with expertise in a certain field, in order to take care of certain aspects of a sub-investigation, while remaining responsible for the investigation as a whole.

All data has to have been received at least one week before the meeting of the committee in order for the paper to be considered by the national bioethics committee.

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.

Participation in health research is entirely the decision of the participant. Neither your doctor nor anyone else can say that you should or should not participate in a study – participation is always your decision. Click here to read more about participating in a scientific study.

If someone is requested to participate in a study, it may be that they have a disease that is to be studied, or that they belong to a group that has certain symptoms that are being studied, or that they have undergone surgery of some kind. Individuals are also requested to be in a control group before a study. It is also so that individuals can on their own initiative respond to advertisements seeking participants or simply request to participate in health research in order to contribute to the scientific search for better diagnoses, better understanding of disease behavior or innovations in the treatment of patients. Click here to read more about participating in a scientific study.

When an individual requests to participate in a study, information must be provided on the purpose of the study, what involves participating, what risks involve participation, how sensitive data that the participant provides or will be retrieved from a medical record or biopsy will be handled, how the security of the data will be secured and what will happen to it after the study. Finally, information must be provided, where appropriate, on what insurance policies apply to the person participating in the study.

After the person concerned has received all the legal information and answers to his/her questions, he/she can consider whether to participate in the investigation. If the answer is positive, the prospective participant is invited to sign what is called informed consent. This means that the person concerned confirms that he/she has received answers to his/her questions and the information that is prescribed by law and the ethics committee has requested to be provided.

The research is different depending on what the research is about, what data is needed and how it should be processed. Often the research itself starts with questions that the researcher needs to answer, often blood samples are taken and various measurements are made, e.g. on the heart and its function, lungs and their capacity, skin characteristics, joint mobility etc., depending on what is to be studied. The ethics committee that has authorized the research ensures that sufficient information is gathered to answer the research questions and that no more information is gathered than is needed.

In some studies, the participants’ endurance is tested and some research factors may be followed by effort, pain or discomfort during the study. It is worth emphasising that all researchers try to minimise pain and other discomfort.

A participant may discontinue from participating in a study at any time and no reason needs to be stated. Read more about withdrawing from a scientific study by clicking here.

Participants in scientific research can withdraw their consent at any time and discontinue the research. This can be done in writing, orally or in other clear forms. Participants who wish to discontinue the research and withdraw their consent can either send a notification of their wish to the scientific ethics committee or the responsible person. Clich here to read more on withdrawing from a scientific study.