Medical records: Written descriptions or interpretations, images, including X-rays, graphs and video and audio recordings that contain information about the patient's health and treatment at the healthcare professional/healthcare institution and other necessary personal information.

A medical record is a collection of medical records that are processed in connection with treatment or obtained from elsewhere for the treatment of a patient in a healthcare institution or a healthcare professional's office.

The medical records must include items necessary for treatment, but at least the following information, where appropriate:

• Name of the patient, address, ID number, title, marital status and next of kin.

• Date of arrival or admission and date of graduation. Reason for arrival or admission.

• The health and medical history that are important for the treatment.

• Warnings, such as about allergies.

• Inspection. Treatment and procedure description, including information on medication and comments from advisory experts.

• Results of research.

• Analysis. The fate and schedule of follow-up treatment.

Health records controller: The senior management of the healthcare institution or healthcare professionals' office where the health records are recorded.

The health register administrator: A doctor, or another healthcare professional, if not a doctor, who is assigned by the administrator to supervise and ensure that the registration and handling of the health register information is in accordance with the provisions of law.

Each entry of medical records information in the medical record shall include the name of the person who records, his/her title and the timing of the entry. Any addition, correction, change or deletion made to the medical record entry shall always be traceable.

The Icelandic Health Records Act no. 55/2009 defines such records, the responsibility for their entry and use.

Biopsies collected from participants in a scientific study:

1. The collection of biological samples from participants in a scientific study is the responsibility of the national body, the scientist or the physician of the participant concerned (for example, for the initial presentation to the prospective participant) responsible for the implementation of the project. According to law (No. 110/2000) biological samples obtained for certain research (and not intended for preservation in a biological sample collection) may be retained for up to 5 years. VSN may exempt from this rule, i.e., allow temporary preservation for longer than 5 years.

2. The responsibility for all aspects of conducting a study, including the handling of biological samples and other data, lies with the responsible person. In the case of international cooperation, the responsible person for the part of the study that is conducted in Iceland shall be responsible for all aspects of the study here, including obtaining authorization from the parties required.

3. Participants must be informed of how biopsies will be taken and for what purpose, how they will be treated and whether or how they will be preserved. The same applies to any information relating to the samples.

4. If the intention is to send biological samples to other countries and the consent of the participants is required. The participants must be informed of any examinations to be carried out on the samples externally, where and for how long the samples will be kept abroad. This does not apply when the need to obtain informed consent from the participants (non-personalised samples) is not necessary.

5. Biopsies may only be sent abroad for certain research aspects, which have been defined in the research plan and approved by VSN. Biopsies should also be informed about this research aspect and have given their consent for sending samples and accompanying information out of the country. A responsible person for the possession and destruction of samples abroad or return to Iceland must be appointed.

6. Biopsies may only be sent out of the country in non-personal form. The national investigator can store a coded list of participants and is responsible for its secure custody. Such a key may under no circumstances be sent out of the country.

7. It is not permitted to send samples out of the country beyond the amount required for the research factors specified in the research plan. The remaining samples shall be returned after the study has been completed. If this is not possible, the investigator in Iceland is responsible for destroying the samples or their remaining parts at the end of the study. This process shall be defined in the research plan.

8. The movement of biological samples for permanent storage abroad is subject to the VSN permit. In general, no permit will be granted to date unless it is clear that the rights and interests of Icelandic biological sample donors are strictly protected, and in the same way their samples would be stored in Icelandic biological sample collections.

Samples obtained from Icelandic biopsy collections:

1. The use of bio samples obtained from Icelandic bio sample collections shall be in accordance with Act No. 110/2000 on Bio sample banks and Regulation No. 134/2001 on the possession and use of bio samples in bio sample collections.

2. The movement of samples from Icelandic biological sample collections is subject to the VSN permit and the rules/ criteria described above also apply in such cases.

3. It is noted that the deceased donors may include individuals who have withdrawn their intended consent for their samples taken for service or treatment to be stored in a biopsy collection for use in scientific research. In this case, biopsies from these individuals may of course not be used.

Applications for authorization for epidemiological studies (data studies) must be submitted to VSN or the Ethical Committee of Health Research according to Article 11 of Act No. 44/2014. A general study form must be used.

“epidemiology is the study of distribution and the effects of a condition or a phenomenon of health in a particular population. It also deals with the exploitation of the research to control health problems.

Epidemiologists are concerned with research on the spread and causes of disease in human populations. The main subject of the research is the relationship between exposure and outcome.

The effects of stimuli can be diverse. Most often they are associated with increased risk of getting sick from a particular disease and are called risk factors. Examples of these are smoking, carcinogens in food, pollution related to employment, high blood pressure, viral infections and inborn mutations in disease genes. The effects of other stimuli are to reduce the likelihood of certain diseases. This category includes food reduction agents, breastfeeding, vaccination and education about the harm of smoking. The endpoints of the studies are usually diseases but can also include accidents, deaths, antibodies in the serum, certain risk behavior and more.

Since the subject of the research is human beings, there is a fundamental difference between the research and any other method of investigating the causes of disease. It is both a strength and a weakness of the research that the subject of the research is human beings. The strength is that there is no doubt that the results can be transferred to living people, whereas there is usually no doubt about results based on animal experiments or on tissue, cells or smaller units.”

(Source: The University of Iceland’s Website.)