General information on informed consent in scientific studies

Scientific research in humans is based on cooperation between researchers and participants. Informed consent includes a covenant between researchers and participants on the conduct of a study.

Scientific research in humans is not permitted unless there is informed consent. However, in cases of urgency where the patient cannot give consent and it is not possible to obtain the consent of the closest family member, a study not part of a treatment is permitted subject to certain conditions. The objective of obtaining informed consent from participants in a scientific research in the field of health is to ensure and protect their rights and interests. Approval for scientific research on humans is discussed in more detail in Chapter V of Act no. 40/2014, on scientific research in the field of health.

The participant shall formally consent to participate in a scientific study in the field of health before it begins. The consent shall be in writing and shall be given voluntarily after the participant has been adequately informed about the study, the risks that may be associated with it, the potential benefits and the nature of the participation. The participant shall be made aware that it is possible to refuse to participate in a study and that it may withdraw from participation at any time after it has begun, without consequences on access to public health services. It is discussed in more detail what education should be provided to the participants before informed consent is obtained in Article 10. regulations no. 230/2018, on how to select and approach people to participate in scientific research in the health field and what training should be provided to them before their consent is sought.

Widespread acceptance of data retention for use in future research

Approval of the participants for the preservation of biopsies and health information for future use in further defined health research may be sought. The national bioethics committee or the Ethical Committee for Health Research sets the conditions for the use of widespread consent. The ethics committee may also decide that new consent from the participants should be sought if it considers it necessary.

• Participants who have given their express or informed consent shall have access to information on the investigations being carried out by the responsible person, institution or undertaking.

• Participants may request that their data be used in specific studies and their use is not permitted.

• Biopsies that are preserved must be permanently stored in a collection of health data for use under the Biopsy and Health Information Collection Act.

• Health information that is stored shall be permanently stored in a health data set for use under the Act on Biometric Datasets and Health Information Collections.

Participants must be informed of this. A biopsy collection must have been authorized by the Minister. The study controller who submits a biopsy or other health information to a health data collection shall negotiate with the collection management how access to data for scientific research will be arranged.

It shall be ensured that the use is within the agreement of those who have donated the biopsies and provided the health information and is in accordance with the laws on personal protection and the treatment of personal data.

Revocation of approval

Participants in a scientific study may withdraw their consent at any time. The same applies to consent for the preservation of biocidal samples or health information for use in future research.

• If approval is revoked, the study of biopsies or health information of the relevant participant shall be discontinued.

• Participants may request that biopsies and health information about them be deleted.

However, deletion cannot be required if the biological sample or information is non-personal, if the biological sample has become part of another material or if the information has already become part of the results of the study.

Eligibility for approval

Those who are self-employed under the provisions of the legal law are eligible to consent to participate in a scientific study. Self-employment alone is not sufficient in all cases. If a self-employed person is thus manifestly unable to acquire information about a scientific study because of physical or mental reasons, such consent shall be subject to the rules governing participation of those who are not eligible to grant consent.

A study involving humans where participants are not qualified for approval may only be authorized if all of the following conditions are met:

A study may be authorized even if there is no reason to believe that the results of the study could improve the health of the person concerned, as the objective is to increase substantially the scientific knowledge of the condition, disease or disability of the person concerned, to the benefit of those in the same age group, with the same type of disability or suffering from the same disease. Such studies must meet the conditions of paragraphs 2, 3 and 4 above and may involve only minor risks and stresses.

Approval for study in emergency situations

In acute cases where the patient cannot consent and it is not possible to obtain the consent of the closest relative, a study not part of the treatment is only permitted if:

• The risk and stress for the patient is minor,

• The patient is not opposed to that and there is no reason to believe that he would have been opposed to participation if he had been qualified to give consent;

• A similar outcome cannot be achieved by studying individuals who can give consent;

• The study is clearly justified in view of the possibility that its results can be useful for the person or persons with the same disease or contribute to important prevention, diagnosis or cure;

• A study in acute cases has been specifically approved by the national bioethics committee or the ethics committee for health research.

The patient or the next of kin should be informed as soon as possible about the study and seek appropriate approval for the continuation of the study.