Consent shall be elicited from participants in a scientific study on human subjects. The consent shall be in writing and freely granted after the participant has been provided with adequate information on the study, risks that participation may entail, potential benefits, and the nature of the participation. The participant shall be informed that he/she may decline to take part in a scientific study, or withdraw from participation at any time after it commences, without stating any reason.
The objective of obtaining informed consent from participanits in a scientific study within the health sector is to secure and protect their rights and interests:
- Respect for their dignity - people shall not be enrolled in a scientific study within the healts sector withour due reason and participants shall enjoy respect in every sense.
- Care for their health and wellbeing - inconvenience and risk due to participation shall at all times be to an acceptable minimum and the objective must be to find ways to diagnose or treat diseases, understand their mechanisims and to imptove health and wellbeing.
- Respect the autonomy of participants concernig the decision to participate or not participate in a biomedical study.
- Respect for the participants right to determine the use, destruction or retention of all research data concerning her person person, incl biological samples.
Consent may, as applicable, consist in answering a questionnaire, provided that the provisions of clauses 1 and 2 on the provision of information are fulfilled.
There are two types of consent:
A) A limited/narrow consent for participation in a single study without allowing health data or biological samples to be retained or to be called upon for participating in a subsequent studies.
B) Participants’ consent may be elicited to retain biological samples and health data for subsequent use in designated scientific research in the health sector (broad consent). The NBC or HREC have to approve further use of samples and linked information and may state conditions for the use of broad consent. The committee concerned may also decide that a renewed consent should be elicited, if it deems necessary.
Participants who have given broad consent shall have access to information on what research is being carried out by the principal investigator, institution or company. Participants may refuse use of their materials in specified studies, in which case their use is prohibited.
Biological samples retained shall be permanently stored in a biobank of scientific samples for use under the provisions of the Biobanks and Health Databanks Act No 110/2000, as amended i.a. 2014.
Health data retained shall be permanently stored in a health databank for use under the provisions of the Biobanks and Health Databanks Act. Participants must be informed of this.
The principal investigator of a study which deposits biological samples in a biobank, or other health data in a health databank, makes an agreement with the management of the bank on arrangements for access to materials for scientific research. It shall be ensured that the use is covered by the participants’ consent under para. 1 and is consistent with the Data Protection Act.