3. Recruiting research participants: consent and the right to demand prior approval of research
The project manager must obtain the written consent of research participants based on good information and voluntariness before they are included in the project. In the event of substantial changes in the project, the project manager must consider whether new consent is necessary.
The project manager must inform research participants about the project, the role of the research participants, risks of injury, disadvantages, benefits for the participant and others, which data will be collected about the individual, and how the data will be processed and stored. Research participants must also be informed about insurance schemes and their right to refuse and to withdraw from the project.
In connection with the approval of the research project, the regional committee for medical and health research ethics (REK) may specify conditions for the content in the information letter. The Norwegian Medicines Agency (Statens legemiddelverk) can specify conditions for research projects that involve clinical trials of medicines. REK has prepared templates for information letters and consent forms in both norwegian and english, which should be followed.
Research participants may consent to human biological material and personal health data being used for specific, broadly defined research purposes. This means that the research participant gives consent for research involving one or more overarching research purposes, research fields and projects. REK may impose conditions for the use of broad consent.
The research participant must be informed about the implications of giving broad consent. Research participants who have given broad consent are entitled to receive information about the project at regular intervals.
People without competence to give their consent
Parents or other people with parental responsibility must give their consent if the research participant is under the age of 16. The same applies if the research participant is between 16 and 18 years old and the research involves surgery or trials of medicines. For people who lack competence to give their consent due to their state of health, intellectual disabilities or legal incapacity, there are special regulations about who must give consent; see Section 17 of the Health Research Act (Helseforskningsloven) (English translation: http://www.ub.uio.no/ujur/ulovdata/lov-20080620-044-eng.pdf), which specifies that the person's next of kin as defined in Section 1-3 b of the Patients' Rights Act (Pasientrettighetsloven) must give their consent.
Section 18 of the Health Research Act has certain additional conditions that must be met for research that includes these groups. For research in clinical emergencies, consent may be given afterwards as long as the other provisions of the Act are fulfilled; see Section 19.
Research without consent
REK may decide that human biological material collected as part of research or in diagnosis and treatment may or must be used for research purposes without obtaining consent. The same applies to data gathered in connection with research or by the health service. Consent is the normal rule. For this reason, it is a prerequisite that it is difficult or impossible to obtain consent. In other words, there must be good reasons for exceptions to the rules about consent and for exemption from the duty of confidentiality in connection with disclosure.
Exceptions to the requirement for consent may be made only if such research is of significant interest to society and the participants' welfare and integrity are ensured; see sections 15, 28 and 35 of the Health Research Act. REK may impose conditions for use, such as requirements for information to the participants.
The patient must have been informed in advance that in some cases human biological material may be used for research, and must have been given the opportunity to opt out of such research. People who reserve the right to require prior approval for any use of their own biological material for research must be listed in the Reservation Register at the Norwegian Institute of Public Health.
Withdrawal of consent
Consent can be withdrawn at any time, and research on the material or personal health data must then stop. A person who withdraws their consent may demand that their biological material is destroyed and that the personal health data are deleted or surrendered within 30 days; see Section 16. This does not apply if:
- the material or the information has been anonymized
- after it has been processed, the material is included in another biological product
- the data have already been included in analyses that have been performed
REK may decide that further research is to be permitted and that the destruction, deletion or surrender of the material is to be postponed until the research project is completed. A prerequisite is that this is justified by particularly strong societal or research interests.
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Version 1.0. Date: 1 January 2012