Personal data and biological material
Some research involves the analysis only of previously gathered material. This can apply to register-based studies or studies of biobank material. Research which only involves the processing of sensitive personal data or analysis of biological material (which can be traced to an individual) must indeed undergo ethical review, but is not automatically subject to the requirement for informed consent.
If such research is deemed essential, the Swedish Ethical Review Authority has the possibility of approving it even without the research participants being informed and consenting. This can be the case if it is deemed practically impossible to inform and obtain consent from theresearch participants, as is the case for example for studies including information or tissue from thousands of research participants.
Please note that it is the Swedish Ethical Review Authority – not the researchers themselves – who determine when the number of research participants is too high for consent to be obtained from each one. The board also has the possibility of setting requirements for compensatory measures, such as the researchers providing information about the study via a national daily newspaper and including contact details in case a research participant wishes to withdraw from the study (opt-out).
Do you have any questions regarding research ethics regulations? As an employee of Lund University, you can turn to forskningsetik [at] lu [dot] se.