The use of human biological material in research is more strictly regulated than the use of health data, because it is considered more sensitive.
a) 'Patient Per' was admitted to hospital with chest pains. A blood sample was taken during the diagnostic workup. 'Doctor Lise' thought that Per's pain was caused by a minor heart attack and ordered treatment. Per recovered and was discharged. Before he left, Per was informed that the biological material he had provided could be used in research without his consent on approval by the Regional Committees for Medical and Health Research Ethics (REK) unless he wanted to register a reservation in the Reservation Register. Per wished to contribute to research, but at the same time several of his relatives had been stricken by serious hereditary bowel cancer. He does not want all his genes to be mapped because he does not want to know whether he is pre-disposed to developing bowel cancer. Per therefore says that he wishes to make a reservation. He does not want the blood sample to be used in research without his consent.
Three years later Doctor Lise suspects that the heart attack Per suffered was a sub-type with a genetic basis, and she wishes to include earlier patients in a research project to study this issue. Per receives a request asking him to consent to the analysis of his material in the project mentioned. The information letter informs him that the researcher will only examine some genes related to known heart problems. Per thinks it is important to contribute to research on his heart problem and gives his consent.
Doctor Lise then performs a full genome sequencing (mapping all genes) using the participants' genes. These sequences are then stored on Lars' computer, now in the form of health data. The research project terminates after two years without Lise having found an explanatory genetic model for the heart attack, and Lise 'anonymises' the full genome sequencing by removing all personal data.
Should we accept that genetic data can be anonymised when all sequences are unique?
b) At the same time, 'Researcher Finn', a colleague of Lise's, is engaged in a project on patients with schizophrenia where he needs a control group for genetic analyses. Lise offers her anonymised data file. Finn then discovers that one of the participants has a gene predisposing for severe bowel cancer and contacts Lise to find out who the gene sequence stems from, and to discuss whether they should help the person concerned. Lise answers that the sequence has been anonymised, but they agree to match it with samples from the treatment biobank where Per's blood sample is still stored. A genome sequence is unique, and the information may save the life of the person concerned, therefore they re-identify Per. Lise is not aware of Per's reason for registering with the Reservation Register and feels that she has a duty 'to save' her former patient by letting him know.
How do you think Lise (Per's treating physician) and Finn (researcher with no link to Per) should deal with the genetic information and findings?
c) Per has made a reservation against research without his consent, but this right of reservation applies to biological material and the genome sequence has the status of health data.
Should there be a right of reservation against the use of certain types of health data, for example, genome data, even though this might limit important research?
Is there a factual difference between the sensitive nature of biological material and the sensitive nature of health data?