Kurt is a teacher in Germany. He has been asked to join a large research project that is looking at the genetics of cardiovascular disease. This will involve giving a DNA sample, answering a questionnaire and allowing details of his treatment to be given to the researchers. This study will directly help clinicians decide which drug to give to those patients who are enrolled in the study. Researchers at the local hospital where Kurt is being treated, in collaboration with a team of researchers from a European university and a medical sciences institute in China, are conducting the study.

Kurt has been asked to give a broad consent that will allow the researchers to keep the DNA sample and information for use in suitably approved future research projects. This will save them the expense of coming back for consent for each new research project. He can choose whether researchers are allowed to come back to him to ask further questions. The DNA will be processed in China and then sent to Europe for analysis. All of the direct identifiers (such as his name and address) will be removed before the samples are sent to China. The samples will, however, be given a code which will remain in a secure location at Kurt’s hospital.

The samples and information collected from Kurt will then be put in a biobank that can be accessed by many other researchers for many years into the future. It is anticipated that when the technology is cheaper, whole genome scans will be carried out on some of the samples and these will be put on the web for other researchers to use.

Excerpted from Director-General for Research and Innovation, European Commission (2010). European Textbook on Ethics in Research. Luxembourg: Publications Office of the European Union.

Questions for Discussion

1. Is it acceptable to obtain consent to the use of the samples and information for many different research projects into the future (broad consent)?
2. Does the coding of samples and information mean that it is not necessary to ask for Kurt’s consent for future research projects?
3. Is it necessary to tell Kurt that the DNA samples will be processed in China, and analysed in a European country?
4. The researchers discover that people with Kurt’s genetic predisposition are more likely to die if they are treated with a drug that is commonly used for heart conditions in Germany. Should they tell Kurt?
5. Do the researchers need to go back to Kurt to get permission for his whole genome scan to be put on the web?