Bioethics issues in human studies

Biobanks

Exchange of data on gene variants:

The Ethics Committees stipulates to guarantee confidentiality by exchanging only anonymized data (Germany, France, Netherlands, UK).
One researcher from UK reported the Ethics Committee requesting double coding.
Ethics Committees from Italy and Poland have no specific rules.
Researchers from Norway and Sweden said that they had no personal experiences with exchange of data on genotype and therefore could not give their Ethics Committee's opinion on this issue.

Exchange of DNA samples

Only anonymized DNA samples can be exchanged (France, Netherlands, UK)
No specific regulations in Poland.
Scientists from France, Poland, and UK noted that for any exchange, ethical approval is required and that approval is only valid for a special purpose (i.e. study).

Information to the participant about the exchange of data on gene variants or samples

According to scientists' reports, no information to the participants about the exchange of data and samples had to be given in Germany and Italy.
In case of identifiable data, this information has to be part of the initial informed consent (France, Poland, Sweden, UK), i.e. the information about the fate of the samples and data had to be passed before recruitment
In case unplanned studies arise, only the exchange of anonymized data and samples is possible with 'blanket permission' [of the Ethics Committee] (UK)
Without informed consent, only anonymized samples or data can be exchanged (Netherlands, Sweden, UK)

The exchange of data and samples should not be regulated too strict if data are processed without any identifier (Germany).
Further scientists point out that it should be possible to exchange data without informing the participant (Germany, Netherlands).
In Sweden, there are groups working to make more detailed regulations for exchange of data and samples.
The confidentiality and protection of privacy was emphasized by all scientists.
Exchange of data and samples is part of an ethical review (UK), however, one scientist (UK) remarked that guidelines are overseen by Ethics Committees and law can be very inflexible and unworkable.
One French scientist expressed the view that the best way to share samples with other scientists would be to send samples in a centralized biobank, for example the Centra de Ressources Biologiques (CRB) would be the best way to share samples with other scientists.