Bioethics issues in human studies

Biobanks

What is the proprietary status of DNA samples?

The NuGO scientists reported about the Ethics Committees' policy regarding the proprietary status of biological samples that

The subject donates the sample to the research coordinator, nobody owns it (Italy, UK)
As all other biological material, it remains the property of the participant. The samples are released for research as consented to by the subject (Netherlands, UK)
The sample is the property of research institution(s) or the principle investigator (PI) carrying out the project (Netherlands, Sweden)
The researchers have the right to exploit the samples according to their research protocol. The participant can withdraw the consent but the sample will not be destroyed until the end of the study (Norway)

How should DNA samples be stored?

Most Ethics Committees in Germany, France, Netherlands, and UK stipulate the samples to be stored anonymously or at least coded.
No specific regulation exists in Poland.
To store the samples in an identified manner is tolerated by Ethics Committees in Norway (for the study period only), Poland (patient data, including genetic information are available to selected researchers), and Italy (depending from the type of study).
One researcher reported in this context their samples having to be stored in a central biobank (Centre de Ressources Biologique (CRB), France).

What is the proprietary status of DNA samples?

Regarding the legal status of the DNA samples, the scientists are of different opinions:

One part says, that the research institution (Germany, Netherlands, UK, Italy, Sweden) or even health authorities (UK) should be the owner, or that the DNA sample should be considered as a gift from the patient for research purposes only (France). The ownership of the research institution would be of importance because it would ensure the availability of the samples to the investigator.
Any drawback to the study or any threat to the research aim may also frustrate the intentions of study subjects who agreed to participate with a certain expectation about the study outcome (UK).
The larger part of scientists are in favour of the subject being the owner (Netherlands, Poland, UK), unless the ownership was not explicitly transferred (Netherlands).
A researcher from UK pointed out that the legal status of DNA samples should respect the interests of both, the individual and the researcher.

How should DNA samples be stored?

The vast majority of scientists think the samples should be stored coded (Germany, Spain, France, Netherlands, Poland, Sweden, UK). This status would allow to follow-up the subject (Netherlands, Spain), trace the subject back to give health information (France), or would be necessary for retrospective audit (UK).
Predominantly the Dutch scientists think that the samples should be stored anonymized (meaning that the identifiers are stripped off permanently and no possibility exists to trace the subject back).
From the inquiry it was obvious that a number of scientists are not aware of the differences between coded, anonymized, or anonymous data or samples. Therefore, an education of scientists in opportunities to work with single or double coded samples and data even during the period of data and sample collection would be necessary. Standards should be developed.