Results of the Inquiry and Citation Review

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Bioethics issues in human studies

Informed consent

Withdrawal of consent

State of discussion

Withdrawal of informed consent

Provided samples and derived data have been stored in an identifiable manner, donors may request that those samples and any human genetic data derived from them be returned to them or destroyed at any time during the course of the study. However, this has some potential to bias study results. Therefore an alternative approach would be to treat the sample as a donation, thus transferring full ownership and control over the sample to the principle investigator or the institution the principle investigator is affiliated with. Under these circumstances, the sample would have to be anonymized when participant withdraw consent. It would depend on the informed consent whether the sample could further be used in an anonymized form or whether can't be used. The same is true for the data collected so far. In prospective studies, it might be possible to use the data up to the point in time until the participant withdraws consent. The sample possibly could be used further when anonymized.

In case a biological sample has to be disposed, cultural backgrounds of the participants should be respected [13].

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