NuGO Guideline 15

Biobanks

Potential legal successor in case the hosting institution closes down or the responsible scientist is not working for the biobank anymore

Whenever transfer of an entire biobank is being considered, the scientists and institution involved should seek the advice and approval of an ethics committee. In principle, if the biobank is transferred to an equivalent institution:

  • Transfer of already unlinked anonymized data and samples should be possible without any restriction. However, this has to be subject to independent review as well, to ensure that the recipient institution is able to maintain the biobank according to established standards.
  • In case of traceable samples and data, unless the research volunteer has given consent to a potential transfer of the sample to an appointed institution, research volunteers must be contacted (see comment) to obtain specific consent for the transfer.
  • If the research volunteer cannot be contacted after a reasonable amount of effort(see Guideline 18), the biobank should have policy rules on how to proceed in such situations. The rules should be made known to the research volunteer who donates material to the biobank so that he/she can make up his/her mind beforehand. (see 50, Article 19-3).
  • The research volunteer's previous wishes, if any, should be followed.
  • The transfer and closing procedures must be monitored by an independent body. Transfer and closing procedures must be monitored by an independent body.

Relevant documents

[ 50 ] Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin