NuGO Guideline 10


Independent review of research using materials stored in a biobank

The ethical review procedures for the use of material and data from a biobank generally may be adapted to the nature of the research and the extent to which the research volunteer concerned could be identified from the biological materials or associated data.

However, prior to the conduct of a research project involving the use of biobank samples and data, an independent review should always be conducted.

It is essential where:

  • the project calls for linking the samples to nominal data
  • bodily substances and associated data are to be transferred to external researchers.

The use of biobank samples and data where the research volunteer is traceable in research is not within the scope of the original consent should require renewal of the informed consent.

Nutrigenomics pilot studies using unlinked anonymized materials from a biobank may be exempt from comprehensive ethical approval [see 50, Articles 21-25]. However, even if samples are unlinked anonymized, it must be verified that the research volunteer had not opposed to the kind of research intended (see Guideline 1). Information on potential objection to a particular research may be kept coded together with study records or data files.

Relevant documents

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