Recommendation CM/Rec (2016)6 of the Committee of Ministers to member States on research on biological materials of human origin.

Wednesday, May 18, 2016

 

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There’s a new arrival in the biobanking normative landscape! On May 11, 2016, Recommendation CM/Rec (2016)6 on research on biological materials of human origin was adopted by the Committee of Ministers of the Council of Europe. This new document succeeds the widely cited Recommendation (2006)4. Containing six (6) chapters and twenty-four (24) articles overall, the new revised Recommendation emphasizes the diverse origins of biological materials, outlines considerations related to the use of samples from persons unable to consent and stresses the difficulty of guaranteeing non-identifiability of samples in our day and age.

More specifically, the Recommendation clarifies its scope of application by providing additional nuances to the type of research projects covered by its provisions. When it comes to identifiability, Recommendation (2016)6 abandons convoluted terminology such as “linked” and “unlinked anonymized materials” and adds a new recommendation calling for non-identifiability to be verified by an appropriate review procedure.

Perhaps the most significant change relates to consent requirements when obtaining biological materials for research. In the past, it was required that information and consent be as “specific” as possible with regard to any foreseen research use. In the new revised Recommendation, however, the concept of using biological materials for future research is explicitly laid out along with the associated consent and governance requirements, which will prove more adaptable. Specific considerations related to persons capable and incapable of consenting have also been added.

The new Recommendation also contains provisions related to the closure of a collection of biological materials; an issue often neglected by both policymakers and research projects. Furthermore, a new section on individual feedback to participants makes these considerations more explicit. Chapter V on population biobanks was removed from the new Recommendation. Indeed, the new text shies away from using the term “biobank” when referring to the storage of biological materials.

Finally, the Public Population Project in Genomics and Society (P3G) is pleased to see an emphasis on the importance of both international collaboration and interoperability by the Committee of Ministers. In this light, please find below a few tools developed by P3G’s International Policy interoperability and data Access Clearinghouse (IPAC), with direct relevance to the provisions of the new Recommendation.

 

P3G Generic Information Pamphlet and Consent Form (2014)

P3G Model Framework for Biobank Access Policy: Core Elements (2013)

P3G Model Framework for Biobank Governance (2013)

 

By Ma’n H. Zawati, LL.B., LL.M.