International requirements for consent in biobank research: qualitative review of research guidelines.

Several stakeholders in the field of biobank research are currently developing and evaluating innovative consent procedures, and in doing so refer to national and international guidelines that regulate biomedical research. The objectives of this study were to present (1) a synthesis of all consent issues mentioned or required in guidelines that are of potential relevance to biobank research and (2) a detailed overview of similarities and differences between these guidelines. This analysis considered a purposive sample of the nine most internationally recognised research guidelines plus a national checklist for developing consent forms. The synthesis of all included research guidelines found 41 issues of potential relevance to consent procedures in biobank research. The guidelines differ substantially with respect to (1) how comprehensively they address these consent issues, (2) their definition and explanation of the issues and (3) how directly or indirectly the issues are mentioned. The set of 41 consent issues presented in this paper should be further developed in a continuous process. Our findings on the differences among major research guidelines also raise the issue of a more systematic development and revision process for these guidelines. The presented set of content issues potentially relevant to consent in biobank research can inform the balanced development or evaluation of consent forms, as well as the development and revision of corresponding research guidelines.