A template for broad consent in biobank research. Results and explanation of an evidence and consensus-based development process

Abstract Background Biobanks increasingly presume long-term storage of biomaterials and data that shall be used for future research projects which are today unspecified. Appropriate consent documents for sample donors must therefore explain the breadth of consent and other elements of the biobank go...

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Bibliographic Details
Published in:European journal of medical genetics 2016-06, Vol.59 (6-7), p.295-309
Main Authors: Strech, D, Bein, S, Brumhard, M, Eisenmenger, W, Glinicke, C, Herbst, T, Jahns, R, von Kielmansegg, S, Schmidt, G, Taupitz, J, Tröger, H.D
Format: Article
Language:English
Subjects:
Biobank
Biological Specimen Banks - trends
Biomedical Research - trends
Biospecimen
Broad consent
Consent form
Ethics
Genetic research
Humans
Medical Education
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Summary:Abstract Background Biobanks increasingly presume long-term storage of biomaterials and data that shall be used for future research projects which are today unspecified. Appropriate consent documents for sample donors must therefore explain the breadth of consent and other elements of the biobank governance framework. Recent reviews demonstrated high variability in what issues these documents mention or not and how the issues are explained. This might undermine the protection of sample donors, complicate networked biobank research, create research waste and impact on public trust. Methods A systematic analysis of international research guidelines and existing broad consent templates was performed. Based on this information an interdisciplinary expert group from the AKMEK (Permanent Working Party of German RECs) developed a draft template and organized a comprehensive stakeholder consultation. After revision the final template was consented by all 53 German RECs. Results This paper briefly explores the spectrum of potentially relevant issues for broad consent forms. It then elaborates the template and how it was designed to be applicable in different types of biobanks. Discussion To further improve the validity and applicability of broad consent forms in biobank and other big data research, practice evaluations are needed. We hope that in this regard the presented template supports the development of new consent forms as well as the evaluation and revision of existing ones.
ISSN:1769-7212
1878-0849
DOI:10.1016/j.ejmg.2016.04.002