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

D. Strech, S. Bein, M. Brumhard, W. Eisenmenger, C. Glinicke, T. Herbst, R. Jahns, S. von Kielmansegg, G. Schmidt, J. Taupitz, H. D. Tröger

Research output: Contribution to journalReview articlepeer-review

45 Scopus citations

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.

Original languageEnglish
Pages (from-to)295-309
Number of pages15
JournalEuropean Journal of Medical Genetics
Volume59
Issue number6-7
DOIs
StatePublished - 1 Jun 2016
Externally publishedYes

Keywords

  • Biobank
  • Biospecimen
  • Broad consent
  • Consent form
  • Ethics
  • Genetic research

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