title: 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 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Hannover Medical School (MHH), Institute for History, Ethics, and Philosophy of Medicine, Germany. Electronic address: strech.daniel@mh-hannover.de.
authors.forename: D
authors.initials: D
authors.lastname: Strech
authors.affiliation: University of Duisburg-Essen, Ethics Committee of the Medical Faculty, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Bein
authors.affiliation: University of Gießen, Research Ethics Committee, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Brumhard
authors.affiliation: Ludwig Maximilians Universität München (LMU), Ethics Committee, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Eisenmenger
authors.affiliation: University of Kiel, Ethics Committee of the Medical Faculty, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Glinicke
authors.affiliation: Humboldt-Universität zu Berlin, Faculty of Law, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Herbst
authors.affiliation: University Hospital of Wuerzburg, Interdisciplinary Bank of Biomaterials and Data Wuerzburg (ibdw), Germany.
authors.forename: R
authors.initials: R
authors.lastname: Jahns
authors.affiliation: University of Kiel, Chair of Public and Medical Law, Germany.
authors.forename: S
authors.initials: S
authors.lastname: von Kielmansegg
authors.affiliation: Technische Universität München (TUM), University Hospital Klinikum Rechts der Isar, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Schmidt
authors.affiliation: University of Mannheim, Professorship for Civil Law, Law of Civil Procedure, Private International Law and Comparative Law, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Taupitz
authors.affiliation: Hannover Medical School (MHH), Research Ethics Committee, Germany.
authors.forename: H D
authors.initials: HD
authors.lastname: Tröger
mesh_terms: D018070:Biological Specimen Banks / Q000639:trends*; D035843:Biomedical Research / Q000639:trends*; D006801:Humans
keywords: Biobank; Biospecimen; Broad consent; Consent form; Ethics; Genetic research