Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections

Abstract

BackgroundFor valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers’ understanding and reactions.MethodsWe tested, revised, and retested template informed consent documents for biobank research by means of 11 focus group interviews with members from the documents’ target population. For the analysis of focus group excerpts we used qualitative content analysis. Revisions were made based on focus group feedback in an iterative process.ResultsFocus group participants gave substantial feedback on the original and on the revised version of the tested documents. Revisions included adding and clarifying explanations, including an info-box summarizing the main points of the text and an illustrative graphic.ConclusionOur results indicate positive effects on the tested and revised informed consent documents in regard to general readability and test-readers’ understanding and reactions. Participatory methods for improving informed consent should be more often applied and further evaluated for both, medical interventions and clinical research. Particular conceptual and methodological challenges need to be addressed in the future.Electronic supplementary materialThe online version of this article (10.1186/s12910-017-0232-7) contains supplementary material, which is available to authorized users.

The reported impact of public involvement in biobanks: A scoping review

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“…Also, three papers did not refer to a specific biobank, and the public involved gave input on hypothetical studies that would become actual biobanks in the future. [31][32][33] More details (including the method of involvement, the tasks addressed by involvement and a short description of the public involved) of the biobanks covered in the studies included can be found in Table 1. Additionally, a Supplementary Table in Appendix 3 provides details on each biobank.…”

The Public’s Awareness of and Attitude Toward Research Biobanks – A Regional German Survey

“…The postal survey was part of a larger project aimed at user-testing and revising an informed consent form for biobank research ( Bossert et al, 2017 ).…”

Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

“…Study designers should take care to incorporate proper language into the informed consents of participants to allow for the request of additional blood draws or sample collections and for the future use of their clinical samples for the purposes of standards and assay development. [14][15][16] Such studies should also ensure that well-established chain-of-custody, sample handling, and sample storage procedures are in place to maintain the quality of these valuable specimens. 17,18 A significant drawback of this approach is that often the samples may not have adequate characterization, may be of limited volume, and are proprietary to the study sponsors.…”