Biospecimen Reporting for Improved Study Quality (BRISQ)

Abstract

Human biospecimens are subject to a number of different collection, processing, and storage factors that can significantly alter their molecular composition and consistency. These biospecimen preanalytical factors, in turn, influence experimental outcomes and the ability to reproduce scientific results. Currently, the extent and type of information specific to the biospecimen preanalytical conditions reported in scientific publications and regulatory submissions varies widely. To improve the quality of research utilizing human tissues it is critical that information regarding the handling of biospecimens be reported in a thorough, accurate, and standardized manner. The Biospecimen Reporting for Improved Study Quality (BRISQ) recommendations outlined herein are intended to apply to any study in which human biospecimens are used. The purpose of reporting these details is to supply others, from researchers to regulators, with more consistent and standardized information to better evaluate, interpret, compare, and reproduce the experimental results. The BRISQ guidelines are proposed as an important and timely resource tool to strengthen communication and publications around biospecimen-related research and help reassure patient contributors and the advocacy community that the contributions are valued and respected.

Dutch Parelsnoer Institute-Cerebrovascular Accident (CVA) Study: A Large Multicenter Clinical Biobank with Standardized Collection and Storage

“…The biobanking protocol according to Biospecimen Reporting for Improved Study Quality (BRISQ) is as follows [31]. Blood collection for the CVA Biobank is performed according to the biobank SOP.…”

Enhancing translational research in paediatric rheumatology through standardization

“…Thus processing conditions that are optimal for one assay are not the same for another, necessitating careful documentation of preanalytical information and harmonization of the methods to document these conditions. The BRISQ (Biospecimen Reporting for Improved Study Quality) guidelines 27 were developed in collaboration with the NCI Biospecimen Research Network to document where biospecimens came from and how they were treated. The guidelines list critical data elements that include general information for consistent documentation of categories of biospecimens and factors that might influence the integrity, quality, and/or molecular composition of biospecimens.…”

New paradigms in translational science research in cancer biomarkers

“…The EDRN brings together investigators from discovery laboratories, clinicians and biostatisticians to discuss issues related to clinical needs and study design and to share resources, such as high quality biospecimens that are collected to address a specific clinical question. An NCI workshop sponsored, Development of Biospecimen Reporting Criteria for Publication , concluded that “human biospecimens are subject to a number of different collection, processing, and storage factors that can significantly alter their molecular composition and consistency” and recommended guidelines for reporting data elements for human biospecimens used in biomedical studies, the Biospecimen Reporting for Improved Study Quality (BRISQ) 13 . These reporting guidelines are intended to allow other researchers to better evaluate and reproduce experimental results.…”

“…Investigators EDRN at the DMCC have developed a study design for phase 2/3 biomarker validation trials 13 . They have termed this the PRoBE design for Prospectivespecimen- collection-Retrospective-Blinded-Evaluation.…”