BIO Comes Into the Cold to Adopt BRISQ

Abstract

Different biospecimen collection, processing, and storage procedures can significantly alter the molecular integrity of biospecimens and contribute to difficulties in reproducing research results. Moreover, the details related to such biospecimen handling procedures are rarely mentioned in scientific publications, making it difficult for readers and reviewers to understand exactly how a study was conducted and what preanalytical variations may have contributed to the study results. In an effort to alleviate these difficulties, a set of recommendations specifically dealing with biospecimen reporting, known as BRISQ (Biospecimen Reporting for Improved Study Quality), was recently published simultaneously in three different journals including Biopreservation and Biobanking (BIO).^1–3

BIO is now formally adopting the BRISQ recommendations in its approach to submission and review of manuscripts to the journal. BIO's Author Guidelines have been updated to highlight the importance of BRISQ, specifically anticipating that authors will document the BRISQ Tier 1 variables in their manuscripts (see Table 1). In this approach BIO joins other prestigious journals that have already^4–6 implemented or will implement the BRISQ guidelines. It is hoped that adoption of the BRISQ recommendations in BIO will help to provide readers with more thorough information to evaluate, interpret, compare, and reproduce experimental results.

Table 1.

Quick-Reference Biospecimen Reporting for Improved Study Quality Summary/Checklist: Tier 1 Items to Report if Known and Applicable

Data elements	Examples
□ Biospecimen type	Serum, urine
Solid tissue, whole blood, or another product derived from a human being
□ Anatomical site	Liver, antecubital area of the arm
Organ of origin or site of blood draw
□ Disease status of patients	Diabetic, healthy control
Controls or individuals with the disease of interest
□ Clinical characteristics of patients	Premenopausal breast cancer patients
Available medical information known or believed to be pertinent to the condition of the biospecimens
□ Vital state of patients	Postmortem
Alive or deceased patient when biospecimens were obtained
□ Clinical diagnosis of patients	Breast cancer
Patient clinical diagnoses (determined by medical history, physical examination, and analyses of the biospecimen) pertinent to the study
□ Pathology diagnosis	Her2-negative intraductal carcinoma
Patient pathology diagnoses (determined by macro and/or microscopic evaluation of the biospecimen at the time of diagnosis and/or prior to research use) pertinent to the study
□ Collection mechanism	Fine-needle aspiration, preoperative blood draw
How the biospecimens were obtained
□ Type of stabilization	Heparin, on ice
The initial process by which biospecimens were stabilized during collection
□ Type of long-term preservation	Formalin fixation, freezing
The process by which the biospecimens were sustained after collection
□ Constitution of preservative	10% neutral-buffered formalin, 10 United States Pharmacopeia heparin units/mL
The make-up of any formulation used to maintain the biospecimens in a nonreactive state
□ Storage temperature	−80°C, 20°C–25°C
The temperature or range thereof at which the biospecimens were kept until distribution/analysis.
□ Storage duration	8 days, 5–7 years
The time or range thereof between biospecimen acquisition and distribution or analysis
□ Shipping temperature	−170°C to −190°C
The temperature or range thereof at which biospecimens were kept during shipment or relocation
□ Composition assessment and selection	Minimum 80% tumor nuclei and maximum 50% necrosis
Parameters used to choose biospecimens for the study

Reprinted from Moore HM, Kelly A, Jewell SD, et al. Biospecimen reporting for improved study quality. Biopreserv Biobank 2011;9:59. Used with permission.

Advances in modern biobanking and increased attention to annotation of biospecimen procedures will help to enable authors to gather the information recommended in BRISQ. Online and web-based tools already exist that can enhance the ability to record, analyze, and generate reports encompassing BRISQ-related data.⁷ However, the editors of BIO recognize that the BRISQ variables shown in Table 1 will not always be available to authors at this moment in biobanking. Nevertheless it is anticipated that authors will do their best to present the recommended information to the editors. Over time, the information recommended for reporting in BRISQ will become second nature to the research community as a part of the Materials and Methods sections of articles. One needs only to look to the recent past to see the rapid evolution of what the community deems as being acceptable metadata. Only a few years ago, it would have been unusual, or even exceptional, for information on ethical approval, conflict of interest, and author contribution to be recorded: now it is de rigueur. We anticipate that the same rapid evolution will occur with the definition of pre-analytical information; the BRISQ guidelines are an important step in that evolution.

What does the adoption of BRISQ mean for readers, authors, and editors of BIO? If you are a researcher who wants to submit to BIO you may consider the following scenarios: 1) If you have already finished your research project or at least have already identified the biospecimens you will be using for your research you might go back to the biobank and request appropriate biospecimen annotation according to the BRISQ guidelines. It is quite possible that you may not get the entire tier 1 data, particularly for previously stored biospecimens; however you will have determined for certain the availability of the data and can then justify such in the methods and/or in the discussion sections of the manuscript as appropriate. 2) If you are both a researcher and a biobanker and for the specific research project you will need to prospectively collect the biospecimens and data, you have the opportunity to collect the information as described in BRISQ. It is possible that such annotation may pose challenges to biospecimen acquisition; however, the annotated biospecimens will be more valuable in the future to facilitate research. 3) If you are planning to conduct research using biospecimens from a biobank that is not under your control, select a biobank that is able to provide you with the required information.

Reviewers and members of the BIO Editorial Board should be aware of BRISQ and review submitted manuscripts accordingly, with an understanding that it will take some time for submitting authors to fully comply with BRISQ.

BRISQ is not the first set of recommendations for publication of research results. Various such recommendations and guidelines are collated on the EQUATOR network (see www.equator-network.org). What can we expect by introducing BRISQ, based on the experience of these other guidelines? As with other guidelines it is important to prospectively and retrospectively analyze the impact of the BRISQ guidelines on the quality of published articles.

The BRISQ recommendations are an important element of moving forward in biobanking and improving the quality of research utilizing biospecimens. We hope that this small step will add to the capacity of biospecimen-related research to help in the understanding of disease and the development of new diagnostic and therapeutic tools. Annotation of biospecimens to comply with BRISQ will require increased effort, as will other changes and improvements to biobanking. On the other hand, we cannot afford not to invest in research infrastructures like biobanks and be surprised that the general quality of research is not what we expect.^8–10

References

Moore

, Kelly

, Jewell

, McShane

, Clark

, Greenspan

, et al. Biospecimen reporting for improved study quality (BRISQ). Biopreserv Biobank, 2011; 9:57–70.

Moore

, Kelly

, Jewell

, McShane

, Clark

, Greenspan

, et al. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathol, 2011; 119:92–101.

Moore

, Kelly

, Jewell

, McShane

, Clark

, Greenspan

, et al. Biospecimen reporting for improved study quality (BRISQ). J Proteome Res, 2011; 10:3429–38.

Simeon-Dubach

, Burt

, Hall

. Quality really matters: The need to improve specimen quality in biomedical research. J Pathol, 2012; 228:431–433.

Simeon-Dubach

, Burt

, Hall

. Quality really matters: The need to improve specimen quality in biomedical research. Histopathology, 2012; 61:1003–1005.

Nature editorial. Announcement: Reducing our irreproducibility. Nature, 2013; 496:398.

Cheah

, Dee

, Cole

, Matzke

, O'Donoghue

, Watson

. An online tool for improving biospecimen data element reporting. Biopreserv Biobank, 2012; 10:501–510.

Prinz

, Schlange

, Asadullah

. Believe it or not: How much can we rely on published data on potential drug targets?. Nat Rev Drug Discov, 2011; 10:712.

Begley

, Ellis

. Drug development: Raise standards for preclinical cancer research. Nature, 2012; 483:531–533.

10.

Simeon-Dubach

, Perren

. Better provenance for biobank samples. Nature, 2011; 475:454–455.