The purpose of this article was to make recommendations for the reporting of data elements for human biospecimens, defined as solid tissues and bodily fluids, used in biomedical studies. Cell lines and biospecimen derivatives such as nucleic acids or proteins, although crucial for biomedical research, are not intended to fall within the scope of these recommendations. The Biospecimen Reporting for Improved Study Quality (BRISQ) recommendations are intended to apply to any study in which human biospecimens are used. This includes biomedical applications such as translational science, biomarker discovery, clinical trials, technology development, and diagnostic-assay and therapeutics development. The recommended data elements would be reported by an author in a journal publication, by a company in a regulatory submission, or by a biorepository distributing biospecimens. It is intended that the list and the elements within it will be interpreted, modified, and applied according to the context of the study being reported. It is also recognized that information corresponding to all data elements may not be available, but at least for some categories (described below) the known or unknown status of these elements should be documented.

The list of data elements discussed includes general information for consistent documentation of classes of biospecimens and factors that might influence the integrity, quality, and/or molecular composition of biospecimens. Reporting the details enumerated in the BRISQ list does not guarantee biospecimen quality and should not be seen as a substitute for empirical quality evaluations. The purpose of reporting these details is to supply others, from researchers to regulatory agencies, with more consistent and standardized information to better evaluate, interpret, compare, and reproduce the experimental results. To maintain consistency with federal regulations on research involving human subjects, information that might enable individual identification of research participants should be withheld.

The attendees further proposed that the BRISQ recommendations should broadly encompass solid tissues and bodily fluids, rather than including separate lists for these biospecimen types. It was also agreed that a committee to develop biospecimen reporting recommendations should be formed to take the effort forward. Many of the individuals and disciplines participating in the workshop were included when the BRISQ committee was subsequently formed.

Formulation of the recommendations was based on consideration of what biospecimen information could enable a science reviewer to fully evaluate or replicate a reported study. The preliminary list included the most commonly available data elements. The committee considered the characteristics of the biospecimens themselves as well as numerous preanalytical factors. Types of data elements include the tissue type and the pathology of the sample; patient characteristics that might influence the biospecimens, such as vital and disease states; and the collection and handling of the biospecimens, for example, the stabilization, shipping, and storage conditions.

Many reporting elements were discussed, but only some were approved by consensus for inclusion in the guidelines. The committee was mindful that certain information, although important to report, may not have direct relevance to the biology or condition of the biospecimen and, therefore, would not be under the purview of the BRISQ recommendations. The committee attempted to carefully balance scientific interest in having access to extensive data about biospecimen collection, processing, and storage against practical challenges in obtaining such detailed information. Each reporting element included in the guidelines is backed by evidence that the factor could have an effect on the structural integrity and molecular characteristics of the biospecimen or on the ability to perform certain assays on the biospecimen and obtain reliable results. Although the committee recognizes that collection of data about biospecimens can increase the operational costs to collect and use biospecimens, cost was not factored into the exclusion of data elements that were or should be considered necessary.

The elements in the BRISQ list are prioritized into 3 tiers according to the relative importance of their being reported. The first tier, items recommended to report, includes information such as the organ(s) or the anatomical site from which the biospecimens were derived and the manner in which the biospecimens were collected, stabilized, and preserved; for quick reference, these items are summarized in Table 1. Reporting these items need not be onerous. For example, Beatty et al.⁷ included most BRISQ Tier 1 items in the following excerpts:

Items beneficial to report form the second tier. These are data elements an evaluator might find helpful to know but may be slightly less crucial to the scientific contribution or less likely to be annotated, such as the time from biospecimen excision/acquisition to stabilization.

Additional items to report compose the third tier. These include information about conditions that might be useful to know concerning the biospecimens but are not known to be as likely to influence research results or are unlikely to be available to researchers, such as environmental factors to which patients were exposed or the type of storage container in which the biospecimens were kept.

The full BRISQ list featured in Table 2 includes each item and its definition along with additional columns that were designed for an author or reviewer to track where the listed items are reported for a particular study. To the right of the Item descriptions is a column assigning each item a unique Roman numeral/letter/number identification code. The far right column provides space to note where each item may be found in a manuscript or application. The far left Apply to column indicates whether the BRISQ item is applicable to “all” biospecimen types or is more appropriate for solid “tissue” biospecimens or “fluid” biospecimens (such as blood, urine, or other fluids). For example, item III.b, “Type of long-term preservation,” is pertinent to all types of biospecimens; item III.b.2, “Time in fixative/preservative solution,” is more relevant to solid tissue than to fluid biospecimens; and item III.c, “Aliquot volume,” applies more often to fluid than to solid tissue biospecimens. See the Appendix for examples of prior studies, with examples of the effect of each BRISQ data element.

When reporting elements of the BRISQ list, standard operating procedures specifying many of the pertinent details, such as blood collection protocols, may be provided or referenced; any referenced documents should be publicly available. It is preferable that most Tier 1 items relevant to the biospecimen and particular scientific study be reported directly in the intended publication rather than be cited from another document. Detailed descriptions that are too lengthy to be accommodated should be made available as supplemental materials online. Whether the laboratory performing the study was operating under any formal certification or accreditation should be stated if applicable to the study being reported.

The BRISQ committee discussed whether to request information that the biorepository and/or researcher had obtained ethical clearance to collect the biospecimens and perform the study. Clearance from an institutional review board or similar body is important to report in publications, and its reporting is generally required by journals. However, it is not immediately pertinent to the structural integrity and molecular characteristics of the biospecimen and is thus not included in the BRISQ recommendations. Similarly, accurate biospecimen-tracking mechanisms are essential to biobanking but not immediately pertinent to the condition of the biospecimen and are thus also not included in the BRISQ data elements list.

Surgical parameters, such as type of anesthesia or receipt of blood or other intraoperative infusates, were recognized to be of potential significance to the condition of the biospecimens. However, these data are often not known. When it is available, information about anesthesia and intraoperative treatments that may influence the condition of the biospecimens should be reported. These elements were not included in the BRISQ list because currently such information is rarely available or not required to be recorded as part of biospecimen collection efforts. If or when surgical parameters are determined to be critical through systematic biospecimen research studies, these elements will be integrated into future recommendations.

Several preservation parameters known to influence the condition of biospecimens and the results of analyses have been included in the list of recommendations. Researchers should state the rationale for the chosen preservation parameters. For example, if the type and temperature of the biospecimen preservative were selected to optimize stability, extraction, and analysis of a particular analyte, this should be mentioned.

The BRISQ committee recognized the need for greater specificity in the anatomic and histologic details reported concerning solid tissue biospecimens. The committee agreed that the level of detail with which pathology characteristics are reported should be enough to sufficiently address the scientific research question. These characteristics include not only the tissue site of the biospecimen and the relation of the biospecimen to the pertinent clinical diagnosis within the tissue site, but also the composition and pathology within the biospecimen where relevant.

Adoption of the BRISQ recommendations is expected to help authors, reviewers, editors, and regulatory officials evaluate whether sufficient information about the biospecimens has been provided to enable assessment of the influence of preanalytical biospecimen factors on study results. If reported, this information will allow improved evaluation, interpretation, comparison, and reproduction of the results from studies that employ human biospecimens. Although items in any tier might not be available or items in Tiers 2 or 3 might not be considered significant to report, increased awareness of their potential influence on biospecimen studies might lead to improved tracking and reporting in the future.

The BRISQ recommendations may be implemented by anyone reporting on studies involving biospecimens. Reviewers, editors, and regulatory officials might also employ the list as a tool for evaluating whether sufficient biospecimen information has been included in a manuscript or application. In addition, the recommendations might be employed by investigators requesting biospecimens from a biospecimen resource: essential items on the list might be checked off to indicate that they are required annotation for the desired samples. Elements of BRISQ that document preanalytical variables for tissue biospecimens could be economically captured using a reporting system such as the Standard PREanalytical Code, or SPREC, which was recently published by the ISBER Working Group on Biospecimen Science.¹⁰

BRISQ reporting items will not be necessarily applicable to every study, and authors and reviewers are urged to use their judgment to decide which factors are essential. It is not always possible for investigators to ascertain every recommended element for every biospecimen, even for Tier 1 items, but unknown elements relevant to the study being reported should be fully acknowledged with a discussion of possible implications that the missing information might have on the study conclusions. Unknown or unreported Tier 1 data elements should not be considered a reason for automatic dismissal of a report or conditional for the award of a grant. The final decision on acceptability of missing Tier 1 information should be specific to the study context.

When consulting the BRISQ list, researchers should evaluate the importance of each item in the context of the study and adjust their reporting accordingly. An item such as “method of enrichment for relevant components,” listed here as Tier 2, might—for example, in the context of a study comparing the efficacy of various enrichment methods—be essential to report and should thus be considered Tier 1 for that study. The converse may also be true, when, for example, an item listed here as Tier 2—such as “temperature between acquisition and stabilization”—is less pertinent to the study at hand—perhaps because the time at this temperature was negligible—and should thus be considered Tier 3.

It is hoped that consideration of the BRISQ recommendations will sensitize the biobanking and research communities and their funding agencies to the importance of tracking preanalytical variables, leading to more judicious selection and handling of experimental human specimens and thus improved study quality. Anecdotally, recommendations such as REMARK seem to have had the effect of spurring researchers to consider the recommendations in advance of conducting their investigations, with the result that researchers might take greater care in the design, conduct, and analysis of their studies. The BRISQ committee envisions a similar trajectory for preanalytical biospecimen data elements. Thus, not only might overall quality of publications improve, but the quality of human biospecimen-dependent investigation in general might improve over time with the formation and adoption of publication recommendations. It is anticipated that biospecimen resources might use these recommendations to improve on their existing standard operating procedures and annotation thereof. Such improvements could include the acquisition of additional relevant biospecimen data based on the BRISQ recommendations and the release of all such data to researchers as a standard procedure. In this way, biospecimen resources might become major players in the universal application of these recommendations.