The committee composed a list of data elements that represent factors believed to often influence biospecimen quality and thus should be considered for reporting, if known or applicable, for the particular study; for example, some list of elements will be more applicable to biospecimens collected for a disease-specific study than those collected for a population-based biospecimen resource. For clarity, these elements are organized according to the lifecycle of the biospecimen (), which spans the period immediately prior to removal from the patient through use in a scientific analysis.
The lifecycle of the biospecimen. The preanalytical phase of the lifecycle of the biospecimen includes each stage from patient to distribution. Preanalytical variables are addressed in the Biospecimen Reporting for Improved Study Quality list.
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 . Reporting these items need not be onerous. For example, Beatty et al.7
included most BRISQ Tier 1 items in the following excerpts:
- Fine-needle aspiration specimens were obtained from 55 surgically removed specimens of breast cancer within 1h of resection, before tissue fixation. The aspirates were obtained using a 22- to 25-gauge needle and spread directly on slides and fixed in ethanol or formalin or placed in CytoLyt for preparation of ThinPrep slides according to the manufacturer's protocol. Corresponding formalin-fixed, paraffin-embedded tissue specimens were fixed in 10% neutral buffered formalin for 18–24h according to routine procedures and embedded in paraffin.”
- All fine-needle aspiration cytologic slides were air dried and stored at room temperature before fluorescence in situ hybridization analysis.”
Quick-Reference Biospecimen Reporting for Improved Study Quality Summary/Checklist: Tier 1 Items to Report if Known and Applicable
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 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.
Biospecimen Reporting for Improved Study Quality Information on Itemsa to Consider Reporting in Publications That Employ Human Biospecimens
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.
The BRISQ committee included members of the NCI Office of Biorepositories and Biospecimen research (OBBR), participants from the OBBR Biospecimen Research Network Symposium, and members of the International Society for Biological and Environmental Repositories (ISBER) and the committees responsible for the REporting recommendations for tumor MARKer prognostic studies (REMARK)8
and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE)9
guidelines. Essential harmonization with similar efforts are underway by these groups.