The Results of the First 6 Years of the NHLBI BioLINCC Program, Q&A with author Lisbeth A. Welniak, PhD

By: Vanessa Claude

July 6, 2017

The NHLBI and NIH are providing researchers with online access to NHLBI biospecimen collections. I've asked one of the authors of the 6 year report, Lisbeth A. Welniak, PhD (Translational Blood Science and Resources Branch; Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute (NHLBI), NIH) a few questions to give background on the NHLBI BioLINCC Program.

1. What is the background for this report (the reason for the BioLINCC and the metrics measured)?

The primary objective of the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) program is to maximize the scientific value of NHLBI biospecimen and data collections by facilitating access to these resources and promoting their use by the scientific community. Prior to BioLINCC, the NHLBI had a biorepository in 1975 and a separate data repository in 2000. Many of the studies in the data repository also had specimens deposited in the biorepository; however, the repositories were managed by different NHLBI divisions and could not readily share information.

In 2007, a 5-year plan by NHLBI leadership was implemented to maximize the scientific value of the resources available in each repository by establishing a coordinating center to link the stored specimens with their clinical data and facilitate their request and distribution through a publicly available online mechanism. The Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) was therefore established in 2008 to develop the infrastructure needed to link the contents of the two repositories and to promote and facilitate the utilization of these resources. 

As a management and oversight tool and to monitor the success of this effort, program utilization metrics were developed to measure the impact of BioLINCC on biorepository access by researchers, including visibility, program efficiency, user characteristics, scientific impact, and research types.

The baseline paper provides additional information on the purpose of BioLINCC and on the methods used in its development:

Giffen CA, Carroll LE, Adams JT, Brennan SP, Coady SA, Wagner EL. Providing contemporary access to historical biospecimen collections: development of the NHLBI biologic specimen and data repository information coordinating center (BioLINCC). Biopreserv Biobank. 2015;13(4):271-279. Epub 2015 Jul 17. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4559201

2. Were any obstacles found to increase fulfillment times other than submissions without funding?

The single most common reason for the termination of requests for biospecimens has been the lack of investigator funding to perform their proposed research. However, in the early years of the program, another obstacle to the fulfillment times of certain biospecimen collections was the state of the biospecimen inventory files compared with the actual locations of the vials in the freezers.

There were also surprises when vials were retrieved including (but not limited to): cracked vials, lower or higher volumes than expected, and unusual visual appearance. These problems came about because, over the years, many of the collections had been bulk transferred into the biorepository from the clinical sites. Because the specimens were not being used, they had never been touched. The result of these issues was the need to either: (a) locate misinventoried vials, (b) go back to the specimen identification processes conducted by BioLINCC to select replacements for low-volume otherwise unsuitable vials, and (c) to have to incorporate an unexpected aliquoting step to create daughter vials from high-volume specimens.

3. What, if any, actions have been identified to overcome obstacles?

Concurrent with the initiation of the BioLINCC program, a prospective QA/QC program was funded and implemented by the biorepository to prospectively identify and correct inventory issues and to flag or discard vials with discrepancies in the inventory management system. This QA/QC program was facilitated by BioLINCC through the provision of clinical data linking files and mapping tools. Another more recent effort by the biorepository has been in inventory review, vial consolidation, and other freezer management techniques, which streamline the workflow associated with vial pulls.

To address the lack of funding, we have issued funding opportunity announcements (FOAs) to maximize the use of the Biospecimen and Data Repositories, listed below for your reference.

RFA-HL-17-022: Maximizing the Scientific Value of the NHLBI Biologic Specimen Repository: Scientific Opportunities (R21): http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-17-022.html

PAR-17-004: Secondary Analyses of Existing Datasets in Heart, Lung, and Blood Diseases and Sleep Disorders (R21): https://grants.nih.gov/grants/guide/pa-files/PAR-17-004.html

4. What should readers/investigators take away from this report?

The NHLBI Biologic Specimen and Data Repositories represent a significant investment of resources both in terms of the funding and scientific oversight of the parent studies in the conduct of the original research and in the maintenance and storage costs associated with long term storage of research resources. To ensure optimal resource management and to identify areas where resources may be underutilized by the target research community, program metrics were designed at the outset and have been enhanced as the BioLINCC program and methods evolved over time.

The metrics used to monitor the BioLINCC program activities have proven to be invaluable for improved biorepository workflows and provide both insight into the scientific utility of a collection and into the use and users of the biospecimens that otherwise would not be possible.

5. How do you see BioLINCC moving forward after these results?

The results illustrate the high impact of BioLINCC on biorepository access as a key resource for the larger scientific community. As the National Heart, Lung, and Blood Institute (NHLBI) provides global leadership in the prevention and treatment of heart, lung, and blood diseases and supports basic, translational, and clinical research in these areas, BioLINCC will become an integral component for increasing the return from NHLBI population-based and outcomes research. BioLINCC can also serve as a model for other biorepository and data infrastructures to facilitate research discoveries from the bench side to the clinic.

Read the full report on the BioLINCC Program's results.

Lis Welniak, PhD

Program Officer, Translational Blood Science and Resources Branch

welniakla@nhlbi.nih.gov

Dr. Lis Welniak’s areas of expertise include management of grants, fellowships, and cooperative agreements in the basic and translational scientific research areas of cellular therapies and the consequences of hematopoietic stem cell transplantation as well as basic and clinical immunobiology research in transfusion medicine.