Can University-Hospital Systems Meet the Needs of Researchers and Patients At The Same Time?

​Written in collaboration with Ryan Colvin, Christine Kramer, and Kelle Moley, MD

Like many academic institutions, our University-Hospital system had some unmet needs when it came to obtaining biospecimens for research; in particular, biospecimens from pregnant women.  Researchers need access to high quality samples and data, but there was no way to track patients throughout their pregnancy. Many patients are willing to participate in research, but they don't want to be approached by multiple staff to be consented into multiple research studies. Finally, our labor and delivery unit was faced with many researchers coming to the floor to obtain specimens which caused confusion. As a result, a team of faculty from our departments of pathology and OBGYN was assembled to address these needs.

Our objective was to create an infrastructure to recruit pregnant subjects, collect biospecimens throughout pregnancy and make them available to researchers along with clinical information and outcomes.  Therefore, beginning in 2008, a system was put into place to consent subjects and track them across a major medical center throughout their pregnancy.  This infrastructure was termed the Women and Infants Health Specimen Consortium (WIHSC).

Biospecimens, including (but not limited to) serum/plasma, urine, follicular fluid, placenta, cord blood, and infant heel stick blood are collected, and processed. Specimens are stored in a previously established university repository. Clinical data is also gathered and stored in a database. A business plan was developed and a cost-recovery fee structure was implemented such that there are no charges for the samples themselves, charges are applied only to cover the services required to collect the data and samples.

The WIHSC has been fortunate to obtain funding to support this structure for six years. Initially funding was directly to the Biobank but currently the WIHSC receives support from researchers with grant money who use the WIHSC services. The cost to maintain this infrastructure has been ~ $250,000/yr. Subjects are recruited from 4 sites and the average enrollment has been ~ 12 subjects/week.  We feel that one of the keys to our success has been that we only collect specimens for hypothesis-driven projects. We do not collect and bank specimens just to collect specimens. As a result, over 4,700 samples have been distributed to 11 researchers from 8 different university departments. To date, over 40,000 samples have been banked for future research and include a variety of clinical outcomes such as gestational diabetes, preeclampsia and premature rupture of membranes. These specimens are available to researchers outside the university as well.

We have successfully formed a biorepository for specimens collected from subjects longitudinally throughout pregnancy that has met the needs of our university-hospital system. This program has allowed many researchers to obtain a variety of specimens from subjects at all stages of pregnancy, but patients sign only a single consent form.  In addition, our Labor and Delivery floor only allows qualified personnel to obtain specimens. We welcome collaboration with researchers interested in obtaining specimens or creating their own biospecimen bank. http://womeninfantsbank.wustl.edu

Are biorepositories the answer to unmet needs in clinical/translational research?