OpenSpecimen allows the tracking of the consent of the participants involved in a study. The management of consent involves:

• Managing consent statements.
• Setting up consent statements for a study.
• Capturing the participant’s consent responses.
• Ensuring that the consent-related obligations are followed during distribution.

Creating consent statements

Administrators can add consent statements along with a unique code for easy identification. The system checks and prevents duplication of consent statements and their codes. The consent statements are standardized and can be used for multiple studies.

Capturing participant responses

One of the many interesting features of the software is the designing of a longitudinal study with specific time points, to which, a user can pre-assign the consent statements and the response of participants can also be captured. To make the process easier for studies involving many participants, OpenSpecimen allows feeding data in bulk. There is also a feature to upload a signed consent form.

Specimen distribution

It’s the responsibility of biobanks involved in specimen distribution to ensure that the distributed specimen is not used for any purpose to which the participant has not given consent. OpenSpecimen allows users to add consent statements in distribution studies as well, which the system compares against the consent linked to the specimen to be distributed and restricts the distribution in case the consents don’t match.

Reporting

OpenSpecimen allows users to query for specimens based on participant consents data. For e.g. Search for DNA specimens from participants who have consented for ‘Use of DNA specimens for research’ or Search for participants who have become 18 in order to re-consent.

Summary

OpenSpecimen simplifies the overall consent management process for a biobank by providing an easy to use platform with multiple features. It helps the biobank not only for efficient management but also in gaining public trust.    

References

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5526496/
2. https://www.fda.gov/ForPatients/ClinicalTrials/InformedConsent/ucm20041763.htm

Written by: Poornima Govindrao, Product Manager, Krishagni

For more details, email contact@krishagni.com

On the other hand, biobanks have a bigger problem – improving their specimen utilization rate. More than two-thirds of American biobanks worry about specimens under-utilization (1,2). Specimens use has both economic and ethical implications. Biobanks are only sustainable if they can recover some of their operating costs by sharing specimens. Since public money is often used to collect and store biospecimens, there is also an ethical obligation to maximize specimen use and avoid duplication efforts (3).

Furthermore, funding bodies and government organizations such as the U.K.’s Medical Research Council want biobanks to maximize biospecimen use to fulfill their ethical obligations to specimen donors and uphold public trust in the biobanking community (2,3).

“Awareness and use can be improved through high-quality online information about the resources.” – Medical Research Council

According to leaders in the biobanking field, biobanks can maximize biospecimen use by engaging in marketing, education, and outreach to ensure that researchers know how to access specimens (1).

Therefore, a web-based easily searchable database of research specimens with good quality dataset will help bridge the gap between biobanks and researchers.

Solution: A Web-Based Biospecimen Catalog

OpenSpecimen is an established biospecimen informatics platform used in 70+ biobanks across 20+ countries. The SpecimenCatalog module within OpenSpecimen enables biobanks to share biospecimen data with internal or external researchers.

For Biobanks

Biobank staff can easily create one or more catalogs within OpenSpecimen without any IT support. What data to expose on the catalog and which specimens to share is configurable and decided by the biobank. For example, one might want to hide rare specimens or the ones collected for a specific study.

Also, multiple catalogs can be created. For example, based on disease like Breast cancer catalog, Lung cancer catalog, or based on the study group.

For Researchers

Researchers can search the SpecimenCatalog using an easy-to-use user interface. Researchers can shortlist specimens of interest and fill in a request form to access these resources. Biobanks receive these requests and initiate the process to review the application. 

Many studies have shown that specimen quality affects research results (4). Researchers need standardized, high-quality biospecimens to perform reproducible experiments (1,4). Furthermore, biobanking best practices recommend linking all specimens to de-identified clinical data and quality management data to maximize the value of specimens to researchers (3). SpecimenCatalog makes it easy to include these datasets.

Biobanks can also create multiple catalogs based on diseases or studies e.g. Breast cancer catalog, Diabetes catalog, etc. Creating new catalogs is very simple and can be done without any IT support.

Summary

SpecimenCatalog closes the gap between biobanks and researchers, making it easier for researchers to find the specimens and data they need, and for biobanks to publicize their biospecimen collections and maximize use of their specimens.

References

1. Sawyer, SJ et al. Ensuring Biobank Value Through Effective Utilization. Biopreserv. Biobank. 2015
2. Cadigan et al. Underutilization of specimens in biobanks: An ethical as well as practical concern? Genet Med. 2014.
3. MRC ethics series. Human Tissue and Biological Samples for Use in Research: Operational and Ethical Guidelines. Medical Research Council. 2014.
4. NCI Best Practices for Biospecimen Resources. National Cancer Institute. 2016.

Written by: Srikanth Adiga, CEO, Krishagni

For more details, email contact@krishagni.com

OpenSpecimen can be integrated with REDCap (or other EDCs like OpenClinica) to eliminate manual data entry and query data across the two systems. The plugin is currently used by many customers including Washington University, Columbia University, Telethon Kids (Perth), and University of British Columbia (Vancouver). 

The plugin performs the one-way data synchronization from REDCap to OpenSpecimen. The data pulled includes all the instrument information (i.e. CRFs) into OpenSpecimen Forms. This data can be used to populate participants, visits, and any other clinical data.

Load balancer helps in achieving high throughput, minimizing response times and better utilisation of resources. A by-product of setting up load balancer is to increase reliability and availability of OpenSpecimen by ensuring there is no single point of failure (SPOF).

Read how OpenSpecimen can help you achieve it.

Deploying OpenSpecimen in High Availability Mode

For more details contact the OpenSpecimen tech support team at support@openspecimen.org

Thanks,