What is Biospecimen Provenance and Why Is It Important?
To explain “biospecimen provenance”: every biosample or tissue sample used in medical research follows a unique journey. This journey starts when a person donates a biosample and ends when a researcher analyzes that same sample. In between, there are various routes, events, and timelines which form part of biospecimen provenance. It’s essential to note that all of these can impact the quality of the sample. Therefore, tracking the details of the sample journey is crucial for several reasons, including scientific quality control, legal requirements, and ethical considerations.
What Is Biospecimen Provenance?
Biospecimen provenance refers to the origin, history, and handling of a biological sample, ensuring that researchers can trace its journey from collection to analysis. According to the Merriam-Webster dictionary, ‘provenance’ means the origin or source of something. In the world of medical research, biospecimen provenance includes critical information that influences the quality of research outcomes.
For example, in antiques, provenance tracks the history of ownership of a valued object. Similarly, in medical research, biospecimen provenance ensures that biological samples can be traced, thus maintaining their integrity and reliability for scientific use. The World Wide Web Consortium defines provenance as information about entities, activities, and people involved in producing data or material, which helps assess its quality and trustworthiness.
Key Components of Biospecimen Provenance
Biospecimen provenance, or biosample provenance, includes four key components:
- Geographic origin
- Previous custodian(s)
- Sample processing history
- Donor information
Each component plays a vital role in maintaining the integrity of tissue samples and other biospecimens used in research.
1. Geographic Origin
Knowing the geographic origin of a biospecimen is a crucial part of biospecimen provenance. The location where a tissue sample is sourced can provide valuable context about environmental, socio-economic, and genetic factors. Moreover, researchers need to be aware of export restrictions from countries such as China, India, and Russia to ensure compliance with national regulations (Hofman et al., 2017).
2. Previous Custodian(s)
An essential part of biospecimen provenance is documenting all previous custodians of the sample. This ensures that the sample was obtained ethically and processed correctly. Ethical sourcing requires informed consent from donors and oversight by ethical bodies. Compliance with regulations like the US Revised Common Rule, European Recommendation Rec(2006)4, and the UK Human Tissues Act (2004) is necessary for all biospecimens.
Additionally, biorepositories that store and manage biosamples must have the appropriate certifications and accreditations, such as:
- ISO 9001 certification for quality management systems.
- ISO 20387 certification for biobank competence and quality control.
- US CAP Accreditation for Biorepositories.
- Licensing by the Human Tissue Authority in the UK.
Knowing the source biorepository is also crucial for recontacting it for additional tissue samples or clinical information and giving credit in research publications. Furthermore, biobanks need a signed material transfer agreement (MTA), which includes restrictions, confidentiality, and biosafety guidelines.
3. Tissue Sample Processing History
The processing history of a tissue sample is another critical aspect of biospecimen provenance. Variations in the collection, handling, and storage of tissue samples can significantly affect their quality and, consequently, the reliability of research results. For instance, during surgery, the warm ischemia time—the time between clamping blood vessels and removing tissue—affects sample quality. Similarly, cold ischemia time, or the time spent on wet ice before freezing, also impacts quality. Therefore, recording these times is a best practice for maintaining tissue sample provenance.
Blood sample processing is another area where variations can occur. Differences in primary containers, pre-centrifugation delay, temperature, and centrifugation parameters can all influence sample quality. To standardize this, the Standard PREanalytical Code (SPREC) is used to systematically record these variations (Betsou et al., 2010). Some biobanks offer this level of detail to researchers.
4. Donor Information
Lastly, donor information, including demographic and clinical data, is part of biospecimen provenance. Biobanks de-identify this information to protect donor confidentiality. Sometimes, researchers may need to return to the biobank for additional donor information, such as disease recurrence. In such cases, knowing the identity of the biobank is essential to access further data.
Why Is Biospecimen Provenance Important?
Researchers require detailed biospecimen provenance information to ensure the quality and reliability of their samples. Without it, the risk of producing irreproducible results increases, which can significantly affect the credibility of scientific studies.
Freedman et al. (2015) analyzed errors that lead to irreproducibility in preclinical research and found that unreliable biological reagents and reference materials are a major cause. They concluded:
‘ … the challenge of increasing reproducibility and addressing the costs associated with the lack of reproducibility in life science research is simply too important and costly to ignore. Lifesaving therapies are being delayed, research budgets face increasing pressure, and drug development and treatment costs are rising. Improving reproducibility remains a critical cornerstone to solving each of these challenges.’
In conclusion, researchers must have access to comprehensive biospecimen provenance information to improve the reproducibility and reliability of their studies. Biosample provenance and tissue sample provenance are essential for ensuring that high-quality, ethically sourced, and properly processed samples are available for scientific research.
References
Hofman, P. et al, Point of View: Traceability and Transparency Should be Mandatory for All Human Biospecimens. (2017) https://www.appliedclinicaltrialsonline.com/view/point-view-traceability-and-transparency-should-be-mandatory-all-human-biospecimens
Betsou F, et al. International Society for Biological and Environmental Repositories (ISBER) Working Group on Biospecimen Science. Standard preanalytical coding for biospecimens: defining the sample PREanalytical code. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1004-11. doi: 10.1158/1055-9965.EPI-09-1268. Epub 2010 Mar 23. PMID: 20332280.Freedman et al. (2015)
Other posts on this Biosample Hub blog include:
- Why Academic / Hospital Biobanks Should Provide Biosamples to Industry
- Ensuring Public Support For Biobank Cooperation With Industry
- The Main Actors Providing Biosamples To Industry
- Biosample Needs of Different Industry Players
- Acceptable Transactions in Biobanking
- What is Commodification?
- Why Biobank Access Policies Should Be Publicly Available
- Biospecimen Provenance: What Researchers Need To Know
