7 Benefits of Provenance in Biospecimen Procurement
Biospecimen procurement has evolved significantly over the last couple of years. Automation, innovative procurement methods, remote procurement, and patient-centered approaches are all important trends that have emerged in the field. These trends reflect the need for greater efficiency, accuracy, and patient engagement in the procurement process, as well as the importance of ensuring accurate provenance of the samples.
In 2010, a study was published in the journal Science that claimed to show that bacteria living in the ocean could incorporate arsenic into their DNA, in place of phosphorus. This finding would have had significant implications for our understanding of the fundamental chemistry of life.
However, after the study was published, many scientists raised concerns about the quality of the data and the lack of provenance information for the biological samples used in the study. Specifically, researchers noted that the authors had not provided sufficient evidence to support their claim that the bacteria were actually using arsenic in place of phosphorus.
This lack of provenance information raised serious concerns about the validity and reliability of the study's findings. In response to these criticisms, the authors of the study acknowledged that they had not provided enough information about the provenance of their samples, and they also admitted to some errors in their experimental procedures.
The study was retracted in 2012, in spite of all the money and effort that had already been poured into it.
The incident highlighted the importance of maintaining accurate and detailed provenance information for biological samples used in research. Consequently, researchers and institutions have taken steps to improve the documentation and tracking of biological samples used in research, with the aim of improving the transparency and reliability of research results.
What is Provenance of Biological Samples?
The provenance of biological samples refers to the documentation of the origin and history of the sample. This includes having information regarding how the sample was collected, processed, stored, and transported.
It is essential to document the provenance of biological samples to ensure that the samples are of high quality and that any experimental results obtained from them are accurate and reliable. Here is some important information to consider:
Donor or source of the sample
Any medical history or treatment received by the donor
Date and location of sample collection
Any preservatives or fixatives used
Storage conditions
Any processing information
Clear understanding of the Informed consent, use of samples
Why is Provenance Important?
Biobanks typically collect and store a vast array of biological specimens from diverse sources, such as hospitals, research institutions, and individual donors. Managing and tracking the origin of these samples throughout their lifecycle can be a complex task. Multiple factors contribute to this convoluted network, including the involvement of numerous stakeholders, decentralized storage locations, and evolving collaborations between different research entities. As a result, tracing the complete history of a sample, from its collection to its current storage location, becomes challenging. This lack of clear provenance raises concerns regarding the reliability and authenticity of the samples, making it difficult to ensure their quality and accurate utilization in research studies.
The absence of proper provenance documentation significantly limits the use of biobank samples. The information about the sample's origin, the characteristics of the individual from whom it was obtained, and the accompanying Informed Consent Form (ICF) are crucial for researchers to ethically and appropriately utilize the samples. Without complete information about the ICF, researchers may face challenges in determining the scope of research for which the samples can be used. This limitation not only hampers the potential applications of the samples but also raises ethical concerns regarding privacy, consent, and compliance with regulatory requirements. Establishing robust provenance protocols and ensuring comprehensive documentation of sample information are essential to overcome these limitations and maximize the utility of biobank samples for various types of research while upholding ethical standards and legal compliance.
In recent years, there has been growing recognition of the importance of provenance in biospecimen procurement. Many organizations, including the National Cancer Institute (NCI) and the International Society for Biological and Environmental Repositories (ISBER), have developed guidelines and best practices for biospecimen collection, processing, and storage. These guidelines emphasize the importance of collecting and documenting provenance information, including the patient's medical history, the specimen collection and processing methods, and the storage conditions.
Sample Traceability
Provenance tracking ensures that researchers can trace the origin of biospecimens accurately. This information is critical for confirming the authenticity of the samples and validating the results of the research. It also helps to prevent the use of fraudulent or counterfeit samples in research or duplicating the studied population, because often more than one sample from a patient may be circulating in the biobanking networks.
Accuracy and Validity of Research
Biospecimens that are not correctly sourced or handled can be contaminated. This will definitely lead to inaccurate results.
Reproducibility of Results
Provenance information is crucial for research reproducibility, as it allows other researchers to verify the quality and consistency of the samples used in a study. It is also necessary for ethical and legal reasons, as it ensures that samples are collected with informed consent and in compliance with relevant regulations and guidelines.
Scientific Validity
Provenance tracking helps to ensure the scientific validity of research results. The documentation of the sample origin and handling enables researchers to confirm that the results obtained are representative of the population under study. It also helps to identify potential sources of error or bias that could affect the accuracy of the results.
Standardization and Quality Control
Knowing the origin of a biospecimen can help identify any issues with the collection, handling, and storage of the specimen. This information can be used to develop best practices for biospecimen procurement, ensuring that future specimens are collected and processed correctly.
Regulatory Compliance
Provenance tracking ensures compliance with regulatory requirements for biospecimen procurement. Regulatory bodies, such as the US Food and Drug Administration and the European Medicines Agency, require detailed documentation of biospecimen provenance as part of the approval process for clinical trials and drug development.
Ethical and Legal Considerations
The provenance of biospecimens can help ensure that the procurement process followed ethical and legal guidelines, and donors' rights were respected through informed consent. Additionally, knowing the provenance can help ensure that the biospecimens are being used for their intended purpose and not being misused or sold on the black market.
The importance of provenance in biospecimen procurement cannot be overstated. The collection, processing, and storage of biospecimens must be carefully controlled and documented to ensure that the specimens are of high quality and can be used effectively in research. Provenance information is essential for ensuring the reproducibility of research findings and for facilitating the sharing of data across different studies. As the field of biospecimen research continues to evolve, it is important for researchers and clinicians to remain vigilant about the importance of provenance and to continue to develop best practices for biospecimen procurement.
Garner Bio Guarantees Specimen Provenance
At Garner Biosolutions, we do not underestimate the importance of ensuring provenance of the biospecimens that we offer to our clients. To achieve this, we leverage our extensive network of hospitals in India who provide us with ethically sourced samples together with all their related metadata. We don’t work through indirect networks, we collect ICFs from patients directly. We only collect prospectively, each sample comes from a unique patient who is not re-recruited. Our process is designed to meet USA compliance standards and protocols including 45 CFR part 46, HIPAA, 21 CFR Part 50/56, and the Uniform Anatomical Gift Act.
Our end goal is to provide the highest quality of biospecimens and the related data that researchers need for precision-driven diagnostics and treatments. Time is always of the essence; don't hesitate to get in touch with our team and learn how we can help gain access to bespoke biospecimens, right on time.
References
Sample, I. (2010, December 2). Nasa's claims of arsenic-based life forms in California undermined. The Guardian. https://www.theguardian.com/science/2010/dec/02/nasa-bacteria-arsenic-phosphorus
Kaufman, M. (2010, December 8). The NASA study of arsenic-based life was fatally flawed, say scientists. Slate. https://slate.com/technology/2010/12/the-nasa-study-of-arsenic-based-life-was-fatally-flawed-say-scientists.html
