Clinical Trials

12 Best Practices to Ensure Quality and Integrity of BioSpecimens in Clinical Research

Biospecimens play an important role in advancing clinical research across various medical fields.  However, the meticulous handling and management of biospecimens are essential to ensure research integrity while respecting patient privacy and consent. 

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Dr. Peace Chikezie

Published 26 Aug 2023

12 Best Practices to Ensure Quality and Integrity of BioSpecimens in Clinical Research - Infiuss Health


Biospecimens play an important role in advancing clinical research across various medical fields. 

However, the meticulous handling and management of biospecimens are essential to ensure research integrity while respecting patient privacy and consent. 

In this blog post, we will provide a simple guide to 12 best practices for the efficient management of biospecimens in clinical trials.


Best Practices for Managing Biospecimens 


1. Obtain Informed Consent with Biosafety Information:


When seeking informed consent, it's vital to provide patients with a full understanding of the research. 

This includes explaining biosafety measures, such as containment protocols for hazardous biospecimens. 

For instance, for a study involving biospecimens with infectious agents, patients should be informed about the use of specialized safety equipment and procedures to prevent any potential exposure.

Also, In a genetic research study that involves collecting specimens like saliva or blood, patients should be informed about how their genetic information will be extracted and analyzed. They should understand the purpose of the research, how their genetic data may be used to explore hereditary conditions, and what measures are in place to keep their genetic information confidential. This empowers patients to make an informed decision about participating in the study.


2. Review and Customize the Study Protocol:


Study protocols need customization to ensure biosafety. This involves a thorough review of eligibility criteria, logistics, and, most importantly, safety procedures. 

If, for example, the biospecimens contain hazardous materials, protocols should outline specific containment and disposal steps to protect both patients and researchers.


3. Effective Communication and Safety Protocols:


Communication is key, especially when biosafety is involved. Teams must have clear and consistent communication regarding biosafety protocols. 

For instance, everyone involved in collecting and handling biospecimens containing hazardous materials should be aware of proper safety measures, including the use of personal protective equipment and containment procedures.


4. Prepare Specimen Kits with Biosafety in Mind:


Biosafety should be a priority when preparing biospecimen collection kits. 

There should be labeling that indicates biohazard status and the inclusion of appropriate containment materials. 

For instance, kits for collecting biospecimens containing infectious agents should include biohazard labels, leak-proof containers, and disinfecting materials.


5. Proper Collection, Storage, and Handling with Biosafety Focus:


Strict adherence to biosafety procedures is essential when collecting, storing, and handling biospecimens. 

This includes following Standard Operating Procedures(SOPs) for biosafety, especially when dealing with hazardous biospecimens. For example, biospecimens containing pathogens should be stored at controlled temperatures to prevent contamination.


6. Ethical Use of Biospecimen Data and Patient Privacy with Biosafety Measures:


In addition to ensuring biosafety, it's crucial to uphold ethical standards when handling biospecimen data, especially when dealing with identifiable biospecimens. Patients need assurance that their data and privacy are protected throughout the research process.

Why it matters:

I. Privacy Assurance: Patients must know that their personal and medical information will be handled with the utmost confidentiality. This includes measures to prevent unauthorized access or data breaches.

II. Data Protection: Emphasize that the research team is committed to using biospecimen data solely for the intended research purposes. This ensures that patients' information won't be misused or shared without consent.

III. Transparency: Maintain transparency about data management and storage procedures. Patients should be informed about the secure systems in place to safeguard their information.


7. Ensure Environmental Stability and Biosafety:


In the world of biospecimen management, maintaining stable environmental conditions is very important. 

Here's why:

A.Sample Integrity: Imagine you're collecting biospecimens for a study on genetic mutations that require frozen storage. Any fluctuation in temperature could compromise the integrity of these samples. Rigorous temperature monitoring ensures that the biospecimens remain intact and usable.

B. Biosafety: Now, consider biospecimens containing infectious agents. These demand not only stable but highly controlled environments. Failure to maintain the correct conditions could lead to accidental exposure, posing serious risks to laboratory staff and the broader community.

8. Accurate Tracking with Data Security and Biosafety Measures:

Implementing a secure inventory system ensures accurate tracking of biospecimens. 

Security measures should extend to protect sensitive data, especially for identifiable biospecimens. 

Robust data security safeguards should be in place to prevent unauthorized access.


9. Comprehensive Documentation, Including Biosafety Records:

In the meticulous world of biobanking, documentation is an indispensable practice that ensures safety, quality, and compliance. 


I. Biosafety Compliance: Rigorous documentation serves as concrete evidence of biosafety compliance. For instance, records of biosafety training and safety protocols followed during biospecimen collection ensure that every precaution was taken to protect staff and participants.

II. Quality Control: Documentation doesn't just showcase adherence to biosafety measures; it also tracks the journey of each biospecimen. Detailed records, from collection to storage, guarantee the reliability and traceability of these valuable assets.

This should include details on the temperature at which each sample was stored, who handled it, and any safety precautions taken during handling.


10. Quality Management and Biosafety Compliance:

Quality assurance evaluations should include rigorous assessments of biosafety protocols. 

Compliance with safety SOPs, especially for biospecimens containing hazardous components, must be strictly adhered to. 

Regular audits can help ensure continued biosafety compliance.


11. Custodianship Procedures and Biosafety Guidelines:

Custodianship procedures in biobanking are like the guardians of biospecimens, responsible for their safekeeping and management. 

They ensure:

a.Biospecimen Protection: Custodianship procedures ensure that every biospecimen is carefully protected throughout its journey, from collection to potential disposal. This safeguards the integrity of these valuable samples.

b. Safety at the Core: Particularly when dealing with biospecimens containing hazardous materials, biosafety is a paramount concern. Custodianship procedures include clear guidelines on how to handle, transfer, or, if needed, dispose of these materials safely.

In a scenario where a biobank needs to transfer biospecimens containing infectious agents to another research facility. Custodianship procedures would dictate each step of this process, from secure packaging to rigorous biosafety protocols during transport. These guidelines guarantee not only the biospecimens' security but also the well-being of everyone involved.


12. Training in Biosafety and Emergency Response

Ongoing training is essential to ensure that all staff members are well-prepared to handle biosafety concerns. 

This training should cover the use of protective equipment, emergency response procedures, and spill containment protocols. 

Regular drills and refreshers help maintain a culture of biosafety within the team.



Effective biospecimen management is the backbone of successful clinical research. 

By following these 12 best practices, researchers can uphold the integrity of clinical trials, respect patient rights, and contribute to advancements in medical science. 

Infiuss Health facilitates the procurement of biospecimens from a diverse range of African countries, leveraging decentralized laboratories equipped with state-of-the-art biobanking capabilities.

Learn more about us by contacting [email protected].




1. How do you find best practices for a company?




Finding best practices for a company involves several steps:


a. Research: Start by researching industry-specific best practices through reputable sources, industry associations, and publications.

b. Benchmarking: Compare your company's processes and performance with industry leaders and competitors.

c. Consult Experts: Seek advice from industry experts and consultants who can provide insights into best practices.

d. Internal Analysis: Evaluate your company's current processes and identify areas for improvement.

e. Adapt and Implement: Once you've identified best practices, adapt them to your company's needs and implement them systematically.


2. Why are biobanks important in research?




Biobanks are critical in research for several reasons:

1. Sample Storage: Biobanks store a vast array of biological samples, including tissues, blood, and DNA, providing researchers with a valuable resource for studying diseases, genetics, and drug development.


2. Longitudinal Studies: Biobanks allow researchers to access samples collected over time, enabling longitudinal studies that track changes in health and disease.


3. Personalized Medicine: They play a pivotal role in advancing personalized medicine by providing the genetic and biological data needed to tailor treatments to an individual's unique profile.


4. Scientific Collaboration: Biobanks promote collaboration among researchers and institutions, accelerating scientific discoveries.


3. What is the biobanking standard?



The biobanking standard refers to a set of guidelines and quality control measures that ensure the proper collection, storage, and management of biological samples and associated data in biobanks. 


These standards, often established by organizations like the International Society for Biological and Environmental Repositories (ISBER) or national regulatory agencies, cover aspects such as sample handling, data management, ethics, and biosafety to maintain the integrity and reliability of stored specimens.


4. What is the difference between a biobank and a biorepository?




Biobank and biorepository are terms often used interchangeably, but there are subtle differences:


Biobank: Typically focuses on the collection, storage, and distribution of biological samples (e.g., blood, tissues) for research purposes. Biobanks often emphasize the linkage of samples with extensive clinical and genetic data.


Biorepository: Primarily focuses on the storage and preservation of biological specimens. While it may also store samples for research, it can have a broader scope, including storage for clinical purposes, diagnostics, or future use. Biorepositories may or may not emphasize extensive data linkage.


5. What is the process of biobanking?




The process of biobanking involves several key steps:


a. Sample Collection: Biological samples (e.g., blood, tissue) are collected from donors, patients, or research participants following established protocols.


b. Processing: Samples are processed, including labeling, dividing into aliquots, and preservation (e.g., freezing, formalin fixation).


c. Data Management: Detailed clinical, genetic, and sample-related data is recorded and linked to each sample.


d. Storage: Samples are stored in controlled environments, often at ultra-low temperatures, to maintain their integrity.


e. Access and Distribution: Researchers request samples and data for specific studies, ensuring compliance with ethical and legal regulations.


f. Quality Control: Regular quality assessments are performed to maintain the integrity of stored samples and data.


g. Ethical Oversight: Biobanking follows strict ethical guidelines to ensure donor privacy, informed consent, and responsible use of samples.


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