Invisible Markets: The Chilling Truth of the Black Market Biospecimen Business
Stefania Longo
on
July 25, 2023
Picture this: a 44 year-old Massachusetts woman runs a black market body part business from her Salem storefront, “Kat’s Creepy Creations”. Sounds like the plot of a horror movie right? Well, unfortunately this was a real headline from a recent article, detailing the story of a nationwide network of individuals who were buying and selling stolen human remains from Harvard Medical School and an Arkansas mortuary. If you’ve been a longtime reader of our blog, you might remember a post published in 2018 depicting a similarly chilling story. It was a problem five years ago, and it still very much is today. These kinds of incidents shed light on the frightening possibilities of what happens when ethics are forgotten as well as the need for increased due diligence and oversight when it comes to sourcing human biological samples (HBS).
Considerations for Biospecimen Procurement
The process of sourcing, storing and procuring human biological samples is extremely sensitive and highly regulated. There are many considerations and challenges that must be adhered to by a variety of stakeholders. Below are several factors that must be considered when procuring biospecimens for research:
Ethics
When dealing with any human biological sample, ethics must remain at the forefront. When ethics are forgotten, situations like the one mentioned above become possible. One of the major ethical topics to consider is informed consent, which consists of providing the donor with information about how the sample will be used, stored and collected (including possible risks) in order to help them make a fully informed decision about the usage of their biospecimen.1 A similarly crucial element in the equation is ensuring donor confidentiality. It is of the utmost importance to protect the privacy of the donor, thus proper data handling and anonymization must be practiced.
Regulations
Navigating the intricate web of legal and regulatory requirements associated with sourcing biospecimens can be quite complicated. Compliance is a key component of the biospecimen procurement process and ensures that international, federal, state and local regulations are being met. Certain countries have specific requirements for the methods of collecting and exporting biospecimens, thus it is essential that proper due-diligence is completed in order to ensure that the samples comply with relevant regulations.2
Resources
Due to the sensitive nature of biospecimen procurement, proper procedures for acquisition, storage and management must be in place. However, not every company is properly equipped to tackle this endeavor. For example, with smaller companies comes a smaller budget, which can hinder their access to necessary resources, such as proper staffing and infrastructure.1 This lack of properly trained personnel and procurement procedures may cause more serious problems down the road and will end up requiring more time and money.
Logistics
The R&D pipeline already has enough bottlenecks and delays, so it’s important to discover ways to improve efficiency in the areas that you do have control over. When it comes to procuring biospecimens, implementing cost-effective and efficient workflows can have a significant impact on the process of sourcing, shipping and tracking samples. If you are sourcing from multiple international partners, more complexity is added to the process due to international regulations and shipping, emphasizing the need for an organized workflow. Also, clear communication between researchers and suppliers is crucial, as any miscommunication regarding handling biospecimens can have serious consequences.
How to be proactive
Discover how Scientist.com has been addressing the HBS black market since 2015 and learn about the crucial steps being taken to prevent exposure to such situations. As part of the Scientist.com network, every organization undergoes an extensive commercial due diligence, covering employment principles, sanctions and watchlists, reviews of negative news and many more. By studying an organization’s background, financial stability, policies and processes, it’s easier to avoid ethical and legal issues later on. It also enables more informed decision making. COMPLi®, an integral part of the Scientist.com platform, provides researchers access to an award-winning suite of tools that provides increased transparency on the status of every human biological sample offered, triggering input from experts when any concerns are detected.
To further enhance the COMPLi solution, Scientist.com has also launched VERIF.i®, an on-site assessment for organizations that provide human biological samples and other regulated services. A 3rd party independent auditor visits the premises of organizations that collect and provide human biological samples for research, to inspect their facilities, processes and practices. These assessments can help verify that the businesses are following proper guidelines and regulations, maintaining ethical standards and ensuring the safe and appropriate handling of human biological samples.
Combining commercial due diligence with our COMPLi suite is intended to collectively prevent black market trafficking of human biological samples. COMPLi drives the highest industry standards to ensure that organizations pay closer attention to the HBS they are sourcing, aligning with external standards and regulations and internal policies and procedures. By enabling traceability, visibility and transparency, we ensure donors are protected.
COMPLi and VERIF.i together:
- Ensure compliance with regulations:
- Confirm businesses adhere to industry specific requirements to significantly reduce the risk of illegal trafficking or misuse of human biological samples.
- Encourage transparency and accountability:
- Businesses can demonstrate using the tools provided that they are committed to ethical practices, fostering trust throughout the industry.
- Aid in the early detection of potential issues:
- Regular supplier assessments can help organizations identify any concerning practices or illegal activities before they escalate into significant problems.
- Ensure the proper handling and storage of samples:
- By inspecting facilities, authorities can check that businesses are taking appropriate measures to safely handle and store human biological samples.
- Eliminate unethical players:
- A combination of due diligence and on-site assessments will help to identify and eliminate unethical businesses, fostering a more reliable and ethical industry environment.
Learn more about COMPLi and VERIF.i.
References
- https://iprocess.net/6-challenges-of-biospecimen-procurement/
- https://www.azenta.com/blog/top-5-pitfalls-biospecimen-sourcing-and-how-avoid-them