The Threat of a Black Market Within the Market: The Hidden Risks of Sourcing Human Biological Samples
Chilling stories and movie plots depicting a hidden, global black market for human biospecimen such as organs, tissue and other elements of the human body seem better suited to myth than reality. Unfortunately, some of these worst-case scenarios are steeped in truth, as demonstrated by the Detroit-based Rathburn conviction that’s been in the news recently. The direct and indirect impact of sourcing human biological samples present serious risks for the scientific research community, and we can all agree that change is needed. This is especially true in the US, which lacks centralized oversight of the use of human samples in research.
Though the use of human bodies for research dates back to ancient times, a standardized system to oversee ethical business practices is a relatively new point of emphasis in the last 60 years. The first major international guidelines — the Nuremburg Code — established informed consent and voluntary participation in scientific research. The Declaration of Helsinki in 1964 built on these policies, forming the basis for today’s Good Clinical Practice guidelines. The EU introduced a series of directives in the 2000s for the utilization of human tissues and cells in research across Europe. Since then, individual member states have passed additional regulatory legislation, such as the Human Tissue Act 2004 in the UK.
In the US, what’s known as the Common Rule was introduced in 1991 to regulate the use of human subjects and their body parts for research. In 2017, federal agencies in the US revised the Common Rule to increase regulation on the handling of human biological samples, heighten informed consent requirements, broaden the number of research categories exempt from the rule and reduce the bureaucratic burden placed on researchers and research organizations. These changes are referred to as the 2018 Requirements since implementation was slated to take effect in 2018, but has since been delayed on two separate occasions (target date is now January 21, 2019) while regulated entities have been granted additional time to comply. Meanwhile, regulated entities are allowed to adopt “burden-reducing provisions of the 2018 Requirements during the delay period, including certain carveouts from the definition of ‘research,’ exemptions, elimination of the continuing review requirement for certain categories of research, and the elimination of the requirement that institutional review boards (IRBs) review grant applications.”
Potential Risks When Sourcing HBS
Though further regulation in the US is on the horizon, the impact an unchecked human body market can have on scientific research and the risk it can place on an organization is significant and growing. First, as individualized medicine and targeted treatments advance, the need for research on human samples increases, making the integrity of sourcing these samples a high priority. Second, the supply of human biological samples available for acquisition has become abundant, increasing visibility and attainability. One result of this trend for large research organizations is that these acquisitions can often “fly under the radar” of internal compliance guidelines due to the low prices compared to other services, making traceability an issue. Finally, and most importantly, the lack of standardized regulations governing the acquisition of human biological samples and increase in suppliers has led to the danger of researchers receiving poor quality specimens — either inaccurate (incorrect genotype, age, race, etc.), duplicate (when more than one donor is needed) and even unethically sourced (e.g. does not follow donor consent stipulations or questionable origin country. Any one of these missteps committed by a research organization sourcing human biological samples can lead to detrimental financial and reputational outcomes.
To remedy these problems and hopefully avoid the horrors revealed in the Detroit conviction, policymakers in the US need to enact laws that establish best practices, including thoroughly checking the source country, establishing traceability of the informed consent form and ensuring visibility of the origin of the material being sourced. However, we’ve all seen how it takes bipartisanship and time to enact national policy, which unfortunately leaves researchers today to seek out their own solution.
A Simple Sourcing Solution
So, what can be done right now to protect individual researchers and research organizations? Some will continue relying on Google to meet their human biological sample sourcing needs, opening up their work and their employer to ethical and sample integrity risks. Regardless of the scope of the project or the amount of human biological samples being sourced, researchers and research organizations don’t have to tackle the issues alone.
In order to continue fighting the diseases that continue to plague mankind, researchers will need to continue to advance science and develop drugs. It is a proven fact that the best way to accomplish this daunting task is to use the targets of these diseases — human beings — to test new theories, new discoveries and eventually, find new cures. Until the US Government passes sweeping legislation regulating the use of human biological samples for research, the best path forward to achieving this goal and ensuring the ethical sourcing of human biological samples is to learn from experts and partner with a trusted third-party industry leader.
Founded in 2007, Scientist.com is the most experienced online marketplace for research services, and we work with over 200 biological sample suppliers and biobanks. Furthermore, our company has worked collaboratively with most of the world’s top-25 pharma to develop a governance process that provides standardization, transparency and ensures ethical sourcing through one single service aptly named Compli™. Researchers can now mitigate risk and reduce overhead while implementing a formal compliance process.