Tackling the Legislation Muddle of Human Biological Samples

scientist.com header  Yevhen Vitte

They might sound mundane to the inexperienced layperson, but to scientists human biological samples (HBS) are, there is no other word for it, precious. Not only are HBS a basic need for fundamental research, they are also a key component of drug development programs.

Matt McLoughlin, Senior Director of Compliance at Scientist.com

Without them researchers would have a hard time investigating how drugs interact with human tissues, organs, fluids, cells or DNA prior to clinical trials. Increasingly, researchers are looking for more and more ways to utilize HBS instead of animal models, which cannot fully mirror the effect drugs might have on humans.

Contributing to higher success rates, lower experimental costs and an abundance of supply, donated human samples are today’s preferred form for toxicity testing. Consequently, human biological samples allow for a better understanding of disease mechanisms for the development of more effective treatments and medical devices.

However, with importance comes complexity, and so the identification, acquisition and provision of human biological samples is marred with difficulties. Supplier evaluations, strict compliance procedures and complicated contracts drastically slow down the processes making them costly, time-consuming and stressful for both suppliers and researchers.

A lack of standardization

“Researchers have to make sure that the sources of samples they’re using are good and proper, but what we currently see is a potential disconnect between the two. This has a great impact on trust and transparency” – Matt McLaughlin, Scientist.com

“Human biological samples are an imperative experimental component for the advancement of science,” says Matt McLoughlin, Senior Director of Compliance at Scientist.com. ”But for being such an important resource, the amount of grey area and lack of standardization creates room for massive errors.”

Matt and his team at Scientist.com have taken it upon themselves to tackle the inexcusable absence of standardization within the identification, acquisition and provision processes of human biological samples. They have created a market space for HBS with only one centralized compliance process known as COMPLI™.

This centralized process allows researchers to access a network of curated resources all in one place. When researchers access it they are able to source the sample they need from this network of HBS suppliers where due diligence information is already available for review.

Rather than having to sit through rounds of negotiations, both parties can get to business with only one legal contract. This reduces risk, increases transparency and enables researchers to access samples in a faster way.

The donor is key

Human biological samples, such as cells, are essential for fundamental research as well as drug development

Human biological samples are sourced either from academic suppliers, such as hospitals, or from commercial suppliers. However, as Matt points out, commercial suppliers are very protective of their supply chain, fearing that transparency could undermine their position within that chain.

“Researchers have to make sure that the sources of samples they’re using are good and proper, but what we currently see is a potential disconnect between the two. This has a great impact on trust and transparency,” says Matt. “Imagine a researcher wants 20 human samples. He goes to two suppliers and orders ten from each. Because of a lack of transparency the researcher might end up with two sets of samples from the same ten people, rather than twenty. This can have a hugely negative effect on research outcomes.”

At this point, the fundamental value of a donor’s sample can be undermined by the associated risk when it is not sourced properly. A lack of transparency can not only greatly impact researchers’ scientific data, but could raise other concerns around ethicality and public perception. Once ruined, public perception, for instance, can greatly impact the funding of research.

Suppliers face almighty challenges

Donor consent, as well as the donor’s understanding of the donation process, are the priority at Scientist.com and should be valued by researchers and suppliers alike

The acquisition and sourcing of human tissues that have been donated for research are associated with a variety of risks. Donor consent stands at the top of this list. Questions, such as ‘how was the consent process communicated to the donor?’, ‘what restrictions are placed on the samples?’ or ‘how long are the samples allowed to be stored?’ increase the complexity of HBS sourcing and makes the compliance process expensive and lengthy.

Regulations can also differ depending on the sample type. “Human embryonic stem cells, for instance, are very strictly regulated,” Matt explains. “A different example are consent-waiver samples or non-consented samples. In the US they are still allowed, but the use of these samples can conflict with a research institution’s internal policies.”

There is another stumbling block in the path of HBS acquisition and provision: “The industry does not only have to comply to countries’ laws, respectively – the Common Law in the US, the EU Directive or the Human Tissues Act in the UK. A company can also be bound to the specific procedures and policies of its business, which can go far beyond the legislation of countries,” Matt explains.  

Growing demand requires standardization

Human embryonic stem cells are one example of HBS that are highly regulated

Human biological samples are collected in so called biobanks. In 2016, the global market for biobanking technologies was valued at $198 billion. It is expected to increase with a compound annual growth rate of 3.9%, reaching an overall value of $240.2 billion by 2021. In 2015, the biobanking use of human stem cells alone, had a revenue of $3.72 billion.

Reasons for this rapid growth are an increased interest in personalized medicines and genetic studies in fields such as drug development, food safety, disease monitoring and forensics. The growing availability of genome editing technologies has decreased costs of research and allowed the study of larger sample volumes in laboratories.

However, this growing demand brings with it a strong need for standardization, which would allow scientists to find the right suppliers in order to meet their research needs. Scientist.com has tackled this issue by simplifying the process, while still ensuring that important regulatory and legislative checkpoints remain in place.

“If we are to find the drugs of tomorrow that are becoming more personalized and more targeted to specific diseases, human biological samples need to be available to researchers in a transparent, accessible and risk-free way,” Matt concludes.

Feeling overwhelmed by the complexity of HBS regulations? Whether you’re a researcher looking for human biological samples from safe sources or a supplier who wants to be part of an international network, get in touch with the experts at Scientist.com and benefit from their industry leading and standardized compliance process here!

Images via Yevhen Vitte, magic pictures, Andrii Vodolazhskyl, Matej Kastelic, nobeastsofierce/Shutterstock.com

Author: Larissa Warneck, Science Journalist at Labiotech.eu

Explore other topics: Drug discoveryStem cells

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