Can commercial interest and the reliable and ethical sourcing of biological samples coexist?

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Can commercial interest and the reliable and ethical sourcing of biological samples coexist?

By Robert Hewitt, PhD, Biosample Hub

For biological samples passing from the donor to the industrial laboratory, there are a wide variety of possible routes, events and schedules, each of which can potentially affect the quality of the sample. For this reason, it is important that researchers know the provenance details of any biospecimens they use. Unfortunately, for industry researchers, this information is often lacking, which affects the reliability of the resulting research.

The reason is that industry researchers often obtain biological samples through a commercial broker. These brokers act as intermediaries between the hospital biobank where the sample was initially collected and stored and the industrial customer. They procure the samples needed for their client and charge a fee for this service. They cannot allow free and unconditional communication between the researcher and the hospital biobank because this would risk their own circumvention and loss of profits. Thus, in general, brokers conceal the source of their samples, so the end user may lack information on the provenance of biological samples.

For the industry scientist who is the end user of the sample, important provenance information to know includes: (a) sample processing history, (b) information about the donor and his or her medical history, (c) the geographic origin of the sample which provides information on the background and ethnicity, and (d) past custodians, which may include one or more brokers.

Even in the simplest cases, there is a huge potential for variation in sample processing. Take the example of diseased tissue removed by a surgeon. These samples should be stored promptly to minimize damage from the anoxia that begins once the tissue is separated from its blood supply. The speed at which conservation starts, by cooling and freezing, is very variable and depends on the efficiency of the biobank team.

To give another example, blood samples must be processed by fractionation into different components (blood cells, plasma and serum) and the efficiency of this process can again vary between different sources. At the most basic level, knowing the identity of the source biobank allows researchers to decide whether samples are likely to be reliable, based on past experience. If this biobank has obtained an appropriate license, certification or accreditation, it will give confidence in the quality and reliability of the samples. For example: license from the Human Tissue Authority in the UK, ISO certification (ISO9001 and ISO20387), US CAP accreditation and CTRNet certification. Researchers unable to assess the reliability of their samples risk producing non-reproducible research. This is not only a waste of large-scale research funding, but it also delays the development of life-saving therapies.

The industry scientist needs information about the sample donor, including demographic information and medical history. To be sure of this information, it is preferable that the scientist is in contact with the source biobank. If additional information is required subsequently, such as the response to treatment or the survival time, it will then be necessary to contact the source biobank again. All of this is made much more difficult if a broker refuses to reveal the source of the samples.

Knowing the geographic origin of a sample is essential as it can provide information on environmental, socio-economic and genetic factors that will help make sense of research results. This is particularly important because the international supply of samples for industry is widespread. In a recent survey conducted by Medicines Discovery Catapult, it was found that diagnostic SMEs in the UK obtained 75% of their samples from other countries. Part of the reason is that in the UK and other Western European countries there is great concern about the ethics of trading in human tissue, so brokers find it much easier to get around. procure samples from other parts of the world, such as Eastern Europe, Asia and USA. It is important to note that some countries like China, India and Russia have legal restrictions on the export of samples, so another reason to be sure of the geographical origin is to avoid the use samples from illegal sources.

The international sourcing of clinical samples may involve a number of business entities operating in different countries, which adds additional degrees of separation between source and end user. It is important that end users are aware of this and the possible effect on the reliability of the information provided on patient consent and sample provenance.

Information on the provenance of samples is clearly vital for a range of scientific, ethical and legal reasons, so what can be done to ensure that when industry obtains samples, they are always accompanied by reliable information on the source. origin ?

One option is for brokers to allow direct communication between the hospital sample source and the end user, but require both parties to sign a contractual agreement that they will not bypass the broker. Such contracts are indeed effectively used by several commercial brokers. However, the fact that they place restrictions on the freedom of companies and biobanks to form partnerships is not always acceptable to either of the potential partners.

Another possibility is for companies to create their own networks of biobanks to provide them with the samples they need. This may be feasible in the long term, but in the short term it is often very difficult to find suitable hospital biobanks with the necessary samples in stock. There are publicly available biobank directories that companies can browse, but these are usually designed with academic researchers in mind and may not indicate whether biobanks are willing or motivated to work with industry. So, for start-ups and those with urgent sample needs, there is usually no alternative but to get samples through brokers.

The recently formed nonprofit Biosample Hub offers one possible solution: an online platform dedicated to the partnership between industry and university biobanks. The platform includes directories of biobanks, companies and inquiries as well as networking features to enable members to communicate. So far, this has been welcomed by academic biobanks in Western Europe, providing the industry with a route to previously inaccessible sources of clinical samples.

There are also promising technological developments such as Blockchain that will help ensure reliable information on the provenance of samples, so the prospects for improving the provenance of biological samples in the future are very promising.

ABOUT THE AUTHOR
Robert Hewitt, MB BS, PhD, is the founder of Biosample Hub, a new platform that connects biotech companies looking for samples, with biobanks that have ethically sourced samples.

Web: www.biosamplehub.org
LinkedIn: https://www.linkedin.com/in/hewittr/
Twitter: https://twitter.com/rhbio





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