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Reducing risks and ensuring compliance throughout the biospecimen procurement process

November 8, 2018

Sourcing biospecimens to support medical research can be challenging and time-consuming. Whether researchers are conducting bench, translational, or clinical research, or searching for new diagnostics or therapeutics, the process of procuring biospecimens can be wrought with complexity, especially when it comes to managing and ensuring compliance.

In order to help convey the value of our game-changing platform for biospecimen procurement, we often compare the iSpecimen Marketplace to online book-buying or travel marketplaces in which the internet matches buyers and sellers, then facilitates a transaction. Though apt, the analogy belies the care and complexity that go into the procurement and distribution of high-quality, richly annotated, de-identified and compliant biospecimens.

Let’s take a look at the differences.

In the general e-commerce space, a consumer with money can typically point and click to purchase and receive the products they have ordered. On the front end, it’s as simple as that.

In the case of the iSpecimen Marketplace, we, too, are focused on streamlining transactions. We make it very easy for researchers to find an exact biospecimen match – whether they seek human tissue, biofluids or viable cells needed for their research. Yet at the same time, behind the scenes, we implement strict controls for the distribution of our “products,” human biospecimens, to ensure that in every case our specimens adhere to all legal and medical industry regulations and best practices.

We match intended and allowable uses of biospecimens

We go to great lengths to determine how researchers intend to use the fluids, cells and tissue we distribute. The researcher must declare their intended use of a sample, which must correspond to a permissible use that would advance human health, such as:

  • Biomarker discovery and validation
  • Instrument / assay development and validation
  • Target discovery and validation
  • Constitution of in vivo / animal models
  • Constitution of in vitro cell models
  • Immortalization of primary cells for cell line creation
  • Education or training

But that’s just one side of the equation. The researcher’s intended use must also align with the uses permitted by the supplier of the biospecimens. These permitted uses are dictated by contractual agreements such as Material Transfer Agreements, the institution’s institutional review board, or another ethics protocol under which the sample was collected – and of course, the consent granted by patients.

In the iSpecimen Marketplace, our newly updated platform automates intended-use matching with a new dropdown menu enabling researchers to select from permitted uses when they place a request for samples.

Quote Requirement Details example

Beyond intended use, the Marketplace matches researchers and sample providers by a host of other criteria, including characteristics of the patient donors, levels of specimen annotation, and country of the specimens’ origin.

This is one example of how the Marketplace is using technology to streamline and simplify procurement processes that by necessity are very complicated. Shouldering the burden of sourcing increasingly specific biospecimens, that stand up to exacting quality and compliance standards, has been no easy task for researchers. With advances in our Marketplace technology, this is all starting to change.

We vet all researchers and specimen providers before engaging

In addition to overseeing the matching process, we vet the researchers themselves, independently verifying that the requester of the specimen is a qualified researcher. He or she must be part of a legitimate commercial business, non-profit organization, educational institution, or government agency. Here, too, sample providers that have partnered with us to make specimens available through the iSpecimen Marketplace can impose related restrictions.

iSpecimen also requires each research organization to sign a Material and Data Use agreement that specifies what they can and cannot do with the samples and data they obtain from iSpecimen. For instance, if samples are transferred to third-parties to conduct testing on behalf of the research organization, these third-parties must also be contractually bound to the same standards for sample and data use. Each agreement also importantly stipulates that researchers must never attempt to re-identify a patient using a sample that they obtain from iSpecimen, even if technology and third-party databases would enable it.

Similarly, we vet biospecimen providers – typically hospitals, clinics, biorepositories and clinical trial management organizations – ensuring they are compliant with IRB protocols and other regulations that guide the collection and use of biospecimens. We also make sure they have the proper collection, processing, and storage equipment and procedures in place and compliantly de-identify specimens and data. Our providers sign a participation agreement specifying their requirements around allowable biospecimen and data uses, specimen and data transfer, and allowable resale rights. And, we audit our providers annually for capabilities and compliance.

We hold ourselves to high patient privacy standards

Finally, at iSpecimen, we uphold rigorous standards to ensure a patient’s privacy is protected. We offer our providers the free use of our de-identification technology to ensure we only receive de-identified patient data from our specimen partners, eliminating the personal health information (PHI) leakage that can otherwise occur with manual de-identification processes. Additionally, our Marketplace technology undergoes regular, rigorous privacy and security audits to ensure it continues to protect the identity of patient donors and is impervious to hackers.

Our technology and specimen procurement processes ensure compliance and reduce risk

Our processes around specimen sharing and procurement are critical to the safe, legal and ethical distribution of biospecimens. The goal, beyond contributing to human health by supporting critical medical research, is to protect the patient, provider and researchers at all times.

Because biospecimens have special qualities related to privacy and ethics, distribution can be a lot more complicated than a typical consumer product exchange. That’s why iSpecimen is responsibly integrating the power of technology into the biospecimen procurement process. This streamlining of compliance management within the Marketplace on a per-specimen basis reduces a significant burden for biospecimen researchers, so they can better focus on advancing their research instead.

Access millions of biospecimens, compliantly

Increasing access, reducing barriers and simplifying biospecimen procurement is our goal. Taking advantage of the iSpecimen Marketplace is easy, with no costs associated with joining – making the path to procurement a much less stressful one!

The iSpecimen Marketplace

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