A human biospecimen is any material taken from a person and used in research: blood and its fractions, tissue, bone marrow, urine, saliva, a fixed block, a frozen section. Buying one is unlike buying a reagent, because the thing that decides whether it is fit for your experiment is not on a specification sheet but in its history. This page sets out what a supplier has to be able to evidence, and what makes a sample worth less than its price.
Where human biological samples come from, and why provenance is the product
Human biological samples reach a research laboratory by three routes: a prospective collection run to a protocol written for your question, a biobank holding material collected earlier under a broad consent, and surplus clinical material released after diagnosis. The three differ in what you can ask of them. A prospective collection can specify the draw, the timing and the handling; a bank can offer numbers and matched controls now; surplus clinical material is cheap and carries whatever handling the clinic gave it. Provenance is not paperwork around the product, it is the product, because it is what tells you which of those three you are holding.
Consent and ethics approval travel with the sample
Documented informed consent is the floor, and its scope matters as much as its existence: research use in general, commercial research, genetic or genomic analysis, and future unspecified use are separate permissions and a consent covering one does not cover the others. Alongside it sits the review board approval for the collection protocol. In the United States research on identifiable private information falls under the Common Rule, and material from living donors sits inside the tissue and cell framework. Ask which consent version this sample was taken under and read it.
Annotation is what makes a sample usable
Two vials of the same tissue from the same bank can be worth very different amounts to the same project, and the difference is annotation. Useful annotation names the diagnosis and how it was made, the stage or grade, treatment before collection, the donor's coded demographics, and for a comparison the criteria the control was chosen on. Poor annotation is not a discount, it is a sample that cannot answer a question, because you will not know afterwards whether a difference is biology or selection.
Handling history decides which assay the sample can serve
The interval between removal and stabilisation, the fixative and its duration, the freezing method, the number of thaws and the storage temperature each close off assays. A block fixed for days will not give you reliable phosphorylation; RNA integrity depends on how quickly the sample was stabilised; repeated freeze and thaw cycles cost viability and function. Ask for those figures for the specific vials on offer, not for the bank's general procedure, and hold the standard the biobanking standard sets rather than a supplier's own wording.
Questions people ask about human biospecimens
What should a biospecimen supplier provide with every sample?
A coded donor identifier, the consent scope and version, the ethics approval reference, the collection and stabilisation times, the storage and thaw history, and the annotation your comparison depends on. Anything missing from that list is a limit on what the sample can prove.
Do I need my own ethics approval to buy one?
Often yes, and it depends on whether the material is identifiable to you rather than on who collected it. Coded material from a bank is frequently outside the scope of a new approval, but that is a determination your own review board makes, not the supplier.
What makes a biospecimen unusable?
A consent that does not cover your use, annotation too thin to support the comparison, or a handling history that has already destroyed the analyte. None of the three is visible in the vial, which is why they are the questions to ask first.