Ethics approvals sit outside a product quote

A quotation can describe a kit. It cannot decide whether you may collect, store, or analyse the material the kit is for. That decision sits with your institution's ethics arrangements, and sometimes with a biosafety committee beside them. This selection guide is for the moment before you order: human material, animal work, and clinical-adjacent samples. It is not medical advice, and it does not tell you the outcome your committee will reach. The product file, once you are allowed to send it, is still written as in how to write a laboratory sourcing enquiry. Laboratory procurement is the route for that file.

If the work is a study, the scientific scope is commissioning a sequencing or proteomics study. Sample classes are introduced under sample preparation. Academic research, the quotation page, and the contact page come after you know the enquiry is allowed to exist.

The decision that precedes a kit

You are choosing whether a purchasing message is the next step, or whether an institutional office must speak first. The criteria are about the material and the institution's rule, not about how urgently the bench wants the kit. A kit for DNA extraction is a product. Blood, a biopsy leftover, a human cell line, a mouse procedure, or a swab that came from a clinic is a governance question. Putting the kit in a cart does not answer the governance question.

The control is a written institutional decision, or a written statement from the office that no decision is required for this exact work. A plan to "get the letter later" is not the control. The branch, when the letter is absent and the rule says it must exist first, is to stop the order and finish the specification as a draft for the committee. You can still name the kit class in the protocol the committee reads.

Human material

Human material includes samples from people and many derivatives: blood, saliva, tissue, cells, and cell lines of human origin. It can include data that identifies people even when the tube is not in your hand. Whether your particular cell line or leftover specimen needs review is the institution's call. Public discussions of research ethics, including the Belmont Report, explain why consent, risk, and selection of people are ethical questions. They are not a form you copy onto a purchase order, and they are not a ruling for your project.

The ordering mistake is to request "kits for our patient samples" in a message that includes names, hospital numbers, or a diagnosis list. A seller does not need those identifiers to quote an extraction class. Your ethics file does. Keep them out of the enquiry. The specification can say "human blood, under an institutional approval already on the laboratory file" only when that sentence is true. If it is not true yet, the specification says the material class and "approval not yet in place; no samples will be sent with this request".

Animal work

Animal work means procedures on animals, or samples taken under those procedures, as your institution defines them. An institutional animal ethics or animal care decision is the relevant permission. This page does not describe how to design an animal experiment and does not give veterinary advice. It says that the decision is not a line item on a reagent quotation.

Separate a product that was made using animals in a manufacturer's process from a procedure you will perform. An antibody's host species is a specification fact you need for the assay. It is not, by itself, your institution's approval to run a new procedure. Ask the office which of those situations you are in. If you are ordering only a reagent and no animal work will occur in your facility, say that in the internal file so the next reader does not assume a procedure was approved because a box arrived.

Clinical-adjacent samples

Clinical-adjacent means the material passed through a care setting, even if the project title says research: leftover diagnostic specimens, swabs collected in a clinic, data from a medical record. Some institutions treat these as requiring both a research ethics decision and a check on whether clinical governance applies. This page cannot sort that boundary for you. The selection criterion is: if a clinician, a hospital, or a patient chart is in the story, ask the office before you order kits against those samples.

The quotation still must not become a clinical claim. Do not specify a kit as diagnosing a disease. Specify the research measurement and the research-use limit. A seller's brochure that uses clinical language is a brochure. Your acceptance test is the research specification. Biosafety basics for research benches keeps containment questions in the safety system rather than in the purchasing adjective.

What a quotation is allowed to be

A quotation is allowed to answer product lines: identity, pack, documents, storage, acceptance. It is allowed to say that a seller will not handle samples, or that sample work is outside the offer. It is not allowed, in any honest reading, to replace an ethics decision. If a reply adds a sentence that sounds like permission to collect human samples, treat that sentence as outside the seller's role and delete it from your internal "approvals" folder. File the ethics letter, if you have one, in the ethics folder. File the quotation in the purchasing folder. The two folders point at each other. They are not the same document.

Commercial intent, for this page, means you may be ready to ask for a quotation and you need to know whether you are early. Asking for a quote is a purchasing step. If your office treats a quote as something that must wait, wait. If your office allows a planning quote with no samples attached, send the kit class and the sentence that no identifiers and no specimens are included.

Criteria for choosing whether to order yet

Use these questions in order.

First, what is the material, in plain words, including cell lines and leftovers? If it is human, animal, or from a care setting, go to the office unless you already have a decision that names this work.

Second, what does the institutional rule say about timing? Approval before any purchase, approval before samples are collected, or approval before samples leave the building are different rules. Follow the one you were given. Do not average them.

Third, does biosafety review apply as well? Infectious material can require containment decisions even when ethics is settled, and ethics can be required even when the organism is familiar. The WHO Laboratory Biosafety Manual and the CDC Biosafety in Microbiological and Biomedical Laboratories are public references. Your committee's decision is the one you file.

Fourth, can the enquiry be written with no identifiers and no request that the seller judge ethics? If yes, and the timing rule allows it, send the product specification. If the enquiry only makes sense when identifiers are attached, it is not ready, and it may never be an appropriate message to a seller.

The branch when any answer is "ask the office" is to ask the office. A slow answer is still the control. Ordering because the kit lead time worries you is how an unapproved collection gains a purchase trail.

Failure modes

The first failure is a complete purchasing file and an empty ethics file. Goods arrive, samples are taken, and the letter is described as "in progress". The purchasing record cannot be rewritten into a retrospective approval by adding the kit's certificate. Stop, and take the actual status to the office.

The second failure is identifiers in the enquiry. A helpful message that includes a spreadsheet of subjects so the seller "understands the project" exports personal data into a commercial thread. The seller needed the tube type. Send the tube type.

The third failure is treating biosafety training as ethics approval, or the reverse. You can be permitted by one committee and still be forbidden by the other. File both decisions when both apply. Working inside a biosafety cabinet is about technique after containment has been set. It is not the approval itself.

This page is not an approval

Nothing here authorises a study, a collection, a diagnostic test, or a treatment. It does not interpret law for your country or your university. The Belmont Report, the WHO manual, and the CDC manual are public background. Your institution's letter is the decision. If you are unsure whether material is human or clinical-adjacent, that uncertainty is itself a reason to ask the office rather than a reason to order.

Research-use language on a reagent does not make a clinical specimen into a research specimen. The specimen's status was decided by how it was obtained and by the approvals that cover it.

Sample integrity is a separate question

Ethics answers whether you may have the sample. Integrity answers whether the sample is still fit for the assay: temperature, time, and labelling. A hot dock or a power cut can ruin an approved sample. It cannot make an unapproved collection acceptable. Specify temperature evidence in the product and shipping lines when you are allowed to move samples, using storing biological samples from fridge to freezer as the handling reference. Keep that scientific line out of the ethics paragraph so neither topic erases the other.

What the enquiry may include

When the timing rule allows a message, include the kit or reagent class, the research measurement, the documents and acceptance checks, and an explicit statement that ethics and biosafety decisions are institutional and are not requested from the seller. State that identifiers are not included. If approval is already on file, you may say that it exists without pasting personal data. If it is not on file, do not imply that it is.

Send the product lines, when you are permitted to send them, through the quotation page or the contact page. Keep the ethics correspondence in the institutional file, not only inside a purchasing thread.