6. Biological Specimen

The term “specimen” is not referenced within the UK. Instead, the following terms are used in relation to specimens:

• “Relevant material” or “human tissue” is any material from a human body, other than gametes, that consists of, or includes cells. This also includes blood (except where held for transplantation). Hair and nails from living persons are specifically excluded from this definition, as are gametes and embryos outside the body.
• “Bodily material” is any material from a human body that consists of, or includes, human cells. Unlike relevant material, this includes gametes, embryos outside the human body, and hair and nails from the body.
• “Tissue” is any human material (e.g., blood, biopsies, urine) and includes relevant and bodily material.

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

As specified in the Human Tissue Act 2004, the Human Tissue Authority (HTA) has jurisdiction regarding the import and export of relevant materials/human tissue and complies with the Code of Practice on import and export set forth in HTA Code of Practice and Standards on Research (Code E).

The import and export of relevant material/human tissue is not in itself a licensable activity under the Human Tissues Act 2004.

However, once the material is imported, storage of this material may be licensable unless it is for a specific research project with ethical approval from an Ethics Committee. HRA’s FAQs explain that it is preferable for imported human tissue to be stored in a licensed establishment where possible, and if so, there is no requirement for Ethics Committee approval to undertake research. However, if the premises where the human tissue will be held are not covered by an HTA license, each research project using the human tissue will require Ethics Committee approval.

If relevant material/human tissue is being imported or exported for an application, the Human Tissue (Quality and Safety for Human Application) Regs 2007 SI 2007/1523 specify that this must be carried out under the authority of a license or third-party agreement with an establishment licensed by the HTA to store material for human application. Because the UK has left the European Union (EU) single market and customs union, there may be regulatory changes to an import/export license to continue to receive tissues and cells for human application from the EU or send tissues and cells intended for human application to the EU. 

Code-E requires imported material to be procured, used, handled, stored, transported, and disposed of in accordance with the donor’s consent. In addition, due regard should be given to safety considerations, and with the dignity and respect accorded to human bodies, body parts, and tissue as delineated in Code-E. Any individual or organization wishing to import human bodies, body parts, and tissue into England, Wales, or Northern Ireland must comply with the guidelines set forth in Code-E.

Exported material should also be procured, used, handled, stored, transported, and disposed of, in accordance with the donor’s consent, with due regard for safety considerations, and with the dignity and respect accorded to human bodies, body parts, and tissue as stated in Code-E. This includes providing donors with adequate information upon taking consent, that their samples may be transported as exported samples for use abroad. It is the responsibility of the recipient country to ensure that, prior to export, the material is handled appropriately and that the required country standards have been met.

In addition, the Guidance on quality and safety of human blood and blood products lists the quality and safety standards when importing or exporting blood into or from the EU/European Economic Area (EEA). The UK is maintaining the existing quality and safety standards for the collection, testing, processing, storage, and distribution of human blood and blood components. The Medicines and Healthcare Products Regulatory Agency (MHRA) should be consulted before importing or exporting blood or blood components. 

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

No, a separate consent is not required, unless it is for a separate sub-study.

The HRA provides guidance on required wording that needs to be included in the patient information sheet as well as informed consent.

See below example of information that needs to be included when tissue samples are expected to be collected during a study.

If a study involves taking tissue samples, your Participant Information Sheet should cover the following:

• Are you asking potential participants if you could access excess samples left over after a routine clinical procedure?
• Are you asking potential participants to donate new samples (perhaps in addition to routine clinical samples)?
• What types of samples would you like to collect (blood, urine, surgical samples, etc.)?
• How often do you intend to collect such samples from them?
• What is/are the likely size(s) of these samples?
• When and where will the samples be collected? For example, will they be collected during routine visits to a clinic or will you be inviting participants to attend research clinics?
• How are you going to collect the samples (needle biopsy, blood draw, etc.)?
• Are there any risks associated with the collection of your research samples? You should give potential participants some idea of what they can expect in terms of the likelihood of something going wrong and how severe such an event might be.
• Is there any likelihood of discovering significant health-related findings during the analysis of these samples? If so, how will this be handled? (Further guidance is available in 'Discovering health-related findings').
• What are you intending to do with the tissue samples?
• What type of consent are you asking potential participants for:
  • Specific consent to use their samples in a specific, described study;
  • Generic consent which covers many possible uses. (More detail is available in 'Generic consent'); or
  • Tiered consent where you are asking for their agreement to a variety of discrete activities (further guidance can be found in 'Generic consent').
• Do you intend to transfer any of these samples out of the UK for analysis? If so, you should provide potential participants with some details of what would be involved.

6.3 Does the local authority require any specific documents for customs clearance?

Yes. The UK Government website contains a step-by-step electronic navigation tool that provides guidance on the UK customs clearance process in order to import goods, into the UK.

• An Economic Operators Registration and Identification (EORI) number, that starts with GB, must be applied for in order to import goods into the UK.
• It is general practice for a business to engage a transporter or customs agent to deal with customs and transport the goods into the UK, and guidance is provided on how to arrange this.
• The value of the goods to be imported is required to be calculated, and a license or certificate may be required for the goods. Guidance is provided on these aspects, as well as labeling, marking, and marketing rules.
• An import declaration must be made before the goods are cleared by UK customs.
• If applicable, a VAT refund may be claimed.
• All invoices and customs paperwork must be retained.