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Human Tissue for Research - Frequently Asked Questions

General Licence Questions

Relevant Material Questions

Licence Exemption Questions

Compliance Questions

 


General Licence Questions

 

What HTA Licences does the University hold?

Cardiff University holds four HTA Licences; two for research purposes, one for anatomy and one for human application. The two Research Licences, a hub and a satellite, cover Heath Park and Cathays Campus respectively. The Anatomy and Human Application Licences are held by the School of Biosciences.

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Will I need my own HTA Licence?

No. Separate licences are not required for individual research projects; research that comes under the remit of the HTA will be covered by the existing licences. However, PIs and researchers working on projects that come under the licence must abide by the Human Tissue Authority’s Codes of Practice and Cardiff University HTA policies and procedures.

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Who is responsible for the HTA Licences?

Each Licence has a Designated Individual (DI) who is legally responsible for ensuring compliance with the conditions of the Licence.

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Who should I contact if I have a question about the HTA Licences?

The Human Tissue Act Compliance Team can answer questions about HTA issues, alternatively each School that stores tissue under the Licence will have at least one Person Designate (PD) who acts at a local level to support the DI and can answer HTA questions.  

Contact information can be found on the ‘Information for Researchers’ page here .

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I work for the UHB, do I still need to come under Cardiff University HTA Licence?

The HTA Licence at Heath Park is held by Cardiff University and covers all research carried out on the Heath Park site, including that of Cardiff & Vale University Health Board staff. Any human tissue used/stored for research purposes at Heath Park will need to come under the Cardiff University HTA Licence, unless one of the exemptions applies.

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Does tissue held for diagnostic purposes come under the Licence?

No. The  research licences cover tissue held for research purposes, any tissue held for diagnostic purposes does not need to come under the Licence.

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Relevant Material Questions

 

How does the HTA define ‘human tissue’?

The HTA has drawn up a list of relevant material that comes under the Licence. Relevant material is defined as any material, other than gametes and nail/hair from the living, removed from the body that consists of or includes human cells. Bodily fluids that are likely to contain cells are considered to be relevant material, e.g. blood, urine, saliva.

For more information see the HTA List of Relevant Material located on the ‘Information for Researchers’ page here .

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What is not considered to be relevant material?

In the Human Tissue Act 2004, references to relevant material from a human body do not include:

  • embryos outside the human body;
  • hair and nail from the body of a living person;
  • cell lines or any other human material created outside the human body;
  • DNA, RNA, serum, plasma (providing it has been separated using a mechanical separator or has undergone a double spin).

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Are cell cultures considered to be relevant material?

Cell cultures are considered to be relevant material if they contain cells that were created inside the human body e.g. if the culture contains original cells from a biopsy or blood sample. Once cells in culture have undergone one full cell-division cycle, the culture no longer contains original cells and the tissue does not have to be held under Licence. Original cells will need to be held under the HTA Licence between receipt and division, unless one of the other exemptions applies.

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Licence Exemption Questions

 

Are there any exemptions to the HTA Licence?

Yes. The following situations do not require research projects to come under HTA Licence:

  • if the project has NRES/REC approval;
  • if the tissue is from a tissue bank with generic NRES/REC approval;
  • if storage is incidental to transportation and held for less than a week;
  • if tissue is stored with the intention of extracting DNA/RNA or other subcellular components and held for less than a week;
  • if the tissue is created outside the human body;
  • if the tissue has been rendered acellular;
  • if the tissue is from someone who died more than 100 years ago.

The Human Tissue Act Compliance Team and relevant PD will need to be informed about any human tissue held, even if it is exempt from the HTA Licence.

Please note: even if a tissue holding is exempt from the HTA Licence, it is not necessarily exempt from consent requirements.

Further information on these exemptions can be found in the Cardiff University HTA Quality Manual located on the ‘Information for Researchers’ page here .

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I have ethical approval from the University, does this count as NRES approval?

No. University School Research Ethics Committees are not recognised by the National Research Ethics Service (NRES). Any tissue stored under University ethical approval will need to come under the HTA Licence.

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I am storing DNA, does my project need to come under the Licence?

No. DNA is not considered to be relevant material by the HTA.

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Can I collect tissue on one site and send it to another site for processing?

Yes. Providing tissue samples are not held for more than 7 days they can be stored on one site prior to transportation to another site without coming under the Licence. If storage at the primary site exceeds 7 days, the tissue will have to be stored under Licence, unless it is covered by one of the exemptions detailed above. The tissue recipients must have an HTA Licence unless one of the exemptions applies.  

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I am storing tissue for less than 7 days before processing, does it need to come under the Licence?

If the processing renders the tissue acellular it does not need to come under an HTA Licence. If the processing itself does not render the tissue acellular it will need to come under an HTA Licence. 

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How long can I keep a tissue sample?

There is no limit on how long a tissue sample can be stored, however if storage goes beyond the end date of an NRES/REC ethical approval, the tissue must be held under the HTA Licence, be disposed of or come under renewed NRES ethics. 

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My research is exempt from the Licence, do I still need to follow the University’s HTA procedures?

Yes, all relevant material within the University must be be held according to HTA Standards.

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Compliance Questions

 

What do I need to do to comply with the Licence?

Many of the requirements of the HTA Licence would be classed as good research practice. In order to comply, PIs need to:

  • inform the PD and Human Tissue Act Compliance Team of any relevant projects;
  • maintain relevant and good quality records;
  • complete and update risk assessments for the tissue;
  • ensure that relevant SOPs are followed;
  • implement recommendations made following internal audit or HTA inspections;
  • ensure staff have the appropriate training;
  • complete the Annual Survey of Holdings;
  • report any adverse events.

Further information can be found in the Cardiff University HTA Quality Manual and all Cardiff University HTA Standard Operating Procedures located on the ‘Information for Researchers’ page here .

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What information do I need to keep for each tissue sample?

As a minimum, the following information should be kept for each sample:

  • Sample ID reference.  This should be unique and anonymous.  It should not include patient details.
  • Tissue type (if more than one stored/used).
  • Date of receipt and details of where it came from.
  • Consent details.  Where the consent form is held.
  • Storage location (building, room, fridge/freezer/cupboard number, shelf).
  • Details and dates of processing.
  • Details and dates of any transfers (if relevant).
  • Date, method and reason for disposal.  

For more information about record keeping, please see the Cardiff University HTA Standard Operating Procedure for Records Management located on the ‘Information for Researchers’ page here .

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What other records need to be kept?

Principal investigators and custodians of human tissue collections must ensure that the following records are captured/created and maintained where required (this list is indicative and not exhaustive):

  • consent (where required), detailing:
    • who gave consent;
    • what the consent related to;
    • whether consent is related to a specific project or for wider use in research;
    • any restrictions on the use stipulated during the consent;
    • if the consent records are in the custody of another organisation, the Principal Investigator or custodian of human tissue collections must ensure that they have documentation that contains assurances of compliance with Human Tissue Act requirements,
  • ethics approval,
  • human tissue use and movement, e.g. receipts, transfer documentation, laboratory log books,
  • maintenance, cleaning and calibration of equipment,
  • risk assessment,
  • tissue destruction, e.g. receipts, laboratory log books,
  • adverse events, including ‘near misses’,
  • local Standard Operating Procedures and quality management documentation,
  • staff training,
  • system for labelling human tissue.

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How do I document that I have assurances of compliance if consent is taken elsewhere?

You will need a written statement from the provider stating that informed consent has been taken for all of the human tissue supplied or the relevant section of an NRES approved protocol, the location of the consent forms and a contact at the establishment holding them should be kept locally along with a blank copy of the consent form.

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I am taking consent, what training do I need?

The HTA have specified that anyone taking consent for the removal or storage of human tissue must be appropriately trained to ensure the consent is valid. Training in informed consent is available through the Good Clinical Practice training sessions provided by UHB and Research, Innovation and Enterprise Services and the online module Human Ethics 2 available through the Staff Development Programme. A record of course completion will need to be kept by the PI and copies made available during internal audits.

For more information about consent and training, please see the ‘Consent’ page here .

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Are there any exemptions from consent?

Yes. Consent is not required for research under the two following circumstances:

  • If the tissue was held before the Act came into force in September 2006.
  • If the tissue is from the living AND the project has NRES ethical approval AND the tissue is anonymised.

Please note that even if the tissue is exempt from consent, a licence may still be required if the project does not have NRES approval.

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Do I need HTA training?

Anyone working with human tissue must receive training on the Human Tissue Act. Training on the Human Tissue Act can be carried out through Cardiff University's Staff Development Programme or via the MRC on-line training course. A record of course completion will need to be kept by the PI and copies made available during internal audits. Any researchers working on tissue held under the HTA Licence must have received HTA training.

For more information about training, please see the Cardiff University HTA Standard Operating Procedure for Staff Training located on the ‘Information for Researchers’ page here . For links to relevant training courses please see the ‘Consent’ page here .

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I am providing human tissue to another organisation, do I need a Material Transfer Agreement (MTA)?

Yes. An MTA for outgoing tissue will reduce the provider’s legal liability for the recipient’s use of the material and can allow access to the results of the research. All MTA’s must be cleared with RACD or UHB R&D Office and must be signed on behalf of the University, not by an individual researcher. 

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I am receiving human tissue from another organisation, do I need an Material Transfer Agreement (MTA)?

Yes. If a researcher wishes to receive tissue from an external organisation it is important to have an MTA in place, this will usually be provided by the tissue supplier. All MTA’s must be cleared with Research, Innovation and Enterprise Services and must be signed on behalf of the University, not by an individual researcher.  

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What should I put in the Risk Assessment?

The HTA risk assessment must cover risks to the tissue. As a minimum, risk assessments need to be written for storage, traceability and transportation (if applicable). Things to consider include package failure, delay or loss in transit, malfunction of storage facilities, unauthorised access to tissue samples, incorrect procedures being carried out, untrained personnel handling the tissue and any other hazards that result in tissue loss.

For more information about risk assessments, please see the Cardiff University HTA Standard Operating Procedure for Risk Management and Contingency Planning located on the ‘Information for Researchers’ page here .

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How do you check that projects comply with HTA Standards?

Schools that store human tissue will be subject to an annual internal audit. This works on a two-year cycle; a face to face audit in the first year and a paper based audit return in the second year.

The purpose of the audit is to ensure:

  • appropriate records are being kept;
  • storage facilities are adequate and maintained;
  • informed consent is being taken and a record kept (if applicable);
  • tissue samples can be traced from receipt to disposal;
  • SOPs are being followed;
  • risk assessments have been carried out;
  • staff have received adequate training

For more information about internal audits, please see the 'Internal Audit' page here

Note: The HTA periodically inspect the University to ensure compliance with the Licence.

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What happens if a research project does not comply with the conditions of the Licence?

Following an internal audit or HTA inspection any compliance issues will be brought to the attention of the project PI and relevant PD and a time frame will be given to rectify these issues. Any unresolved compliance issues will be reported to the DI, Head of School and higher if necessary. Any major issues of non-compliance that are brought to the attention of the HTA could result in the suspension of the Licence, whereupon all research conducted under the Licence would have to cease immediately.

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