Use of Human Material in Research

(updated 11/09/18)

Note: the following procedures do not apply to human cadavers/material derived from cadavers. Contact the Centre for Anatomy and Human Identification for further information on this topic.

  1. Definition of Human Material
  2. Guidance on ethical review and approval of clinically-related research activities
  3. Guidance on ethical review and approval of non-clinical research involving human participants
  4. Obtaining Blood/Blood products from the Scottish National Blood Transfusion Service
  5. Projects Involving Taking Blood from Healthy Co-workers
  6. DNA Theft
  7. Ensuring Confidentiality & Data Protection
  8. Keeping Track of Samples
  9. Handling Human Material Safely
  10. Other Useful Links

 

1. Definition of Human Material

Human Material: referred to in the Human Tissue Act as 'relevant material' and defined as material that has come from a human body and consists of, or includes, human cells. Cell lines created outside the human body are excluded, as are hair and nail from living people. Live gametes and embryos outside the human body are also excluded.

2. Guidance on ethical review and approval of clinically-related research activities

Does your research activity involves one or more of the following?

  • investigation of the safety or efficacy of a medicine, therapeutic device, foodstuff or placebo in humans
  • patients, their carers, or a social care organisation
  • access to anonymised collections of patient data
  • use of any NHS resources including staff time, clinical support services or NHS facilities
  • collection or use of donor identifiable human material
  • human material obtained from a tissue bank

If yes, it is classed as clinically-related and you must consult the Tayside Medical Science Centre website for further guidance. You can also seek advice from the East of Scotland Research Ethics Service via their Help Line email ethicshelpline.tayside@nhs.net.

3. Guidance on ethical review and approval of non-clinical research involving human participants

If your research project involves human participants but is not clinically-related, go to the University of Dundee Research Ethics web pages and work through the application and guidance materials.

4. Obtaining Blood/Blood Products from the Scottish National Blood Transfusion Service (SNBTS)

SNBTS now reviews all non-therapeutic issues of blood and tissues and their components via a centralised internal committee. To enable the SNBTS Committee to assess each request, researchers are asked to complete and submit an application along with a summary study design/protocol. Forms are available from and returnable to:

Miss Isabel Ward, SNBTS R&D Administrator, National Science Laboratory, 21 Ellen's Glen Road, Edinburgh, EH17 7QT, Tel: 0131 314 5658, Fax: 0131 536 6764, E-mail: I.Ward@nhs.net.

Receipt, use and final fate of all material received from SNBTS must be detailed in a Consignment Register.

5. Projects Involving Taking Blood from Healthy Co-workers

Such projects must be approved by the Medicine/Life Sciences School Research Ethics Committee. See the University of Dundee Research Ethics web pages for further information.

See below for useful templates specific to taking blood from healthy co-workers, available to download and customise.

6. DNA Theft

Having human material with the intention of its DNA being analysed, without the consent of the person from whom the material came, became unlawful from 1 September 2006. Note: the crime of DNA theft extends to human hair, nail and gametes.

7. Ensuring Confidentiality & Data Protection

Samples of human material are often accompanied by personal data relating to the donor. This may take the form of official medical records, brief personal details and/or results of tests/experiments carried out on donated samples. Any data that can be linked to an identifiable individual, however derived, is subject to the General Data Protection Regulation (GDPR). Breaches of this can result in prosecution of individual employees, their managers or the University. If you are handling personal data you must adhere to the University’s Data Protection Policy.

8. Keeping Track of Samples

All samples of human material must be carefully catalogued and tracked. The person responsible must ensure records are kept that detail:

  • date sample received/collected;
  • secure storage location;
  • specific use;
  • final fate/disposal.

9. Handling Human Material Safely

Activities involving the use of human material, like any other work activity, must be risk assessed and the assessment should be recorded in the UoD Risk Assessment Database. The risk assessment must clearly detail the control measures required to ensure the work is carried out safely. An example assessment – serial number 5 in the UoD Risk Assessment Database – has been provided to simplify this task and SLS Safety will provide further assistance upon request. The finalised risk assessment must be read and signed by all personnel involved in the activity and the specified control measures must be implemented.

10. Other Useful Links