Working with Human Material
The Sanger Institute uses human tissue samples, DNA and RNA donated by the living and the deceased in its research. In addition the Institute uses induced pluripotent stem cells and human embryonic stem cell lines. The Institute does not use human embryos in any of its research at this time.
All research using human material must comply with the Human Tissue Act (2004) and with the Human Materials Policy and Ethical Guidelines. This means that, where appropriate, consent and ethical approval must be obtained from research participants before using their samples, and ethical approval from a Health Research Authority – Research Ethics Committee must be obtained for the storage and use of material that contains human cells (defined in the Act as ‘relevant material’), at the Sanger Institute.
The regulations for working with human materials, i.e. DNA, RNA, tissue and human-derived cell-lines, can be complex. This is because the legislation covering the use of human tissues requires researchers to have donor consent and ethical approval, but these requirements vary according the circumstances in which the sample was collected, the type of sample and the use to which it is being put.
Researchers at the Institute are expected to contact the Research Governance Office for advice when considering research using human material, even if the material will be purchased from a commercial vendor.
HuMFre (Human Materials Form electronic)
Projects using human material must be registered on the HuMFre system and the Sample Custodian (individual whom holds the Research Ethics Committee approval associated with the material) must complete and authorise the form before it can be signed off and material can be brought onto campus. This does not negate any requirements for a legal agreement to cover the transfer of material.
All projects using and storing material containing human cells must be approved by an Health Research Authority – Research Ethics Committee (REC). Material can only be used and stored for the duration of the ethical approval. Such material can only be used in future projects where there is existing and appropriate REC approval for those projects.
Projects analysing human DNA or RNA must have approval from an appropriate REC.
In most circumstances, consent is required from the donor whenever a sample is taken for use in research.
Research using human induced Pluripotent Stem Cells (iPSC) and human Embryonic Stem Cell (hESC) lines is not covered by the Human Fertilisation and Embryology Act (2008). Nevertheless, there are some restrictions on use that the Institute expects researchers to be aware of.
Where the intention is to create iPSCs, researchers must have ethical approval from a Research Ethics Committee (REC) and where possible donor consent. Commercially available iPSCs are exempt from these requirements, although researchers should make best efforts to ensure that such lines were created ethically.
Use of hESC lines requires approval from the UK Stem Cell Steering Committee. This includes for importation or exportation of hESC lines and accessing or depositing hESC lines into the UK Stem Cell Bank.
The Institute’s Use of Human Material policy and the Human Tissue Act (2004) will also apply to the collection and use of human samples for the generation of iPSC or hESC.
All projects using iPSC and hESC must be registered on the HuMFre system and approved before such material can be brought onto campus.