The Culture Collections recognises that researchers working with biological samples taken from human donors need to know that the material they are working with has been obtained legally, ethically and with due consideration for the wellbeing, privacy and dignity of the donor.
The Culture Collections is not usually involved in the origination of the cell lines in its catalogue, and therefore has not been involved in obtaining informed consent from the donor or others authorised to give consent on behalf of the donors. The exception to this has been ECACC’s involvement in the European Bank of induced Pluripotent Stem Cell (EBiSC) lines – see below.
ECACC sources the cell lines for its catalogue from research organisations and individuals from around the world. Confirmation of donor consent would only be available from the originators of the cell lines. The level of informed consent required may vary depending on the requirements based on the country of origin of the cell line.
For depositors from the UK, ECACC requires proof that the clinical material was obtained with informed consent as per the Human Tissue Act (HTA) 2004. For depositors outside of the UK, ECACC requires depositors to show that due diligence was observed, and clinical samples were taken in accordance with local legislation.
Many cell lines in our collections were deposited prior to the legal requirement for informed consent (ie the introduction of the HTA in the UK). Should it be proven that the primary tissue was taken without prior consent of the donor or the donor's immediate family, then ECACC will endeavour to acquire consent to continue supply and distribution of the cell line.
Since the introduction of the Human Tissue Act (2004) Culture Collections requires all researchers who wish to deposit human cell lines or clinical samples into our collection to show that the samples were obtained with informed consent. Documentational evidence will be required to back up all donations and should be in line with local legislation.
All documentation associated with these samples is securely held here at ECACC in accordance with the UK Data Protection Act 1998 and 2003.
ECACC is licensed under section 16 of the Human Tissue Act (2004) for the following activities:
The storage of material (whole blood and peripheral blood lymphocytes) for specific research purposes
Storage of tissues and/or cells intended for human application and the import/export of tissues and /or cells intended for human application.
ECACC is also licensed under regulation 7 and schedule 1 of the Human Tissue (Quality & Safety for Human Application) Regulations 2007. Our licence number is 12114.
For all iPSC lines which have been deposited into EBiSC, a review has been carried out to ensure that at the point of primary tissue procurement, consent was obtained in line with EBiSC requirements. More information can be found on the EBiSC website.
Full Ethical consent was received from all participants in the HipSci project. All the consent forms used in the HipSci project can be found on the HipSci website.
Participants in the MND Collections study originally gave their informed consent for their DNA and clinical information to be used for genetic research into the causes of MND. In 2014, the MND Collections received REC approval to enable the use of EBV transformed cell lines and peripheral blood lymphocytes stored as part of the MND Collections to be used in studies that go beyond the explicit consent of the participants. And in 2019 the MND Collections received REC approval for the use of iPSCs that have been created from the MND Collections to further understanding about MND and for use in the study of potential therapeutic drugs and their targets.
ECACC currently supplies several cell lines which were established from species listed under the Convention on International Trade in Endangered Species of Wild Flora and Fauna (CITES).
In order to comply with International CITES regulations, ECACC applies to the UK Wildlife Licensing department of the Animal and Plant Health Agency for CITES Re-Export permits for the supply of CITES cell lines.
Scientists can be reassured that the use of these cell lines means that no additional animals are taken from the wild, or from captive bred colonies to provide biological samples for research use.
Culture Collections also requires all UK researchers who deposit animal cell lines to show that the samples were obtained following MRC guidance.
In the use of genetic resources, the Culture Collections of Public Health England (PHE) will put in place best practices to comply with national legislation to implement the Nagoya Protocol and will perform due diligence regarding access and benefit sharing in all its activities involving those resources. PHE’s aims are to engender trust, to facilitate science, and to ensure that benefits are shared.
Human Tissue Act (2004). [online] Available at: https://www.legislation.gov.uk/ukpga/2004/30/contents [Accessed 08.12.2020].
CITES. [online] Available at: https://cites.org/eng [Accessed 08.12.2020].
Guidance: Animal testing and research. [online] Available at: https://www.gov.uk/guidance/research-and-testing-using-animals [Accessed 08.12.2020].
The Nagoya Protocol on Access and Benefit-sharing. [online] Available at: https://www.cbd.int/abs/ [Accessed 08.12.2020].
Published: April 2021
Review date: April 2024
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