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Consent and Primary Tissue Procurement

In accordance with industry best practice, EBiSC has developed standardised forms of Donor Information and Consent, to support procurement and donation of primary tissue on terms that are suitable for production and sharing of induced pluripotent stem (iPS) cell lines, and associated data.

Not all iPS cell lines in the EBiSC catalogue have been created from donated tissue consented in the form of the EBiSC templates. EBiSC banked lines have been generated from primary material procured from a range of patient and disease cohorts for a variety of research projects, and the form of consent provided upon donation could therefore reflect a number of different terms and conditions that might restrict or affect the use of the original samples and any material generated from it. All EBiSC lines have been reviewed to ensure that originating tissue donors were fully informed at the time of donation, and that consent was obtained for:

  • Production of iPSCs
  • Sharing of iPSCs for research
  • Voluntary donation of primary material
  • Anonymization / pseudonymisation of donor data.

The EBiSC Donor Information and Consent templates have been scrutinised by experts in the field and approved by Research Ethics Committees in the UK and the USA. Use of the EBiSC templates upon collection of primary tissue ensures donors are fully informed that:

  • their cell material may be used for the production of iPSCs
  • derivatives such as iPSCs may be shared internationally to support both academic and industry research
  • cells and/or derivatives may be used to generate genetic data, including whole genome sequencing, and that this data may be stored and made available to researchers
  • their clinical data may be disclosed to researchers by a healthcare professional on a routine basis through access to medical records
  • if they wish to withdraw, they may have remaining primary samples returned or destroyed, and can stop further disclosure of health information, but iPSCs and associated data will not destroyed.

The Templates

Consent documentation must receive favourable opinion from your local research ethics committee prior to using it to obtain donor consent.