Biological samples are collected by independent clinicians and sent to HipSci for the derivation of iPSCs. The HipSci project has not and does not collect personal identifiable data on any donor sample sent to us. We therefore do not have the actual patient consent forms - either blank or completed - or the patient information leaflets provided to the patients. What we do have is exemplar model ethics forms that have been used for the collection of samples. Clinical sample providers obtained ethics in alignment with the absolute core requirements we have for the HipSci project (e.g. Banking and sharing of iPSC lines with researchers, sharing of data, no further need for ethical approval for research studies using the derived cell lines etc).
To help clinicians engage with open access initiatives like HipSci, we have provided exemplar documents used in this project to provide guidance on what needs to included in the PILs and consent forms.
The Participant Information Leaflet and the Consent Form are exemplars which cannot be used for enrolment of cases. These documents were generated by the NIHR BioResource and members of the HipSci consortium membership committee. The study was approved by: NRES Committee East of England - Cambridge Central, Study title: Generation of Induced Pluripotent Stem (iPS) Cells and Rare Diseases. REC Ref: 15/EE/0049
The following documents have been provided by NIHR Rare Diseases Translational Research Collaboration and the NIHR Great Ormond Street Hospital Biomedical Research Centre. This study was approved by NRES Committee London-Bloomsbury, Study title: Molecular Genetics of Human Birth Defects - mapping and gene identification. REC Ref: 08/H0713/82