What is it? Why is it important?
Donor consent can be obtained either through:
- The participation in a clinical study (consent in a clinical study) or research project (consent in a research project). The donor or study participant agrees that:
- Collected BM can be used for the clinical study / research project
- Leftover BM not needed for the clinical study / research project can be used for further-use research
- A general consent where patients admitted to a local hospital for treatment, agree that leftover BM not needed for diagnostic purposes can be used for further-use research.
What do I need to do?
Based on the use / furhter-use of BM in a research project or clinical study, familiarise yourself with the requirements regarding donor/study participant consent (e.g. further-use and informed consent, informed consent process).
In the event a donor or study participant withdraws consent:
- No more BM or HrPD can be collected from participants. Upon final data analysis, both the BM and the HrPD must be anonymized
- Leftover BM destined for further-use research, requires that the BM and HrPD is either destroyed or anonymized
The process used to anonymize BM must be submitted and approved by the Ethics Committee (EC)
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
SOPs, Forms and Templates – see in particular
- Obtaining consent SOP