Basic↦Biobanking↦Donor↦In Research
What is it? Why is it important?
A donor is a person who donates Biological Material (BM) (e.g. blood, organ tissue, or other seminal fluids) for research. A donor must initially consent to their BM being used for research.
Donor consent can be obtained either through:
- Donor participation in a clinical study or 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.
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A donor can withdraw consent.
- For study participants no more BM or HrPD can be collected. 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.
What do I need to do?
Based on the use / furhter-use of donor BM in research, familiarise yourself with the requirements regarding donor consent (e.g. further-use and informed consent, informed consent process, )
Leftover BM from biopsies no longer needed by the pathologist, can either be collected:
- Anonymously: at collection, BM carries no donor identification markers thus preventing donor identification. The donor can still oppose to anonymization of his/her BM, as it is possible that information of significant health interest could become avaialble. Explain the consequences of anonymisation in the ICF.
- In a coded form: based on the retention of a donor-identification-log, donors can be re-identified at a later time point. The log is kept separate from the BM or BIMS (biobanking database).
In both instances, the donor / study participant agrees for his/her BM being used in further research.
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In the event of anonymously collected BM, the process used to ensure anonymisation must be submitted and approved by the Ethics Committee.
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.