What is it? Why is it important?
Measures should be taken to ensure donor safety, as the collection of Biological Material (BM) might involve potential health risks (e.g. infection, hematoma, bleeding). Health risk occurrences are documented, with special procedures for Serious Events (SE).
A SE is a health risk attributed to the sampling of BM. In the event of a SE, the project leader of a HRO project must interrupt the project and inform the EC within 7 days. The EC decides on the safety of the project and its continuation within 30 days.
A SE is an adverse event where it cannot be excluded that it is attributable to the sampling of BM, and which:
- Requires inpatient treatment not envisaged in the protocol, or extends a current hospital stay
- Results in permanent or significant incapacity or disability; or
- Is life-threatening or results in death
In order to guarantee participant (donor) safety, further events can be defined in the protocol. The EC can also request that additional events (not included above) are listed and handled as serious.
SEs that occur in connection with an investigation involving a radiation source on which the FOPH has delivered an opinion, require that the SE is additionally reported to the FOPH within 7 days.
What do I need to do?
Define potential risks to donors as a result of the collection of BM. Document risks and define risk control-measures to reduce risks.
Risk control-measures can include to:
- Exclude certain risk groups (e.g. donors with low haemoglobin, haemophilia, pregnancy)
- Limit the collection volume (e.g. blood volume, number of biopsies)
- Equip facilities for the safe collection of BM (e.g. sterile environment, professional staff)
- Limit blood draws to 2 attempts (e.g. avoid to prick the donor more than 2 times)
- Train staff on collection safely measures (e.g. disinfect injection site, ware protection gloves)
- Monitor donor status after the collection of BM (e.g. normal blood pressure)
- Monitor donor and train staff on the handling of post collection adverse events (e.g. drowsiness, pain, bruises)
Write an SOP on how to ensure donor safety. Define how to manage risk occurrence in research a project, and how to proceed in the event of a SE.
Donor risk assessment can also be documented in a project relevant Risk Assessment Form.
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
- Safety and complaint SOP
Swissethics – see in particular
- Topics / Biobanks and data registries
Declaration of Taipei – see particular principles
- 9 Data protection and patient rights
- 10 Confidentiality
- 19 Protection of donors
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular section
- 4 General requirements
HRO – see in particular article
- Art. 21 Serious events