What is it? Why is it important?
Rather than donor identifying information (e.g. name, date of birth), collected Biological Material (BM) including any associated Health-related Personal Data (HrPD) are given individualized codes. The aim is to protect donor identity.
BM and HrPD can either be:
- Coded (=pseudo-anonymised): a donor-identification-log (= donor coding key) is created and codes are matched with donor identifying information. The log is kept access-protected and handled by a person not involved in the project.
- Anonymized: in this case there is no donor-identity-log and the BM cannot be traced back to the donor. Donors have the right to abstain from having their data anonymized, as important health information might become available during analysis
The anonymization process is not always straight forward (e.g. BM can be collected anonymously, the donor-identity-log can be destroyed). In either case, the anonymization processes must be approved by EC.
For coded data, the code can only be broken if:
- It is necessary to avert immediate risks to donors
- A legal basis exits for breaking the code
- It is required in orer to guarantee donor rights. This applies in paticular when a donor withdraws consent (e.g. does not agree for its BM being used in research)
In the event that a study participant withdraws consent, no more BM or HrPD can be collected from the participant. Upon final data analysis, both the BM and the HrPD must be anonymized.
If a study participant or donor of BM withdraws consent for its (leftover) BM being used in further-use research, requires that the BM and HrPD is either destroyed or anonymized. Study participants and donors can dissent to anonymisation, as important health-related information might become available through the analysis of BM. The consequence of anonymisation regarding donated or leftover BM and HrPD are explained in the PIS and ICF.
What do I need to do?
- Familiarize yourself with: Laws and regulation related to the coding and anonymization of BM and HrPD
- The set-up a coding system applicable to your biobank (e.g. type of BM, collection date, collection site, donor code)
- If applicable, define anonymization procedures to be submitted and approved by EC, include:
- How donor dissent to anonymization is respected
- How anonymization procedures in the event of donor withdrawal are handled
- Describe procedures for the handling of the donor-identity-log (e.g. access protected, conditions for breaking the code)
- Designate a person responsible for the management of the donor-ID-log (e.g. also referred to as a coding or encryption key). In a research projects the key holder is independent of the project
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.
SOP, Forms and Templates – see in particular
- Data Quality SOP
- Data Management Plan Template
Swissethics – see in particular
- Topics/Coding of trial subjects accepted by swissethics
HRA – see in particular articles
- Art. 3 Definition of coded and anonymised health related data and biological material
- Art. 35 Anonymisation and coding
- Art. 56 Registration
HRO – see in particular articles
- Art 25 Anonymization
- Art. 26 Coding
- Art 27 Conditions for breaking the code