Basic↦Biobanking↦Definition↦Data Coding / Anonymisation
What is it? Why is it important?
In the biobanking database (BIMS), rather than donor identifying information (e.g. name, date of birth), Biological Material (BM) and 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): here a donor-identification-log (= donor coding key) is created, where codes are matched with donor identifying information. The log is kept access protected and handled by a person not involved in the project.
- Anonymized: as no donor-identity-log exists or has been destroyed, prevents the donor to be identified,. 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.
More
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, or
- Is necessary to guarantee donor rights. In particular this applies when a donor withdraws consent (e.g. does not agree for its BM being used in research)
In the event 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. Both study participant and donor can dissent to anonymisation as important health related data might become available. The consequence of anonymisation regarding donated or leftover BM& HrPD are explained in the PIS&ICF.
What do I need to do?
Familiarize yourself with:
- Laws and regulation related to the coding and anonymization of BM and HrPD
- 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.
External Links
Swissethics – see in particular
- Topics/Coding of trial subjects accepted by swissethics
Swiss Law
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