What is it? Why is it important?
Various laws and ordinances regulate and address data protection issues:
- The Federal Act on Data Protection (FADP)
- Data protection in clinical research is governed by the Human Research Act (HRA) including its 2 ordinances:
- The Clinical Trials Ordinance (ClinO)
- The Human Research Ordinance (HRO)
Based on the HRA:
- Data confidentiality must be guaranteed at all times
- Any recorded study data including implemented changes as well as persons that document data must be traceable (e.g. through the availability of an audit trail)
- Access to study data must be protected with regulated access control measures
- Aims to protect the privacy and the fundamental rights of persons and their processed data.
- Defines data processing as any operation that handles personal data in particular the collection, storage, use, revision, disclosure, archiving or destruction of data
- Applies to any data that is processes from natural- and legal persons
- Private person
- Federal bodies
The Federal Data Protection and Information Commissioner (FDPIC) is the competent authority for data processing by federal bodies and private persons, including enterprises.
Supervision regarding any data processed by cantonal or communal authorities is regulated by the cantonal and communal data protection commissioners.
What do I need to do?
To ensure data confidentiality:
- Limit the number of staff given access to study data (e.g. access to data entry, study documents are safely locked away)
- Access should be based on required circumstances necessary to perform delegated task(s). This will ensure purposeful and appropriate data handling
- Code study data at the time of data collection in order to protect participant identity (e.g. see swissethics guideline on how to code study participants)
- Freely consent to the use of their data by signing the study informed consent form
- Hold rights regarding the use of their data
For more information refer to Ethics and Laws in this Study Guide.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
The Federal Council – see in particular
- FADP – Federal Act on Data Protection
Swissethics see in particular
- Coding and storage subject information – Coding of trial subjects
Swiss Clinical Trial Organisation – see in particular
- Regulatory Affairs Watch, Issue 1, April 2019 – Essential information on data protection
ICH GCP E6(R2) – see in particular guidelines
- 2.11 Confidentiality of records
- 4.9 Records and reports
HRA – see in particular articles
- Art. 8 Right to receive information
- Art. 17 Consent to further use for research
ClinO – see in particular article
- Art. 9 Consequences of revocation of consent
HRO – see in particular article
- Art. 10. Consequences of revocation of consent