What is it? Why is it important?
Chapter 3 of the HRO ordinance regulates research related to the further-use of:
- Sampled Biological Material (BM) collected as per routine procedures
- Collected health-related personal data (HRpD) collected as per routine procedures
According to the law, Informed Consent (IC) procedures must be adapted based on whether project data:
- Contains genetic information from participants
- Is un-coded: participant identifiers (e.g. name, address, DOB) are documented together with participant / project HRpD
- Is coded: participants are allotted individualised project IDs. IDs together with participant identifiers are kept separate from participant/project HRpD data (e.g. a Participant Identification-Log)
- Is anonymised: means required for participant identification has been deleted (e.g. participant identifiers, project ID, Participant Identification-Log)
Different Informed Consent (IC) regulations apply based on:
- Whether the project includes the further-use of genetic or non-genetic data
- How BM / HRpD is stored in the database (e.g. un-coded, coded, anonymised)
IC regulations for further-use of genetic BM / HRpD:
- Un-coded: project information to participants must be provided in writing and orally and consent is given in writing
- Coded: project information to participants must be provided in writing or orally and consent is given in writing
- Anonymisation: project information to participants must be provided in writing or orally and the participant does not dissent to anonymization
IC regulations for further use of non-genetic HRpD:
- Un-coded: project information to participants must be given in writing or orally and consent is given in writing
- Coded: project information to participants must be given in writing or orally and participant gives no dissent to data collection
What do I need to do?
As a project leader apply IC procedures based on:
- Planned further-use of HRpD (genetic / non-genetic) and BM (genetic)
- How participant information is stored in the project database (e.g. un-coded, coded, anonymised)
Adaptations include how:
- Participants are informed about the project, which is either:
- In writing and orally
- In writing or orally
- IC is collected from participants, which is either:
- In writing
- Participant does not dissent to its BM / HRpD being used for research
As a researcher responsible for a particular research site:
- Define local IC procedures
- Define how the Participant ID-Log can be protected from unauthorised access and accidental disclosure (e.g. access is only permissible by authorized staff)
Participants must provide consent and the Ethics Committee (EC) must approve the project prior to using data for research purposes.
In exceptional cases where participant ICF is missing, the EC will evaluate and decide whether data from participants with missing consent can be used in the project. Aspects to clarify for EC include:
- Is it impossible or disproportionately difficult to obtain consent or to provide information on the right to dissent, or would this impose an undue burden on the person concerned?
- Are there any documented refusals?
- Do research interests outweigh the interests of the person concerned in deciding on the further use of his or her biological material and data?
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
Swissethics – see in particular
- Templates and checklists
- Study protocols / Further use with consent
HRA – see in particular article
- Art. 34 Absence of informed consent
HRO – see in particular chapter / section
- Chapter 3, section 2. Informed Consent and Information