What is it? Why is it important?
The General Consent (GC) allows hospital patients to consent to their health related data and/or biological material being used for further research. Thus, the source of any collected data is based on treatment due to some given illness.
- The GC does not cover the consent of any data and/or biological material collected according to a study protocol (prospective research)
- Data collected with the GC can be used at some later date (retrospective research)
- Before data collected through GC can be used in a defined research project, requires that the project and any intended data is initially submitted to the EC for approval
All Swiss universities and some cantonal hospitals have approved the implementation of a GC. For researchers the GC offers a harmonized and standardized solution, with the prospect of sharing information in the event of planning joint studies or research projects.
What do I need to do?
Evaluate whether you want to collect participant data and/or biological material for further use that currently has not been assigned to a specific study or research project.
If so, inform yourself regarding any GC implemented at your local hospital or use an officially approved GC template.
Planned studies or research projects planning to use data collected with GC also need initial EC approval.
Use of GC might require some structural organisation. Inform yourself on how GC processes are managed at your hospital, such as:
- How can I access the official GC template?
- How and when do participants receive the GC?
- How are GC hard copies archived (signed and dated)?
- How is the consent recorded in the electronic system of the hospital?
- How are consent withdrawals managed and documented?
- How can I access data from consenting participants?
EC approval for projects using data collected with GC only becomes necessary once you plan a specific study or research 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
Swissethics – see in particular
- Templates for general consent in German, French, or Italian
- Guidelines on the retention period of biological material and personal data of further use projects without consent
unimedsuisse - see in particular
- General Consent
HRO – see in particular chapter
- Chapter 3, section 2. Informed consent and information in the further use of biological material and health-related data for research