Development↦Management↦Study Documents↦General Consent
Was betrifft es? Warum ist das wichtig?
A General Consent (GC) is a consent form used by hospitals with the aim to ask patients if they would agree to donate their leftover biological material (BM) and/or collected health related personal data (HrPD) for further research.
The source of BM and HrPD is therefore based on the hospital treatment of some given illness.
A GC:
- Can be used in retrospective research, where the required BM and/or HrPD has already been collected. Still, prior to be given access, a defined research project must be submitted and approved by the Ethics Committee (EC)
- Does not cover prospective research, where BM and/or HrPD are collected according to a study protocol. Consent regarding any further-use of leftover BM and/or HrPD in studies is collected with a study respective consent form
Mehr
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.
Was muss ich befolgen?
As a researcher, planning a research project with already collected BM and/or HrPD:
- Define a research project that includes the use of retrospective data and material
- Contact the hospital representative responsible for the management of the GC. Request an assessment regarding the availability of project required BM and/or HrPD. Access will only granted from patients that approved sharing and signed the GC
- Submit the project to the EC for approval. Only upon EC approval will access to BM and/or HrPD be granted
Inform yourself how the GC is managed at your hospital. Questions to ask might be:
- How and when do patients receive the GC?
- Can I use the GC template of the hospital?
- How are GCs archived?
- How are patient approved GC recorded in the electronic system of the hospital?
- How are consent withdrawals managed and documented?
- How is the access to BM and/or HrPD from patients that signed the GC managed?
Wo kann ich Hilfe anfordern?
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
External Links
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
References
unimedsuisse - see in particular
- General Consent
Swiss Law
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