Development↦Management↦Study Documents↦General Consent
What is it? Why is it important?
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.
A General Consent:
- Offers a harmonized and standardized solution, with the prospect of sharing data and BM aimed at research
- Can be used in retrospective research, where the BM and/or HrPD has already been collected. All research project must be approved by the Ethics Committee (EC) in order to use BM or HrPD covered by the GC
- Does not cover prospective research, where BM and/or HrPD are collected according to a study protocol. The consent for further-use of leftover BM and/or HrPD collected in a clinical study must be obtained through a study-specific ICF
What do I need to do?
If you plan a research project with already collected BM and/or HrPD:
- Contact the hospital representative responsible for the management of the GC. Request an assessment regarding the availability of BM and/or HrPD
- Submit the project to the EC for approval. Only upon EC approval will access to BM and/or HrPD be granted
Inform yourself on 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 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?
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
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