Development↦Biobanking↦Donor Consent↦For Further Use
What is it? Why is it important?
Further-use refers to already sampled Biological Material (BM) and collected Health-related-Personal-Data (HrPD) destined for research purposes.
Further-use material originate either from:
- Hospital patients
- Study or project participants
In both instances prior consent is required.
Patients treated at a hospital complete:
- A General Consent Form (GCF): On the form patients are informed and asked whether they would agree to donate any leftover BM and HrPD to further research (e.g. BM not needed for treatment purposes)
Study or project participants complete:
- A consent form for further-use (ICF): On the form participants are informed and asked whether they would agree to donate any leftover BM, not needed for the study/project, to further research. The further-use consent form is handled separately from the study / project consent. A participant can agree to study/project participation, but can at the same time dissent to donate any left-over BM to further research
Collection of BM and donor identification
Leftover BM from biopsies no longer needed by the pathologist, can either be collected:
- Anonymously: upon collection the donor can no longer be identified. Still, the donor can oppose for his/her BM to be anonymized, as information can be generated that would be of important health interest
- In a coded form: donor identity is coded and can be re-identified thanks to a donor-identification-log that is kept separate from the BM or BIMS (biobanking database).
In both instances the donor / study participant must agree for the BM to be used for further research. In the event of anonymously collected BM, the process used to ensure that the BM remains anonymous upon collection must be submitted and approved by the Ethics Committee.
What do I need to do?
Plan consent procedures based on the intended target group.
- For hospital patients request a GCF from your hospital
- For clinical study/project participants include a separate information and consent form for further-use
- Describe the consent process of further-use in a SOP or WI and include:
- How consent is obtained
- Procedures in the event of consent withdrawal (e.g. destruction or anonymisation of BM and HrPD)
- Communication means with donors
- Describe how to document donor information and collected BM (e.g. in BIMS or a separate dataset)
Ensure donors receive the required information needed to take a decision, and have the opportunity to ask questions.
The GCF or any other additional consent forms for further-use require EC approval.
In anticipation that a doror / study participant withdraws from the study, include in the PIS/ICF that already collected BM and HrPD will be retained and used in the study. If this information is missing the BM and its associate data must be destroyed.
An option is to anonymise the data, but the donor / study participant can refuse to have its BM and HrPD anonymised (e.g. important results might become available through its analysis). Thus, the wishes of the donor / study participant must be taken into consideration. In any event, after finalising the data analysis, BM and any associates data from donors / study participants must be anonymised, or destroyed.
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
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
Swissethics – see in particular
- Templates and Checklists / patient information and declaration of consent
- Further-use of BM and HrPD / Biobanks
ICH GCP E6(R2) – see in particular guideline
- 1.28. Informed consent definition
- 4.8. Informed consent of trial participants
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular section
- 5.8 Informed consent
Declaration of Helsinki – see in particular principles
- 25-32 Informed Consent
HRA – see in particular article and chapter
- Art. 7 Consent
- Chapter 2, section 2. Information and consent
HRO – see in particular articles and chapter
- Art. 8 Information
- Art. 9 Exemption to written form
- Art. 10 Consequences of revocation of consent
- Art. 24 Further use
- Art. 30 Anonymisation of biological material and genetic personal data
- Chapter 3, section 2. Informed consent and information in further use of biological material and health-related data