Development↦Management↦Study Documents↦Informed Consent Form
What is it? Why is it important?
The Informed Consent Form (ICF) is an Ethics Committee (EC) required document handed out to participants either separately or as a joint document with the Patient Information Sheet PIS.
By signing the ICF, participants confirm their willingness to voluntarily participate in a study. The ICF must be dated and signed together with the researcher.
An ICF:
- Is a short summary of information provided in the PIS
- Is site specific (i.e. sites include their contact details for participants to reach site specific researchers, such as the Site-INV)
- Has a section for participants and researchers to date an sign the document (i.e. either in person or with an electronic signature)
- Is integrated in an informed consent process that must be described in the study protocol
- Must be submitted and approved by EC
- Is only valid once a participant has dated and signed the document
More
Consent given in an electronic form is permissible provided that the chosen method:
- Unmistakably identifies the study participant concerned
- Prevents an overhasty decision
- Is protected against modification
In the application dossier to the EC provide a document that describe how the requirements above are met.
Researchers should not coerce or unduly influence participants to participate or continue to participate in a study.
What do I need to do?
As a SP-INV:
- Select from swissethics (EC) the ICF template applicable to your study
- Summarise main information needed for study participants to sign and date the document
In order for participants to decide on study participation, they must:
- Be informed about the study:
- Through personal contact and discussions with health care provider
- In writing by receiving a copy of the ICF and PIS
- Understand and be able to comply with expected study tasks (e.g. time investment, provision of biological material and health related data, administration of the study`s investigational product (IMP / IMD), report on potential adverse events)
- Know their rights
- Be given adequate time to decide
ICF management includes to:
- Train study staff on the informed consent process
- Establish a site-delegation-log listing staff responsible to recruit and inform participants
- Provide each participant with a signed copy of the ICF (i.e. either on paper or in electronic form)
- Ensure signed ICFs remain at the study site protected from unauthorised access
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ICF quality checks include:
- All information except signatures are legible
- For identification purposes:
- The name of staff signing the ICF is clearly spelt in capital letters
- A participant sticker for later identification is attached, or participant name and date of birth are included
- Participants have personally dated and signed the document (i.e. either in person or with an electronic signature)
- The time when the document was signed is entered (i.e. automatically recorded in an electronic signatures). This is especially important if study relevant procedures are planned the same day
- Participants and study staff sign the ICF together on the same date
- A signed copy is handed out to participants
Mistakes to avoid in the ICF process
- To leave date and place empty
- Pre-enter date & place on behalf of the participant
- Forget to make participant sign the ICF
- Personally forget to sign the document
- Have the document signed by non-authorised staff not listed on the site-delegation-log
- To use an outdated or amended non EC approved ICF in the study
- In a multi-centre study: forward signed and dated ICFs from a participating study site to the SP-INV of the study
Signed ICFs of a participating study site are filed in the ISF and not in the TMF of the study.
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External Links
Swissethics – see in particular
- Broad selection of Patient Information (PIS) and Informed Consent Form (ICF) templates
References
ICH GCP E6(R3) – see in particular guidelines
- Glossary: Definition informed consent
- 2.8 Informed consent of trial participants
- II GCP Principles Nr. 2 Informed consent is an integral part of the ethical conduct of a trial
ISO 14155:2020 Medical device (access liable to costs) - see in particular section
- 5.8 Informed consent
Declaration of Helsinki – see in particular principles
- 25 – 32 Free Informed Consent
Swiss Law
HRA – see in particular articles
- Art. 7 Consent
- Art. 8 Right to receive information
- Chapter 2, section 2 Information and Consent
- Chapter 3, all sections. Requirements vulnerable persons
ClinO – see in particular articles
- Art. 4a Inclusion of relevant groups of persons
- Art. 7 Information given to participants
- Art. 8 Exemption to written form
ClinO-MD – See in particular
- Art. 3a Inclusion of relevant groups of persons
- Art. 3b Applicable provisions (refer to ClinO)
HRO – see in particular articles and chapter
- Art. 2c Inclusion of relevant groups of persons
- Art. 8 Information given to participants
- Art. 9 Exemption to written form