Development↦Management↦Study Documents↦Informed Consent Form
What is it? Why is it important?
The Informed Consent Form (ICF) is a document handed out together with the PIS, where participants voluntarily confirm their willingness to participate in a study.
- Consent is documented in writing. Both participant and resepctive investigator (SP-INV or Site-INV) date and sign the ICF
- Only after the participant has signed the ICF and thus formally agreed to participate in the study, can study assessments and procedures start (e.g. participant questionnaire, analytical screening tests)
In order for participants to decide on study participation information is provided:
- Verbally through personal discussion with health care providers
- Through answering any questions participants might have about the study
- In writing by handing out a copy of the PIS to participants
In order to decide whether to participate in a study, participants should be:
- Unmistakably informed and understand their contribution to the study (e.g. time investment, provision of biological material and health related data, administration of IMP/MD and the appearance of potential side effects)
- Given ample opportunity to ask questions in order to make a sound decision regarding participation
- Given adequate time to decide
- Informed regarding their right to with-hold or revoke their consent at any time, without stating reasons why participation is no longer desired
- Informed that revoking consent carries no disadvantages on ongoing or future medical treatments or care given to participants
Neither Site-INV, nor the study staff, should coerce or unduly influence participants to participate or continue to participate in a study.
What do I need to do?
Implement informed consent procedures where
Each participant is provided with his / her personal ICF, and:
- Enters his/her name, gender, and date of birth
- Personally enters place, dates and signs the ICF
Site-INV / SP-INV or delegated person:
- Enters name (legibly) and personally dates and signs the ICF immediately after the participant
- Provides the participant with a signed copy of the ICF
- Makes a note in the medical history and study database confirming study inclusion
- Files ICF in ISF
- The study delegation log must clearly list designated study staff responsible for informing participants about the study including dating and signing the ICF. In most cases this would be the SP-INV or a Site-INV.
- Document time when ICF was obtained. This is especially important if study relevant procedures are planned the same day.
- Ensure that all hand-written text is clearly legible, with personal signatures being excluded.
- Document the whole ICF process in the source data of the patient (e.g. medical records). In the event of any deviations to the process, provide explanations enabling reconstruction of procedures.
Regarding the ICF process do NOT:
- Leave date and place empty
- Pre-enter date & place on behalf of the participant
- Forget to make participant sign the document
- Personally forget to sign the document
- Have the document signed by a non-authorised staff member
- In a multi-centre study forward signed and dated ICF documents of a participating study site to the SP-INV of the study
Signed ICFs of a participating study site are filed in the site specific ISF and not in the TMF of the study. The ICF remains at the study site where participants were recruited for the study.
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
- Broad selection of patient information and ICF templates
- Conception and application of an electronic informed consent
- Time for consideration
- Monetary contributions to patients participating in research projects
ICH GCP E6(R2) – see in particular guidelines
- 1.28 Informed consent definition
- 4.8 Informed consent of trial participants
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 Informed Consent
HRA – see in particular articles
- Art. 7. Consent
- Chapter 2, section 2. Information and consent
- Chapter 3 all sections. Requirements vulnerable persons
HRO – see in particular articles and chapter
- Art. 8 Information given to participants
- Art. 10 Consequences of revocation of consent
- Art. 11 Research projects in emergency situations
- Chapter 3, section 2. Informed consent and information in further use of biological material and health-related data
ClinO – see in particular articles
- Art. 7 Information given to participants
- Art. 9 Consequences of revocation of consent
- Art. 15 Post hoc consent in emergency situations