Development↦Management↦Study Documents↦Informed Consent Process
What is it? Why is it important?
The Informed Consent Process (ICP) describes procedures used to obtain participant:
- Consent for study participation
- Re-consent for study participation during study conduct due to changes potentially affecting study participants and their willingness to remain in the study
The ICP:
- Is described in the study protocol or in an SOP
- Defines study relevant staff responsible for its implementation (e.g. staff delegation-log)
- Provides guidance on how to obtained consent, such as:
- To start with an assessment of participant study eligibility (e.g. compliance with study inclusion & exclusion criteria)
- Provide information (PIS) and explain the study to participants (e.g. study design, intervention, safety issues, required investment)
- Upon participant study agreement, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF)
- Provides participant with a signed ICF copy
- Makes a note in the patient file and study database confirming study inclusion
- To file the ICF in the ISF
More
The implementation of an ICP can face increased challenges based on:
- The target population of the study (e.g. healthy volunteers, pregnant women, children, adolescents, persons unable to give consent)
- The complexity of the study (e.g. placebo controlled studies, emergency situations, inclusion of legal representatives)
- Expected study risks (e.g. first in man, intervention with novel drugs lacking extensive safety profiles, vulnerable target population)
- The collection of biological material and health related persona data for further-use projects
In the event of a substantial amendment affecting study participants during study conduct, requires that participants:
- Are informed about the changes including potential consequences (e.g. additional safety concerns, sampling of biological material, visits, data collection, and time investments)
- Re-consent to amended study procedures by dating and signing an updated EC approved ICF
What do I need to do?
As a SP-INV describe the ICP applicable to your study, such as:
- Staff involved in consent acquisition
- Means of informing and obtaining consent (e.g. in writing and/or orally, inclusion of witness or qualified translator)
- Consent documentation (e.g. in patient file)
- Timing of consent. This is especially important if study relevant procedures are planned the same day, or post-hoc, incomplete information, or step-wise consent is planned
- Inclusion of participants by means of advertisement
- Participant remuneration procedures
- The further-use of data and biological material from participants that withdrew from the study or were lost to follow-up
In order to ensure that the ICP is correctly implemented during study conduct, plan monitoring steps, such as to ensure:
- Study staff remains trained on ICPs and are informed about potential changes
- Only EC approved documents (ICF, PIS) are used (e.g. document management)
In the event of ICP deviations, provide explanations in a note-to-file enabling reconstruction of procedures.
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:
- Checklist for the recruitment of study participants by means of advertising
- Specimen text for advertisement
- Guidelines on the retention period of biological material and personal data of further-use projects without consent
- Conception and application of an electronic informed consent
- Time for consideration
- Monetary contributions to patients participating in research projects
References
ICH GCP E6(R2) – see in particular guideline
- 4.8. Informed consent of trial subjects
Declaration of Helsinki – see in particular principles
- 25 – 32 Informed Consent
ISO 14155:2020 Medical devices (access liable to costs) - see in particular sections
- 5.8 Informed consent
Swiss Law
HRA – see in particular articles and chapters
- Art. 16 Informed consent
- Art. 17 Consent to further use for research
- Art. 18 Incomplete consent
- Chapter 3, section 1. Research involving children, adolescents, adults lacking capacity.
- Chapter 3, section 2. Research involving pregnant women, IFV embryos, foetuses
- Chapter 3, section 3. Research involving prisoners
- Chapter 3, section 4. Research in emergency situation
ClinO – see in particular articles
- Art. 7 Informed Consent
- Art. 8 Exception to the written form
- Art. 9 Consequences of revocation of consent
- Art. 15 Post hoc consent in emergency situations
HRO – see in particular articles and chapter
- Art. 8 Informed Consent
- Art. 9 Exception to the written form
- Art. 10 Consequences of revocation of consent
- Art.11 Research projects in emergency situations
- Art. 41 Research involving deceased persons
- Art. 44 Informed consent involving embryos and foetuses
- Chapter 3, section 2. Informed consent and information in further use of biological material and health-related data