What is it? Why is it important?

The informed consent process describes how consent is obtained including procedures in the event participants withdraw, have to re-consent or are lost to follow-up.

Processes differ based on the following main aspects:

  • What is the target population of the study? Healthy volunteers, pregnant women, children, adolescents, persons unable to give consent, etc.
  • How complex is the study design? Placebo controlled studies, emergency situations, inclusion of legal representative, etc.
  • What are the expected study risks? First in man, intervention with novel drugs lacking extensive safety profiles, vulnerable target population
  • Is the aim to further use collected study data for research? Biological material and health related data

What do I need to do?

Based on the Swiss law, describe the consent process 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)
  • Timing (e.g. post-hoc consent, incomplete information or step-wise consent)
  • Inclusion of participants by means of advertisement
  • Participant remuneration procedures
  • Further use of data and material from participants that withdrew or were lost to follow up

More

In order to ensure that the consent process is correctly implemented, during study conduct, ongoing surveillance is important.

Aspects to include:

  • The consent process of the study must be clearly described in the study protocol, including in a relevant SOP or WI.
  • Staff is trained on the consent process and informed about any relevant changes to this process
  • During study conduct only current and EC approved version of the ICF can be used for participant recruitment and consent
  • The ICF must be correctly dated and signed by both staff and study participant:
    • Only staff listed on the delegation log, and having been delegated the task of consent can sign and date the document
  • On the ICF:
    • All information except signatures are legible
    • For identification purposes, name of staff signing the ICF is entered
    • Participant name, date of birth is entered
    • Participants have personally dated and signed the document
    • If applicable, the time when the document was signed is entered
    • Participant and staff sign the ICF together at the same time
    • Study staff should never sign before the participant has entered his/her signature
  • The original signed and dated ICF:
    • Is filed in the ISF of the study site
    • A signed copy is handed out to participants

In the event of a substantial amendment that results in an adaptation of the PIS requires that participants:

  • Are informed about changes including potential consequences of the amendment (e.g. additional safety concerns, sampling of biological material, visits, data collection, and time investments).
  • Re-consent and sign the updated ICF (with date and signature)

All signed versions of the ICF are kept in the ISF of the study site.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – in particular see:

  • 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 - see in particular sections (access liable to cost)

  • 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 chapters

  • 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
  • Chapter 3, section 2. Informed consent and information in further use of biological material and health-related data
  • Art. 41 Research involving deceased persons
  • Art. 44 Informed consent involving embryos and foetuses
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • PIS – Participant Information Sheet
  • SOP – Standard Operating Procedures
  • WI – Working Instructions
Development ↦ Management ↦ Study Documents ↦ Informed Consent Process
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Development ↦ Management ↦ Study Documents ↦ Informed Consent Process

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