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 (i.e. due to changes potentially affecting participant willingness to remain in the study)

 

The key steps in the ICP are to:

  • Assess the participant’s eligibility (e.g. compliance with study inclusion & exclusion criteria)
  • Hand out the Participant Information Sheet (PIS) and explain the study to the participant (e.g. study design, intervention, safety issues, time investment, further-use of study data and biological material)
  • Answer questions the participant may have, and to provide the participant with ample time to decide on study participation
  • Sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF), once the participant has agreed to participate in the study
  • Provide the participant with a signed copy of the ICF
  • Document study inclusion in the patient file and the study database
  • File the ICF in the ISF

More

The implementation of an ICP can face increasing challenges due to:

  • 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)
  • Increased 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 during study conduct, participants should:

  • Be 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 ICF, approved by the EC

What do I need to do?

As a SP-INV, describe:

  • ICP procedures applicable to your study in an SOP or study protocol
  • Means on how to inform and obtain consent (e.g. in writing and/or orally, exemption from the written form)
  • How to document consent (e.g. in patient file, study database)
  • The timing of consent (e.g. with study procedures planned the same day, or post-hoc, incomplete information, step-wise consent)
  • How to document ICP deviations (e.g. note to file)

 

Additional aspects to include:

  • The use of advertisement
  • Participant remuneration procedures
  • Handling of data and biological material from participants who withdrew from the study, or were lost to follow-up

 

To ensure that the ICP is correctly implemented during study conduct, ensure that:

  • Study staff remains trained on the SOP and are informed about potential changes
  • Study staff authorized to carry out the ICP are defined in a delegation log
  • Only EC approved documents (ICF, PIS) are used (e.g. document management)

 

Where can I get help?

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

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
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit EC – Ethics Committee
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ICP – Informed Consent Process
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • PIS – Participant Information Sheet
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor Investigator
  • WI – Working Instructions
Development ↦ Management ↦ Informed Consent Process ↦ Procedures
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Informed Consent Process ↦ Procedures

Please note: the Easy-GCS tool is currently under construction.