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


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

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


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
  • 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 ↦ Study Documents ↦ Informed Consent Process

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

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

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