Development↦Management↦Informed Consent Process↦Procedures
Was betrifft es? Warum ist das wichtig?
The Informed Consent Process (ICP) describes how persons or hospital patients are recruited for study participation.
Key steps include to:
- Assess the person`s/patient’s eligibility (i.e. compliance with study inclusion & exclusion criteria)
- Hand out the Participant Information Sheet
- Explain and ensure persons/patients understand:
- Their rights (e.g. right to information, right to withdraw from the study)
- The conduct of the study (e.g. research question, study design)
- Safety issues (e.g. participant risk-benefit)
- Requirements (e.g. time investment, providing health-related personal data and biological material)
- Potential additional consent (e.g. further-use of leftover biological material)
Once the person/patient has agreed to study participation:
- Both the participant and Site-INV sign and date the Informed Consent Form (ICF)
- The ICF is filed in the Investigator Site File ISF
- The participant receives a signed copy of the ICF
- Study inclusion is documented in the patient file and the study database
Mehr
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 Ethics Committee (EC)
Was muss ich befolgen?
As a SP-INV, describe ICP procedures in an SOP/WI or in the study protocol.
Aspects to consider include:
- Means on how to inform and obtain consent (e.g. in writing and/or orally, exemption from the written form)
- The timing of consent (e.g. with study procedures planned the same day, or post-hoc in emergency situations, incomplete information, step-wise consent)
- Special provisions (e.g. language barriers, children as target population)
- How to document consent (e.g. in patient file, study database)
To ensure ICPs are correctly implemented during study conduct:
- Train study staff on ICPs, including potential changes
- Ensure study staff authorized to carry out ICPs are defined in a delegation-log
- Ensure persons/patients have the opportunity to ask questions, and are given adequate time to decide on study participation
- Ensure only Ethics Committee (EC) approved documents (ICF, PIS) are used (e.g. document management)
- Define how to document ICP deviations (e.g. note to file)
Mehr
For the ICP additional aspects may include:
- The use of advertisement
- Participant remuneration
- Handling of data and biological material from participants who withdrew from the study, or were lost to follow-up
- Re-consent during study conduct (i.e. due to a protocol amendment potentially affecting participant willingness to remain in the study)
All these aspects must be discussed and submitted to the Ethics Committee (EC) for approval
Wo kann ich Hilfe anfordern?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), 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(R3) – see in particular guideline
- II. Principles of ICH GCP Nr. 2 Informed consent
- 2.8. Informed consent of trial participants
- Appendix C.3 Essentiality of Trial Records
Declaration of Helsinki – see in particular principles
- 25 – 32 Free and 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. 3f Definition health-related personal data
- Art. 16 Informed consent
- Art. 17 Consent to further use for research
- Art. 18 Incomplete information
- 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 Information
- Art. 8 Exception to written form
- Art. 9 Consequences of revocation of consent
- Art. 15 Post hoc consent in emergency situations
ClinO-MD – see in particular articles
- Art. 3b Participant information, consent
- Art. 3d Emergency situations
HRO – see in particular articles and chapter
- Art. 8 Informed Consent
- Art. 9 Exception to 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 for and information on further use of biological material and health-related data