What is it? Why is it important?

Participants who agree to participate in a study or research project have rights, such as:

 

  • To be truly and completely informed about:
    • Expected obligations arising from participation (e.g. potential safety issues, damage coverage, financing)
    • Safety risk or concerns as soon as they become available
    • Measures taken to protect Personal Data (PD) and Biological Material (BM)
    • Aspects related to genetic testing (e.g. purpose, significance to persons involved, insurance disclosure) – see under MORE
    • Potential benefits to them or others with the same disease

 

  • Their right to:
    • Ask questions regarding study participation (e.g. nature, purpose, duration)
    • Contact study staff in the event of safety issues or other concerns
    • Withdraw from the study at any time without giving a reason
    • Consequences of revoking consent to further use of collected PD and BM
    • Right to information regarding their health - see under MORE
    • Have any recorded data errors corrected or deleted

More

Participants have the right to information regarding:

  • Treatment results, or
  • Treatment results relating to their health. They have the right  to forgo such information or to designate a person who is to take this decision for them (e.g. random findings / diagnosis, impact of genetic testing)

 

In the event genetic testing, prenatal genetic testing, or testing for family planning purposes is conducted, and results arise concern regarding the health of the study participant, he or she must be informed regarding:

  • The purpose, nature and significance of the test;
  • The frequency and nature of the disorder screened for;
  • Medical, psychological and social implications of the test;
  • The possible significance of the results for the person concerned and for family members, and their right not to know.

 

When presymptomatic testing is conducted the study participant must additionally be informed about the conditions under which insurance providers may request the disclosure of the test results

What do I need to do?

As a SP-INV or Site-INV:

  • Know the rights of study participants
  • Ensure rights are documented in the Patient Information Sheet (PIS) for participants to read or refer to during study conduct
  • Ensure participants understand their rights before being asked to sign the Informed Consent Form (ICF)

 

It is the responsibility of the SP-INV and Site-INV to make sure participants know and understand their rights. In the event of:

  • Communication problems (e.g. language), plan for an independent qualified translator to be consulted
  • Physical or cognitive problems, plan for information and consent to be provided in a non-written form, with a written confirmation from a witness confirming adherence to the informed consent process

 

The information may be provided in stages. It may be additionally presented in a non-textual form

Where can I get help?

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

References

The Federal Act on Data Protection - see in particular

  • Art. 6 Principles

Declaration of Helsinki – see in particular

  • 4, 7-9, 14 General principles

ICH GCP E6(R2) – see in particular guidelines

  • 4.8 Informed Consent

Swiss Law

HRA – see in particular articles

  • Art. 8 Right to receive information
  • Art. 15 Safety and protective measures
  • Art. 16 Informed Consent

ClinO – see in particular articles

  • Art. 7 Information
  • Art. 7a Information in case of genetic testing
  • Art. 7b Information in case of prenatal risk assessment
  • Art. 7c Form of consent
  • Art. 8 Exception to written form
  • Art. 9 Consequences of revocation to consent
  • Art. 18 Storage of health-related data and biological material

ClinO-MD – see on particular article

  • Art. 3b Provision for participant information are given in ClinO Art. 7-9

HRO – see in particular article

  • Art. 5 Storage of health-related data and biological material
  • Art. 8 Information
  • Art. 8a Information in case of genetic testing
  • Art. 8b Information in case of prenatal risk assessment
  • Art. 8c Form of consent
  • Art. 9 Exception to written form
  • Art. 9a Communication of results
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • PD – Personal Data
  • PIS – Participant Information Sheet
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Development ↦ Protocol ↦ Study Participants ↦ Participant Right
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
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 Drug or Device
Current Path (click to copy): Development ↦ Protocol ↦ Study Participants ↦ Participant Right

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