What is it? Why is it important?

When participating in a study or research project, study / project participants have both risks and benefits.

 

Risks may include that:

  • The new study treatment may cause serious side effects, does not work as intended or is not better than a standard treatment
  • A participant is part of the placebo group and thus not part of the treatment group
  • Medical appointments become too cumbersome or time consuming causing unwanted disruptions in daily life

 

Benefits may include that participants:

  • Get access to novel treatments not yet available to the general public
  • Become more closely monitored with more frequent health check-ups
  • Can play a more active role in their health care

 

In any case, the risk-benefit ratio of the study must be favourable with participant safety taking precedence over research interest (i.e. principles of ethics)

More

In studies, participants also have responsibilities. When signing the Informed Consent Form (ICF), participants agree to comply with study instructions.

 

Not complying with study instruction can carry risks, such as when participants:

  • Do not report all experienced Adverse Events (AEs for IMP AEs for IMD) during study conduct
  • Abstain or forget to inform the study team regarding the unintended intake of co-medications
  • Decide to stop medication intake or dosage prior to consulting back with the study physician

What do I need to do?

As a SP-INV and Site-INV, define any risks and burdens participants may be subjected to in your study.

 

Ensure study risks:

  • Are documented in the Participant Information Sheet (PIS) in such a manner for a lay person to understand its implications
  • Are explained to participants, and processes are in place that ensure that questions are answered to the participant`s satisfaction

 

Participants must understand any study risks before signing the Informed Consent Form (ICF). 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

 

During the informed consent process, benefits to study participants can be discussed. However, in order to guarantee participant safety, informing about potential study risks should be the focus.

Where can I get help?

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

References

The Federal Act on Data Protection

Declaration of Helsinki – see in particular

  • 4, 7-9, 14 General principles
  • 16 – 18 Risks, burdens and benefits

ICH GCP E6(R2) – see in particular guidelines

  • 4.8 Informed Consent
  • 5.16 Safety Information

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. 5 Rules of Good Clinical Practice
  • Art. 7 Information
  • Art. 8 Exception to written form
  • Art. 9 Consequences of revocation to consent
  • Art. 19, 20, 49, and 61 Risk Categorisation

ClinO-MD – see in particular article

  • Art. 6 Risk categorisation of clinical investigations

HRO – see in particular article

  • Art. 7 Risk categorisation
Abbreviations
  • AE – Adverse Event
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • PIS – Participant Information Sheet
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Development ↦ Protocol ↦ Study Participants ↦ Participant Risks and Benefits
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 ↦ Protocol ↦ Study Participants ↦ Participant Risks and Benefits

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