What is it? Why is it important?

A “vulnerable participant” is any individual who lacks the ability to fully decide or consent to study participation. Studies with vulnerable participants require that it is not possible to obtain equivalent findings from non-vulnerable subjects.

Additional procedures ensure that the rights of these participants are protected, such as to:

  • Clarify whether the study:
    • Involves more than “minimal risks and burdens”?
    • Has an expected direct benefit for participants?
    • Expects to generate substantial findings?
  • Seek consent from legal representative(s) or relative(s)
  • Request the opinion of a study- independent physician (emergency situation)
  • Provide a PIS / ICF suitable for children or adolescents
  • Check that vulnerable participants do not visibly express an opposition to study participation (verbally or through their behaviour)

More

Vulnerable participants include

Children, adolescents, persons lacking capacity, persons in emergency situations, pregnant & breastfeeding women and their foetus or infant, prisoners.

Based on the law, special informed consent procedures apply for vulnerable participants

Special requirements for the recruitment of vulnerable participants

Children with capacity participating in a study with an expected direct benefit:

  • Informed consent of the child
  • Written consent of the legal representative

Children with capacity participating in a study without expected direct benefit:

  • Informed consent of the child
  • Written consent of the legal representative
  • The study entails no more than minimal risks and burdens
  • Study data is expected to benefit future children with the same disease or situation

Children lacking capacity participating in study with expected direct benefit:

  • Written consent of the legal representative
  • The child does not visibly express opposition verbally or through his/her behaviour

Children lacking capacity participating in a study without expected direct benefit:

  • Written consent of the legal representative
  • The child does not visibly express opposition verbally or through his/her behaviour
  • The study entails no more than minimal risks and burdens
  • Study data is expected to benefit future children with the same disease or situation

Adolescents with capacity participating in as study with or without expected direct benefit:

  • Adolescent written informed consent
  • If the study entails more than minimal risks and burdens, requires a written consent of the legal representative

Adolescents lacking capacity participating in a study with an expected direct benefit:

  • Written consent of the legal representative
  • Adolescent does not visibly express opposition verbally or through his/her behaviour

Adolescents lacking capacity participating in a study without expected direct benefit:

  • Similar to expected benefit, and
  • The study entails no more than minimal risks and burdens
  • Study data is expected to benefit future adolescents with the same disease or situation

What do I need to do?

When recruiting vulnerable study participants :

  • Take necessary measures to safeguard their specific rights and welfare
  • During study conduct ensure to seek additional consent from participants in the event:
    • Children/adolescents reach legal age of maturity
    • Adults regain capacity to consent (e.g. post-hoc consent in emergency situations)
  • Exclude participants from study participation who show signs of objection (dissent), even though legal representative gives consent

Participant not able to provide consent prior to study inclusion (e.g. emergency setting), are provided with the opportunity as soon as possible (post-hoc consent).

In the event that a participant from an emergency study refuses post-hoc consent, destroy all already collected data and biological material.

More

Special requirements for studies with pregnant and breast-feeding women:

  • Pregnant women can only be recruited in studies that evaluate methods of induced abortion, after the women have decided to undergo abortion
  • Study outcome must be monitored both in the pregnant woman, foetus and breast-fed infant

Where can I get help?

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

External Links

Swissethics – see in particular

  • Research with children and adolescents

References

Declaration of Helsinki – see in particular principles

  • 19-20 Vulnerable groups and individuals

ISO 14155:2020 Medical Devices (access liable to costs) – see in particular sections and annex

  • 5.7 Vulnerable populations
  • 5.8.3 Special circumstances for informed consent
  • 7.7 Subject privacy and confidentiality of data
  • 10.7 Medical care of subjects Respect of participants
  • Annex A Vulnerable population (A.15)

SAMS manual Research with human subjects – see in particular chapters

  • Chapter 5 Research with children and adolescents
  • Chapter 8 Information and consent
  • Chapter 9 Respect of participants

Swiss Law

FEDLEX – law is available online under number

  • 810.308 HRA

HRA – see in particular articles

  • Art. 11 Subsidiarity
  • Art. 21-24 Research involving Children, Adolescents and Adults lacking Capacity
  • Art. 25-27 Research involving Pregnant Women and Embryos and Foetuses in vivo
  • Art. 28-29 Research involving Prisoners
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • ICF – Informed Consent Form
  • ISO – International Organization for Standardization
  • PIS – Participant Information Sheet
  • SAMS – Swiss Academy of Medical Sciences
Conduct ↦ Ethics and Laws ↦ Participant Protection ↦ Consent of Vulnerable Participants
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Ethics and Laws ↦ Participant Protection ↦ Consent of Vulnerable Participants

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