What is it? Why is it important?

The protection of study participants should be guaranteed at all times:

  • Studies can only be carried out if equivalent findings cannot be obtained through other means
  • The risk-benefit ratio must be favourable, as risks and burdens must not be disproportionate to the expected benefits
  • Studies must be socially valuable, where the answer is important enough to justify some risks or inconveniences to study participants
  • Participant selection must be fair and unbiased
  • Special protection must be given to vulnerable population groups (e.g. children, emergency situations, pregnant women)
  • Studies must undergo an independent review by EC (e.g. EC aims to protect participant safety and rights)

More

Based on scientific requirements, the study methodology must be rigorous, with its design able to provide one or more understandable answers.

Participants cannot be remunerated for their participation in a study. However, compensation for time and travel expenses can be given.

What do I need to do?

As a SP-INV or Site-INV, you are responsible for the protection, safety and well-being of your study participants.

Example 1: External safety information requires an urgent interruption of the study, and an evaluation of its ongoing safety. As participant protection has first priority at all times, the Site-INV immediately interrupts the study and implements protective measures.

Example 2: A study performed in an emergency situation requires the postponement of the participant’s consent. Consent is obtained at a later time point when the participant is able to express his/her will. If the participant refuses consent and as a consequence study participation, all collected study data and/or biological material is destroyed.

When working on the design and feasibility assessment of your study, ensure to identify and comply with all applicable legal requirements (e.g. HRA, ClinO. ClinO-MD, HRO, ISO)

Where can I get help?

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

References

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

  • 5.8 Informed consent
  • 5.7 Vulnerable populations
  • 6.2 Risk management
  • 7.4 Risk assessment for potentially unacceptable risks
  • Annex B Investigator’s brochure
  • Annex H Application of ISO 14971 to clinical investigations
  • Annex G EC responsibilities

SAMS handbook Research with human subjects – see in particular chapters

  • Chapter 4 Scientific requirements
  • Chapter 5 Selection of study participants
  • Chapter 6 Assessment of risk and benefits
  • Chapter 7 Independent review by EC
  • Chapter 8 Information and consent
  • Chapter 9 Respect of participants

MDR 2017-745 – see in particular articles

  • Art. 64-68 Clinical investigation on incapacitated subjects / minors/ pregnant or breastfeeding women / in emergency situation

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.30 HRA
  • 810.301 HRO
  • 810.305 ClinO

HRA – see in particular articles

  • Art. 6 Non-discrimination
  • Art. 7 Consent
  • Art. 8 Right to information
  • Art. 11 Subsidiarity
  • Art. 12 Risks and burdens
  • Art. 13 Placebo
  • Art. 14 Gratuitousness
  • Art. 16 Informed consent
  • Art. 21-24 Involvement of persons lacking capacity

ClinO – see in particular articles

  • Art. 5 Rules of Good Clinical Practice
  • Art. 7 Information
  • Art. 9 Consequences of revocation of consent
  • Art. 15 Post hoc consent

HRO - see in particular articles

  • Art. 8 Information
  • Art. 9 Exceptions to the written form
  • Art. 10 Consequences of Revocation of Consent
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-DM – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ISO – International Organization for Standardization
  • MDR – Medical Device Regulation
  • SAMS – Swiss Academy of Medical Sciences
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Concept ↦ Ethics and Laws ↦ Research Integrity ↦ Participant Protection
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): Concept ↦ Ethics and Laws ↦ Research Integrity ↦ Participant Protection

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