What is it? Why is it important?

The Human Research Act (HRA) regulates through its Human Research Ordinance (HRO) research involving:

  • Deceased persons
  • Embryos and foetuses from induced abortions, spontaneous abortions including stillbirths

Studies must initially be submitted and approved by EC who reviews:

  • The completeness of the application dossier
  • Professional qualifications of the project leader
  • The scientific quality of the project
  • Compliance with IC procedures
  • Compliance regarding storage of HRpD and BM
  • Compliance with the prohibition if commercialisation

A research project can only be carried out on deceased persons, embryos and foetuses from induced or spontaneous abortions, if the death has been ascertained. Additional regulations apply (e.g. deceased person undoing artificial respiration, research with embryos and foetuses)

More

Research involving deceased persons undergoing artificial respiration can only be carried out if:

  • Equivalent findings cannot be obtained with deceased persons not undergoing artificial respiration, and
  • The researcher who carries out the project has not been involved in the determination of death or authorised to issue instructions to persons involved in this procedure

Research involving embryos and foetuses requires that:

  • In the event of an induced abortion, the decision of the pregnant woman to terminate her pregnancy is definitive
  • The pregnant woman or couple receive written and oral information, such as:
    • Purpose of the research project
    • Their right to withhold or revoke consent
    • The handling of BM and HRpD
  • Consent is given in writing. Exceptions from the written form must be approved by EC

What do I need to do?

As a project leader:

  • Familiarise yourself with the HRO law applicable to your project. Beware of references made to articles in the HRA law
  • Ensure compliance with IC procedures (embryos and foetuses)
  • For projects with deceased persons undergoing respiration define and document:
    • The process that proves independence of project researchers regarding determination of death
    • Arguments why this type of research approach is required (use of artificial respiration)
  • Submit research project to the EC for approval
  • Report to EC the completion or discontinuation of your research project within 90 days

The project leader must notify the EC regarding changes to the research project (e.g. project leader, protocol changes regarding deceased person undergoing artificial respiration).

The research project can only start after EC approval has been received.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Templates and checklists
    • Study protocols / Research involving deceased persons

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.308 HRA
  • 810.301 HRO

HRA – see in particular articles

  • Art. 37 Additional requirements
  • Art. 39 Requirements for research in embryos and foetuses from induced abortions

HRO – see in particular chapters

  • Chapter 4 Research involving deceased persons
  • Chapter 5 Research involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • HRpD – Health-Related Personal Data
  • IC – Informed Consent
Basic ↦ Ethics and Laws ↦ Human Research Ordinance ↦ Deceased Persons Embryos and Foetuses
Study
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Basic Protocol
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Basic Monitoring
Basic Drug or Device
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Ends after having assessed and evaluated study feasibility

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Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
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Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
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Starts with participant recruitment

Ends after the last participant has completed the last study visit

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Ends after study publication and archiving

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Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Human Research Ordinance ↦ Deceased Persons Embryos and Foetuses

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