What is it? Why is it important?

The Declaration of Helsinki is an internationally recognised declaration, submitted by the World Medical Association (WMA).

The document defines ethical principles for medical research involving human participants. It also includes research with not-anonymised human material and data.

The document provides research principles regarding:

  • Risks, burdens, and benefits
  • Vulnerable groups and individuals
  • Scientific requirements and the research protocol
  • Role of the Ethics Committee
  • Privacy and confidentiality
  • Informed consent
  • Use of placebo
  • Post-trial provisions
  • Research registration, publication, and dissemination of results
  • Unproven interventions in clinical practice

What do I need to do?

As a SP-INV and Site-INV make yourself familiar with the declaration and its principles, such as:

  • The duties of researching physicians: to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of research participants, which includes their personal data
  • Study participant risks, burdens and benefits: medical research can only be conducted if research objective(s) and its foreseeable benefits outweigh any risks and burdens to study participants
  • Vulnerable groups and individuals: can only participate in research if it cannot be carried out in a non-vulnerable group. They must receive special protection and stand to benefit from any research results

Where can I get help?

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

References

The World Medical Association – see in particular

  • Medical Ethics: Declaration of Helsinki - Medical research involving human subjects
Abbreviations
  • CTU – Clinical Trials Unit
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
  • WMA – World Medical Association
Basic ↦ Ethics and Laws ↦ Principles of Ethics Research ↦ Declaration of Helsinki
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): Basic ↦ Ethics and Laws ↦ Principles of Ethics Research ↦ Declaration of Helsinki

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