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 subjects, including research on identifiable human material and data (e.g. HRO).


Research principles addressed in the document include:

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

External Links

Declaration of Helsinki - Ethical Principles for Medical Research involving Human Subjects

  • 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

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
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.