Your Easy Guide to Clinical Studies

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

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

References

The World Medical Association – see in particular

• Medical Ethics: Declaration of Helsinki - Medical research involving human subjects