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:
- Risks, burdens, and benefits
- Vulnerable groups and individuals (e.g. infant and children, pregnant women, prisoners, emergency patients)
- 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?
- 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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
Declaration of Helsinki - Ethical Principles for Medical Research involving Human Subjects