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 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)
• Meaningful engagement with potential participants
• 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 and others involved in medical research: to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of research participants, which includes their personal data
• Scientific principles: design and execution of medical research should produce reliable, valid knowledge and avoid research waste
• 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

External Links

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