Table 3.

Other significant changes to the text of the Declaration of Helsinki in the 2000 revision (see Appendix 2 for full text of Declaration of Helsinki)

Paragraph number	Subject of the changes
8 (new paragraph)	Research on people from vulnerable groups
13 (modified paragraph) committees	Ethics committees have the right to monitor research; disclosure of potential conflicts of interest to ethics
16 (modified paragraph)	Design of all studies to be publicly available
21 (modified paragraph)	Explicit mention of protection of confidentiality of information about the patient
22 (modified paragraph)	Provisions where consent cannot be obtained in writing
25 (modified paragraph)	‘Consent’ changed to ‘assent’ with respect to research involving children
26 (new paragraph)	Provisions where consent from subject not possible
31 (modified paragraph)	Requirement to fully inform patient what aspects of their care relate to the research
32 (new paragraph)	Use of unproven techniques to save life or re-establish health should be made the object of research and the results recorded and published where appropriate