Table 1.

Key changes in the Tokyo (1975) revision of the Declaration of Helsinki

Introduction
3rd, 4th and 5th paragraphs	Nature and purpose of medical research
6th paragraph	Respect for environment and for animals used in research
7th paragraph	Keep Declaration under review
Basic Principles
I.2	Independent committee review of research protocols
I.5	Interests of human subject must prevail over interests of science and society
I.8	Obligations regarding accuracy in publishing
I.9–I.11	Enhanced requirements for informed consent
I.12	Protocol must declare that requirements of Declaration of Helsinki adhered to
Medical Research Combined With Professional Care (Clinical Research)
II.2	Best current therapy should be comparator arm
II.3	Assurance of access to best proven methods
II.4	Refusal of research participation not to affect doctor–patient relationship
II.5	When doctor considers it is essential not to obtain informed consent*
Non-therapeutic Biomedical Research Involving Human Subjects (Non-clinical Biomedical Research)
III.2	Less detail regarding consent (most of detail moved to Basic Principles section)
III.4	Well-being of subject takes precedence over interests of science and society (see I.5)

^*This is the only paragraph from the 1975 (and subsequent minor revisions) completely removed at the Edinburgh (2000) revision. (N.B. These are listed under the numbering system of the paragraphs in the Declaration with the exception of the ‘Introduction’ section, which is not numbered.)