(1) | Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects. | Art. (16), Declaration of Helsinki | Proportional |
(2) | All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher. | Art. (17), Declaration of Helsinki | Proportional |
(3) | Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study. | Art. (18), Declaration of Helsinki | Proportional |
(4) | For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent and the research entails only minimal risk and minimal burden. | Art. (28), Declaration of Helsinki | Absolute |
(5) | The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances: … the patients who receive any intervention less effective than the best proven one, placebo or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. | Art. (33), Declaration of Helsinki | Absolute |