4 Declaration of Helsinki - law aspects
| 4 Declaration of Helsinki - law aspects |
| The Declaration of Helsinki was always intended to be a guideline, but although it is not supposed to be legally prescriptive some articles (Article 9 for example) have the flavour of a legal document. Authorities in various countries have incorporated it into the laws of their country, so sections of Helsinki have in fact become law. For instance, in the USA some of it was incorporated into the Code of Federal Regulations such as CFR21 312.120 and it is also referenced in ICH GCP (E6) and other major guidelines. But there is confusion over the use of the Declaration: different laws refer to different versions of Helsinki, most companies refer to the 1996 version, but some ethics committees want to have reference to the 2000 version. |
|
|
