What are the effects of the fifth revision of the Declaration of Helsinki?
This "education and debate section" focuses on the 2000 revision of the Declaration of Helsinki, and comprises four articles commissioned from researchers working in the developing world, the developed world, the pharmaceutical industry, and a patient representative.
South African researcher Stephen Tollman argues that "despite the increasingly inclusive aspirations of the revised declaration, some of the absolute and exclusionary language could unintentionally endanger research in developing countries". Consumer advocate Hilda Bastian lists nine gains for consumer rights arising from the revision, but goes on to discuss a number of perceived problems in more detail. UK researcher Richard Doll distinguishes five different types of medical research and claims that "strict application of the declaration’s principles would make a wide range of clinical, biological and epidemiological research impracticable or invalid".
To some extent this conclusion is mirrored in the article from two members of the pharmaceutical industry. Laurence Hirsch and Harry Guess of Merck Laboratories say that several provisions in the revision do not provide better protection of research participants in clinical trials, and inadvertently hamper the development of safe and effective vaccines and drugs.