General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoAcknowledgements
Ver el documentoForeword
Abrir esta carpeta y ver su contenidoIntroduction
Abrir esta carpeta y ver su contenido1. Methodologies for Research and Evaluation of Herbal Medicines
Abrir esta carpeta y ver su contenido2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Abrir esta carpeta y ver su contenido3. Clinical Research
Cerrar esta carpeta4. Other Issues and Considerations
Ver el documento4.1 Pragmatic Research Issues
Ver el documento4.2 Ethics
Ver el documento4.3 Education and Training
Ver el documento4.4 Surveillance Systems
Ver el documentoReferences
Abrir esta carpeta y ver su contenidoAnnexes
Abrir esta carpeta y ver su contenidoAnnex I. Guidelines for the Assessment of Herbal Medicinesa
Abrir esta carpeta y ver su contenidoAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
Abrir esta carpeta y ver su contenidoAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Abrir esta carpeta y ver su contenidoAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Abrir esta carpeta y ver su contenidoAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
Abrir esta carpeta y ver su contenidoAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Abrir esta carpeta y ver su contenidoAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Abrir esta carpeta y ver su contenidoAnnex VIII. Guideline for Good Clinical Practicea
Abrir esta carpeta y ver su contenidoAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
Ver el documentoAnnex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine
 

4.2 Ethics

The international ethical guidelines for biomedical research involving human subjects (see Annex VI) should be implemented in each clinical trial. An ethics committee, according to each institution's guidelines should review each trial.

Whenever applicable, rescue treatment may be provided to patients involved in a clinical trial involving the use of a placebo or unproven treatment. Use of the rescue treatment may be a secondary outcome measure.

In some countries and hospitals, there are ethical issues that restrict the use of clinical trials. In some cases, the use of a placebo is even illegal, particularly for patients suffering from certain illnesses, such as cancer. Therefore, clinical trials must always be conducted within the framework of the prevailing law in a given country or state.

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