Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
(1993; 94 pages)
Table of Contents
View the documentFOREWORD
Open this folder and view contents1. INTRODUCTION
Open this folder and view contents2. GENERAL CONSIDERATIONS IN HERBAL MEDICINE RESEARCH
Close this folder3. RESEARCH STUDIES
View the documentLITERATURE BACKGROUND
View the documentPROTOCOL PREPARATION
View the documentQUALITY SPECIFICATIONS OF PLANT MATERIALS AND PREPARATION
Open this folder and view contentsNON-CLINICAL STUDIES
Close this folderCLINICAL TRIALS USING HERBAL MEDICINES
View the documentCLINICAL TRIAL PROTOCOL DEVELOPMENT
View the documentPHASES OF A CLINICAL TRIAL
View the documentETHICS REVIEW BOARD
View the documentRESPONSIBILITIES OF INVESTIGATORS
View the documentRESPONSIBILITIES OF THE SPONSOR
View the documentDATA MANAGEMENT
View the documentSTATISTICAL ANALYSIS
View the documentREPORTING
View the documentEVALUATION OF HERBAL MEDICINE RESEARCH
Open this folder and view contentsTECHNOLOGY TRANSFER AND EDUCATION
Open this folder and view contents4. USING THE GUIDELINES
Open this folder and view contentsANNEXES
View the documentNOTES
View the documentBIBLIOGRAPHY
View the documentSELECTED WHO PUBLICATIONS OF RELATED INTEREST
 

ETHICS REVIEW BOARD

The trial protocol should be considered by an ethics review board. The board will generally be established at an institutional level but boards existing at a regional or national level can also be used. The board will be an independent body constituted of both medical and non-medical members who are not involved in the experimental activity of the trial under review. The board will verify that the rights of the patients participating in the trial are protected and that the trial is justified in medical and social terms. The board will also consider the suitability of the trial protocol, patient selection and patient protection, and issues of informed consent of patients. The work of the board should be guided by the World Medical Association’s Declaration of Helsinki (Annex 2).

The board will work under standard operating procedures which will be developed by each institution taking into consideration all necessary requirements of local regulatory authorities and related governmental agencies including such rules as those for Good Clinical Practice (GCP).

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