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
 

RESPONSIBILITIES OF INVESTIGATORS

The investigators who participate in the design of the protocol will also be responsible for preparing all necessary material for review by the ethics review board.

The investigators must be aware of such responsibilities as the following:

• the appropriate medical care of patients in the study:

• the ethical requirements for the trial (such as selection of patients, advice to patients);

• a knowledge of the product used in the trial,

• an appreciation of research methodology and the conduct of clinical trials (such as the recording and evaluation of results);

• an appreciation of the importance of careful monitoring of the trial and the need to take necessary action, to alter or terminate the trial if patients appear to be harmed by some aspect of the trial.

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