World Health Organization Publication : Year 2006 ; Issue 9241594454 - in English: Handbook ; Quality Practices in Basic Biomedical Research

By Deborah Kioy, Dr.

Book Id: WPLBN0000201418
Format Type: PDF eBook
File Size: 1.3 MB
Reproduction Date: 2005

Title:	World Health Organization Publication : Year 2006 ; Issue 9241594454 - in English: Handbook ; Quality Practices in Basic Biomedical Research
Author:	Deborah Kioy, Dr.
Volume:
Language:	English
Subject:	Health., Public health, Wellness programs
Collections:	Medical Library Collection, World Health Collection
Historic Publication Date:
Publisher:	World Health Organization


Citation APA MLA Chicago Dr, D. K. (n.d.). World Health Organization Publication : Year 2006 ; Issue 9241594454 - in English. Retrieved from http://www.gutenberg.us/

Description
Medical Reference Publication

Excerpt
This document is the revised version of the draft handbook Quality standards in basic biomedical research (TDR/PRD/QSBR/01.1), published in 2001. The draft handbook was based on the deliberations of a specialized scientific working group (SWG) convened by the UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases (TDR).1 The SWG, composed of independent scientific experts, met in Geneva 4-6 September 2000 to discuss various aspects related to Good Laboratory Practice (GLP) and sound scientific working practices. They concluded there was a pressing global need for dissemination of information and guidance to cover basic biomedical research.

Table of Contents
TABLE OF CONTENTS FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 SCOPE AND PRINCIPLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 1. INTRODUCTION TO QUALITY PRACTICES IN BIOMEDICAL RESEARCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 2. WHAT IS BASIC BIOMEDICAL RESEARCH? . . . . . . . . . . . . . . . . . . . . . . . 17 2.1 Basic biomedical research: drug development model . . . . . . . . . . . . . 17 2.1.1 Stage 1a: discovery per se . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 2.1.2 Stage 1b: transitional research . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 2.1.3 Stage 1c: non-regulated, non-clinical research . . . . . . . . . . . . . . . 18 2.2 Basic biomedical research other than drug development . . . . . . . . . . 18 2.2.1 Stage 1a: discovery stage per se . . . . . . . . . . . . . . . . . . . . . . . . . . 19 2.2.2 Stage 1b: transitional research . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 2.2.3 Stage 1c: practical proof of principle (POP) stage . . . . . . . . . . . . 19 3. WHAT IS QUALITY IN RESEARCH? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 3.1 Relationship between study and data . . . . . . . . . . . . . . . . . . . . . . . . . 27 3.2 Data, records and report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 3.3 Reproducibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 3.4 The purpose of quality practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 4. THE QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH . . . . . . 31 4.1 Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 4.1.1 Quality policy and staff responsibility . . . . . . . . . . . . . . . . . . . . . 31 4.1.2 Personnel and training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 4.2 Physical resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 4.3 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 4.3.1 Prescriptive documents: research proposals and study plans . . . . . 37 4.3.2 Standard operating procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 4.3.3 Descriptive documents: good record keeping . . . . . . . . . . . . . . . . . 43 4.3.4 Use of notebooks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 4.3.5 Reporting results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 4.3.6 Storage and archiving of records . . . . . . . . . . . . . . . . . . . . . . . . . . 49 4.4 Supervision /quality assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 4.4.1 Reviewing staff qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 4.4.2 Verification of results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 4.4.3 Evaluation and review of final report . . . . . . . . . . . . . . . . . . . . . . 52 4.5 Publishing practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 4.5.1 Reporting the results in smaller, separate publications . . . . . . . . . 54 4.5.2 Publishing negative results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 4.5.3 Assigning credit to contributors . . . . . . . . . . . . . . . . . . . . . . . . . . 55 4.5.4 List of authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 4.5.5 Choice of publishing forum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 4.5.6 Patents and scientific publishing . . . . . . . . . . . . . . . . . . . . . . .