World Health Organization Publication : Year 2007 ; Issue 9789241563383 - in English: Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-Poor Settings

By Patricia A. Marshall, Dr.

Book Id: WPLBN0000207599
Format Type: PDF eBook
File Size: 1.1 MB
Reproduction Date: 2005

Title:	World Health Organization Publication : Year 2007 ; Issue 9789241563383 - in English: Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-Poor Settings
Author:	Patricia A. Marshall, 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 Marshall, Dr, P. A. (n.d.). World Health Organization Publication : Year 2007 ; Issue 9789241563383 - in English. Retrieved from http://gutenberg.cc/

Description
Medical Reference Publication

Excerpt
Professional and public debates concerning the application of guidelines for ethical conduct in studies carried out in developing countries are likely to continue as new information becomes available. Researchers in biomedicine, public health, and the social and behavioural sciences confront the challenging task of adhering to national and international regulations in social and cultural environments in which ethical guidelines may not be easily translated or applied. Increased awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings is needed. But strengthening professional knowledge about international research ethics is not enough. Investigators also require practical advice on the best methods or models for articulating ethical guidelines in the field. Empirical research on a wide range of issues relevant to the application of ethical guidelines is needed, including studies of macro social and economic developments that drive the globalization of the biomedical research enterprise. Technological and financial resources are also necessary to build capacity for local collaborators and communities to ensure that results of research are integrated into existing health systems. This requires collaborative efforts and engaged commitment on the part of investigators, funding agencies, policy-makers, governmental institutions, and industry

Table of Contents
TABLE OF CONTENTS EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 1.1 Ethical principals in scientific reseach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1.2 Historical background: declarations, guidelines and policies . . . . . . . . . . . . . . . . . . 8 1.3 Recent developments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 2. ETHICAL CHALLENGES IN RESEARCH DESIGN . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 2.1 Cultural context . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 2.2 Health disparities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 2.3 Strengthening the commitment to ethical conduct in research design . . . . . . . . . . 13 2.3.1 Collaborative partnership in research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 2.3.2 Capacity building . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 2.3.3 Independent ethical review of protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 2.4 Standard of care and access to fair benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 2.4.1 Access to fair benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 3. ETHICAL CONSIDERATIONS FOR INFORMED CONSENT . . . . . . . . . . . . . . . . . . . . . 23 3.1 The process of informed consent: cultural and social context . . . . . . . . . . . . . . . . 23 3.1.1 Comprehension of information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 3.1.2 Communication of risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 3.1.3 Decisional authority for consent to research . . . . . . . . . . . . . . . . . . . . . . . . 27 3.1.4 Communication, social position and power inequities . . . . . . . . . . . . . . . . . . 30 3.2 Preparation and documentation of the consent form . . . . . . . . . . . . . . . . . . . . . . 31 3.2.1 Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 3.2.2 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 4. CASE ANALYSIS: ETHICAL DILEMNAS IN HEALTH RESEARCH IN RESOURCE-POOR SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35 Case 1: Old problems but new challenges: ethics review and informed consent in a clinical trial for HIV/AIDS in China (Gail Henderson and Dongbao Yu) . . . . . . . . .35 Case 2: Designing a group-based intervention to promote condom use in HIV serodiscordant couples in three countries: India, Thailand and Uganda (Janet W. McGrath, Moses Kamya, David D. Celentano, and Andrew Fullem) . . . . .38 Case 3: Clinical trial of antimalarial drugs in Kenya (Duncan Ngare) . . . . . . . . . . . . . . . .41 Case 4: The impact of community dynamics on conducting scientific research in sub-Saharan Africa (Clement A. Adebamowo) . . . . . . . . . . . . . . . . . . . . . . . .44 Case 5: Protecting confidentiality of participants in studies of behaviours that transmit HIV-1 in Russia (Robert Heimer and Olga Borodkina) . . . . . . . . . . . . . .46 Case 6: A study of low birth weight in Madhya Pradesh, India (Ayesha De Costa) . . . . . . .49 Case 7: Evaluating the natural history of Plasmodium vivax infection in children in Papua New Guinea (Peter Zimmerman and John Taime) . . . . . . . . . . . . . . . . .52 Case 8: Phase III trial of antibiotics to reduce chorioamnionitis-related perinatal HIV transmission in Malawi (Irving Hoffman and Charles Mwansambo) . . . .