Ethical challenges in study design and informed consent for health research in resource-poor settings / Patricia A. Marshall.

Format:

Book

Government document

Author/Creator:

Marshall, Patricia Loomis.

Contributor:

World Health Organization.

Series:

Special topics (Special Programme for Research and Training in Tropical Diseases. Social, Economic, and Behavioural Research) ; no. 5.

Special topics, 1683-5409 ; no. 5

Language:

English

Subjects (All):

Medicine--Research--Moral and ethical aspects.

Medicine.

Medicine--Research--Moral and ethical aspects--Case studies.

Medicine--Research--Moral and ethical aspects--Cross-cultural studies.

Human experimentation in medicine--Moral and ethical aspects.

Human experimentation in medicine.

Human experimentation in medicine--Moral and ethical aspects--Case studies.

Human experimentation in medicine--Moral and ethical aspects--Cross-cultural studies.

Physical Description:

1 online resource (88 p.)

Edition:

1st ed.

Place of Publication:

Geneva, Switzerland : World Health Organization, c2007.

Language Note:

English

Summary:

This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.

Contents:

Intro

CONTENTS

EXECUTIVE SUMMARY

1. INTRODUCTION

1.1 Ethical principles in scientific research

1.2 Historical background: declarations, guidelines and policies

1.3 Recent developments

2. ETHICAL CHALLENGES IN RESEARCH DESIGN

2.1 Cultural context

2.2 Health disparities

2.3 Strengthening the commitment to ethical conduct in research design

2.4 Standard of care and access to fair benefits

3. ETHICAL CONSIDERATIONS FOR INFORMED CONSENT

3.1 The process of informed consent: cultural and social context

3.2 Preparation and documentation of the consent form

4. CASE ANALYSIS: ETHICAL DILEMMAS IN HEALTH RESEARCH IN RESOURCE-POOR SETTINGS

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)

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)

Case 3: Clinical trial of antimalarial drugs in Kenya (Duncan Ngare)

Case 4: The impact of community dynamics on conducting scientific research in sub-Saharan Africa (Clement A. Adebamowo)

Case 5: Protecting confidentiality of participants in studies of behaviours that transmit HIV-1 in Russia (Robert Heimer and Olga Borodkina)

Case 6: A study of low birth weight in Madhya Pradesh, India (Ayesha De Costa)

Case 7: Evaluating the natural history of Plasmodium vivax infection in children in Papua New Guinea (Peter Zimmerman and John Taime)

Case 8: Phase III trial of antibiotics to reduce chorioamnionitis-related perinatal HIV transmission in Malawi (Irving Hoffman and Charles Mwansambo).

Case 9: Ethical review of epidemiological health studies in Pakistan: responsibilities of researchers for medical care of participants (Asad J. Raja)

Case 10: Research and employment opportunities in resource-poor settings (Jeannine Coreil and Gladys Mayard)

5. RECOMMENDATIONS

5.1 Recommendations for good practice

5.2 Recommendations for research on research ethics

REFERENCES.

Notes:

"Social, Economic and Behavioural (SEB) Research"--Cover.

"Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by UNICEF/UNDP/World Bank/WHO"--Cover.

"TDR/SDR/SEB/ST/07.1"--Cover.

Includes bibliographical references (p. 69-79).

ISBN:

1-281-30744-0

9786611307448

92-4-068244-9

OCLC:

476127746