Double Standards in Medical Research in Developing Countries

• Main Author: Macklin, Ruth
• Format: eBook Book
• Language: English
• Published: Cambridge, UK ; New York, NY Cambridge University Press 27.05.2004
• Edition: 1
• Series: Cambridge Law, Medicine and Ethics
• Subjects: Developing countries; Medical care; Medical care > Research > Developing countries; Medical ethics; Medical ethics > Developing countries; Medical research; Public health; Public health > Research > Developing countries; Social conditions
• ISBN: 9780521833882; 0521541700; 0521833884; 9780521541701
• DOI: 10.1017/CBO9780511495359

This book examines the ethical controversies that have surrounded the design and conduct of international medical research sponsored by industrialized countries or industry, and carried out in developing countries. The chief concern is that research subjects in developing countries may be exploited...

Table of Contents:

• What the guidelines say -- Harmonizing international guidelines -- The future -- NOTES -- Index
• Cover -- Half-title -- Series-title -- Title -- Copyright -- Contents -- Acknowledgments -- 1 International research contested: controversies and debates -- Why do clinical research in developing countries? -- Which countries are "developing"? -- Health needs in developing countries -- The controversy that launched debates -- The proposed Surfaxin study -- Revision of the Declaration of Helsinki -- Procedural solutions -- Agreement on underlying propositions -- Responsiveness to the health needs of the population -- Needed research in developing countries -- Ethical guidelines: pragmatic or aspirational? -- NOTES -- 2 Maintaining ethical standards in research -- Ethical standards and "standard of care" -- Treat like cases alike -- What do the guidelines say? -- Declaration of Helsinki -- The CIOMS International Guidelines -- The UNAIDS Guidance Document -- The NBAC Report -- The Nuffield Council Report -- US Regulations and the FDA -- ICH Guidelines for Good Clinical Practice -- Conclusions -- NOTES -- 3 Striving for justice in research -- Distributive justice in global research -- Global disparities and health equity -- Justice, health care, and research -- Post-trial benefits of research: obligation or charity? -- What the guidelines say -- Responses to the CIOMS guideline -- The FDA and PhRMA -- National regulations and guidelines -- Conclusions -- NOTES -- 4 Avoiding exploitation -- Definitional debates -- What is exploitation in multinational research? -- What guidelines and commentators say -- CIOMS Guideline 10 -- UNAIDS Guidance Document -- NBAC report -- Nuffield report -- Candidates for circumstances of exploitation in international research -- Inducing vulnerable subjects as exploitation -- Best current treatment and post-trial benefits as undue inducements -- Conclusion -- NOTES
• 5 Providing safeguards: informed consent and review of research -- Allegations of violations -- Inadequacies of safeguards -- Fraud and corruption -- Informed consent: standards and practices -- The challenge of cultural differences -- Spousal authorization for research -- Adherence to US rules: universal standards or ethical imperialism? -- Signing consent forms -- Oral versus written consent documents -- Unfamiliarity with modern science -- Research ethics committees: do they provide adequate protection? -- What the guidelines say -- The CIOMS debates -- More disagreements: the NBAC survey -- Conclusions -- NOTES -- 6 Making drugs affordable -- Differential pricing -- Prior agreements -- International collaborative efforts and public-private partnerships -- The Concept Foundation -- The vaccine gap -- Combating malaria -- The Global Fund -- Manufacture of generic copies of patented drugs and compulsory licensing -- NOTES -- 7 Respecting, protecting, and fulfilling human rights -- Human rights and the concept of dignity -- The United States and human rights -- Human rights in the conduct of research -- Right to health care, right to health -- The role of WHO -- HIV/AIDS and the right to health -- Human rights, access, and affordability of drugs -- Human rights, international guidelines, and ethical principles -- Respect for autonomy -- Protection of vulnerable persons -- Beneficence -- Justice -- NOTES -- 8 Striving for a single standard -- A single standard for control groups -- "Early Versus Delayed Initiation of Antiretroviral Therapy" -- Providing successful products after a trial is concluded -- Irreconcilable differences -- Building capacity and assessing ethics in ongoing research -- Dilemmas in future HIV/AIDS preventive vaccine trials -- The control group in vaccine trials -- Treatment for subjects who become infected