Global Campaign for Microbicides

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Research Ethics

International principles of ethics in biomedical research provide a starting place for designing and implementing clinical trials that ensure autonomy, beneficence and justice to trial participants and communities where research takes place. However, declarations and documents cannot by themselves resolve the more complex issues that arise in the implementation of HIV prevention research. Through the Research Ethics Initiative, the Global Campaign for Microbicides seeks to:

  1. Build consensus among investigators, advocates, ethicists and others in the microbicide community around ethical issues in the conduct of microbicide trials;
  2. Build capacity among NGOs and other civil society representatives regarding ethical reasoning and the conduct of trials;
  3. Help strike an appropriate balance between the need to protect the rights and interests of trial participants and host communities, and the urgency of developing a safe and effective microbicide.

Publication:

Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International Consultation

To download the full report, please click here - 3.4MB

Ethics Report Cover 282KB
Chapter 1: Introduction: Rethinking the Ethical Roadmap - 516kb
Chapter 2: Background: How Microbicides Are Developed and Tested - 238kb
Chapter 3: The Shifting Focus of Ethical Concern: From Thinking About Risks to Thinking About Benefits - 172kb
Chapter 4: How Informed is Informed Consent? - 221kb
Chapter 5: What to Do About Male Partners? - 276kb
Chapter 6: The Question of Enrolling Adolescents - 376kb
Chapter 7: Defining Benefits and the Standard of Care - 321kb
Chapter 8: Antiretroviral Treatment in Clinical Trials - 219kb
Chapter 9: Testing Second-Generation Microbicides - 173kb
Chapter 10: After the Trial: Continued Access and Post-Approval Status - 131 kb
Chapter 11: Conclusions and New Questions - 432kb
Appendices

Other Publications

International AIDS Society Rapid Report:
Stakeholder Consultation to Address Issues Related to Tenofovir Prophylactic Research
19-20 May 2005, Seattle, Washington, USA
Referenced in GC News #55.