Global Campaign for Microbicides

Home

Home » Trial Ethics » Research Ethics

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 sought 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.

Publications:
 

Standards of Prevention in HIV Prevention Trials

A consultation report and recommendations by the Global Campaign for Microbicides, the US Centers for Disease Control and Prevetion, and the Joint United Nations Programme on HIV/AIDS. Support for this project was made possible by USAID.


 

 

Mapping the Standards of Care at Microbicide Clinical Trial Sites

In mid - 2006 the Global Campaign for Microbicides embarked on a project to map the care and prevention services provided to women enrolled in large-scale (Phase IIb and III) microbicide effectiveness trials.

The goal was four-fold:

  1. To conduct an independent assessment of the health care and prevention services provided to women in the trials --and to some extent, their partners, family, and surrounding community
  2. To better understand the factors that inform care-related decisions at trial sites
  3. To explore the microbicide field's progress toward achieving the ethical aspirations laid out in key ethics guidance documents
  4. To make recommendations to strengthen the fields ability to respond to care-related challenges in the future

We encourage you to read the:

Full Report (77 pages)

Executive Summary (22 pages)

Consultation on Operationalizing Access to HIV Treatment and Care

Meeting Report, June 19th and 20th, 2008

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.