Ethical Challenges in HIV Prevention Research

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Ethical Challenges in HIV Prevention Research

• David Borasky, MPH, CIP
• Office of International Research Ethics
• Regulatory Affairs and Quality Assurance
• Family Health International
• 9 December 2008

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Todays presentation

• Introduction to FHI
• Ethical challenges in HIV Prevention Research
• Working to overcome the challenges

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FHI Global Presence
Programs Programs w/ Country Office
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FHI Research Portfolio

• HIV prevention
• Pre-Exposure Prophylaxis (e.g. Tenofovir
  Truvada)
• microbicides (e.g. SAVVY, Cellulose Sulphate)
• behavioral interventions
• Contraceptive development / use
• Public health
• surveillance
• monitoring and evaluation
• Behavioral and Social Science research
• Health Services Research

David Borasky, March 21, 2006
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Office of International Research Ethics (OIRE)

• Training in basic research ethics
• Research Ethics Training Curriculum
• Consultation and Technical Assistance
• Management of the FHI Protection of Human
  Subjects Committee (Ethics Committee)

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The Protection of Human Subjects Committee (PHSC)

• Members carefully selected based on experience
• Vulnerable populations
• Bioethics
• International research
• Public health research
• Independent committee
• All members receive training

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Standards as per Federalwide Assurance

• Ethical standards
• Respect for Persons
• Beneficence
• Justice
• Procedural standards
• United States regulations

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Ethical Challenges in HIV Prevention Research
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Challenge HIV Disproportionately Affects
Vulnerable Populations

• Contributing factors to vulnerability
• Poverty
• Low education
• High risk activities (injecting drug use)
• Stigmatized activities (sex work, MSM)
• Poor access to health care

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Challenge HIV Disproportionately Affects
Vulnerable Populations

• Possible Solutions in prevention research
• Clear application of ethical principle of Justice
• Develop additional protections and safeguards
• Engage community stakeholders
• Sensitive dissemination of study results

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Challenge Local Standard of Care

• Why an issue?
• Some diseases must be done in resource
  constrained settings
• Contributing Factors
• Social injustice / global health inequalities

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Issue Local Standard of Care

• Possible Solutions
• Application of Beneficence maximize benefits
• Enhance local capacity through research
• Link participants and healthcare
• Seek buy-in from donors

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Challenge Providing Ancillary Care

• Why an issue?
• Populations at risk for HIV often have additional
  unmet health care needs, and may turn to the
  researchers to meet these needs.
• Contributing Factors
• Social injustice / global health inequalities

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Issue Ancillary Care

• Possible Solutions
• Know the population and what health issues they
  will bring to the study with them
• Be prepared to either meet these needs or to make
  appropriate referrals to care

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Issue Care and Treatment of Seroconverters

• Why an issue?
• HIV prevention research will lead to people
  becoming infected with HIV during the research.
• HIV infected study participants may not develop
  AIDS and require care for many years after the
  research has ended.

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Issue Care and Treatment of Seroconverters

• Possible Solutions
• Before starting the research, there should be a
  clear plan for those who become HIV infected
• What are the local treatment options?
• Help get infected participants into the HIV care
  system
• When necessary, set aside funds to pay for future
  treatment.
• Develop a system for monitoring infected
  individuals after the study is complete

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Issue Post-trial Access

• Why an issue?
• Research ethics principle of distributive justice
• Concern that new effective therapies may be
  expensive and out of reach for study population
• This leads to concern about exploitation.

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Issue Post-trial Access

• Possible Solutions
• Develop pre-trial agreements with key
  stakeholders
• Drug manufacturers
• Ministry of Health / Public Health system
• International donors

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Issue Informed Consent

• Why an issue?
• Universal research requirement
• Contributing Factors
• Western focus on legal aspects
• Compliance concerns / GCP
• Low literacy
• Language

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Issue Informed Consent

• Possible Solutions
• Application of Respect for Persons
• Think beyond the form and traditional
  expectations
• How can we do it better?
• Evaluate the process
• Is it conducive to true informed consent

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Cross-cutting solutions

• Complement clinical trials with formative
  research
• Complete the research picture
• Acknowledge role of other stakeholders e.g.
  activists, media, faith-based organizations
• Proper investment in research site capabilities
• Create an effective informed consent process

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Cross-cutting solutions

• Truly collaborate on all levels
• Scientific
• Research ethics
• Community engagement
• Government / policy

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Questions Comments
Thank you