Ethical Guidelines for Research

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					HPTN Ethics Guidance for
       Research
  Kathleen M. MacQueen, PhD, MPH
   Jeremy Sugarman, MD, MPH, MA
          27 February 2003
               December 2002
Number of people living with HIV/AIDS
                         Total                   42 million
                         Adults                38.6 million
                           Women               19.2 million
                         Children under 15 years 3.2 million

People newly infected with HIV in 2002
                         Total                    5 million
                         Adults                 4.2 million
                           Women                  2 million
                         Children under 15 years 800 000

AIDS deaths in 2002
                                       Total                 3.1 million
                                       Adults                 2.5 million
 UNAIDS/WHO
                                        Women                 1.2 million
 AIDS epidemic update: December 2002
                                       Children under 15 years 610 000
    Why guidance? Why now?

   Lack of uniform guidance in national and
    international ethics documents
   Global health inequities
   HPTN should be proactive, not reactive



                 “Ratchet it up”
        HPTN Ethical Challenges

   What are acceptable standards of care?
   How should host countries be selected?
   How should stigma be dealt with?
   Who has ethical authority? Who is
    accountable?
   Are all research designs ethically equal?
   Can informed consent be assured?
   Is there meaningful community involvement?
     HPTN Structural Challenges

   Wide range of research > Flexibility
   Diverse local contexts > Responsive
   Collaboration > Procedural, not
    prescriptive
   Compatibility with existing HPTN &
    DAIDS procedures
   Prevention & public health perspective
       Research Continuum


Concept Development

   Protocol Development

       Site Preparation

           Research Implementation

               Knowledge Dissemination

                Translation & Sustainability of Benefits
                  Assumptions

   Participants and communities

   Obligations
    • Process not
    prescription
    • Do what is doable,
    achieve the achievable
    • Creativity,




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    persistence,
    partnership
                             Ketan Joshi, South Africa 2000
                                   Framework
                  Mapping the Research Continuum


                 General considerations
                 Meeting local needs and priorities
                 Care and prevention
                 Informed consent
Concept Development

  Protocol Development
     Site Preparation

        Research Implementation

           Knowledge Dissemination
            Translation & Sustainability of Benefits
HPTN Ethics Guidance for Research
                General Considerations
                                  Conduct scientifically and ethically
                                sound research that is grounded in a
                                               participatory process




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Gary Lewis, JHU/CCP, South Africa, 1999
HPTN Ethics Guidance for Research
        General Considerations

 Respect the
 integrity of
 the local
 community, the
 indigenous




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 culture, and
 host country
 laws and norms                     Elizabeth Serlemitsos, JHU/CCP, Zambia 2002
HPTN Ethics Guidance for Research
                             General Considerations

                                                     Protect the
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                                                     vulnerable,
                                                     promote
                                                     equality, and
                                                     minimize
                                                     research-
                    Ketan Joshi, South Africa 2000
                                                     related harms
HPTN Ethics Guidance for Research
          Local Needs & Priorities

   Research to address local needs
   Seek ways to make benefits accrue broadly




    Nrityanjali Academy, India 2001   JHCCP Photoshare
                   HPTN Ethics Guidance for Research
                          Local Needs & Priorities

                       Assure implementation of effective
                        interventions
                                                 Seek to
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                                                  transfer
                                                  infrastructure
                                                  and
                                                  technology to
                   Mike Bailey, JHU/CCP, Zambia
                                                  local providers
HPTN Ethics Guidance for Research
                                 Care and Prevention

                                   Choose designs that      reflect best practices
                                                             in HIV prevention
                                                            lead to scientifically
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                                                             valid results
                                                            can be used to
                                                             develop locally
                                                             responsive
                                                             prevention programs




                    JHU/CCP, Peru 1996
HPTN Ethics Guidance for Research
         Care and Prevention

  Ensure all people screened or enrolled have
  reasonable access to practically achievable,
  effective means of prevention for HIV and STI
  transmission




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                   Nrityanjali Academy, India 2001
HPTN Ethics Guidance for Research
           Care and Prevention
   Seek ways to




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    improve local
    access to care

   Avoid creating
    dual standards
    wherever
    possible
                                    Harvey Nelson, Zambia 2001
HPTN Ethics Guidance for Research
             Informed Consent




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                                    JHU/CCP, Peru 1996

   Plan for needs during pre-enrollment, enrollment, and
    continuation stages
   Consider community and individual level obligations
HPTN Ethics Guidance for Research
            Informed Consent




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                                              JHU/CCP, Zambia 1993
   Provide clear
   explanations of
  • experimental procedures
  • non-experimental procedures that are a
    necessary part of the research design
  • procedures provided solely as a benefit
              Implementation

   Guidance is based on procedures and
    strategies already used by at least some
    HPTN researchers
   Broad, consistent implementation will
    require additional effort
                            Concept Development

                              Protocol Development
                                 Site Preparation

                                    Research Implementation

                                       Knowledge Dissemination
                                        Translation & Sustainability of Benefits
       From Principles to Practice


Concept Development
        • Partnerships
        • Research to address local needs
        • Best practices in HIV prevention
       From Principles to Practice


Concept Development

   Protocol Development

            • Partnerships
            • Scientifically valid results likely
            • Identify experimental, non-experimental,
              and beneficial procedures
       From Principles to Practice


Concept Development

   Protocol Development

       Site Preparation
                • Partnerships
                • Respect for communities, participants
                • Research to address local needs
                • Broad local benefits
                • Improve local access to care
                • Plan for informed consent
       From Principles to Practice


Concept Development

   Protocol Development

       Site Preparation

           Research Implementation
                  • Partnerships
                  • Respect for communities, participants
                  • Assure access to HIV/STI prevention
                  • Assure fully informed consent
       From Principles to Practice


Concept Development

   Protocol Development

       Site Preparation

           Research Implementation

               Knowledge Dissemination
                   • Partnerships
                   • Respect for communities, participants
       From Principles to Practice


Concept Development               • Partnerships
                                  • Implement effective
   Protocol Development           interventions
       Site Preparation

           Research Implementation

               Knowledge Dissemination

                Translation & Sustainability of Benefits
          A Living Document


   Barriers & facilitators to implementation
    need to be identified
    • Working groups, protocol teams, sites
   Guidance should be refined as
    • experience is garnered
    • new research is designed
    • significant events occur
        Tell us what you think!




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   Comment box
   HPTNethics@fhi.org




                         Gary Lewis, JHU/CCP, South Africa 1999

				
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