Transcript Slide 1

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Good Participatory Practice (GPP)
Guidelines for Biomedical
HIV Prevention Trials 2011,
Second Edition
Why were the GPP guidelines created?
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In response to the pre-exposure prophylaxis (PrEP) trial
controversies in Cambodia and Cameroon in 2004 and 2005
To help prevent misunderstanding and miscommunication
among research stakeholders
Based on the idea that what happens with one product, in one
trial, in one region affects all biomedical HIV prevention
stakeholders: trial participants, research teams, funders,
sponsors, community stakeholders, and product developers
GPP guidelines development
 Just as other aspects of clinical trial conduct are
informed by guidelines, the relationship between
research entities and stakeholders should be informed
by a set of guidelines.
 The GPP guidelines were developed to facilitate the
building of effective partnerships among all research
stakeholders.
GPP guidelines development
 The first edition of the guidelines was developed by an
international, multidisciplinary working group, with input
from stakeholders around the globe.
 The second edition incorporates feedback gathered
through global consultations and piloting.
GPP guidelines development
 The guidelines are meant to serve as a
companion to the UNAIDS/WHO
publication Ethical Considerations in
Biomedical HIV Prevention Trials.
 More specifically, they are intended to
explain how “Guidance Point 2:
Community Participation” can be applied.
GPP guidelines, second edition
What is the objective of the 2011 GPP guidelines?
Objective of the GPP guidelines
 To set global standard practices for stakeholder
engagement.
 To provide trial funders, sponsors, and implementers
with systematic guidance on how to effectively engage
with stakeholders in the design, conduct, and outcome of
biomedical HIV prevention trials.
Who should use the GPP guidelines?
Intended audience of the GPP guidelines
 The GPP guidelines are primarily written for trial funders,
sponsors, and implementers.
 Stakeholders, such as NGOs, policymakers, and CABs, can
use the GPP guidelines to understand the methods of
stakeholder engagement and to evaluate the engagement
efforts of research teams.
How is GPP different from
Good Clinical Practice (GCP)?
How is GPP different from GCP?
GPP is about working with stakeholders.
Research
Investigator
GCP
Trial
participants
Stakeholders
Research
teams
(and trial
sponsors and
funders)
GPP
Stakeholders
Stakeholders
Stakeholders
Stakeholders
Stakeholders
What is in the second edition of the
GPP guidelines?
Contents of the GPP guidelines, second edition
The Topic Areas are divided into
subsections:
A. Definition
B. Relevance to good
participatory practice
C. Special considerations
D. Good participatory practices
E. Additional guidance
How does GPP define stakeholders?
Definition of stakeholders
The GPP guidelines define stakeholders as individuals,
groups, organizations, government bodies, or any other
individuals or collections of individuals who can influence
or are affected by the conduct or outcome of a biomedical
HIV prevention trial.
In the guidelines, the term “stakeholders” is allencompassing and includes any individual or collection of
individuals who have a stake in a biomedical HIV
prevention trial.
Examples of stakeholders
How do the GPP guidelines
define stakeholder engagement?
Definition of stakeholder engagement
 It is a process through which trial funders,
sponsors, and implementers build meaning
relationships with stakeholders.
 Its goal is to shape the research process by
using the expertise of stakeholders.
 It is not recruitment!
Why is stakeholder engagement
necessary in the research process?
Why stakeholder engagement?
Stakeholder engagement improves research quality:
 Stakeholders, especially community stakeholders, have
critical knowledge about local cultures and dynamics of the
HIV epidemic that trial entities may lack. Their feedback can
help ensure that the research and procedures are culturally
sensitive and appropriate.
 A wide range of stakeholders can give research teams
advice about research questions, procedures, and conduct.
 Stakeholders’ advice can lead to better recruitment, better
retention, better adherence, better data, and greater
likelihood of uptake, should HIV prevention interventions
prove safe and effective.
Why stakeholder engagement?
Stakeholder engagement not only makes the
research better; it is also ethical.
If stakeholders will be affected by the research,
even if only in an indirect or a minor way, they have
the right to be meaningfully engaged and to help
shape the process.
How can research teams engage
with external stakeholders?
Stakeholder advisory mechanisms
Engaging with CABs is only one of many, many ways in
which research teams can engage with stakeholders.
Stakeholder advisory mechanisms
Engaging with CABs is often necessary but is seldom sufficient
for adequate stakeholder engagement.
Many mechanisms exist for effective engagement between
researchers and the wide array of research stakeholders.
How can the GPP guidelines
be used most effectively?
They must be adopted and implemented
Adoption of
guidelines
Ethics,
principles,
expectations
Development
of guidelines
and
Establishment
of resources
and support for
participatory
practices
Implementation
of participatory
practices
Monitoring
Evaluation
Ensuring GPP uptake
Implement:
 Trial sponsors and research teams should follow the
practices outlined in subsection D for each GPP topic
area.
 Implementation should be tailored to individual site and
research environment.
Monitor:
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Stakeholders can assess.
Research teams can assess themselves.
Community stakeholders, such as community groups or
CABs, can assess research teams.
Trial monitors can conduct assessments.
Ensuring GPP uptake
Evaluate:
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How did the engagement improve the research?
Did stakeholders provide useful feedback during the
research lifecycle?
How do various stakeholders feel about the quality of the
engagement process and their relationships with the
research team?
Can an association be made between engagement and trial
outcomes?
Note: As with monitoring, all stakeholders can be involved in the
evaluation process and share their perspectives.
How will the GPP guidelines be adopted?
How will GPP be adopted?
 Investment in building relationships is a long-term
process!
 Adoption of the guidelines will be different in every
setting. There isn’t one answer or formula. It will depend
on the country, institution, sponsor, and trial site.
Who can require adherence to GPP guidelines?
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Funders and sponsors
National governments
Ethics Committees or IRBs
NGOs/civil society
Research teams
Community stakeholders
Or ... increased awareness may cause GPP to
become standard practice for conducting research.
Thank you!
www.avac.org/gpp