Good Participatory Practice (GPP) Guidelines for Biomedical HIV Prevention Trials 2011, Second Edition
Mar 15, 2016
Good Participatory Practice (GPP)Guidelines for Biomedical
HIV Prevention Trials 2011, Second Edition
Why were the GPP guidelines created?
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?
Research Investigator
Trial participants
GCP
Research teams
(and trial sponsors and
funders)
StakeholdersStakeholder
s Stakeholders
Stakeholders Stakeholder
sStakeholders
GPP
GPP is about working with 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.DefinitionB.Relevance to good participatory practiceC.Special considerationsD.Good participatory practicesE.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 all-encompassing 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
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: 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:
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?
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