79C3C34C52B45572883A05D425EB0F82
Good Participitory Practice: Guidelines for Biomedical HIV Prevention Trials
https://www.unaids.org/sites/default/files/media_asset/JC1853_GPP_Guidelines_2011_en_0.pdf
http://leaux.net/URLS/ConvertAPI Text Files/0FDA871A1131633BD426324D1B704FBE.en.txt
Examining the file media/Synopses/0FDA871A1131633BD426324D1B704FBE.html:
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator crime:
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p.000083: 36 Philpott S et al. The Challenge of Defining Standards of Prevention in HIV Prevention Trials. Journal of Medical
p.000083: Ethics, 2011, 37:244–248.
p.000083: 37 Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International
p.000083: Consultation. Washington, DC, Global Campaign for Microbicides, 2005.
p.000083: 38 Ethical and Policy Issues in International Research:ClinicalTrials in Developing Countries. Vol. I. Report and
p.000083: Recommendations of the National Bioethics Advisory Commission. Washington, DC, United States National Bioethics
p.000083: Advisory Commission, 2001.
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p.000084: The Joint United Nations Programme on HIV/AIDS (UNAIDS) brings together ten UN agencies in a common
p.000084: effort to fight the epidemic: the Office of the United Nations High Commissioner for Refugees (UNHCR), the United
p.000084: Nations Children’s Fund (UNICEF), the World Food Programme (WFP), the United Nations Development Programme (UNDP),
p.000084: the United Nations Population Fund (UNFPA), the United Nations Office on Drugs and Crime (UNODC), the
p.000084: International Labour Organization (ILO), the United Nations Educational, Scientific and Cultural Organization
p.000084: (UNESCO), the World Health Organization (WHO), and the World Bank.
p.000084:
p.000084: Leveraging the AIDS response, UNAIDS works to build political action and to promote the rights of all people for better
p.000084: results for global health and development. Globally, it sets policy and is the source of HIV-related data. In
p.000084: countries, UNAIDS brings together the resources of the UNAIDS Secretariat and 10 UN system organizations for
p.000084: coordinated and accountable efforts to unite the world against AIDS.
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p.000084: UNAIDS
p.000084: 20 AVENUE APPIA
p.000084: CH-1211 GENEVA 27 SWITZERLAND
p.000084:
p.000084: Tel: (+41) 22 791 36 66
p.000084: Fax: (+41) 22 791 48 35
p.000084: e-mail: distribution@unaids.org www.unaids.org
p.000084:
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Political / Prosecuted
Searching for indicator prosecuted:
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p.000077: Council for International Organizations of Medical Sciences, 2002.
p.000077:
p.000077: Nuffield Council on Bioethics, 2002
p.000077: The 2002 Nuffield Council on Bioethics report on The Ethics of Research Related to Healthcare in
p.000077: Developing Countries provides an ethical framework for designing or conducting externally sponsored
p.000077: research in the developing world. The 2004 follow-up report, co-hosted with the Medical Research Council of
p.000077: South Africa, discusses how the guidelines could be applied in practice, particu- larly in light of conflicting ethical
p.000077: advice.
p.000077: Citation: The Ethics of Research Related to Healthcare in Developing Countries. London, Nuffield Council on
p.000077: Bioethics, 2002; and The Ethics of Healthcare Related Research in Developing Countries: A Follow-up
p.000077: Discussion Paper. London, Nuffield Council on Bioethics, 2005.
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p.000078: 78
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p.000078: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000078:
p.000078:
p.000078: Nuremberg Code, 1949
p.000078: This code of research ethics came out of the ruling of the International Military Tribunal that prosecuted Nazi war
p.000078: criminals at the end of the Second World War.
p.000078: Citation: Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10.
p.000078: Vol. 2. Washington, DC, United States Government Printing Office, 1949:181–182.
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p.000078: Other references
p.000078: Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage Controversy, Convey Your
p.000078: Message, and Disseminate Results, 2010
p.000078: The Communications Handbook for Clinical Trials is a practical guide developed for site-level research teams,
p.000078: communicators, advocates, and others working on HIV prevention trials. It provides guidance on how to anticipate and
p.000078: respond to the special communication chal- lenges posed by the conduct of clinical research.
p.000078: Citation: Robinson ET et al. Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage
p.000078: Controversy, Convey Your Message, and Disseminate Results. Washington, DC, Microbicides Media Communications
p.000078: Initiative and Research Triangle Park, NC, FHI, 2010.
p.000078:
p.000078: Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, 2001
p.000078: This is a report and set of recommendations published by the United States National Bioethics Advisory Commission
p.000078: for United States policy on conducting clinical trials in developing countries.
p.000078: Citation: Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Vol. I. Report
...
Political / political affiliation
Searching for indicator party:
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p.000056: trial- related harms will be addressed and mitigated can significantly influence community stakeholder perceptions of
p.000056: the trial and of how well community stakeholder concerns will be addressed.
p.000056:
p.000056: 3.13.C. Special considerations
p.000056: Sponsors typically give specific and binding guidance to research teams on how to determine and report physical harms
p.000056: as adverse events. It is good practice to define similarly stringent procedures for the determination, documentation,
p.000056: reporting, and manage- ment of social harms that trial participants may experience. Examples of social harms
p.000056: due to trial participation include stigma, discrimination, and verbal, emotional, physical, or sexual abuse.
p.000056:
p.000056: 3.13.D. Good participatory practices for policies on trial- related harms
p.000056: 1. Research teams and relevant stakeholders list anticipated physical and social harms that might occur due to
p.000056: trial partic- ipation.
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p.000057: 2. Research teams and relevant stakeholders discuss and develop policies on trial-related physical and social harms,
p.000057: considering the following issues:
p.000057: a. Strategies to prevent or reduce the risk of trial-related harms.
p.000057: b. Procedures to encourage and facilitate reporting of social harms.
p.000057: c. Procedures to investigate events that have been reported indirectly, such as through a third party, taking
p.000057: confiden- tiality issues into account.
p.000057: d. Procedures for reporting social harms and whether these are to be reported to sponsors, ethics committees,
p.000057: and regulatory bodies, even if not specifically required by them.
p.000057: e. Procedures for ensuring optimal referrals to appropriate services for trial-related harms.
p.000057: f. Strategies to inform trial participants of the potential risks of engaging with media.
p.000057: g. Compensation or insurance policies, when applicable, for specific trial-related harms, coverage provided by
p.000057: the policies, how claims are made, and how participants are informed of their rights in relation to the policies.
p.000057: 3. Research teams and relevant stakeholders review follow-up strategies to reduce trial-related physical and social
p.000057: harms over the course of the trial.
p.000057: 4. Research teams maintain clear written records of discussions and agreements. This includes recommendations,
p.000057: actions taken by the research team, and any unresolved issues that require follow-up.
p.000057: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000057: ensure the effective management of physical and social harms related to participation in a trial.
p.000057:
p.000057: 3.13.E. Additional guidance
p.000057: 1. Ethical considerations in biomedical HIV prevention trials
p.000057: (Guidance Point 11, page 40, Potential Harms).1
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p.000058:
p.000058: Good participatory practice guidelines for biomedical HIV prevention trials 2011
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Searching for indicator political:
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p.000027: conduct formative research activities.
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p.000028: 3.2 Stakeholder advisory mechanisms
p.000028: 3.2.A. Definition
p.000028: The term “stakeholder advisory mechanisms” refers to strategies or approaches that facilitate meaningful dialogue among
p.000028: research teams and relevant stakeholders about planned or ongoing clinical trials. Stakeholder advisory
p.000028: mechanisms provide research teams with information about relevant stakeholders’ perspectives on the design, planning,
p.000028: and implementation of a specific clinical trial and facilitate open communication about research goals,
p.000028: processes, and results. These mechanisms also provide relevant stakeholders with the opportunity to engage with
p.000028: research teams during the life-cycle of a trial.
p.000028: Stakeholder advisory mechanisms may be informal or formal. They can be built and sustained by the trial site or may
p.000028: already exist in the area.
p.000028: 1. Informal stakeholder advisory mechanisms may be events or less formal means by which research teams seek
p.000028: relevant stakeholders’ views on proposed or ongoing research. Examples include stakeholder meetings, local
p.000028: events, focus group discussions, interviews, consultations, and suggestion boxes. They may involve individuals,
p.000028: existing organisations, local employer associations, local government or traditional committees, or other advocacy,
p.000028: charitable, cultural, political, religious, or social groups.
p.000028: 2. Formal stakeholder advisory mechanisms typically involve established groups that develop an ongoing
p.000028: relationship with the research team at a particular trial site. Examples are trial participant groups (former or
p.000028: current participants),professional groups (local scientists, service providers, media, or experts on local
p.000028: socio-cultural issues), non-governmental organisation advisory groups (with representatives from different non-
p.000028: governmental organisations or community-based organisa- tions), and community advisory boards (see definition
p.000028: below).
p.000028: 3. Community advisory boards (CABs), also referred to as community advisory groups (CAGs), are a common
p.000028: example of a formal stakeholder advisory mechanism. They are composed of individuals or stakeholder representatives
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p.000029: and provide an independent advisory voice. They facili- tate community stakeholder participation and involvement
p.000029: in the research process. They meet regularly with research team representatives, inform community stakeholders about
p.000029: proposed and ongoing research, and provide feedback to research teams about local norms and beliefs, as well as
p.000029: local views and concerns that arise during specific trials.
p.000029: The composition of community advisory boards or groups varies from site to site but is intended to reflect the
p.000029: diversity of community stakeholder interests and needs. They may include members or representatives of the
p.000029: surrounding area, individuals in the population from which participants will be recruited, people living with or
...
p.000083: 38 Ethical and Policy Issues in International Research:ClinicalTrials in Developing Countries. Vol. I. Report and
p.000083: Recommendations of the National Bioethics Advisory Commission. Washington, DC, United States National Bioethics
p.000083: Advisory Commission, 2001.
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p.000084:
p.000084:
p.000084: The Joint United Nations Programme on HIV/AIDS (UNAIDS) brings together ten UN agencies in a common
p.000084: effort to fight the epidemic: the Office of the United Nations High Commissioner for Refugees (UNHCR), the United
p.000084: Nations Children’s Fund (UNICEF), the World Food Programme (WFP), the United Nations Development Programme (UNDP),
p.000084: the United Nations Population Fund (UNFPA), the United Nations Office on Drugs and Crime (UNODC), the
p.000084: International Labour Organization (ILO), the United Nations Educational, Scientific and Cultural Organization
p.000084: (UNESCO), the World Health Organization (WHO), and the World Bank.
p.000084:
p.000084: Leveraging the AIDS response, UNAIDS works to build political action and to promote the rights of all people for better
p.000084: results for global health and development. Globally, it sets policy and is the source of HIV-related data. In
p.000084: countries, UNAIDS brings together the resources of the UNAIDS Secretariat and 10 UN system organizations for
p.000084: coordinated and accountable efforts to unite the world against AIDS.
p.000084:
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p.000084: UNAIDS
p.000084: 20 AVENUE APPIA
p.000084: CH-1211 GENEVA 27 SWITZERLAND
p.000084:
p.000084: Tel: (+41) 22 791 36 66
p.000084: Fax: (+41) 22 791 48 35
p.000084: e-mail: distribution@unaids.org www.unaids.org
p.000084:
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Political / vulnerable
Searching for indicator vulnerable:
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p.000018:
p.000018: Funding From One or More Sources
p.000018:
p.000018:
p.000018: Sponsors
p.000018:
p.000018:
p.000018: Coordinating Centre
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p.000018: Data Laboratory
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p.000018: Clinical Safety
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p.000018: Pharmacy
p.000018: Social Science Stakeholder
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p.000018: Implementing Institution
p.000018:
p.000018: Trial Sites Trial Sites
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p.000018: Basic structure of a typical biomedical HIV prevention trial network. Funding from one or more sources is distributed
p.000018: through a network coordinating centre directly to trial sites or to implementing institutions such as universities that
p.000018: then send funds to trial sites. Trial networks may have several centres responsible for different aspects of trial
p.000018: conduct: data management, laboratory, pharmacy, clinical, safety, social science, and stakeholder engagement.
p.000018: Monitoring of trial conduct may be executed through the coordinating centre or outsourced to an independent
p.000018: monitoring organisation.
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p.000018: 1.5 Rationale for GPP guidelines
p.000018: Constructive long-term stakeholder engagement helps ensure the ethical and scientific quality of research as well
p.000018: as its relevance to community stakeholders.1,25 Stakeholders, in particular community stakeholders, have unique
p.000018: expertise to contribute to the research process. They possess critical knowledge and understandings of local
p.000018: cultures and perspectives, languages, dynamics of the local HIV epidemic, concerns of vulnerable or marginalised
p.000018: populations, and local priorities that trial funders, sponsors, and implementers may lack.
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p.000019: UNAIDS / AVAC
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p.000019: Stakeholder collaboration can help ensure that research questions and procedures are culturally sensitive and
p.000019: appropriate, thus improving recruitment, retention, adherence, and other trial outcomes. It can help avoid reinforcing
p.000019: existing inequalities and increase sensitivity to the needs of vulnerable populations. An essential component of
p.000019: stakeholder engagement is improving stakeholder knowledge and understanding of the research process, building
p.000019: research literacy and competencies. This, in turn, enables stakeholders to contribute more effectively to the process
p.000019: of guiding research and helps to address the power imbalance between research teams and community stake- holders.
p.000019:
p.000019: Strengthening meaningful collaboration among stakeholders fosters greater trust and respect between trial funders,
p.000019: sponsors, and imple- menters, and other stakeholders. Stakeholder engagement that is trans- parent and mutually
p.000019: respectful can minimise misunderstandings and reduce the chances of unnecessary conflict or controversy. Following good
p.000019: participatory practices through the entire research life-cycle helps facilitate local ownership of research, enables
p.000019: more equitable relationships, and increases the likelihood of successful research conduct, trial completion, and
p.000019: application of research results.
p.000019:
p.000019: 1.6 Applying GPP
p.000019: The GPP guidelines broadly describe systematic ways to establish and maintain effective stakeholder engagement that can
p.000019: be applied in diverse locations globally. The specificity of the content of the GPP guidelines enables monitoring of
p.000019: stakeholder engagement activities.
p.000019:
p.000019: The most effective way for the GPP guidelines to be implemented is for trial sponsors to adopt them as a requirement in
p.000019: trial conduct and to monitor their implementation and evaluate their effectiveness. As an essential element of
p.000019: successful trial implementation, effective
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p.000042: 3.7 Site selection
p.000042: 3.7.A. Definition
p.000042: Site selection is the process by which trial funders, sponsors, or networks evaluate sites for funding for a trial
p.000042: protocol, inclusion in a multisite trial, or inclusion in a trial network.
p.000042:
p.000042: 3.7.B. Relevance to good participatory practice
p.000042: Site assessment of stakeholder engagement programmes or plans for their development is critical to anticipating a
p.000042: site’s ability to conduct a trial according to good participatory practice.
p.000042:
p.000042: 3.7.C. Special considerations
p.000042: New sites may not have the full range of stakeholder engage- ment plans and advisory mechanisms in place. Optimal
p.000042: sites for selection already have established stakeholder engagement processes and programmes or, in the
p.000042: case of new sites, have demonstrated commitment to establishing such processes.
p.000042:
p.000042: 3.7.D. Good participatory practices for site selection
p.000042: 1. Trial funders, sponsors, or network representatives assess sites with respect to stakeholder engagement programmes,
p.000042: taking into account the following issues:
p.000042: a. Evidence of or plans for development and maintenance of meaningful relationships with relevant stakeholders.
p.000042: b. Evidence of previous stakeholder engagement activities for sites that have conducted research.
p.000042: c. Findings from formative research activities or a workplan for completing formative research activities.
p.000042: d. Previous development of multiple stakeholder advisory mechanisms or a workplan to develop them.
p.000042: e. Demonstrated awareness and consideration of human rights issues that may be raised by the trial, particularly
p.000042: as they relate to vulnerable, marginalised, or criminalised groups.
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p.000043: 2. Trial funders, sponsors, or network representatives continue to monitor site progress towards developing
p.000043: appropriate plans, resolving identified issues, and following good participatory practices during the site development
p.000043: phase of the trial.
p.000043: 3.8 Protocol development
p.000043: 3.8.A. Definition
p.000043: Protocol development is the process of creating and modifying a trial protocol. The protocol describes the rationale,
p.000043: objectives, design, methodology, statistical considerations, ethical considera- tions, and organisation of a trial.
p.000043:
p.000043: 3.8.B. Relevance to good participatory practice
p.000043: A range of stakeholders can provide meaningful input into many aspects of trial protocol development. In particular,
p.000043: community stakeholders bring expertise that can assist research teams in ensuring that protocol designs and
p.000043: procedures are locally appro- priate, are acceptable to the trial population, and optimise successful
p.000043: implementation of the trial.
p.000043:
p.000043: 3.8.C. Special considerations
p.000043: 1. Opportunities for protocol review and input by local research teams and relevant stakeholders vary by trial. In
p.000043: some circum- stances, particularly multicountry or multisite trials, protocol development may be largely centralised.
p.000043: It is good practice in the protocol development process to incorporate mecha- nisms to facilitate stakeholder input
p.000043: early in the process.
p.000043: 2. Research teams can consider documenting community stake- holder input into protocol development and sharing these
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p.000055: d. Whether any non HIV-related services will be available to partners of trial participants.
p.000055: e. The impact on local service delivery of any services offered or referred to by the trial.
p.000055: 4. Research teams maintain clear written records of discussions and agreements. This includes relevant stakeholder
p.000055: recom- mendations, actions taken by the research team, and any unre- solved issues.
p.000055: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds to ensure provision
p.000055: of the locally discussed, non HIV-related care package.
p.000055: 3.12.E. Additional guidance
p.000055: See Mapping the Standards of Care at Microbicide Clinical Trial Sites.35
p.000055:
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p.000056: Good participatory practice guidelines for biomedical HIV prevention trials 2011
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p.000056: 3.13 Policies on trial-related harms
p.000056: 3.13.A. Definition
p.000056: Policies on trial-related harms describe how research teams will treat and compensate trial participants should they
p.000056: experience physical or social harms that are determined to be associated with trial participation, as well as how such
p.000056: harms will be addressed and mitigated.
p.000056:
p.000056: 3.13.B. Relevance to good participatory practice
p.000056: A key ethical obligation of research teams is to maximise benefits and minimise harms for trial participants. Relevant
p.000056: stakeholders can provide valuable input about possible social harms of trial participation. These are of particular
p.000056: concern for individuals or groups who may be vulnerable, marginalised, stigmatised, or who have less power in society.
p.000056: Relevant stakeholders can also provide advice about local expectations of research team obligations to address
p.000056: trial-related physical and social harms. Discussing with stakeholders before a trial starts and clearly explaining how
p.000056: trial- related harms will be addressed and mitigated can significantly influence community stakeholder perceptions of
p.000056: the trial and of how well community stakeholder concerns will be addressed.
p.000056:
p.000056: 3.13.C. Special considerations
p.000056: Sponsors typically give specific and binding guidance to research teams on how to determine and report physical harms
p.000056: as adverse events. It is good practice to define similarly stringent procedures for the determination, documentation,
p.000056: reporting, and manage- ment of social harms that trial participants may experience. Examples of social harms
p.000056: due to trial participation include stigma, discrimination, and verbal, emotional, physical, or sexual abuse.
p.000056:
p.000056: 3.13.D. Good participatory practices for policies on trial- related harms
p.000056: 1. Research teams and relevant stakeholders list anticipated physical and social harms that might occur due to
p.000056: trial partic- ipation.
p.000056:
p.000057: 57
p.000057:
p.000057: UNAIDS / AVAC
p.000057:
p.000057:
p.000057: 2. Research teams and relevant stakeholders discuss and develop policies on trial-related physical and social harms,
p.000057: considering the following issues:
p.000057: a. Strategies to prevent or reduce the risk of trial-related harms.
...
p.000064: 4.1).38
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p.000065: UNAIDS / AVAC
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p.000065: Conclusion
p.000065: Well-conducted biomedical HIV prevention trials are essential to discov- ering additional options to reduce new HIV
p.000065: infections. The GPP guide- lines set global standard practices for stakeholder engagement. When applied during
p.000065: the entire life-cycle of a biomedical HIV prevention trial, they enhance both the quality and outcomes of research.
p.000065: While there is much guidance in the field on how to conduct trials, the GPP guide- lines are the only set of global
p.000065: guidelines that directly address how to engage stakeholders in the design, conduct, and outcome of biomedical HIV
p.000065: prevention trials.
p.000065:
p.000065: Adherence to good participatory practices is an investment that benefits the research process. These practices
p.000065: facilitate the engagement of relevant stakeholders to achieve mutual gains in local capacity building for biomed- ical
p.000065: HIV prevention research. Significant power imbalances exist between trial funders, sponsors, and implementers and
p.000065: community stakeholders— the GPP guidelines are a critical resource to help address and mitigate these disparities. A
p.000065: core aim of the guidelines is to enhance the skills of individ- uals and groups who are most vulnerable to both HIV and
p.000065: to exploitation. The GPP guidelines help build community stakeholder capacity for more robust engagement in the
p.000065: research process and improved decision-making abilities.
p.000065:
p.000065: Effective stakeholder engagement can exist only when appropriate funds and resources are made available to research
p.000065: teams so they may adhere to good participatory practice. Sponsors of biomedical HIV prevention trials are responsible
p.000065: for enabling GPP by ensuring ample budget allocations and staff time to facilitate participatory approaches.
p.000065:
p.000065: Investment in establishing mutually respectful relationships and building capacity of community stakeholders is a
p.000065: long-term process that extends throughout and beyond the life-cycle of any single clinical trial. Although it is highly
p.000065: beneficial to maintain and support key staff at trial sites and
p.000065:
p.000065:
p.000066: 66
p.000066:
p.000066: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: sustain relationships that have been developed with local partners during the course of a trial, sponsors of biomedical
p.000066: HIV prevention trials often only support implementation of specific clinical trials. Investing in collab- orative
p.000066: long-term, sustained relationships between research teams and relevant stakeholders, such as academic
...
Searching for indicator vulnerability:
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p.000016: There is an urgent need to develop additional strategies to address the HIV pandemic. Along with necessary behavioural
p.000016: and structural changes, a broad range of biomedical HIV prevention and treatment options is required to meet the
p.000016: diverse needs of individuals and populations. There are many inherent complexities in conducting biomedical HIV
p.000016: prevention trials. By acknowledging and under- standing these challenges and complexities, trial funders, sponsors,
p.000016: and implementers can more appropriately and effectively facilitate a mutually beneficial participatory approach to
p.000016: conducting biomedical HIV prevention trials.
p.000016:
p.000016: Biomedical HIV prevention research cannot succeed without mean- ingful stakeholder engagement, particularly given the
p.000016: need to involve large numbers of healthy, HIV-negative volunteers as trial partici- pants. It is optimal that
p.000016: experimental HIV prevention options are tested for safety and effectiveness in populations who need these interventions
p.000016: the most and are likely to use them should they prove effective. However, the very factors that increase HIV risk in
p.000016: such populations may contribute to increased vulnerability to exploitation. This underscores the importance of
p.000016: meaningful partnerships with community stakeholders.
p.000016:
p.000016: A wide range of factors creates, enhances, and perpetuates the risk of HIV infection. Structural determinants can
p.000016: increase vulnerability to HIV at an individual or population level by undermining ability to avoid HIV exposure.
p.000016: Underlying determinants of the HIV epidemic can be entrenched in the social, cultural, legal, institutional, or
p.000016: economic fabric of society. Examples of these determinants include gender and other power inequalities,
p.000016: gender-based violence, economic instability including poverty, migration, human rights
p.000016: violations,homophobia,discriminatory practices,HIV-related stigma, social marginalisation, and criminalisation of
p.000016: HIV transmission. Recognition of these factors is the first step in developing practices
p.000016:
p.000017: 17
p.000017:
p.000017: UNAIDS / AVAC
p.000017:
p.000017:
p.000017: that avoid inadvertently replicating or reinforcing them in the design and conduct of biomedical HIV prevention
p.000017: trials.While stakeholder engagement helps empower and equip community stakeholders to engage in the research
p.000017: process in a meaningful fashion, it also harnesses the expertise that community stakeholders can contribute to the
p.000017: design and conduct of research.
p.000017:
...
Health / Drug Usage
Searching for indicator drug:
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p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049: UNAIDS / AVAC
p.000049:
p.000049:
p.000049: 3.10.D. Good participatory practices for standard of HIV prevention
p.000049: 1. Research teams and relevant stakeholders negotiate the HIV prevention package during the protocol development phase
p.000049: of the trial.
p.000049: 2. Research teams determine which stakeholders already provide HIV prevention services, what types of
p.000049: services they provide, and their capacity to provide adequate services.This will enable research teams to provide
p.000049: optimal referrals and make linkages when necessary.
p.000049: 3. Research teams and relevant stakeholders discuss and negotiate the comprehensive HIV prevention package and
p.000049: consult local HIV prevention service providers when appro- priate. All scientifically validated methods are discussed,
p.000049: and their appropriateness for the trial design and population assessed, including:
p.000049: a. Risk assessment and risk-reduction counselling— including partner and couple counselling.
p.000049: b. Male and female condoms—with appropriate instructions and demonstrations.
p.000049: c. Testing for and treatment of sexually transmitted infec- tions.
p.000049: d. Sterile injecting equipment and drug substitution treatment.
p.000049: e. Medical male circumcision.
p.000049: f. Post-exposure prophylaxis.
p.000049: g. Other novel HIV risk-reduction strategies as they become available.
p.000049: 4. Research teams and relevant stakeholders discuss and negotiate the comprehensive HIV prevention package,
p.000049: taking account of the following:
p.000049: a. The HIV prevention package required as a minimum for the trial protocol.
p.000049: b. Current HIV prevention standards and services available nationally and locally.
p.000049:
p.000050: 50
p.000050:
p.000050: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000050:
p.000050:
p.000050: c. Current national laws on HIV prevention strategies and services, as well as national ethical guidance on research.
p.000050: d. The trial’s funding source, any implications this may have for the prevention package, and how these will be
p.000050: addressed to ensure participants are offered a comprehen- sive package.
p.000050: e. The HIV prevention services and options that will be offered through referral mechanisms.
p.000050: f. The HIV prevention services that will be available to partners of trial participants.
p.000050: g. The impact that any services offered by the trial, as well as those to which participants will be referred by the
p.000050: trial, could have on local services.
...
p.000066: long-term, sustained relationships between research teams and relevant stakeholders, such as academic
p.000066: institutions, ministries of health, and non-governmental organisations, can improve research literacy, enhance the
p.000066: success of stakeholder engagement, and provide the foundation for future trials.
p.000066:
p.000066: The GPP guidelines are intended to provide trial funders, sponsors, and implementers with systematic guidance on how to
p.000066: effectively engage with relevant stakeholders in the design and conduct of biomedical HIV preven- tion trials.
p.000066: Developing participatory processes that balance the opinions of all stakeholders while achieving the scientific goals
p.000066: of a trial can ensure that the needs of both community stakeholders and the broader HIV preven- tion field are met.
p.000066:
p.000066: In a forward-looking approach, it is important to gather and analyse stake- holders’ experiences with the
p.000066: implementation of the GPP guidelines. Recommendations for modifications and refinements based on experience and
p.000066: reflection can be sent to gpp@unaids.org or avac@avac.org, where they will be gratefully received and considered in
p.000066: future updates of these guidelines.
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: UNAIDS / AVAC
p.000067:
p.000067:
p.000067: Annex 1. Acronyms and abbreviations
p.000067: AE – Adverse event
p.000067: AIDS – Acquired Immunodeficiency Syndrome
p.000067: ARV – Antiretroviral drug
p.000067: CAB – Community Advisory Board CAG – Community Advisory Group CBO – Community-Based Organisation
p.000067: CIOMS – Council for International Organizations of Medical Science
p.000067: EC – Ethics committee
p.000067: DSMB – Data safety monitoring board DSMC – Data safety monitoring committee GCLP– Good Clinical Laboratory Practice GCP
p.000067: – Good Clinical Practice
p.000067: GMP – Good Manufacturing Practice GPP – Good Participatory Practice HIV – Human Immunodeficiency Virus
p.000067: IDMC – Independent data monitoring committee
p.000067: IDU – Injecting drug use
p.000067: IRB – Institutional review board
p.000067: MSM – Men who have sex with men NGO – Non-governmental organisation PEP – Post-exposure prophylaxis
p.000067: PMTCT – Prevention of mother-to-child transmission
p.000067: PrEP – Pre-exposure prophylaxis REC – Research ethics committee SOP – Standard operating procedure STI – Sexually
p.000067: transmitted infection
p.000067: UNAIDS – Joint United Nations Programme on HIV/AIDS
p.000067: WHO – World Health Organization
p.000067:
p.000067:
p.000067:
p.000068: 68
p.000068: 68
p.000068:
p.000068: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000068:
p.000068:
p.000068: Annex 2. Glossary
p.000068: Accrual. The process of recruiting participants into a clinical trial in order to reach target participant
p.000068: numbers.
p.000068: Acquired immunodeficiency syndrome (AIDS). The most severe mani- festation of infection with human immunodeficiency
p.000068: virus (HIV), charac- terised by deterioration of the immune system and susceptibility to a range of opportunistic
p.000068: infections and cancers. (See human immunode- ficiency virus.)
p.000068: Activist. A person or group who acts on the behalf of a cause in order to bring about change.
p.000068: Adverse event (AE). An unwanted effect experienced by a partici- pant in a clinical trial. This may or may not
p.000068: be related to the product or procedure being studied.
p.000068: Advocate. A person or group who advocates on the behalf of indi- viduals, groups, or a specific cause.
p.000068: Antiretroviral (ARV) drug. A drug or medication that acts against or suppresses a retrovirus such as HIV.
p.000068: AVAC. An international, non-profit organisation that uses education, policy analysis, advocacy, and community
p.000068: mobilisation to accelerate the ethical development and eventual global delivery of AIDS vaccines and other new HIV
p.000068: prevention options as part of a comprehensive response to the pandemic.
p.000068: Biomedical HIV prevention trial. A clinical trial that aims to discover safe and effective products or procedures to
p.000068: prevent HIV transmission.
p.000068: Blinded trial or masked trial. A clinical trial designed to prevent the participants, research teams, or both, from
p.000068: knowing which participants are in the experimental arm or group and which are in the control arm or group of a trial,
p.000068: in order to reduce bias.
p.000068: Clinical trial. A research study that uses human volunteers to answer specific questions about the safety,
p.000068: efficacy or effectiveness, and medical effects of a specific procedure, medication, product, or treatment. A
p.000068: clinical trial process may include Phases I, II, IIb, III, and IV (post-marketing evaluation).
p.000068:
p.000069: 69
p.000069:
p.000069: UNAIDS / AVAC
p.000069:
p.000069:
p.000069: Community advisory boards (CABs) or community advisory groups (CAGs). Boards or groups composed of individuals
p.000069: or stakeholder representatives that act as an independent advisory voice and facilitate community stakeholder
...
p.000069: during sexual inter- course, for the purpose of protecting against sexually transmitted infec- tions (including HIV)
p.000069: or preventing pregnancy. (See female condom or male condom.)
p.000069: Control arm or group. The group of participants in a clinical trial who receive the placebo or control product or
p.000069: procedure. (See placebo.)
p.000069: Data and safety monitoring board (DSMB) or independent data monitoring committee (IDMC). An independent
p.000069: committee estab- lished by a trial sponsor to assess, at intervals, the progress of a clinical trial, safety data, and
p.000069: critical efficacy or effectiveness endpoints. A data and safety monitoring board may recommend to the sponsor that a
p.000069:
p.000070: 70
p.000070:
p.000070: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000070:
p.000070:
p.000070: trial be stopped or modified if there are safety concerns, if trial objec- tives have been achieved, or if assessment
p.000070: of trial progress reveals that continuing the trial would be futile since it will no longer be possible to answer the
p.000070: research question that the trial is addressing.
p.000070: Ethics committee. See research ethics committee.
p.000070: Experimental arm or group. The group of participants in a clinical trial who receive the procedure, product, or drug
p.000070: being studied.
p.000070: Female condom. A pouch that when inserted in the vagina before vaginal intercourse, provides protection
p.000070: against most sexually trans- mitted infections, including HIV, and pregnancy. During anal sex, the female condom,
p.000070: when placed on the penis after removing the inner ring, provides protection against most sexually transmitted
p.000070: infections, including HIV. Currently made of polyurethane (female condom 1) or a synthetic latex (female condom 2), it
p.000070: is stronger than the natural latex used in male condoms, odourless, non-allergenic, and usable with oil-based
p.000070: and water-based lubricants. For vaginal intercourse, it can be inserted vaginally prior to intercourse, is not
p.000070: dependent on male erection, and does not require immediate withdrawal after ejaculation. (See also male condom.)
p.000070: Formative research activities. Activities that enable research teams to gain an informed understanding of local
p.000070: populations, socio-cultural norms and practices, local power dynamics, local perceptions, channels of communication and
p.000070: decision-making, and local history of research, as well as the needs and priorities of people locally affected by or
p.000070: able to influence a clinical trial. Formative research activities usually consti- tute the initial phase of stakeholder
...
Searching for indicator influence:
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p.000012: Use this section and its optimal practices to guide specific stakeholder engagement activities when conducting
p.000012: biomedical HIV prevention trials
p.000012:
p.000012: Formative Research Activities
p.000012: Stakeholder
p.000012: Advisory Mechanisms
p.000012: Stakeholder Engagement Plan
p.000012: Stakeholder Education Plan
p.000012:
p.000012: Communications Plan Issues Management Plan Site Selection
p.000012: Protocol Development
p.000012:
p.000012: Informed Consent Process
p.000012: Standard of HIV Prevention
p.000012: Access to HIV Care and Treatment
p.000012:
p.000012: Non HIV-Related Care
p.000012:
p.000012: Policies on
p.000012: Trial-Related Harms
p.000012: Trial Accrual, Follow-Up, and Exit
p.000012: Trial Closure and Results Dissemination
p.000012: Post-trial Access to Trial Products or Procedures
p.000012:
p.000013: 13
p.000013:
p.000013: UNAIDS / AVAC
p.000013:
p.000013:
p.000013: 1. The importance of good participatory practice
p.000013:
p.000013: 1.1 Who are stakeholders?
p.000013: The starting point of good participatory practice is the identification of key stakeholders in the conduct of a
p.000013: biomedical HIV prevention trial. Stakeholders are individuals, groups, organisations, government bodies, or any other
p.000013: individuals or collections of individuals who can influence or are affected by the conduct or outcome of a biomedical
p.000013: HIV prevention trial. In this guidance document, the term “stake- holders” is all-encompassing. It describes any
p.000013: individual or collection of individuals who have a stake in a biomedical HIV prevention trial.
p.000013:
p.000013: Examples of stakeholders are illustrated in Figure 2 and can include trial participants, families of trial
p.000013: participants, prospective trial partic- ipants, individuals resident within, or surrounding, the area where research is
p.000013: conducted, people living with HIV or affected by HIV, prevention and treatment advocates and activists,
p.000013: non-governmental organisations (NGOs), community-based organisations (CBOs), community groups, religious leaders,
p.000013: opinion leaders, media, govern- ment bodies, national and local health-care authorities, service providers,
p.000013: trial funders, trial sponsors, and trial implementers.
p.000013:
p.000013: The definition of “community” is more complicated, as it is a dynamic term that has different meanings to
p.000013: different people.19 This term is often used to refer to a group of people who have a common set of interests, share a
p.000013: common set of characteristics, or live in a common area. Individuals can be a part of multiple “communities” at the
p.000013: same time. The term “community” is also used to refer to the public at large or to a physical location.
p.000013:
p.000013: In the GPP guidelines, the preferred term is “community stake- holders”, rather than “community”, and refers to both
p.000013: individuals and groups that are ultimately representing the interests of people who would be recruited to or
p.000013: participate in a trial, and others locally
p.000013:
p.000014: 14
p.000014:
p.000014:
p.000014:
p.000014: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000014:
p.000014:
p.000014: affected by a trial. Examples of “community stakeholders” are the population to be recruited, trial participants,
p.000014: people living in the area where the research is conducted, people living with HIV in the area, local HIV-positive
p.000014: groups or networks, people in the area who are affected by the HIV epidemic, local non-governmental organisa-
p.000014: tions, community groups, and community-based organisations. Trial funders, sponsors, and implementers, as well as
p.000014: government bodies or representatives of high-level authority structures, are explicitly excluded from the term
p.000014: “community stakeholders” but are clearly considered trial stakeholders.
p.000014:
p.000014: Figure 2. Layers of Biomedical HIV Prevention Trial Stakeholders
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Examples
p.000014:
p.000014:
p.000014: Trial Participant
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: m
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Various stakeholders may influence or be affected by a biomedical HIV prevention trial. Stakeholders include trial
p.000014: participants and other community stakeholders as well as a broader range of national and international stakeholders.
p.000014:
p.000015: 15
p.000015:
p.000015: UNAIDS / AVAC
p.000015:
p.000015:
p.000015: 1.2 What is stakeholder engagement?
p.000015: Of key importance in good participatory practice is sustained, collab- orative partnering with stakeholders. In the GPP
p.000015: guidelines, the term “stakeholder engagement” refers to processes through which trial funders, sponsors, and
p.000015: implementers build transparent, meaningful, collaborative, and mutually beneficial relationships with interested or
p.000015: affected individuals, groups of individuals, or organisations, with the ultimate goal of shaping research collectively.
p.000015:
p.000015: Successful stakeholder engagement requires a broad, inclusive, and multifaceted understanding of the context in
p.000015: which a biomed- ical HIV prevention trial is conducted. It begins with an inclusive perspective for identification of
p.000015: potential stakeholders. Stakeholder identification is a dynamic process, as stakeholders, interests, priorities,
p.000015: perspectives, and aspects of culture may change over time. Research teams are responsible for identifying stakeholders,
p.000015: a process which begins by determining the trial population to be recruited, consid- ering those who are affected by the
p.000015: trial in the local area, consulting with already known stakeholders, and building on that expertise to develop a richer
p.000015: understanding of potential and known stakeholders.
p.000015:
p.000015: Different stakeholders will have different perspectives. Some stake- holders will have competing interests or
...
p.000022:
p.000023: 23
p.000023:
p.000023: UNAIDS / AVAC
p.000023:
p.000023:
p.000023: 2.3 Integrity
p.000023: Maintaining the highest standards of scientific and ethical integrity is fundamental to achieving the scientific goals
p.000023: of a biomedical HIV prevention trial, maximising benefits for community stakeholders, and advancing global HIV
p.000023: prevention science.
p.000023: Scientific integrity requires adherence to scientific processes in order to ensure that trials meet the highest
p.000023: scientific standards and achieve valid results.
p.000023: Ethical integrity requires consideration of broader societal and ethical issues as well as adherence to
p.000023: universal ethical principles that include respect for persons, beneficence, and justice.6
p.000023:
p.000023: 2.4 Transparency
p.000023: Open, honest, timely, and clear communication enables transpar- ency and fosters collaborative, trusting, and
p.000023: constructive relationships. Transparency is relevant to the research process as well as to the roles of stakeholders.
p.000023: Transparency about research includes ensuring that stakeholders receive open, honest, and understandable information
p.000023: about the objectives and processes of a trial. Transparency means ensuring that feedback from a broad range of
p.000023: stakeholders is acknowledged and addressed.
p.000023: Transparency about the role of stakeholders includes ensuring that stakeholders are clear on their respective roles and
p.000023: responsibilities; the constituents, if any, they each represent; and the extent to which their input may influence
p.000023: trial-related decisions. Adherence to the principle of transparency means that stakeholders communicate about
p.000023: circumstances that may affect previously agreed levels of consultation, involvement, collaboration, and
p.000023: decision-making.
p.000023:
p.000023: 2.5 Accountability
p.000023: Accountability is fundamental to sustaining relationships built on trust and mutual respect.
p.000023:
p.000024: 24
p.000024:
p.000024: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000024:
p.000024:
p.000024: Trial funders, sponsors, and implementers are accountable to the society at large for conducting scientifically
p.000024: valid and ethical research. They are accountable to all research stakeholders for the use of partic- ipatory practices
p.000024: and for responding to input from relevant stake- holders as mutually agreed. They are also accountable for ensuring
p.000024: that funding is adequate to enable optimal engagement between research teams and other stakeholders.
p.000024: Community stakeholders and other relevant stakeholders are accountable for ensuring that their input into
p.000024: the research process is fair and constructive, respects the scientific process, and is in the best self-identified
p.000024: interests of community stakeholders.Where stake- holders accept the responsibility to act as liaisons or
p.000024: representatives between research teams and other stakeholders, they are accountable for representing the interests of
p.000024: those they represent, sharing informa- tion about planned or ongoing trials with them, and expressing their needs and
p.000024: concerns to research teams.
p.000024:
p.000024: 2.6 Community stakeholder autonomy
...
p.000025: results dissem- ination—and is not limited to the specific topic areas highlighted in this section. While this section
p.000025: describes stakeholder engagement processes in the general sequence in which they may occur, these processes are not
p.000025: necessarily sequential or time-limited; they can take place as parallel, overlapping, or ongoing activities.
p.000025: The application of each practice or set of practices will vary by location, the type of trial being
p.000025: conducted, and trial site experi- ence with respect to previously established stakeholder engagement programmes and
p.000025: activities.
p.000025: The good participatory practices section is divided into 16 topic areas covering the course of the research
p.000025: life-cycle.Topic areas in section 3 are divided into the following subsections:
p.000025: A. Definition.
p.000025: B. Relevance to good participatory practice.
p.000025: C. Special considerations.
p.000025: D. Good participatory practices.
p.000025: E. Additional guidance.
p.000025:
p.000026: 26
p.000026:
p.000026: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000026:
p.000026:
p.000026: 3.1 Formative research activities
p.000026: 3.1.A. Definition
p.000026: Formative research activities enable research teams to gain an informed understanding of local populations,
p.000026: socio-cultural norms and practices, local power dynamics, local percep- tions, channels of communication and
p.000026: decision-making, and local history of research, as well as the needs and priorities of people who are locally affected
p.000026: by and able to influence the trial. Formative research activities usually constitute the initial phase of stakeholder
p.000026: outreach and engagement.
p.000026:
p.000026: 3.1.B. Relevance to good participatory practice
p.000026: Collaborating with community stakeholders to devise questions, gather information, and analyse results related to
p.000026: formative research activities ensures that stakeholders’ expertise and under- standing of local perceptions, cultures,
p.000026: and traditions inform trial design and conduct. Collaborating with community stakeholders on formative research
p.000026: activities builds trust and lays the founda- tion for meaningful engagement.
p.000026:
p.000026: 3.1.C. Special considerations
p.000026: 1. Formative research activities can be conducted informally to gather information about local populations and research
p.000026: areas or formally as a part of approved, funded protocols.
p.000026: 2. Different sites will have specific needs regarding formative research activities. Whereas new trial sites may
p.000026: require extensive formative research activities, experienced trial sites may require more focused activities.
p.000026: Studying an experi- mental option new to the area, recruiting from a new location or population,
p.000026: gathering stakeholder feedback regarding previous trials, and the changing nature of cultures are all reasons why
p.000026: experienced trial sites may benefit from formative research activities.
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: UNAIDS / AVAC
p.000027:
p.000027:
p.000027: 3.1.D. Good participatory practices for formative research activities
p.000027: 1. Research teams identify key informants and relevant stake- holders that can assist in planning, implementing,
p.000027: and reviewing the process and results of formative research activi- ties (see also Section 1.2).
...
p.000036: Effective stakeholder education is key to building research literacy and, ultimately, empowering community
p.000036: stakeholders as decision-making agents. Building research literacy lays the foun- dation for a supportive environment
p.000036: for research that extends beyond the lifespan of a specific biomedical HIV prevention trial.
p.000036:
p.000036: 3.4.C. Special considerations
p.000036: 1. While it is important that all relevant stakeholders improve their knowledge of research processes, enhancing
p.000036: research literacy for community stakeholders will foster more equitable relationships.
p.000036: 2. The goals and outcomes of stakeholder education are different from those of recruitment activities. While
p.000036: stakeholder
p.000036:
p.000036: b Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000036: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000036: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000036: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000036: clear.
p.000037: 37
p.000037:
p.000037: UNAIDS / AVAC
p.000037:
p.000037:
p.000037: education can positively influence trial recruitment activities, a stakeholder education plan can help clarify the
p.000037: differences between participant recruitment and stakeholder education.
p.000037: 3.4.D. Good participatory practices for stakeholder education planning
p.000037: 1. Research teams, with input from relevant stakeholders, determine what education is needed in order to enhance
p.000037: stakeholder understanding of, and engagement with, a specific planned trial and biomedical HIV prevention
p.000037: research more generally.
p.000037: 2. Research teams and relevant stakeholders discuss and negotiate a stakeholder education plan to cover the
p.000037: life-cycle of the trial.The plan defines the following:
p.000037: a. The range of different stakeholders that could benefit from specific education about HIV, HIV prevention
p.000037: options, and general research literacy.
p.000037: b. The level of knowledge that is optimal and desired by stakeholders to support effective engagement. This will be
p.000037: influenced by the type of engagement defined for each stakeholder in the stakeholder engagement plan (see
p.000037: Section 3.3).
p.000037: c. The methods and frequency of educational activities.
...
p.000045: c. The general literacy level of the population to be recruited and how to assess the literacy level of prospective
p.000045: partici- pants.
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000046:
p.000046:
p.000046: d. Considerations and requirements for illiterate participants, including discussion of possibilities of who may
p.000046: serve appropriately as a witness to the informed consent process.
p.000046: e. The prevalence of different languages in the area and which languages are required for obtaining
p.000046: informed consent from individuals.
p.000046: f. Local and legal forms of identity (name and age) verifica- tion and local practices around the use of names.
p.000046: g. The legal, local, and trial sponsor definitions of a “minor” and consideration of legal and local
p.000046: determinations of who can serve as a minor’s guardian.
p.000046: h. Locally appropriate reimbursement and compensation.
p.000046: i. Appropriate strategies to ensure participant rights are protected, including voluntariness of
p.000046: participation, ensuring undue inducement is avoided, and mitigating the influence of social desirability in influencing
p.000046: individual agreement to enrol.
p.000046: j. Strategies to ensure comprehension of informed consent materials and critical trial-related terms and
p.000046: concepts, including the use of visual or audio formats, flipcharts, props, analogies, and other supportive
p.000046: materials and methods.
p.000046: k. Techniques to assess comprehension of trial participation and the frequency with which they are to be used.
p.000046: l. Explanation of potential trial-related harms and how such harms will be addressed (see Section 3.13).
p.000046: m. Strategies to ensure that follow-up of participants after missed visits respects agreements between the participant
p.000046: and research team about how to contact the participant.
p.000046: n. Consideration of the length of informed consent forms and the estimated time required to complete the informed
p.000046: consent process.
p.000046: o. Preferred ways for participants to contact research teams and stakeholders independent from the research team to
p.000046: ask questions or express concerns about trial participation.
p.000046: p. Ways to pilot informed consent materials.
p.000046:
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p.000047:
p.000047:
p.000047: 2. Research teams maintain clear written records of discus- sions and agreements. This includes community
p.000047: stakeholder recommendations, actions taken by the research team, and any unresolved issues that require follow-up.
p.000047: 3. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
...
p.000047: risk reduction methods provided or made available to participants in biomedical HIV prevention trials.
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000048:
p.000048:
p.000048: 3.10.B. Relevance to good participatory practice
p.000048: Helping trial participants reduce their risk of acquiring HIV is a key ethical obligation of research teams.
p.000048: Determining the components of the HIV prevention package is a joint effort between research teams and relevant
p.000048: stakeholders. Trial sponsors and implementers must work with relevant stakeholders in establishing the type,
p.000048: scope, and process by which participants are provided with, or referred to, services to access the full HIV prevention
p.000048: package. How trial sites help participants prevent HIV acquisition is often at the forefront of community stakeholder
p.000048: concerns. Therefore, successful negotiation with stakeholders about the prevention package to be provided to trial
p.000048: participants is likely to have a significant influence on community stakeholder perceptions of a trial.
p.000048:
p.000048: 3.10.C. Special considerations
p.000048: 1. Deviations from expected standard HIV prevention packages at a trial site or among trial sites in multisite studies
p.000048: may be caused by national legal restrictions.
p.000048: 2. When funding-body restrictions limit which prevention methods can be paid for by trial funds, research teams
p.000048: have the responsibility to find other ways to provide these methods, such as through alternative funding streams or
p.000048: linkages with non-governmental organisations or community-based organ- isations.
p.000048: 3. Research teams may need to review the HIV prevention package regularly, taking into consideration new HIV coun-
p.000048: selling models and risk reduction methods that are scientifi- cally validated and, when appropriate, approved by
p.000048: national bodies for use.
p.000048: 4. To improve relevant stakeholder understanding of the preven- tion package offered and the clinical trial process,
p.000048: research teams can describe the trial as comparing the study product plus the HIV prevention package, with the
p.000048: placebo (or comparator arm) plus the HIV prevention package.
p.000048:
p.000048:
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p.000049:
p.000049: 3.10.D. Good participatory practices for standard of HIV prevention
...
p.000051: 3.11.A. Definition
p.000051: Access to comprehensive HIV care and treatment refers to care and treatment services made available to
p.000051: individuals who are identified as HIV-positive during the screening process and to trial participants who acquire HIV
p.000051: infection during the trial. Comprehensive HIV care includes all preventive, psychoso- cial, psychological, and
p.000051: clinical components of HIV care. HIV treatment refers to antiretroviral therapy regimens internationally recognised as
p.000051: optimal for the management of HIV.
p.000051:
p.000051: 3.11.B. Relevance to good participatory practice
p.000051: Trial sponsors and implementers are ethically obligated to ensure that participants who acquire HIV during trial
p.000051: participation have access to clinical evaluation, and stage-appropriate HIV care and treatment.This issue is often at
p.000051: the forefront of community stake- holder concerns.Therefore, how access to HIV care and treatment is negotiated with
p.000051: relevant stakeholders and how it is provided to trial participants are likely to have a significant influence on
p.000051: community stakeholder perceptions of a trial.
p.000051:
p.000051: 3.11.C. Special considerations
p.000051: 1. HIV care and treatment guidelines vary by country.
p.000051: 2. Treatment options may improve over time and research teams may need to modify their HIV care and treatment access
p.000051: plans in line with updated national guidelines.
p.000051: 3. Mechanisms to provide HIV care and treatment require long-term logistics planning as people living
p.000051: with HIV require lifelong care and treatment, and, for some participants, HIV treatment may begin after trial exit or
p.000051: completion.
p.000051: 3.11.D. Good participatory practices for access to HIV care and treatment
p.000051: 1. Research teams identify local HIV care and treatment services, local HIV non-governmental organisations or
p.000051: community- based organisations, and HIV support groups, determine
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p.000052:
p.000052:
p.000052: their capacities, and seek their views and perspectives. This enables research teams to design optimal referral
p.000052: mechanisms in consultation with service providers.
...
p.000055: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds to ensure provision
p.000055: of the locally discussed, non HIV-related care package.
p.000055: 3.12.E. Additional guidance
p.000055: See Mapping the Standards of Care at Microbicide Clinical Trial Sites.35
p.000055:
p.000056: 56
p.000056:
p.000056: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000056:
p.000056:
p.000056: 3.13 Policies on trial-related harms
p.000056: 3.13.A. Definition
p.000056: Policies on trial-related harms describe how research teams will treat and compensate trial participants should they
p.000056: experience physical or social harms that are determined to be associated with trial participation, as well as how such
p.000056: harms will be addressed and mitigated.
p.000056:
p.000056: 3.13.B. Relevance to good participatory practice
p.000056: A key ethical obligation of research teams is to maximise benefits and minimise harms for trial participants. Relevant
p.000056: stakeholders can provide valuable input about possible social harms of trial participation. These are of particular
p.000056: concern for individuals or groups who may be vulnerable, marginalised, stigmatised, or who have less power in society.
p.000056: Relevant stakeholders can also provide advice about local expectations of research team obligations to address
p.000056: trial-related physical and social harms. Discussing with stakeholders before a trial starts and clearly explaining how
p.000056: trial- related harms will be addressed and mitigated can significantly influence community stakeholder perceptions of
p.000056: the trial and of how well community stakeholder concerns will be addressed.
p.000056:
p.000056: 3.13.C. Special considerations
p.000056: Sponsors typically give specific and binding guidance to research teams on how to determine and report physical harms
p.000056: as adverse events. It is good practice to define similarly stringent procedures for the determination, documentation,
p.000056: reporting, and manage- ment of social harms that trial participants may experience. Examples of social harms
p.000056: due to trial participation include stigma, discrimination, and verbal, emotional, physical, or sexual abuse.
p.000056:
p.000056: 3.13.D. Good participatory practices for policies on trial- related harms
p.000056: 1. Research teams and relevant stakeholders list anticipated physical and social harms that might occur due to
p.000056: trial partic- ipation.
p.000056:
p.000057: 57
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p.000057:
p.000057:
p.000057: 2. Research teams and relevant stakeholders discuss and develop policies on trial-related physical and social harms,
p.000057: considering the following issues:
p.000057: a. Strategies to prevent or reduce the risk of trial-related harms.
p.000057: b. Procedures to encourage and facilitate reporting of social harms.
p.000057: c. Procedures to investigate events that have been reported indirectly, such as through a third party, taking
p.000057: confiden- tiality issues into account.
p.000057: d. Procedures for reporting social harms and whether these are to be reported to sponsors, ethics committees,
...
p.000062: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000062: ensure comprehensive dissemination of results for participants, community stakeholders and other relevant
p.000062: stakeholders.
p.000062: 3.16 Post-trial access to trial products or procedures
p.000062: 3.16.A. Definition
p.000062: The term “post-trial access to trial products or procedures” refers to making the prevention product or procedure
p.000062: tested in the trial available to trial participants and local community stake- holders (1) should the new product or
p.000062: procedure be scientifically validated or approved by relevant authorities, and (2) in the form of follow-on, open
p.000062: label, or other such studies before product licensure or approval, should an efficacy or effectiveness trial have a
p.000062: compelling positive finding, with no safety concerns.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: UNAIDS / AVAC
p.000063:
p.000063:
p.000063: 3.16.B. Relevance to good participatory practice
p.000063: Research ethics call for maximising benefits to stakeholders who participate in research. Thus, local community
p.000063: stakeholders are to be among the first to gain access to new prevention products should they be found safe and
p.000063: effective. How trial sites commu- nicate and interact with community stakeholders about issues of access to the
p.000063: prevention product or procedure studied is likely to have a significant influence on community stakeholder percep-
p.000063: tions of a trial.
p.000063:
p.000063: 3.16.C. Special considerations
p.000063: 1. Availability of newly identified products or procedures to trial participants and other community stakeholders will
p.000063: depend on the biomedical HIV prevention strategy being tested.
p.000063: 2. After a trial is completed, other trials may be needed to corroborate findings.
p.000063: 3. After results from relevant trials are available, it may take time for normative agencies and appropriate
p.000063: regulatory authori- ties, including national governments, to approve the new product or procedure. Approval
p.000063: processes and timelines will differ by product or procedure and by country.
p.000063: 4. National regulatory authorities make the ultimate decision about whether a new product or procedure will be
p.000063: approved for use within a particular country.
p.000063: 5. Availability and pricing of new products or procedures may be affected by product-manufacturer parameters as well
p.000063: as by agreements with trial sponsors.
p.000063: 3.16.D. Good participatory practice practices for post-trial access to trial products or procedures
p.000063: 1. Research teams discuss with relevant stakeholders, early in the trial process, issues affecting future product or
p.000063: procedure availability, including the need for corroborated biomedical evidence, pursuit of licensure, production
p.000063: rights, and addi- tional marketing and distribution research.
p.000063:
p.000063:
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p.000064: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000064:
p.000064:
...
p.000070: being studied.
p.000070: Female condom. A pouch that when inserted in the vagina before vaginal intercourse, provides protection
p.000070: against most sexually trans- mitted infections, including HIV, and pregnancy. During anal sex, the female condom,
p.000070: when placed on the penis after removing the inner ring, provides protection against most sexually transmitted
p.000070: infections, including HIV. Currently made of polyurethane (female condom 1) or a synthetic latex (female condom 2), it
p.000070: is stronger than the natural latex used in male condoms, odourless, non-allergenic, and usable with oil-based
p.000070: and water-based lubricants. For vaginal intercourse, it can be inserted vaginally prior to intercourse, is not
p.000070: dependent on male erection, and does not require immediate withdrawal after ejaculation. (See also male condom.)
p.000070: Formative research activities. Activities that enable research teams to gain an informed understanding of local
p.000070: populations, socio-cultural norms and practices, local power dynamics, local perceptions, channels of communication and
p.000070: decision-making, and local history of research, as well as the needs and priorities of people locally affected by or
p.000070: able to influence a clinical trial. Formative research activities usually consti- tute the initial phase of stakeholder
p.000070: outreach and engagement.
p.000070: Futility. The inability of a clinical trial to achieve one or more of its objectives. This determination
p.000070: may be suggested, for example, during an interim analysis of a trial by a data safety monitoring board.
p.000070: Good Clinical Laboratory Practice (GCLP). Guidelines that set a standard for compliance by laboratories
p.000070: involved in the analysis of samples from clinical trials. These guidelines provide guidance to ensure that
p.000070: trial laboratory data are reliable, repeatable, auditable, and easily reconstructed in a research setting.
p.000070:
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071: UNAIDS / AVAC
p.000071:
p.000071:
p.000071: Good Clinical Practice (GCP). Internationally recognised guidelines for designing, conducting, recording, and reporting
p.000071: clinical trials in which humans participate. GCP provides guidance to ensure that trial data are credible and to
p.000071: protect the rights, safety, and well-being of trial partici- pants. The guidelines were issued by the
p.000071: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals
p.000071: for Human Use.
p.000071: Good Manufacturing Practice (GMP). Quality assurance practices that ensure that products are consistently produced and
p.000071: controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation.
p.000071: Good manufacturing practices are aimed primarily at diminishing the risks inherent in any pharmaceutical or
p.000071: medical device production.
...
p.000073: Research network. See network.
p.000073: Research team. A group of investigators and staff involved in imple- menting biomedical HIV prevention trials. Research
p.000073: teams can include investigators and staff at a specific trial site as well as investigators and staff working at
p.000073: coordinating centres, institutions, or agencies.
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000074:
p.000074:
p.000074: Scientific process. A recognised systematic way to form and test hypotheses by designing controlled
p.000074: experiments to collect data, analyse results, and draw conclusions in order to acquire new knowledge or to correct,
p.000074: refine, and integrate previous knowledge.
p.000074: Seroconversion. The process by which a newly infected person develops antibodies that can be detected by
p.000074: an HIV antibody test. Development of antibodies may occur anywhere from weeks or months following HIV infection.
p.000074: Sexually transmitted infections (STIs). Infections caused by microor- ganisms that are transmitted from one person to
p.000074: another during sexual or intimate contact.
p.000074: Stakeholders or trial stakeholders. Individuals, groups, organisations, governments, or other entities that are
p.000074: affected by the outcome of a biomedical HIV prevention trial or that can influence proposed research through their
p.000074: input and actions. (See community stakeholders.)
p.000074: Standard operating procedure (SOP). A document that gives step- by-step instructions for how to conduct a procedure, in
p.000074: order to ensure that each staff member can perform the procedure in the same way.
p.000074: Stigma. AIDS-related stigma refers to a pattern of prejudice, discounting, discrediting, and discrimination directed at
p.000074: people perceived to have HIV or AIDS, their significant others and close associates or their social groups.
p.000074: Therapeutic HIV vaccine. A compound designed to stimulate the immune response to HIV in a person already
p.000074: infected with the virus, in order to control the infection. Also referred to as an immunotherapeutic vaccine. (See
p.000074: vaccine and HIV vaccine.)
p.000074: Trial arm or group. A group within a clinical trial formed of participants who have been assigned a particular product
p.000074: or procedure during a trial. (See control arm or group, experimental arm or group.)
p.000074: Trial funder. An individual or entity responsible for financing the cost of a trial.
p.000074: Trial implementer. Investigators, research staff, and all others specifi- cally responsible for executing
p.000074: biomedical HIV prevention trials. Implementers may be employed by governments, government-spon-
p.000074:
p.000075: 75
p.000075:
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p.000075:
p.000075:
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p.000072: Medical male circumcision. The surgical removal of the entire foreskin of the penis. Three clinical trials conducted in
p.000072: sub-Saharan Africa have shown that medically performed male circumcision is safe and can reduce men’s risk
p.000072: of HIV infection during vaginal sex by about 60%. Prevalence of male circumcision varies by geography,
p.000072: religion, and cultural practices.
p.000072: Men who have sex with men (MSM). Men who have sexual contact with other men, regardless of whether or not they also
p.000072: have sex with women or have a personal or social gay or bisexual identity. This concept also includes men
p.000072: who self-identify as heterosexual but have sex with other men.
p.000072: Microbicides. A range of products that could be used vaginally or rectally (such as a gel, cream, ring, film,
p.000072: suppository or sponge) that are being tested to determine if they reduce or prevent the transmission of HIV and other
p.000072: disease-causing organisms during vaginal and anal intercourse.
p.000072: Network or research network. A cooperative of research institutions or centres conducting clinical trials under a
p.000072: common research agenda.
p.000072: Non-governmental organisation (NGO). A not-for-profit, registered entity or group that is organised on
p.000072: local, national, or international levels but is not an agency of local or national governments.
p.000072: Placebo. An inactive substance that is designed to appear like an exper- imental product being studied in all aspects
p.000072: except for the absence of the active ingredient under study. In clinical trials, the safety and effec- tiveness of an
p.000072: experimental product are assessed by comparing data from the experimental product trial arm to those from the placebo
p.000072: arm.
p.000072: Post-exposure prophylaxis (PEP). Antiretroviral medicines prescribed and taken after exposure or possible exposure to
p.000072: HIV, to reduce the risk of acquiring HIV. The exposure may be occupational, as in a needle stick injury, or
p.000072: non-occupational, as in the case of rape.
p.000072: Pre-exposure prophylaxis (PrEP). Antiretroviral drugs used by a person who does not have HIV infection to be taken
p.000072: before possible exposure to HIV in order to reduce the risk of acquiring HIV infection.
p.000072: Product or trial arm assignment. The specific study product or procedure, such as the experimental or ‘active’
p.000072: arm or the placebo arm,
p.000072:
p.000072:
p.000073: 73
p.000073:
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p.000073:
p.000073:
p.000073: to which a participant is assigned for the designated follow-up period. (See placebo and experimental arm.)
p.000073: Protocol. A document that details the rationale, goals, design, method- ology, statistical considerations, and
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Health / HIV/AIDS
Searching for indicator HIV:
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p.000002:
p.000002: Good participatory practice
p.000002: Guidelines for biomedical HIV prevention trials 2011
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: UNAIDS / JC1853E (Second edition, June 2011)
p.000002:
p.000002: © Joint United Nations Programme on HIV/AIDS (UNAIDS) 2011. All rights reserved
p.000002: The designations employed and the presentation of the material in this publication do not imply the expression of any
p.000002: opinion whatsoever on the part of UNAIDS concerning the legal status of any country, territory, city or area or of its
p.000002: authorities, or concerning the delimitation of its frontiers or boundaries.
p.000002: UNAIDS does not warrant that the information published in this publication is complete and correct and shall not be
p.000002: liable for any damages incurred as a result of its use.
p.000002:
p.000002:
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p.000002:
p.000002:
p.000002: UNAIDS – 20 avenue Appia – 1211 Geneva 27 – Switzerland Telephone: (+41) 22 791 36 66 – Fax: (+41) 22 791 48 35
p.000002: E-mail: distribution@unaids.org – Internet: http://www.unaids.org
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Good participatory practice
p.000002: Guidelines for biomedical HIV prevention trials 2011
p.000002:
p.000002: UNAIDS / AVAC
p.000002:
p.000002:
p.000002: Contents
p.000002: Introduction 5
p.000002: Objective of the good participatory practice (GPP) guidelines 5
p.000002: Intended audience of the GPP guidelines 5
p.000002: Scope of the GPP guidelines 5
p.000002: Development of the GPP guidelines 7
p.000002: Organisation and how to use the GPP guidelines 10
p.000002: 1. The importance of good participatory practice 14
p.000002: 1.1 Who are stakeholders? 14
p.000002: 1.2 What is stakeholder engagement? 16
p.000002: 1.3 The wider context of HIV 17
p.000002: 1.4 The dynamics of biomedical HIV prevention trials 18
p.000002: 1.5 Rationale for GPP guidelines 19
p.000002: 1.6 Applying GPP 20
p.000002: 2. Guiding principles of GPP in biomedical HIV prevention trials 22
p.000002: 2.1 Respect 22
p.000002: 2.2 Mutual understanding 22
p.000002: 2.3 Integrity 24
p.000002: 2.4 Transparency 24
p.000002: 2.5 Accountability 24
p.000002: 2.6 Community stakeholder autonomy 25
p.000002: 3. Good participatory practices in biomedical HIV prevention trials 26
p.000002: Introduction to good participatory practices 26
p.000002: 3.1 Formative research activities 27
p.000002: 3.2 Stakeholder advisory mechanisms 29
p.000002: 3.3 Stakeholder engagement plan 35
p.000002: 3.4 Stakeholder education plan 37
p.000002: 2
p.000002:
p.000002: Good participatory practice guidelines for biomedical HIV prevention trials 2011
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p.000002:
p.000002:
p.000002: 3.5 Communications plan 39
p.000002: 3.6 Issues management plan 41
p.000002: 3.7 Site selection 43
p.000002: 3.8 Protocol development 44
p.000002: 3.9 Informed consent process 45
p.000002: 3.10 Standard of HIV prevention 48
p.000002: 3.11 Access to HIV care and treatment 52
p.000002: 3.12 Non HIV-related care 55
p.000002: 3.13 Policies on trial-related harms 57
p.000002: 3.14 Trial accrual, follow-up, and exit 59
p.000002: 3.15 Trial closure and results dissemination 60
p.000002: 3.16 Post-trial access to trial products or procedures 63
p.000002: Conclusion 66
p.000002: Annex 1. Acronyms and abbreviations 68
p.000002: Annex 2. Glossary 69
p.000002: Annex 3. Additional guidance 77
p.000002: References 82
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p.000003: 3
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p.000003: UNAIDS / AVAC
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p.000003:
p.000003: Section 1:
p.000003: The Importance of Good Participatory Practice
p.000003:
p.000003: Section 2:
p.000003: Guiding Principles
p.000003: of GPP in Biomedical HIV Prevention Trials
p.000003:
p.000003: Section 3:
p.000003: Good Participatory Practices in Biomedical HIV Prevention Trials
p.000003:
p.000003:
p.000003:
p.000003: Who are Stakeholders?
p.000003:
p.000003:
p.000003: What is Stakeholder Engagement?
p.000003:
p.000003:
p.000003: The Wider Context of HIV
p.000003:
p.000003: The Dynamics of Biomedical HIV Prevention Trials
p.000003:
p.000003: Rationale for GPP Guidelines
p.000003:
p.000003:
p.000003: Applying GPP
p.000003:
p.000003: Respect
p.000003:
p.000003:
p.000003: Mutual Understanding
p.000003:
p.000003:
p.000003: Integrity
p.000003:
p.000003:
p.000003: Transparency
p.000003:
p.000003:
p.000003: Accountability
p.000003:
p.000003:
p.000003: Community Stakeholder Autonomy
p.000003: Formative Research Activities
p.000003: Stakeholder
p.000003: Advisory Mechanisms
p.000003: Stakeholder Engagement Plan
p.000003: Stakeholder Education Plan
p.000003:
p.000003: Communications Plan Issues Management Plan Site Selection
p.000003: Protocol Development
p.000003:
p.000003: Informed Consent Process
p.000003: Standard of HIV Prevention
p.000003: Access to HIV Care and Treatment
p.000003:
p.000003: Non HIV-Related Care
p.000003:
p.000003: Policies on
p.000003: Trial-Related Harms
p.000003: Trial Accrual, Follow-Up, and Exit
p.000003: Trial Closure and Results Dissemination
p.000003: Post-trial Access to Trial Products or Procedures
p.000003:
p.000004: 4
p.000004:
p.000004: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000004:
p.000004:
p.000004: Introduction
p.000004:
p.000004: Objective of the good participatory practice (GPP) guidelines
p.000004: The good participatory practice (GPP) guidelines provide trial funders, sponsors, and implementers with systematic
p.000004: guidance on how to effec- tively engage with stakeholders in the design and conduct of biomedical HIV prevention
p.000004: trials.
p.000004: In the GPP guidelines,“design and conduct of biomedical HIV prevention trials” refers to activities required for the
p.000004: development, planning, imple- mentation, and conclusion of a trial, including dissemination of trial results.
p.000004:
p.000004: Intended audience of the GPP guidelines
p.000004: The GPP guidelines are primarily written for trial funders, trial sponsors, and trial implementers. Trial funders,
p.000004: sponsors, and implementers include investigators, research staff, and all others involved in designing, financing, and
p.000004: executing biomedical HIV prevention trials.They can include govern- ments, government-sponsored research networks,
p.000004: non-governmental organisations, academic institutions, foundations, public–private partner- ships, and pharmaceutical
p.000004: or other companies.
p.000004: Stakeholders not directly involved in funding, sponsoring, or implementing trials can use the guidelines to better
p.000004: understand the objectives, expectations, and methods of stakeholder engagement and to better evaluate such efforts.
p.000004:
p.000004: Scope of the GPP guidelines
p.000004: The GPP guidelines provide a framework for development of effective stakeholder engagement programmes. The goal of
p.000004: effective stakeholder engagement programmes is to build mutually beneficial, sustained rela- tionships between trial
p.000004: funders, sponsors, and implementers and other stakeholders that are transparent and respectful, that address
p.000004: interests of community stakeholders, and that support the conduct of scientifically rigorous and ethical biomedical HIV
p.000004: prevention trials.
p.000004:
p.000005: 5
p.000005:
p.000005: UNAIDS / AVAC
p.000005:
p.000005:
p.000005: This GPP guidelines publication is a companion document to the UNAIDS/ WHO Ethical considerations in biomedical
p.000005: HIV prevention trials,1 which contains explicit guidance on community participation, capacity building,
p.000005: monitoring, informed consent, standard of prevention, and other key ethical issues.The GPP guidelines were developed to
p.000005: enable trial funders, sponsors, and implementers to adhere to Guidance Point 2 of Ethical considerations, “Community
p.000005: Participation”, which states:“To ensure the ethical and scien- tific quality and outcome of proposed research, its
p.000005: relevance to the affected community, and its acceptance by the affected community, researchers and trial sponsors
p.000005: should consult communities through a transparent and mean- ingful participatory process which involves them in an early
p.000005: and sustained manner in the design, development, implementation, monitoring, and distribution of results of
p.000005: biomedical HIV prevention trials”.
p.000005: The GPP guidelines provide comprehensive guidance on the participa- tory conduct of biomedical HIV prevention trials
p.000005: and are not intended to provide guidance on all scientific and ethical aspects of these trials. Multiple guidance
p.000005: documents already exist that address overall scientific and ethical trial conduct, such as Good Clinical
p.000005: Practice,2, 3 Good Clinical Laboratory Practice,4 the Declaration of Helsinki,5 The Belmont Report,6 Guidelines
p.000005: of the Council for International Organizations of Medical Sciences (CIOMS),7 the Nuffield Council Guidance
p.000005: on ethics of research related to health care in devel- oping countries,8,9 the UNAIDS/WHO Ethical
p.000005: considerations in biomedical HIV prevention trials,1 and various national guidelines.
p.000005: GPP is unique, as it is the only global guidance document to provide guidance about the relationship between a trial’s
p.000005: funders, sponsors, and implementers, and other stakeholders in the context of biomedical HIV prevention trials. Good
p.000005: Clinical Practice (GCP), in contrast, provides ethical guidance specifically for the relationship between investigators
p.000005: and trial participants and for ensuring the integrity of trial data.
p.000005: The principles of GPP in Section 2 apply to all biomedical HIV preven- tion trials, as they outline expectations and
p.000005: the foundations for building meaningful partnerships among stakeholders in biomedical HIV preven- tion research.
p.000005: The good participatory practices outlined in the 16 topic areas of Section 3 of these guidelines are applicable to all
p.000005: large-scale effectiveness and efficacy trials.
p.000005:
p.000006: 6
p.000006:
p.000006: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000006:
p.000006:
p.000006: The complete GPP guidelines are most relevant for trials that are larger and have substantial impacts on
p.000006: individuals and areas where trials are conducted. However, the GPP guidelines can also serve as a guide for other
p.000006: types of trials and studies. Examples of these can include smaller safety studies, follow-on studies, behavioural
p.000006: studies, HIV treatment trials, and studies of other diseases.
p.000006:
p.000006: Development of the GPP guidelines
p.000006: The GPP guidelines were born out of a recommendation from the UNAIDS Creating Effective Partnerships in
p.000006: Research process in 200510 that was a response to the controversies and debates of pre-exposure prophylaxis
p.000006: (PrEP) trials in Cambodia and Cameroon.11, 12, 13
p.000006: Development of the original guidelines, led by an international working group, involved exploration and analysis of
p.000006: different viewpoints and the creation of objective measures of community stakeholder engagement in the design and
p.000006: conduct of biomedical HIV prevention trials. Feedback on the draft set of guidelines was provided via interviews,
p.000006: e-mail requests, and listserv postings and represented a diverse range of perspectives, geography, and expertise
p.000006: including advocates, trial site staff, researchers, clinical trial investigators, community liaison officers, members
p.000006: of community advisory boards,policy-makers,industry representatives,research funders,and sponsors.
p.000006: The GPP guidelines were published in 2007, applied in different settings, and were the subject of formal consultations
p.000006: with stakeholder groups in Africa, the Americas, Asia, and Europe. These AVAC-supported consulta- tions validated the
p.000006: importance of the adoption of the GPP guidelines by trial sponsors and of their implementation at trial sites around
p.000006: the world. Recommendations from the consultations have been incorporated in this second edition of the GPP guidelines.
p.000006: The GPP guidelines are dynamic and will change over time. Recom- mendations for modifications and refinements based on
p.000006: experience and reflection can be sent to gpp@unaids.org or avac@avac.org. They will be gratefully received and
p.000006: considered in future updates of the guidelines.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: UNAIDS / AVAC
p.000007:
p.000007:
p.000007: Figure 1. GPP Timeline
p.000007:
p.000007:
p.000007: Timeline of GPP and Ethical Considerations
p.000007: GPP Guidelines Ethical Considerations
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: July: Cambodia government decides not to support PrEP trial16
p.000007:
p.000007: February: Cameroon stops PrEP trial in progress16
p.000007: March: Nigerian PrEP trial is discontinued16
p.000007:
p.000007: May: IAS global PrEP consultation with trial sponsors, researchers, and advocates17
p.000007:
p.000007: April & June: UNAIDS ‘Creating Effective Partnerships’ regional consultations10
p.000007:
p.000007: June: UNAIDS ‘Creating Effective Partnerships’ international consultation10
p.000007:
p.000007: September: UNAIDS/AVAC working group starts drafting GPP guidelines for biomedical HIV prevention trials
p.000007:
p.000007: May – June: Multiple global stakeholders review draft of GPP guidelines
p.000007:
p.000007: July: Pre-publication draft of GPP guidelines released for comments
p.000007: November: UNAIDS/AVAC GPP guidelines,
p.000007: 1st Edition published18
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: August 2008 – May 2009: Global GPP consultations sponsored by AVAC with multiple stakeholder groups
p.000007:
p.000007: May: AVAC report-back meeting from global consultations
p.000007:
p.000007: May 2009 – May 2010: Synthesis of recommendations from global consultations; revision of GPP guidelines
p.000007: March: AVAC/UNAIDS GPP Revision Working Group Meeting
p.000007: July: Draft version of GPP guidelines,
p.000007: 2nd Edition released for public comment
p.000007: GPP guidelines, 2nd Edition published
p.002000: 2000
p.002000:
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p.002004: 2004
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p.002005: 2005
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p.002006: 2006
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p.002010: 2010
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p.002010:
p.002010:
p.002010:
p.002011: 2011
p.002011:
p.002011: February: UNAIDS regional consultations on ethical considerations in international HIV vaccine trials14
p.002011:
p.002011: May: Ethical considerations in HIV preventive vaccine research UNAIDS guidance document published15
p.002011:
p.002011:
p.002011:
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p.002011:
p.002011:
p.002011:
p.002011: May: UNAIDS/WHO establish working group to revise Ethical considerations
p.002011:
p.002011: July: UNAIDS/WHO Expert Committee Meeting to revise Ethical considerations
p.002011:
p.002011: July: Pre-publication draft of Ethical considerations released for comments
p.002011: November: UNAIDS/WHO
p.002011: Ethical considerations in biomedical HIV prevention trials published1
p.002011:
p.002011:
p.002011:
p.002011:
p.002011:
p.002011:
p.002011: June: UNAIDS/WHO Eastern Europe- Central Asia expert consultation on the ethical engagement of people who inject drugs
p.002011: in HIV prevention trials
p.002011:
p.002011: December: UNAIDS/WHO Asia region expert consultation on the ethical engagement of people who inject drugs in HIV
p.002011: prevention trials
p.002011:
p.002011: April: UNAIDS/WHO Latin America- Caribbean expert consultation on the ethical engagement of people who inject drugs in
p.002011: HIV prevention trials
p.002011:
p.002011: Guidance Point 20: People who inject drugs
p.002011:
p.000008: 8
p.000008:
p.000008: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: This timeline shows the development of the UNAIDS/AVAC Good Participatory Practice guide- lines for biomedical HIV
p.000008: prevention trials and the UNAIDS/WHO Ethical considerations for biomedical HIV prevention trials. The GPP
p.000008: guidelines document was developed after a series of regional consultations in 2005 that focused on defining the key
p.000008: elements needed for creating effective partnerships for HIV prevention trials. The first GPP guidelines document was
p.000008: published in 2007. It was developed as a companion to the UNAIDS/WHO guidance document Ethical considerations that
p.000008: addresses key ethical issues in a set of guidance points with commentaries.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
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p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: UNAIDS / AVAC
p.000009:
p.000009:
p.000009: Organisation and how to use the GPP guidelines
p.000009: The GPP guidelines are presented in three main sections that are colour- coded to enable users to easily navigate the
p.000009: document:
p.000009:
p.000009: Section 1: The importance of good participatory practice defines the key terms used in the document and describes the
p.000009: realities and the underlying determinants of the HIV epidemic, the context of conducting biomedical HIV prevention
p.000009: trials, and why a participatory approach is necessary to effectively conduct trials.
p.000009:
p.000009: Section 2: Guiding principles of GPP in biomedical HIV preven- tion trials outlines the set of principles that serve
p.000009: as the foundation of the relationships among trial funders, sponsors, and implementers and other stakeholders.These
p.000009: principles include respect, mutual under- standing, integrity, transparency, accountability, and community stake-
p.000009: holder autonomy.
p.000009:
p.000009: Section 3: Good participatory practices in biomedical HIV prevention trials describes optimal practices
p.000009: to follow when designing and conducting biomedical HIV prevention trials. Under 16 topic areas, this section outlines
p.000009: expected stakeholder engagement activities that take place at each stage of the research life-cycle.The topic areas
p.000009: are:
p.000009:
p.000009: 1. Formative research activities 9. Informed consent process
p.000009: 2. Stakeholder advisory mechanisms 10. Standard of HIV prevention
p.000009: 3. Stakeholder engagement plan 11. Access to HIV care and treatment
p.000009: 4. Stakeholder education plan 12. Non HIV-related care
p.000009: 5. Communications plan 13. Policies on trial-related harms
p.000009: 6. Issues management plan 14. Trial accrual, follow-up, and exit
p.000009: 7. Site selection 15. Trial closure and results dissemination
p.000009: 8. Protocol development 16. Post-trial access to trial products or
p.000009: procedures
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000010:
p.000010:
p.000010: Topic areas in the good participatory practices section are divided into the following subsections:
p.000010: A. Definition.
p.000010: B. Relevance to good participatory practice.
p.000010: C. Special considerations.
p.000010: D. Good participatory practices.
p.000010: E. Additional guidance.
p.000010:
p.000010: After the Conclusion (pages 66-67), the reader will find three useful annexes:
p.000010:
p.000010: Annex 1 presents the acronyms and abbreviations used in this document. Annex 2 is a glossary of the essential terms
p.000010: used throughout the GPP guidelines. Annex 3 introduces other international reference guidelines and key documents,
p.000010: for further reading.
p.000010:
p.000010:
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p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: UNAIDS / AVAC
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Section 1:
p.000011: The Importance of Good Participatory Practice
p.000011: Section 2:
p.000011: Guiding Principles
p.000011: of GPP in Biomedical HIV Prevention Trials
p.000011: Section 3:
p.000011: Good Participatory Practices in Biomedical HIV Prevention Trials
p.000011:
p.000011:
p.000011: The Importance of Good Participatory Practice defines the key terms used in the document and describes the realities
p.000011: and the underlying determinants of the HIV epidemic, the context of conducting biomedical HIV prevention trials, and
p.000011: why a participatory approach is necessary to effectively conduct trials.
p.000011: Guiding Principles of GPP in Biomedical HIV Prevention Trials outlines the set of principles that serve as the
p.000011: foundation of
p.000011: the relationships among trial funders, sponsors, and implementers and other stakeholders.
p.000011: Good Participatory Practices in Biomedical HIV Prevention Trials describes optimal practices for trial funders,
p.000011: sponsors,
p.000011: and implementers to follow when designing, conducting, and concluding biomedical HIV prevention trials. Under 16 topic
p.000011: areas, this section outlines expected stakeholder engagement activities that take place at each stage of the research
p.000011: life-cycle.
p.000011:
p.000011:
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p.000012: 12
p.000012:
p.000012: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Section 1:
p.000012: The Importance of Good Participatory Practice
p.000012:
p.000012: Section 2:
p.000012: Guiding Principles
p.000012: of GPP in Biomedical HIV Prevention Trials
p.000012:
p.000012: Section 3:
p.000012: Good Participatory Practices in Biomedical HIV Prevention Trials
p.000012:
p.000012:
p.000012: Use this section to understand the meaning of stakeholder engage- ment, the context of biomedical HIV prevention
p.000012: trials, and why a participatory approach is necessary to effectively conduct trials
p.000012:
p.000012:
p.000012: Who are Stakeholders?
p.000012:
p.000012:
p.000012: What is Stakeholder Engagement?
p.000012:
p.000012:
p.000012: The Wider Context of HIV
p.000012:
p.000012: The Dynamics of Biomedical HIV Prevention Trials
p.000012:
p.000012: Rationale for GPP Guidelines
p.000012:
p.000012:
p.000012: Applying GPP
p.000012: Use this section to understand the principles that guide the foundation of the relationships among biomedical HIV
p.000012: preven- tion stakeholders
p.000012:
p.000012:
p.000012: Respect
p.000012:
p.000012:
p.000012: Mutual Understanding
p.000012:
p.000012:
p.000012: Integrity
p.000012:
p.000012:
p.000012: Transparency
p.000012:
p.000012:
p.000012: Accountability
p.000012:
p.000012:
p.000012: Community Stakeholder Autonomy
p.000012: Use this section and its optimal practices to guide specific stakeholder engagement activities when conducting
p.000012: biomedical HIV prevention trials
p.000012:
p.000012: Formative Research Activities
p.000012: Stakeholder
p.000012: Advisory Mechanisms
p.000012: Stakeholder Engagement Plan
p.000012: Stakeholder Education Plan
p.000012:
p.000012: Communications Plan Issues Management Plan Site Selection
p.000012: Protocol Development
p.000012:
p.000012: Informed Consent Process
p.000012: Standard of HIV Prevention
p.000012: Access to HIV Care and Treatment
p.000012:
p.000012: Non HIV-Related Care
p.000012:
p.000012: Policies on
p.000012: Trial-Related Harms
p.000012: Trial Accrual, Follow-Up, and Exit
p.000012: Trial Closure and Results Dissemination
p.000012: Post-trial Access to Trial Products or Procedures
p.000012:
p.000013: 13
p.000013:
p.000013: UNAIDS / AVAC
p.000013:
p.000013:
p.000013: 1. The importance of good participatory practice
p.000013:
p.000013: 1.1 Who are stakeholders?
p.000013: The starting point of good participatory practice is the identification of key stakeholders in the conduct of a
p.000013: biomedical HIV prevention trial. Stakeholders are individuals, groups, organisations, government bodies, or any other
p.000013: individuals or collections of individuals who can influence or are affected by the conduct or outcome of a biomedical
p.000013: HIV prevention trial. In this guidance document, the term “stake- holders” is all-encompassing. It describes any
p.000013: individual or collection of individuals who have a stake in a biomedical HIV prevention trial.
p.000013:
p.000013: Examples of stakeholders are illustrated in Figure 2 and can include trial participants, families of trial
p.000013: participants, prospective trial partic- ipants, individuals resident within, or surrounding, the area where research is
p.000013: conducted, people living with HIV or affected by HIV, prevention and treatment advocates and activists,
p.000013: non-governmental organisations (NGOs), community-based organisations (CBOs), community groups, religious leaders,
p.000013: opinion leaders, media, govern- ment bodies, national and local health-care authorities, service providers,
p.000013: trial funders, trial sponsors, and trial implementers.
p.000013:
p.000013: The definition of “community” is more complicated, as it is a dynamic term that has different meanings to
p.000013: different people.19 This term is often used to refer to a group of people who have a common set of interests, share a
p.000013: common set of characteristics, or live in a common area. Individuals can be a part of multiple “communities” at the
p.000013: same time. The term “community” is also used to refer to the public at large or to a physical location.
p.000013:
p.000013: In the GPP guidelines, the preferred term is “community stake- holders”, rather than “community”, and refers to both
p.000013: individuals and groups that are ultimately representing the interests of people who would be recruited to or
p.000013: participate in a trial, and others locally
p.000013:
p.000014: 14
p.000014:
p.000014:
p.000014:
p.000014: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000014:
p.000014:
p.000014: affected by a trial. Examples of “community stakeholders” are the population to be recruited, trial participants,
p.000014: people living in the area where the research is conducted, people living with HIV in the area, local HIV-positive
p.000014: groups or networks, people in the area who are affected by the HIV epidemic, local non-governmental organisa-
p.000014: tions, community groups, and community-based organisations. Trial funders, sponsors, and implementers, as well as
p.000014: government bodies or representatives of high-level authority structures, are explicitly excluded from the term
p.000014: “community stakeholders” but are clearly considered trial stakeholders.
p.000014:
p.000014: Figure 2. Layers of Biomedical HIV Prevention Trial Stakeholders
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Examples
p.000014:
p.000014:
p.000014: Trial Participant
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: m
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Various stakeholders may influence or be affected by a biomedical HIV prevention trial. Stakeholders include trial
p.000014: participants and other community stakeholders as well as a broader range of national and international stakeholders.
p.000014:
p.000015: 15
p.000015:
p.000015: UNAIDS / AVAC
p.000015:
p.000015:
p.000015: 1.2 What is stakeholder engagement?
p.000015: Of key importance in good participatory practice is sustained, collab- orative partnering with stakeholders. In the GPP
p.000015: guidelines, the term “stakeholder engagement” refers to processes through which trial funders, sponsors, and
p.000015: implementers build transparent, meaningful, collaborative, and mutually beneficial relationships with interested or
p.000015: affected individuals, groups of individuals, or organisations, with the ultimate goal of shaping research collectively.
p.000015:
p.000015: Successful stakeholder engagement requires a broad, inclusive, and multifaceted understanding of the context in
p.000015: which a biomed- ical HIV prevention trial is conducted. It begins with an inclusive perspective for identification of
p.000015: potential stakeholders. Stakeholder identification is a dynamic process, as stakeholders, interests, priorities,
p.000015: perspectives, and aspects of culture may change over time. Research teams are responsible for identifying stakeholders,
p.000015: a process which begins by determining the trial population to be recruited, consid- ering those who are affected by the
p.000015: trial in the local area, consulting with already known stakeholders, and building on that expertise to develop a richer
p.000015: understanding of potential and known stakeholders.
p.000015:
p.000015: Different stakeholders will have different perspectives. Some stake- holders will have competing interests or
p.000015: power imbalances within groups, as well as differences in social organisation, hierarchies, gender issues, and
p.000015: relative social and economic status that may then create division and disagreement during the course of a trial. If
p.000015: there is oppo- sition or disagreement among stakeholders, then those issues must be addressed in a way that is honest,
p.000015: transparent, and respectful to all parties.
p.000015:
p.000015: Stakeholders in biomedical HIV prevention research can learn from other fields that have successfully adopted
p.000015: participatory research approaches, which seek to engage community stakeholders as equal members who share control over
p.000015: all aspects of the research process.20,
p.000015: 21, 22, 23, 24
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000016:
p.000016:
p.000016: 1.3 The wider context of HIV
p.000016: There is an urgent need to develop additional strategies to address the HIV pandemic. Along with necessary behavioural
p.000016: and structural changes, a broad range of biomedical HIV prevention and treatment options is required to meet the
p.000016: diverse needs of individuals and populations. There are many inherent complexities in conducting biomedical HIV
p.000016: prevention trials. By acknowledging and under- standing these challenges and complexities, trial funders, sponsors,
p.000016: and implementers can more appropriately and effectively facilitate a mutually beneficial participatory approach to
p.000016: conducting biomedical HIV prevention trials.
p.000016:
p.000016: Biomedical HIV prevention research cannot succeed without mean- ingful stakeholder engagement, particularly given the
p.000016: need to involve large numbers of healthy, HIV-negative volunteers as trial partici- pants. It is optimal that
p.000016: experimental HIV prevention options are tested for safety and effectiveness in populations who need these interventions
p.000016: the most and are likely to use them should they prove effective. However, the very factors that increase HIV risk in
p.000016: such populations may contribute to increased vulnerability to exploitation. This underscores the importance of
p.000016: meaningful partnerships with community stakeholders.
p.000016:
p.000016: A wide range of factors creates, enhances, and perpetuates the risk of HIV infection. Structural determinants can
p.000016: increase vulnerability to HIV at an individual or population level by undermining ability to avoid HIV exposure.
p.000016: Underlying determinants of the HIV epidemic can be entrenched in the social, cultural, legal, institutional, or
p.000016: economic fabric of society. Examples of these determinants include gender and other power inequalities,
p.000016: gender-based violence, economic instability including poverty, migration, human rights
p.000016: violations,homophobia,discriminatory practices,HIV-related stigma, social marginalisation, and criminalisation of
p.000016: HIV transmission. Recognition of these factors is the first step in developing practices
p.000016:
p.000017: 17
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p.000017: UNAIDS / AVAC
p.000017:
p.000017:
p.000017: that avoid inadvertently replicating or reinforcing them in the design and conduct of biomedical HIV prevention
p.000017: trials.While stakeholder engagement helps empower and equip community stakeholders to engage in the research
p.000017: process in a meaningful fashion, it also harnesses the expertise that community stakeholders can contribute to the
p.000017: design and conduct of research.
p.000017:
p.000017: 1.4 The dynamics of biomedical HIV prevention trials
p.000017: Power inequalities always exist between funders and funding recipients with respect to a range of issues, such as
p.000017: decision-making processes, priority setting, control of resources, and equitable recognition of input. Biomedical HIV
p.000017: prevention trials are often funded by institu- tions in developed countries and conducted with multiple partner
p.000017: institutions worldwide, including those in developing countries. Disparities among these institutions and
p.000017: partners can introduce or reinforce power inequalities between and among trial implementers and the funders or sponsors
p.000017: of trials. This can then translate into inequalities between trial implementers and other stakeholders.
p.000017:
p.000017: The fact that many biomedical HIV prevention trials are conducted in multiple settings and countries introduces another
p.000017: level of complexity. Variation in cultures, physical environments, infrastructure, research experience, health
p.000017: policies, and national laws can introduce inequali- ties among research teams and between research teams and site-level
p.000017: community stakeholders. Power inequalities between research teams and community stakeholders can include
p.000017: imbalances in literacy, education, and economic resources, as well as those inherent in patient–provider
p.000017: relationships. National, racial, ethnic, and linguistic differences between members of research teams and
p.000017: community stakeholders can also exacerbate inequalities.
p.000017:
p.000017: In order to achieve meaningful community stakeholder participa- tion and partnership, it is essential to recognise
p.000017: these various power inequalities and address them.
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000018:
p.000018:
p.000018: Figure 3. Example of a Trial Network
p.000018:
p.000018: Funding From One or More Sources
p.000018:
p.000018:
p.000018: Sponsors
p.000018:
p.000018:
p.000018: Coordinating Centre
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Data Laboratory
p.000018:
p.000018: Clinical Safety
p.000018:
p.000018: Pharmacy
p.000018: Social Science Stakeholder
p.000018:
p.000018:
p.000018:
p.000018: Implementing Institution
p.000018:
p.000018: Trial Sites Trial Sites
p.000018:
p.000018:
p.000018: Basic structure of a typical biomedical HIV prevention trial network. Funding from one or more sources is distributed
p.000018: through a network coordinating centre directly to trial sites or to implementing institutions such as universities that
p.000018: then send funds to trial sites. Trial networks may have several centres responsible for different aspects of trial
p.000018: conduct: data management, laboratory, pharmacy, clinical, safety, social science, and stakeholder engagement.
p.000018: Monitoring of trial conduct may be executed through the coordinating centre or outsourced to an independent
p.000018: monitoring organisation.
p.000018:
p.000018:
p.000018: 1.5 Rationale for GPP guidelines
p.000018: Constructive long-term stakeholder engagement helps ensure the ethical and scientific quality of research as well
p.000018: as its relevance to community stakeholders.1,25 Stakeholders, in particular community stakeholders, have unique
p.000018: expertise to contribute to the research process. They possess critical knowledge and understandings of local
p.000018: cultures and perspectives, languages, dynamics of the local HIV epidemic, concerns of vulnerable or marginalised
p.000018: populations, and local priorities that trial funders, sponsors, and implementers may lack.
p.000018:
p.000019: 19
p.000019:
p.000019: UNAIDS / AVAC
p.000019:
p.000019:
p.000019: Stakeholder collaboration can help ensure that research questions and procedures are culturally sensitive and
p.000019: appropriate, thus improving recruitment, retention, adherence, and other trial outcomes. It can help avoid reinforcing
p.000019: existing inequalities and increase sensitivity to the needs of vulnerable populations. An essential component of
p.000019: stakeholder engagement is improving stakeholder knowledge and understanding of the research process, building
p.000019: research literacy and competencies. This, in turn, enables stakeholders to contribute more effectively to the process
p.000019: of guiding research and helps to address the power imbalance between research teams and community stake- holders.
p.000019:
p.000019: Strengthening meaningful collaboration among stakeholders fosters greater trust and respect between trial funders,
p.000019: sponsors, and imple- menters, and other stakeholders. Stakeholder engagement that is trans- parent and mutually
p.000019: respectful can minimise misunderstandings and reduce the chances of unnecessary conflict or controversy. Following good
p.000019: participatory practices through the entire research life-cycle helps facilitate local ownership of research, enables
p.000019: more equitable relationships, and increases the likelihood of successful research conduct, trial completion, and
p.000019: application of research results.
p.000019:
p.000019: 1.6 Applying GPP
p.000019: The GPP guidelines broadly describe systematic ways to establish and maintain effective stakeholder engagement that can
p.000019: be applied in diverse locations globally. The specificity of the content of the GPP guidelines enables monitoring of
p.000019: stakeholder engagement activities.
p.000019:
p.000019: The most effective way for the GPP guidelines to be implemented is for trial sponsors to adopt them as a requirement in
p.000019: trial conduct and to monitor their implementation and evaluate their effectiveness. As an essential element of
p.000019: successful trial implementation, effective
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000020:
p.000020:
p.000020: stakeholder engagement requires that trial sponsors provide ample time allocation, adequate human resources, and
p.000020: sufficient funds in site budgets for implementation of Section 3 of the GPP guidelines.
p.000020:
p.000020: Other stakeholders, such as national authorities, institutions, ethics committees, institutional review boards, and
p.000020: community stakeholders can also require that the GPP guidelines be followed when research is conducted in their
p.000020: country, institution, or area.
p.000020:
p.000020: Monitoring stakeholder engagement is a complex process. To measure whether the GPP guidelines are being
p.000020: followed, stake- holders can first consult the list of optimal practices in each topic area of Section 3 and determine
p.000020: if the various activities have been executed. Because stakeholder engagement is based on relationships, it may be
p.000020: perceived differently by different stakeholders and may be difficult to measure. Comprehensive monitoring of GPP
p.000020: compliance includes documenting and analysing how well practices have been followed as well as to what extent
p.000020: stakeholders feel the practices have been followed. Comprehensive evaluation of stakeholder engagement requires
p.000020: determining how stakeholders feel regarding the impact of those participatory practices on research and stakeholder
p.000020: relation- ships. This information can be gained through site records, meeting minutes, monitoring report forms,
p.000020: surveys, interviews, focus group discussions, and other methods.
p.000020:
p.000020: A variety of other resources and tools may help stakeholders under- stand, implement, and monitor GPP. Users can
p.000020: refer to AVAC’s website for new or revised materials. UNAIDS and AVAC welcome requests for additional tools as well as
p.000020: submissions of materials that are already in use.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000021: 21
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p.000021: UNAIDS / AVAC
p.000021:
p.000021:
p.000021: 2. Guiding principles of GPP in biomedical HIV prevention trials
p.000021: The guiding principles of good participatory practice described below reflect a set of values that constitute the
p.000021: foundation for positive, collab- orative, and mutually beneficial relationships that trial funders, sponsors, and
p.000021: implementers can foster with all other stakeholders. These prin- ciples are fundamental to sustaining partnerships and
p.000021: ensuring that collectively identified goals are achieved.They also serve to strengthen the foundation for conducting
p.000021: research that contributes to the iden- tification of additional HIV prevention options. The GPP guidelines have been
p.000021: developed within the framework of these principles.
p.000021:
p.000021: 2.1 Respect
p.000021: Respect among stakeholders is key to communicating effectively, fostering trust, and developing partnerships to
p.000021: achieve collective goals. Respect is demonstrated when stakeholders communicate and act in ways that value and honour
p.000021: each other’s perspectives and realities.
p.000021:
p.000021: Ethical research requires fundamental respect for human rights and for confidentiality of trial participants. It also
p.000021: requires respect for local values, cultures, and perspectives as well as respect for the scientific process.
p.000021:
p.000021: 2.2 Mutual understanding
p.000021: A common understanding about objectives and how to achieve them is essential to effective partnerships among
p.000021: stakeholders.This requires stakeholders to develop competency in both socio-cultural issues and research processes. The
p.000021: initial competency level of different stake- holders will depend on their prior exposure to specific socio-cultural
p.000021: environments and to biomedical HIV prevention trials.
p.000021:
p.000021: Socio-cultural competency includes understanding the norms, practices, and beliefs of relevant local cultures, and
p.000021: local social circum-
p.000021:
p.000022: 22
p.000022:
p.000022: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000022:
p.000022:
p.000022: stances, as well as diverse community stakeholder perspectives, priori- ties, and research needs. Building
p.000022: socio-cultural competency enables collaboration among stakeholders with diverse priorities and informs the development
p.000022: of appropriate trial designs and procedures.
p.000022:
p.000022: Research competency includes understanding the scientific process of defining research questions, developing
p.000022: appropriate trial designs, and collecting, analysing, and disseminating data to ensure valid results. Building research
p.000022: competency enables and empowers stakeholders to provide meaningful input into the research process and enhances
p.000022: understanding of the concepts, purposes, practices, limitations, and results of biomedical HIV prevention trials.
p.000022:
p.000022: Figure 4. Trial Competency Range
p.000022: high
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Socio-cultural competency
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: low high
p.000022: Research competency
p.000022:
p.000022: Socio-cultural and research competency are shown as gradients along two axes. Individual stakeholders start
p.000022: their involvement at a particular position on the graph, based on their socio-cultural competency and their research
p.000022: competency. A principal investigator new to a particular location may have high research competency but low
p.000022: socio-cultural competency at the start of the design phase of a trial. A community stakeholder new to
p.000022: biomedical HIV prevention research may have high socio-cultural competency but low research competency when their
p.000022: involvement with a trial begins. All stakeholders share ongoing responsibility to review and strengthen both
p.000022: socio- cultural and research competencies in order to improve mutual understanding.
p.000022:
p.000023: 23
p.000023:
p.000023: UNAIDS / AVAC
p.000023:
p.000023:
p.000023: 2.3 Integrity
p.000023: Maintaining the highest standards of scientific and ethical integrity is fundamental to achieving the scientific goals
p.000023: of a biomedical HIV prevention trial, maximising benefits for community stakeholders, and advancing global HIV
p.000023: prevention science.
p.000023: Scientific integrity requires adherence to scientific processes in order to ensure that trials meet the highest
p.000023: scientific standards and achieve valid results.
p.000023: Ethical integrity requires consideration of broader societal and ethical issues as well as adherence to
p.000023: universal ethical principles that include respect for persons, beneficence, and justice.6
p.000023:
p.000023: 2.4 Transparency
p.000023: Open, honest, timely, and clear communication enables transpar- ency and fosters collaborative, trusting, and
p.000023: constructive relationships. Transparency is relevant to the research process as well as to the roles of stakeholders.
p.000023: Transparency about research includes ensuring that stakeholders receive open, honest, and understandable information
p.000023: about the objectives and processes of a trial. Transparency means ensuring that feedback from a broad range of
p.000023: stakeholders is acknowledged and addressed.
p.000023: Transparency about the role of stakeholders includes ensuring that stakeholders are clear on their respective roles and
p.000023: responsibilities; the constituents, if any, they each represent; and the extent to which their input may influence
p.000023: trial-related decisions. Adherence to the principle of transparency means that stakeholders communicate about
p.000023: circumstances that may affect previously agreed levels of consultation, involvement, collaboration, and
p.000023: decision-making.
p.000023:
p.000023: 2.5 Accountability
p.000023: Accountability is fundamental to sustaining relationships built on trust and mutual respect.
p.000023:
p.000024: 24
p.000024:
p.000024: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000024:
p.000024:
p.000024: Trial funders, sponsors, and implementers are accountable to the society at large for conducting scientifically
p.000024: valid and ethical research. They are accountable to all research stakeholders for the use of partic- ipatory practices
p.000024: and for responding to input from relevant stake- holders as mutually agreed. They are also accountable for ensuring
p.000024: that funding is adequate to enable optimal engagement between research teams and other stakeholders.
p.000024: Community stakeholders and other relevant stakeholders are accountable for ensuring that their input into
p.000024: the research process is fair and constructive, respects the scientific process, and is in the best self-identified
p.000024: interests of community stakeholders.Where stake- holders accept the responsibility to act as liaisons or
p.000024: representatives between research teams and other stakeholders, they are accountable for representing the interests of
p.000024: those they represent, sharing informa- tion about planned or ongoing trials with them, and expressing their needs and
p.000024: concerns to research teams.
p.000024:
p.000024: 2.6 Community stakeholder autonomy
p.000024: Community stakeholder autonomy describes the community stake- holders’ right to support or refuse proposals to conduct
p.000024: research in a particular area, depending on the community stakeholders’ self-iden- tified interests and desires.
p.000024: Different stakeholder groups may well have different perspectives on the relevance or appropriateness of a specific
p.000024: trial, adding complexity to the situation.
p.000024: Good participatory practice strives to maximise the opportunity for stakeholders to understand the local, national, and
p.000024: global benefits of a specific trial and to make informed decisions regarding the appropri- ateness of a proposed trial.
p.000024: While a wide range of stakeholders generally participates in the design, approval, and implementation of a
p.000024: particular trial protocol, the self-identified interests of community stakeholders ultimately determine whether
p.000024: or not a trial is conducted in a particular area.
p.000024:
p.000024:
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p.000025:
p.000025:
p.000025: 3. Good participatory practices in biomedical HIV prevention trials
p.000025:
p.000025: Introduction to good participatory practices
p.000025: The design, planning, and implementation of biomedical HIV preven- tion trials are guided by a range of standards such
p.000025: as Good Clinical Practice,2,3 Good Clinical Laboratory Practice,4 and Good Manufacturing Practice.26 This
p.000025: section describes a systematic framework that trial funders, sponsors, and implementers can use to develop
p.000025: meaningful and sustained partnerships with relevant stakeholders in the planning and conduct of biomedical HIV
p.000025: prevention trials. The good partici- patory practices are intended to be adopted by trial sponsors, imple- mented at
p.000025: trial sites globally, and monitored.
p.000025: Appropriate and meaningful stakeholder engagement occurs at all stages of the research life-cycle—from trial design to
p.000025: results dissem- ination—and is not limited to the specific topic areas highlighted in this section. While this section
p.000025: describes stakeholder engagement processes in the general sequence in which they may occur, these processes are not
p.000025: necessarily sequential or time-limited; they can take place as parallel, overlapping, or ongoing activities.
p.000025: The application of each practice or set of practices will vary by location, the type of trial being
p.000025: conducted, and trial site experi- ence with respect to previously established stakeholder engagement programmes and
p.000025: activities.
p.000025: The good participatory practices section is divided into 16 topic areas covering the course of the research
p.000025: life-cycle.Topic areas in section 3 are divided into the following subsections:
p.000025: A. Definition.
p.000025: B. Relevance to good participatory practice.
p.000025: C. Special considerations.
p.000025: D. Good participatory practices.
p.000025: E. Additional guidance.
p.000025:
p.000026: 26
p.000026:
p.000026: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000026:
p.000026:
p.000026: 3.1 Formative research activities
p.000026: 3.1.A. Definition
p.000026: Formative research activities enable research teams to gain an informed understanding of local populations,
p.000026: socio-cultural norms and practices, local power dynamics, local percep- tions, channels of communication and
p.000026: decision-making, and local history of research, as well as the needs and priorities of people who are locally affected
p.000026: by and able to influence the trial. Formative research activities usually constitute the initial phase of stakeholder
p.000026: outreach and engagement.
p.000026:
p.000026: 3.1.B. Relevance to good participatory practice
p.000026: Collaborating with community stakeholders to devise questions, gather information, and analyse results related to
p.000026: formative research activities ensures that stakeholders’ expertise and under- standing of local perceptions, cultures,
p.000026: and traditions inform trial design and conduct. Collaborating with community stakeholders on formative research
p.000026: activities builds trust and lays the founda- tion for meaningful engagement.
p.000026:
p.000026: 3.1.C. Special considerations
p.000026: 1. Formative research activities can be conducted informally to gather information about local populations and research
p.000026: areas or formally as a part of approved, funded protocols.
p.000026: 2. Different sites will have specific needs regarding formative research activities. Whereas new trial sites may
p.000026: require extensive formative research activities, experienced trial sites may require more focused activities.
p.000026: Studying an experi- mental option new to the area, recruiting from a new location or population,
...
p.000027: 3.1.D. Good participatory practices for formative research activities
p.000027: 1. Research teams identify key informants and relevant stake- holders that can assist in planning, implementing,
p.000027: and reviewing the process and results of formative research activi- ties (see also Section 1.2).
p.000027: 2. Research teams designate trial site staff responsible for managing formative research activities.
p.000027: 3. Research teams and relevant stakeholders develop a formative research activity plan that describes:
p.000027: a. Key information and questions that need to be gathered and answered in order to support effective planning and
p.000027: implementation of the trial.
p.000027: b. The most appropriate methods to collect the required information.
p.000027: c. Research team members and community stakeholders best suited to collect the required information.
p.000027: d. Approval or notification processes that are required for specific activities.
p.000027: e. Implementation plans, including timelines and required resources.
p.000027: 4. Research teams and relevant stakeholders discuss the findings and their implications for trial design, conduct, and
p.000027: develop- ment of meaningful stakeholder engagement.
p.000027: 5. Research teams document formative research activities and findings, including techniques used, information
p.000027: collected, areas where clarification or attention is needed, and how findings will inform the trial planning and
p.000027: implementation process.
p.000027: 6. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000027: conduct formative research activities.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
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p.000028:
p.000028: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000028:
p.000028:
p.000028: 3.2 Stakeholder advisory mechanisms
p.000028: 3.2.A. Definition
p.000028: The term “stakeholder advisory mechanisms” refers to strategies or approaches that facilitate meaningful dialogue among
p.000028: research teams and relevant stakeholders about planned or ongoing clinical trials. Stakeholder advisory
p.000028: mechanisms provide research teams with information about relevant stakeholders’ perspectives on the design, planning,
p.000028: and implementation of a specific clinical trial and facilitate open communication about research goals,
p.000028: processes, and results. These mechanisms also provide relevant stakeholders with the opportunity to engage with
p.000028: research teams during the life-cycle of a trial.
p.000028: Stakeholder advisory mechanisms may be informal or formal. They can be built and sustained by the trial site or may
p.000028: already exist in the area.
p.000028: 1. Informal stakeholder advisory mechanisms may be events or less formal means by which research teams seek
p.000028: relevant stakeholders’ views on proposed or ongoing research. Examples include stakeholder meetings, local
p.000028: events, focus group discussions, interviews, consultations, and suggestion boxes. They may involve individuals,
p.000028: existing organisations, local employer associations, local government or traditional committees, or other advocacy,
p.000028: charitable, cultural, political, religious, or social groups.
p.000028: 2. Formal stakeholder advisory mechanisms typically involve established groups that develop an ongoing
p.000028: relationship with the research team at a particular trial site. Examples are trial participant groups (former or
p.000028: current participants),professional groups (local scientists, service providers, media, or experts on local
p.000028: socio-cultural issues), non-governmental organisation advisory groups (with representatives from different non-
p.000028: governmental organisations or community-based organisa- tions), and community advisory boards (see definition
p.000028: below).
p.000028: 3. Community advisory boards (CABs), also referred to as community advisory groups (CAGs), are a common
p.000028: example of a formal stakeholder advisory mechanism. They are composed of individuals or stakeholder representatives
p.000028:
p.000029: 29
p.000029:
p.000029: UNAIDS / AVAC
p.000029:
p.000029:
p.000029: and provide an independent advisory voice. They facili- tate community stakeholder participation and involvement
p.000029: in the research process. They meet regularly with research team representatives, inform community stakeholders about
p.000029: proposed and ongoing research, and provide feedback to research teams about local norms and beliefs, as well as
p.000029: local views and concerns that arise during specific trials.
p.000029: The composition of community advisory boards or groups varies from site to site but is intended to reflect the
p.000029: diversity of community stakeholder interests and needs. They may include members or representatives of the
p.000029: surrounding area, individuals in the population from which participants will be recruited, people living with or
p.000029: affected by HIV, current or former trial participants, religious or opinion leaders, and representatives of other
p.000029: sections of society as determined by the trial’s location and eligibility criteria.
p.000029:
p.000029:
p.000029: Figure 5. Examples of Stakeholder Advisory Mechanisms
p.000029:
p.000029: Stakeholder Advisory Mechanisms
p.000029:
p.000029:
p.000029: Informal Formal
p.000029:
p.000029: E x a m p l e s o f M e c h a n i s m s
p.000029:
p.000029: Stakeholder meetings
p.000029: Local events
p.000029: Ongoing dialogue with CBOs
p.000029: Focus group discussions
p.000029: Call in radio shows
p.000029: CABs NGO
p.000029: advisory groups
p.000029: Participant groups
p.000029: Groups already established in the area
p.000029:
p.000029:
p.000029: Stakeholder advisory mechanisms can include informal and formal stakeholder advisory mechanisms (see definition 3.2.A).
p.000029: All of these mechanisms, as well as others, may be used to facilitate important dialogue between research teams and
p.000029: other stakeholders. While community advisory boards (CABs) are one example of a stakeholder advisory
p.000029: mechanism, there are many other ways that research teams can effectively engage with stakeholders.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
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p.000030:
p.000030: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000030:
p.000030:
p.000030: 3.2.B. Relevance to good participatory practice
p.000030: Establishment, maintenance, and engagement of stakeholder advisory mechanisms throughout the research process are
p.000030: key to establishing meaningful partnerships with community stake- holders and to ensuring continuous dialogue about
p.000030: biomedical HIV prevention research and specific trials.
p.000030:
p.000030: 3.2.C. Special considerations
p.000030: 1. Community advisory boards or groups were first developed in the context of HIV research in the United States of
p.000030: America and Europe. Over the past two decades, they have become a standard element of HIV research worldwide.
p.000030: Nonetheless, the establishment of a community advisory board or group may not always translate as best practice
p.000030: in all locations globally. In many settings, they are necessary but not sufficient for gaining adequate and
p.000030: appropriate community stakeholder input. Careful consideration needs to be given to the range of stakeholder advisory
p.000030: mechanisms that are required to best support effective participatory practices.
p.000030: 2. The need to identify and establish new stakeholder advisory mechanisms may vary from site to site and within a
p.000030: single site, over time. Stakeholder identification and inclusion considers the dynamic stakeholder landscape, as well
p.000030: as whether a trial is conducted in a research-naïve area or at a well-established research facility.
p.000030: 3. Formative research activities (see Section 3.1) help research teams to comprehensively identify which groups or
p.000030: individ- uals are relevant stakeholders and why.
p.000030: 4. While community advisory boards or groups can assist research teams in thinking about best strategies
p.000030: for trial recruitment, individual members of community advisory boards or groups are not research staff and do
p.000030: not participate in implementing actual trial procedures such as recruitment of prospective participants.
p.000030: 5. While community advisory boards or groups are often funded by research networks or trial sites, they are intended
p.000030: to be an independent advisory voice that is free to express concerns about proposed or ongoing research.
p.000030:
p.000031: 31
p.000031:
p.000031:
p.000031:
p.000031: UNAIDS / AVAC
p.000031:
p.000031:
p.000031: Figure 6. The Role of Community Advisory Boards
p.000031:
p.000031: y
p.000031:
p.000031:
p.000031:
p.000031: Research Team
p.000031: CAB
p.000031: Stakeholders
p.000031:
p.000031:
p.000031: y
p.000031:
p.000031:
p.000031: Community advisory boards (CABs) can play an important role in translating infor- mation between research teams and
p.000031: stakeholders. While community advisory boards are a key mechanism by which research teams inform stakeholders and
p.000031: receive their feedback, research teams are responsible for using other advisory mechanisms in addition to
p.000031: CABs to reach a broader range of stakeholders.
p.000031:
p.000031:
p.000031:
p.000031: Figure 7. Examples of How Research Teams can Engage with Stakeholders
p.000031:
p.000031: Ongoing dialogue with CBOs
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Research Team
p.000031:
p.000031: NGO advisory group
p.000031:
p.000031: Focus group discussions
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Stakeholders
p.000031:
p.000031: Local meetings or events
p.000031:
p.000031: CABs
p.000031:
p.000031:
p.000031: Examples of advisory mechanisms that research teams may use to engage with stake- holders to facilitate ongoing
p.000031: communication and collaboration.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
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p.000032: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000032:
p.000032:
p.000032: 3.2.D. Good participatory practices for stakeholder advisory mechanisms
p.000032: 1. Research teams comprehensively identify and map local stakeholders in order to determine which are relevant
p.000032: to trial implementation and key to sustained stakeholder engage- ment (see Section 1.2).
p.000032: 2. Research teams designate trial site staff responsible for managing activities and relationships involving
p.000032: stakeholder advisory mechanisms.
p.000032: 3. Research teams ensure that the development or identifica- tion of stakeholder advisory mechanisms is
p.000032: transparent to community stakeholders.
p.000032: 4. Research teams and relevant stakeholders identify stakeholder advisory mechanisms needed to ensure greater
p.000032: and more inclusive involvement of relevant stakeholders, in addition to community advisory boards or groups.
p.000032: 5. Research teams ensure that representation of stakeholders is comprehensive, including representatives of
p.000032: populations that will be recruited into trials, and that interactions with stake- holders are meaningful and responsive
p.000032: for all parties.
p.000032: 6. Research teams and relevant stakeholders identify the training needs of members of advisory mechanisms and build
p.000032: their capacity to understand concepts, purposes, practices, and limitations of clinical trials, increasing their
p.000032: ability to provide meaningful input to the research process.
p.000032: 7. Research teams review on an ongoing basis the composi- tion of existing mechanisms and the need for new advisory
p.000032: mechanisms to ensure that relevant stakeholders continue to be represented during the course of a trial.
...
p.000032: requests, concerns, recommendations, actions taken by the research team, and any unresolved issues that require
p.000032: follow-up.
p.000032:
p.000033: 33
p.000033:
p.000033: UNAIDS / AVAC
p.000033:
p.000033:
p.000033: 10. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000033: support establishment, ongoing capacity-building, maintenance, and activities of stakeholder advisory mechanisms.
p.000033: 11. For formal stakeholder advisory mechanisms, research teams and relevant stakeholders determine:
p.000033: a. The purpose of each stakeholder advisory mechanism, which may result in establishing terms of reference or
p.000033: by-laws.
p.000033: b. The scope of responsibilities of each stakeholder advisory mechanism, such as the responsibility to develop,
p.000033: review, discuss, and provide input on relevant trial documents and procedures.
p.000033: c. The structure of each stakeholder advisory mechanism, which may result in establishing guidelines to elect a chair-
p.000033: person and define the duration of service for members.
p.000033: d. The frequency of meetings, the frequency with which principal investigators or other key trial staff members attend
p.000033: meetings, and the ways in which members can communicate with research teams between meetings.
p.000033: e. Reimbursement policies, if appropriate.
p.000033: f. Mechanisms by which individuals or groups can raise concerns with research teams and with off-site
p.000033: trial sponsors in the event that a conflict or concern related to the site emerges.
p.000033: 3.2.E. Additional guidance
p.000033: See Recommendations for Community Involvement in National Institute of Allergy and Infectious Diseases
p.000033: HIV/AIDS Clinical Trials Research.27
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000034:
p.000034:
p.000034: 3.3 Stakeholder engagement plana
p.000034: 3.3.A. Definition
p.000034: The stakeholder engagement plan describes strategies and mecha- nisms for building relationships and constructively
p.000034: engaging with a broad range of local, national, and international stakeholders.
p.000034:
p.000034: 3.3.B. Relevance to good participatory practice
p.000034: A comprehensive stakeholder engagement plan enables research teams to collaborate with stakeholders and
p.000034: facilitate a more participatory approach to biomedical HIV prevention research. An effective stakeholder
p.000034: engagement plan will help research teams design and implement research that is effective and locally acceptable,
p.000034: and also lays the foundation for a supportive environ- ment for research that extends beyond the lifespan of a specific
p.000034: biomedical HIV prevention trial.
p.000034:
p.000034:
p.000034:
p.000034: Figure 8. Stakeholder Engagement through the Research Life-cycle
p.000034:
p.000034: Stakeholder Input and Engagement
p.000034:
p.000034:
p.000034: Research questions Protocol Recruitment Enrolment Follow-up Results Dissemination of results
p.000034: Resear c h Life-cycle
p.000034:
p.000034:
p.000034: Robust stakeholder engagement occurs at all stages of the research life-cycle, including during trial design,
p.000034: recruitment, implementation, trial closure, results dissemination, negotiations of next steps, and development of
p.000034: future research questions.
p.000034:
p.000034:
p.000034:
p.000034: a Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000034: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000034: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000034: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000034: clear.
p.000034:
p.000035: 35
p.000035:
p.000035: UNAIDS / AVAC
p.000035:
p.000035:
p.000035: 3.3.C. Special considerations
p.000035: Being familiar with and appreciating the relationship dynamics among different stakeholders increases the research
p.000035: team’s ability to effectively and constructively engage with a broad range of relevant stakeholders, deepens
p.000035: understanding of local context, and will inform the development of the stakeholder engagement plan.
p.000035:
p.000035: 3.3.D. Good participatory practices for stakeholder engagement planning
p.000035: 1. Research teams comprehensively identify relevant stake- holders (see Section 1.2 and Section 3.1)
p.000035: within and surrounding the research area as well as regionally, nationally, and internationally.
p.000035: 2. Research teams designate trial site staff responsible for managing activities and relationships involving
p.000035: stakeholder engagement planning.
p.000035: 3. Research teams and relevant stakeholders discuss and negotiate a stakeholder engagement plan to cover the
p.000035: life- cycle of the trial.The plan defines the following:
p.000035: a. The range of different stakeholders to be engaged, specifi- cally ensuring inclusion of relevant
p.000035: non-governmental organisations and community-based organisations and groups.
p.000035: b. The type of engagement that is appropriate for each stake- holder, such as being informed, consulted, collaborated
p.000035: with, or empowered to make decisions.
p.000035: c. The frequency and type of engagement methods to be used, such as public meetings, workshops, joint decision- making
p.000035: models, or delegated decision-making.
p.000035: d. The process by which new relevant stakeholders will be identified and engaged.
p.000035: e. The frequency with which the engagement plan will be reviewed.
p.000035: f. The criteria by which to review the success of the engage- ment plan.
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000036:
p.000036:
p.000036: 4. Research teams implement the plan and maintain clear written records of discussions and agreements, as
p.000036: well as stakeholder engagement activities. This includes stakeholder recommendations, actions taken by the research
p.000036: team, and any unresolved issues that require follow-up.
p.000036: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000036: manage activities and relationships involved in stakeholder engage- ment plans.
p.000036: 3.4 Stakeholder education planb
p.000036: 3.4.A. Definition
p.000036: The stakeholder education plan describes strategies and mecha- nisms for providing relevant education about a specific
p.000036: planned trial—and about biomedical HIV prevention research in general—in order to enhance research
p.000036: literacy.
p.000036:
p.000036: 3.4.B. Relevance to good participatory practice
p.000036: Effective stakeholder education is key to building research literacy and, ultimately, empowering community
p.000036: stakeholders as decision-making agents. Building research literacy lays the foun- dation for a supportive environment
p.000036: for research that extends beyond the lifespan of a specific biomedical HIV prevention trial.
p.000036:
p.000036: 3.4.C. Special considerations
p.000036: 1. While it is important that all relevant stakeholders improve their knowledge of research processes, enhancing
p.000036: research literacy for community stakeholders will foster more equitable relationships.
p.000036: 2. The goals and outcomes of stakeholder education are different from those of recruitment activities. While
p.000036: stakeholder
p.000036:
p.000036: b Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000036: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000036: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000036: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000036: clear.
p.000037: 37
p.000037:
p.000037: UNAIDS / AVAC
p.000037:
p.000037:
p.000037: education can positively influence trial recruitment activities, a stakeholder education plan can help clarify the
p.000037: differences between participant recruitment and stakeholder education.
p.000037: 3.4.D. Good participatory practices for stakeholder education planning
p.000037: 1. Research teams, with input from relevant stakeholders, determine what education is needed in order to enhance
p.000037: stakeholder understanding of, and engagement with, a specific planned trial and biomedical HIV prevention
p.000037: research more generally.
p.000037: 2. Research teams and relevant stakeholders discuss and negotiate a stakeholder education plan to cover the
p.000037: life-cycle of the trial.The plan defines the following:
p.000037: a. The range of different stakeholders that could benefit from specific education about HIV, HIV prevention
p.000037: options, and general research literacy.
p.000037: b. The level of knowledge that is optimal and desired by stakeholders to support effective engagement. This will be
p.000037: influenced by the type of engagement defined for each stakeholder in the stakeholder engagement plan (see
p.000037: Section 3.3).
p.000037: c. The methods and frequency of educational activities.
p.000037: d. The stakeholders who could also deliver or facilitate the delivery of activities in the stakeholder education plan.
p.000037: e. The frequency with which the stakeholder education plan will be reviewed.
p.000037: f. The criteria by which to review the success of the stake- holder education plan.
p.000037: 3. Research teams implement the plan and document stake- holder education activities, including questions that
p.000037: arise, topics that cause confusion, and suggestions for future educa- tional activities.
p.000037: 4. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000037: support activities outlined in the stakeholder education plan.
p.000037:
p.000038: 38
p.000038:
p.000038: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000038:
p.000038:
p.000038: 3.5 Communications planc
p.000038: 3.5.A. Definition
p.000038: The communications plan describes policies and strategies that will increase broad awareness of the trial, facilitate
p.000038: dissemina- tion and understanding of correct information about trial design, conduct, and results, and coordinate
p.000038: communication between the research team and relevant stakeholders.
p.000038:
p.000038: 3.5.B. Relevance to good participatory practice
p.000038: Ongoing, transparent, and accurate communication with relevant stakeholders about proposed and ongoing research is
p.000038: essential for respectful, transparent relationships and builds trust among stake- holders.Additionally, consultation
p.000038: with relevant stakeholders will help research teams design communications strategies that are effective and help create
p.000038: a supportive and conducive environ- ment for trial initiation and implementation.
p.000038:
p.000038: 3.5.C. Special considerations
p.000038: The communications plan exclusively addresses external commu- nication. However, effective internal communication,
p.000038: especially across multidisciplinary teams, is a prerequisite to attaining effective external communications.
p.000038:
p.000038: 3.5.D. Good participatory practices for communications planning
p.000038: 1. Research teams and relevant stakeholders comprehensively identify potential audiences within and
p.000038: surrounding the research area as well as regionally, nationally, and internationally.
p.000038: 2. Research teams and relevant stakeholders discuss and negotiate a communications plan to support open channels
p.000038:
p.000038: c Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000038: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000038: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000038: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000038: clear.
p.000038:
p.000039: 39
p.000039:
p.000039: UNAIDS / AVAC
p.000039:
p.000039:
p.000039: of communication about the trial throughout its life-cycle. The plan describes the following:
p.000039: a. The information needs of the different stakeholders at various stages of the research life-cycle, from early phases
p.000039: of stakeholder engagement to recruitment, enrolment, trial closure, and results dissemination.
p.000039: b. The key messages to be communicated about the trial, such as the purpose, risks, benefits, ongoing progress,
p.000039: closure, and results dissemination.
p.000039: c. The various communication methods that will be used for specific stakeholders, taking into account literacy levels
p.000039: and language needs.
p.000039: d. Local stakeholders who could deliver or facilitate commu- nications activities.
p.000039: e. Specific training needs necessary to effectively deliver messages.
p.000039: f. Procedures and timelines for disseminating information and procedures for actively addressing inquiries about the
p.000039: trial or HIV prevention research.
p.000039: g. The frequency with which the communications plan will be reviewed.
p.000039: h. The criteria by which to review the success of the commu- nications plan.
p.000039: 3. Research teams develop communication materials in under- standable language and translate them as needed,
p.000039: seeking input from relevant stakeholders.
p.000039: 4. Research teams implement the plan and maintain clear written records of discussions, agreements, and
p.000039: communica- tion activities.This includes relevant stakeholder recommen- dations, actions taken by the research team,
p.000039: and any unre- solved issues that require further follow-up.
p.000039: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000039: support activities outlined in the communications plan.
p.000039:
p.000039:
p.000039:
p.000040: 40
p.000040:
p.000040: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000040:
p.000040:
p.000040: 3.5.E. Additional guidance
p.000040: See Communications Handbook for Clinical Trials: Strategies, tips, and tools to manage controversy, convey your
p.000040: message, and dissemi- nate results.28
p.000040: 3.6 Issues management pland
p.000040: 3.6.A. Definition
p.000040: The issues management plan describes how research teams intend to manage issues of concern or any unexpected
p.000040: developments that may emerge before, during, or after the trial, including those that could limit the support for, or
p.000040: success of, the specific trial or future biomedical HIV prevention trials.
p.000040: Examples of the types of issues that may emerge are negative media coverage, rumours about the trial, socio-cultural
p.000040: taboos around certain trial procedures, developments in other HIV prevention trials, premature closure of a trial
p.000040: for reasons of harm, futility, or proven efficacy in interim analyses, recruitment chal- lenges, or protocol issues.
p.000040:
p.000040: 3.6.B. Relevance to good participatory practice
p.000040: The risk that unexpected developments will negatively affect a trial can be mitigated if research teams work closely
p.000040: with relevant stakeholders to identify and plan for such risks and if relevant stakeholders provide advice and
p.000040: direction on how to resolve issues when they do arise. By developing an issues management plan prior to trial
p.000040: implementation, research teams are better equipped to deal with issues or risks as they arise and are more likely to
p.000040: avert a crisis.
p.000040:
p.000040:
p.000040: d Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000040: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000040: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000040: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000040: clear.
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041: UNAIDS / AVAC
p.000041:
p.000041:
p.000041: 3.6.C. Special considerations
p.000041: Research teams may find it helpful to participate in communica- tions networks of biomedical HIV prevention trials to
p.000041: share and discuss emerging issues and their potential management.
p.000041:
p.000041: 3.6.D. Good participatory practices for issues management planning
p.000041: 1. Research teams identify and list all known issues that could emerge and undermine the success of the trial before,
p.000041: during, or after trial completion.
p.000041: 2. Research teams and relevant stakeholders discuss and negotiate an issues management plan to cover the
p.000041: life-cycle of the trial.The plan defines the following:
p.000041: a. A site-level strategy to manage unexpected developments and emerging concerns.
p.000041: b. Key trial site staff who are responsible for addressing emerging issues.
p.000041: c. A chain of communication within the research team and with relevant stakeholders for emerging issues.
p.000041: d. Relevant stakeholders who can act as advisers and help implement steps of the issues management plan.
p.000041: e. Key messages created to address anticipated concerns.
p.000041: f. Clear processes by which media reports and media requests will be addressed.
p.000041: 3. Research teams implement the plan and maintain clear written records of issues that emerge, how they are
p.000041: responded to, and their outcome.
p.000041: 4. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000041: support activities outlined in the issues management plan.
p.000041: 3.6.E. Additional guidance
p.000041: See Communications Handbook for Clinical Trials: Strategies, tips, and tools to manage controversy, convey your
p.000041: message, and dissemi- nate results.28
p.000041:
p.000042: 42
p.000042:
p.000042: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000042:
p.000042:
p.000042: 3.7 Site selection
p.000042: 3.7.A. Definition
p.000042: Site selection is the process by which trial funders, sponsors, or networks evaluate sites for funding for a trial
p.000042: protocol, inclusion in a multisite trial, or inclusion in a trial network.
p.000042:
p.000042: 3.7.B. Relevance to good participatory practice
p.000042: Site assessment of stakeholder engagement programmes or plans for their development is critical to anticipating a
p.000042: site’s ability to conduct a trial according to good participatory practice.
p.000042:
p.000042: 3.7.C. Special considerations
p.000042: New sites may not have the full range of stakeholder engage- ment plans and advisory mechanisms in place. Optimal
p.000042: sites for selection already have established stakeholder engagement processes and programmes or, in the
p.000042: case of new sites, have demonstrated commitment to establishing such processes.
p.000042:
p.000042: 3.7.D. Good participatory practices for site selection
p.000042: 1. Trial funders, sponsors, or network representatives assess sites with respect to stakeholder engagement programmes,
p.000042: taking into account the following issues:
p.000042: a. Evidence of or plans for development and maintenance of meaningful relationships with relevant stakeholders.
p.000042: b. Evidence of previous stakeholder engagement activities for sites that have conducted research.
p.000042: c. Findings from formative research activities or a workplan for completing formative research activities.
p.000042: d. Previous development of multiple stakeholder advisory mechanisms or a workplan to develop them.
p.000042: e. Demonstrated awareness and consideration of human rights issues that may be raised by the trial, particularly
...
p.000043: phase of the trial.
p.000043: 3.8 Protocol development
p.000043: 3.8.A. Definition
p.000043: Protocol development is the process of creating and modifying a trial protocol. The protocol describes the rationale,
p.000043: objectives, design, methodology, statistical considerations, ethical considera- tions, and organisation of a trial.
p.000043:
p.000043: 3.8.B. Relevance to good participatory practice
p.000043: A range of stakeholders can provide meaningful input into many aspects of trial protocol development. In particular,
p.000043: community stakeholders bring expertise that can assist research teams in ensuring that protocol designs and
p.000043: procedures are locally appro- priate, are acceptable to the trial population, and optimise successful
p.000043: implementation of the trial.
p.000043:
p.000043: 3.8.C. Special considerations
p.000043: 1. Opportunities for protocol review and input by local research teams and relevant stakeholders vary by trial. In
p.000043: some circum- stances, particularly multicountry or multisite trials, protocol development may be largely centralised.
p.000043: It is good practice in the protocol development process to incorporate mecha- nisms to facilitate stakeholder input
p.000043: early in the process.
p.000043: 2. Research teams can consider documenting community stake- holder input into protocol development and sharing these
p.000043: recommendations with protocol review bodies, even when not explicitly required by such bodies.
p.000043: 3.8.D. Good participatory practices for protocol development
p.000043: 1. Trial sponsors and network leadership provide opportuni- ties and time for local research teams to contribute to
p.000043: trial protocol development.
p.000043:
p.000044: 44
p.000044:
p.000044: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000044:
p.000044:
p.000044: 2. Trial sponsors, network leadership, and local research teams provide opportunities and time for local
p.000044: stakeholders, in particular community stakeholders, to contribute to trial design issues and procedures such as
p.000044: products to be tested, trial objectives, recruitment strategies, informed consent materials and procedures,
p.000044: reimbursement policies, counsel- ling approaches, follow-up procedures, and post-trial access to trial products or
p.000044: procedures.
p.000044: 3. Research teams maintain clear and transparent communica- tion about the protocol development process with relevant
p.000044: stakeholders, in particular, formal stakeholder advisory mech- anisms.
p.000044: 4. Research teams provide relevant stakeholders with draft versions of the protocol and make technical
p.000044: information as accessible as possible by providing protocol summaries and translated materials, or by facilitating
p.000044: workshops, as necessary.
p.000044: 5. Research teams inform relevant stakeholders of protocol reviews and approval processes and provide regular
p.000044: updates.
p.000044: 6. Trial sponsors or implementers make full, final protocols of trials available and easily accessible to
p.000044: stakeholders.
p.000044: 7. Research teams maintain clear written records of discussions and agreements. This includes relevant stakeholders’
p.000044: recom- mendations, actions taken by the research team, and any unre- solved issues that require follow-up.
p.000044: 8. Trial sponsors ensure sufficient funding and research teams allocate resources and time to support stakeholder
p.000044: engage- ment in the protocol development process.
...
p.000045: research staff is confidential. Only designated research staff members have access to confidential information about
p.000045: the identity of trial participants. The informed consent process itself is conducted in accordance with Good Clinical
p.000045: Practice.2
p.000045:
p.000045: 3.9.D. Good participatory practices for the informed consent process
p.000045: 1. Research teams discuss the following topics with community stakeholders during development of the informed consent
p.000045: materials and procedures:
p.000045: a. Who needs to be consulted locally to enable research teams to invite individuals to join the trial.
p.000045: b. What local cultural practices may affect individual deci- sion-making ability, and how working within these struc-
p.000045: tures can be facilitated while ensuring protection of indi- vidual autonomy to provide informed consent.
p.000045: c. The general literacy level of the population to be recruited and how to assess the literacy level of prospective
p.000045: partici- pants.
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000046:
p.000046:
p.000046: d. Considerations and requirements for illiterate participants, including discussion of possibilities of who may
p.000046: serve appropriately as a witness to the informed consent process.
p.000046: e. The prevalence of different languages in the area and which languages are required for obtaining
p.000046: informed consent from individuals.
p.000046: f. Local and legal forms of identity (name and age) verifica- tion and local practices around the use of names.
p.000046: g. The legal, local, and trial sponsor definitions of a “minor” and consideration of legal and local
p.000046: determinations of who can serve as a minor’s guardian.
p.000046: h. Locally appropriate reimbursement and compensation.
p.000046: i. Appropriate strategies to ensure participant rights are protected, including voluntariness of
p.000046: participation, ensuring undue inducement is avoided, and mitigating the influence of social desirability in influencing
p.000046: individual agreement to enrol.
p.000046: j. Strategies to ensure comprehension of informed consent materials and critical trial-related terms and
p.000046: concepts, including the use of visual or audio formats, flipcharts, props, analogies, and other supportive
p.000046: materials and methods.
p.000046: k. Techniques to assess comprehension of trial participation and the frequency with which they are to be used.
...
p.000046: ask questions or express concerns about trial participation.
p.000046: p. Ways to pilot informed consent materials.
p.000046:
p.000047: 47
p.000047:
p.000047: UNAIDS / AVAC
p.000047:
p.000047:
p.000047: 2. Research teams maintain clear written records of discus- sions and agreements. This includes community
p.000047: stakeholder recommendations, actions taken by the research team, and any unresolved issues that require follow-up.
p.000047: 3. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000047: allow informed consent materials to be properly developed, piloted, translated, and implemented, including materials
p.000047: to assess participants’ ongoing consent.
p.000047: 3.9.E. Additional guidance
p.000047: 1. Informed consent is the cornerstone of ethically conducted research and is explicitly discussed in guidance
p.000047: documents that address the overall ethical conduct of research, such as the Declaration of Helsinki,5 CIOMS
p.000047: guidelines,7 The Belmont Report,6 Good Clinical Practice,2 the World Health Organization Handbook for Good Clinical
p.000047: Research Practice,3 the Nuremberg Code,29 the Nuffield Council Guidance on health research in devel- oping
p.000047: countries,8, 9 and UNAIDS/WHO Ethical considerations in biomedical HIV prevention trials,10 and in relevant
p.000047: national guidelines.
p.000047: 2. There are extensive literature and other resources on the devel- opment of informed consent processes in multiple
p.000047: contexts, including a range of innovative approaches to measure and assess participant understanding, to address
p.000047: literacy issues, and to accommodate the desire of participants to consult with families and friends. 30, 31, 32, 33, 34
p.000047: 3.10 Standard of HIV prevention
p.000047: 3.10.A. Definition
p.000047: The term “standard of HIV prevention” refers to the package of comprehensive counselling and state-of-the-art HIV
p.000047: risk reduction methods provided or made available to participants in biomedical HIV prevention trials.
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000048:
p.000048:
p.000048: 3.10.B. Relevance to good participatory practice
p.000048: Helping trial participants reduce their risk of acquiring HIV is a key ethical obligation of research teams.
p.000048: Determining the components of the HIV prevention package is a joint effort between research teams and relevant
p.000048: stakeholders. Trial sponsors and implementers must work with relevant stakeholders in establishing the type,
p.000048: scope, and process by which participants are provided with, or referred to, services to access the full HIV prevention
p.000048: package. How trial sites help participants prevent HIV acquisition is often at the forefront of community stakeholder
p.000048: concerns. Therefore, successful negotiation with stakeholders about the prevention package to be provided to trial
p.000048: participants is likely to have a significant influence on community stakeholder perceptions of a trial.
p.000048:
p.000048: 3.10.C. Special considerations
p.000048: 1. Deviations from expected standard HIV prevention packages at a trial site or among trial sites in multisite studies
p.000048: may be caused by national legal restrictions.
p.000048: 2. When funding-body restrictions limit which prevention methods can be paid for by trial funds, research teams
p.000048: have the responsibility to find other ways to provide these methods, such as through alternative funding streams or
p.000048: linkages with non-governmental organisations or community-based organ- isations.
p.000048: 3. Research teams may need to review the HIV prevention package regularly, taking into consideration new HIV coun-
p.000048: selling models and risk reduction methods that are scientifi- cally validated and, when appropriate, approved by
p.000048: national bodies for use.
p.000048: 4. To improve relevant stakeholder understanding of the preven- tion package offered and the clinical trial process,
p.000048: research teams can describe the trial as comparing the study product plus the HIV prevention package, with the
p.000048: placebo (or comparator arm) plus the HIV prevention package.
p.000048:
p.000048:
p.000048:
p.000048:
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p.000049:
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p.000049:
p.000049:
p.000049: 3.10.D. Good participatory practices for standard of HIV prevention
p.000049: 1. Research teams and relevant stakeholders negotiate the HIV prevention package during the protocol development phase
p.000049: of the trial.
p.000049: 2. Research teams determine which stakeholders already provide HIV prevention services, what types of
p.000049: services they provide, and their capacity to provide adequate services.This will enable research teams to provide
p.000049: optimal referrals and make linkages when necessary.
p.000049: 3. Research teams and relevant stakeholders discuss and negotiate the comprehensive HIV prevention package and
p.000049: consult local HIV prevention service providers when appro- priate. All scientifically validated methods are discussed,
p.000049: and their appropriateness for the trial design and population assessed, including:
p.000049: a. Risk assessment and risk-reduction counselling— including partner and couple counselling.
p.000049: b. Male and female condoms—with appropriate instructions and demonstrations.
p.000049: c. Testing for and treatment of sexually transmitted infec- tions.
p.000049: d. Sterile injecting equipment and drug substitution treatment.
p.000049: e. Medical male circumcision.
p.000049: f. Post-exposure prophylaxis.
p.000049: g. Other novel HIV risk-reduction strategies as they become available.
p.000049: 4. Research teams and relevant stakeholders discuss and negotiate the comprehensive HIV prevention package,
p.000049: taking account of the following:
p.000049: a. The HIV prevention package required as a minimum for the trial protocol.
p.000049: b. Current HIV prevention standards and services available nationally and locally.
p.000049:
p.000050: 50
p.000050:
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p.000050:
p.000050:
p.000050: c. Current national laws on HIV prevention strategies and services, as well as national ethical guidance on research.
p.000050: d. The trial’s funding source, any implications this may have for the prevention package, and how these will be
p.000050: addressed to ensure participants are offered a comprehen- sive package.
p.000050: e. The HIV prevention services and options that will be offered through referral mechanisms.
p.000050: f. The HIV prevention services that will be available to partners of trial participants.
p.000050: g. The impact that any services offered by the trial, as well as those to which participants will be referred by the
p.000050: trial, could have on local services.
p.000050: 5. Research teams and relevant stakeholders discuss how the HIV prevention package will be implemented and monitored,
p.000050: including uptake and standards of referral services.
p.000050: 6. Research teams maintain clear written records of discussions and agreements. This includes recommendations,
p.000050: actions taken by the research team, and any unresolved issues that require follow-up.
p.000050: 7. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000050: ensure provision of the comprehensive HIV prevention package.
p.000050: 3.10.E. Additional guidance
p.000050: 1. Ethical considerations in biomedical HIV prevention trials
p.000050: (Guidance Point 13, page 45, Standard of HIV Prevention).1
p.000050: 2. Ethical considerations in biomedical HIV prevention trials (page 13, selected circumstances in which biomedical HIV
p.000050: prevention trials should not be conducted).1
p.000050: 3. Mapping the Standards of Care at Microbicide Clinical Trial Sites.35
p.000050: 4. The challenge of defining standards of prevention in HIV prevention trials.36
p.000050:
p.000050:
p.000050:
p.000050:
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p.000051:
p.000051: UNAIDS / AVAC
p.000051:
p.000051:
p.000051: 3.11 Access to HIV care and treatment
p.000051: 3.11.A. Definition
p.000051: Access to comprehensive HIV care and treatment refers to care and treatment services made available to
p.000051: individuals who are identified as HIV-positive during the screening process and to trial participants who acquire HIV
p.000051: infection during the trial. Comprehensive HIV care includes all preventive, psychoso- cial, psychological, and
p.000051: clinical components of HIV care. HIV treatment refers to antiretroviral therapy regimens internationally recognised as
p.000051: optimal for the management of HIV.
p.000051:
p.000051: 3.11.B. Relevance to good participatory practice
p.000051: Trial sponsors and implementers are ethically obligated to ensure that participants who acquire HIV during trial
p.000051: participation have access to clinical evaluation, and stage-appropriate HIV care and treatment.This issue is often at
p.000051: the forefront of community stake- holder concerns.Therefore, how access to HIV care and treatment is negotiated with
p.000051: relevant stakeholders and how it is provided to trial participants are likely to have a significant influence on
p.000051: community stakeholder perceptions of a trial.
p.000051:
p.000051: 3.11.C. Special considerations
p.000051: 1. HIV care and treatment guidelines vary by country.
p.000051: 2. Treatment options may improve over time and research teams may need to modify their HIV care and treatment access
p.000051: plans in line with updated national guidelines.
p.000051: 3. Mechanisms to provide HIV care and treatment require long-term logistics planning as people living
p.000051: with HIV require lifelong care and treatment, and, for some participants, HIV treatment may begin after trial exit or
p.000051: completion.
p.000051: 3.11.D. Good participatory practices for access to HIV care and treatment
p.000051: 1. Research teams identify local HIV care and treatment services, local HIV non-governmental organisations or
p.000051: community- based organisations, and HIV support groups, determine
p.000051:
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p.000052:
p.000052:
p.000052: their capacities, and seek their views and perspectives. This enables research teams to design optimal referral
p.000052: mechanisms in consultation with service providers.
p.000052: 2. During protocol development, research teams and relevant stakeholders discuss access to HIV care and treatment for
p.000052: the following:
p.000052: a. Individuals who are identified as HIV-positive during the screening process.
p.000052: b. Individuals who become HIV-positive during the trial.
p.000052: c. Women who are identified as HIV-positive during the screening process or who acquire HIV during the trial, and when
p.000052: appropriate HIV-positive men, for provision of information about the risk of mother-to-child HIV trans- mission and the
p.000052: benefits of vertical transmission preven- tion services.
p.000052: 3. Research teams and relevant stakeholders discuss the HIV care and treatment package, taking account of the
p.000052: following:
p.000052: a. The HIV care and treatment package required as a minimum for the trial protocol.
p.000052: b. Current national HIV care and treatment guidelines and policies and local provision of HIV care and treatment
p.000052: services.
p.000052: c. Anticipated numbers of people likely to be found HIV-positive during screening and the anticipated
p.000052: numbers of participants likely to seroconvert during the trial.
p.000052: d. Current national laws that could affect a person’s right or ability to access HIV care and treatment.
p.000052: e. HIV care and treatment services that will be offered through referral mechanisms.
p.000052: f. The possibility of negotiating provisions for priority access to national care and treatment programmes, at the
p.000052: time needed, for individuals who become HIV-positive during a trial.
p.000052:
p.000052:
p.000052:
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p.000053:
p.000053:
p.000053: g. Treatment regimens that will be available if the technology under study has the potential to give rise to
p.000053: antiretroviral resistance.
p.000053: h. Local health institution responsibilities and proposed trial sponsor and implementer commitments regarding:
p.000053: • Who will finance and who will deliver specific HIV care and treatment services.
p.000053: • The duration of HIV care and treatment services being provided by each partnering stakeholder.
p.000053: i. The impact that any services offered by the trial, or to which participants will be referred, could have on local
p.000053: services.
p.000053: 4. Research teams include a description of the HIV care and treatment package in informed consent forms for screening
p.000053: and enrolment.
p.000053: 5. Research teams and relevant stakeholders discuss optimal referral procedures and the most appropriate way to
p.000053: ensure that all individuals screened and enrolled are aware of how to access the HIV care and treatment services.
p.000053: 6. Research teams and relevant stakeholders discuss how to monitor access to HIV care and treatment
p.000053: services. They consider how to gather and analyse information on numbers of seroconverters who access HIV care,
p.000053: barriers to accessing HIV care and treatment programmes and other issues that may arise.
p.000053: 7. Research teams maintain clear written records of discussions and agreements. This includes relevant stakeholder
p.000053: recom- mendations, actions taken by the research team, aspects of HIV care and treatment that will not be offered and
p.000053: why, and any unresolved issues that require follow-up.
p.000053: 8. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000053: ensure that the locally agreed HIV care and treatment package can be effectively delivered.
p.000053:
p.000053:
p.000053:
p.000053:
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p.000054:
p.000054:
p.000054: 3.11.E. Additional guidance
p.000054: 1. The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.5
p.000054: 2. Ethical considerations in biomedical HIV prevention trials
p.000054: (Guidance Point 14, page 48, Care and Treatment).1
p.000054: 3. Ethical considerations in biomedical HIV prevention trials (page 13, selected circumstances in which biomedical HIV
p.000054: prevention trials should not be conducted).1
p.000054: 4. Mapping the Standards of Care at Microbicide Clinical Trial Sites.35
p.000054: 3.12 Non HIV-related care
p.000054: 3.12.A. Definition
p.000054: Non HIV-related care refers to health and social care services provided or made available to trial participants
p.000054: that are not directly related to HIV prevention, HIV care and treatment, or trial-related harm.The non HIV-related
p.000054: care services appropriate for trial participants will depend on the trial population and local health priorities.
p.000054: Examples could include provision of female or male sexual and reproductive health care, management of infec- tious
p.000054: diseases, nutritional health, psychiatric care, and psychoso- cial services.
p.000054:
p.000054: 3.12.B. Relevance to good participatory practice
p.000054: Access to non HIV-related care can provide benefits for partici- pants, contribute to their welfare, and improve
p.000054: clinical trial outcomes. Negotiating the range of non HIV-related services available to participants at the trial site
p.000054: or via referral will assist in ensuring that relevant stakeholders clearly understand the breadth of services available
p.000054: and reasons for inclusion and exclusion of certain services.
p.000054:
p.000054: 3.12.C. Special considerations
p.000054: Non HIV-related care packages may vary from site to site, depending on local health priorities and local
p.000054: standards of care.
p.000054:
p.000054:
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p.000055:
p.000055:
p.000055: 3.12.D. Good participatory practices for non HIV-related care
p.000055: 1. Research teams identify the existence and capacity of local social care and primary health-care services and of
p.000055: secondary and tertiary diagnostic and treatment services. This enables the provision of appropriate referrals and
p.000055: linkages, should the need arise.
p.000055: 2. Research teams and relevant stakeholders discuss access to non HIV-related care services during the trial’s
p.000055: protocol development phase.
p.000055: 3. Research teams and relevant stakeholders discuss non HIV-related care services to be offered to participants
p.000055: and consult with local social and health-care service providers when appropriate. Discussions take account of the
p.000055: following:
p.000055: a. Non HIV-related care services required by the trial protocol.
p.000055: b. Additional non HIV-related care services that community stakeholders would like to see the trial site offer to
p.000055: partici- pants.
p.000055: c. Services that will be offered through referral.
p.000055: d. Whether any non HIV-related services will be available to partners of trial participants.
p.000055: e. The impact on local service delivery of any services offered or referred to by the trial.
p.000055: 4. Research teams maintain clear written records of discussions and agreements. This includes relevant stakeholder
p.000055: recom- mendations, actions taken by the research team, and any unre- solved issues.
p.000055: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds to ensure provision
p.000055: of the locally discussed, non HIV-related care package.
p.000055: 3.12.E. Additional guidance
p.000055: See Mapping the Standards of Care at Microbicide Clinical Trial Sites.35
p.000055:
p.000056: 56
p.000056:
p.000056: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000056:
p.000056:
p.000056: 3.13 Policies on trial-related harms
p.000056: 3.13.A. Definition
p.000056: Policies on trial-related harms describe how research teams will treat and compensate trial participants should they
p.000056: experience physical or social harms that are determined to be associated with trial participation, as well as how such
p.000056: harms will be addressed and mitigated.
p.000056:
p.000056: 3.13.B. Relevance to good participatory practice
p.000056: A key ethical obligation of research teams is to maximise benefits and minimise harms for trial participants. Relevant
p.000056: stakeholders can provide valuable input about possible social harms of trial participation. These are of particular
p.000056: concern for individuals or groups who may be vulnerable, marginalised, stigmatised, or who have less power in society.
p.000056: Relevant stakeholders can also provide advice about local expectations of research team obligations to address
p.000056: trial-related physical and social harms. Discussing with stakeholders before a trial starts and clearly explaining how
p.000056: trial- related harms will be addressed and mitigated can significantly influence community stakeholder perceptions of
p.000056: the trial and of how well community stakeholder concerns will be addressed.
p.000056:
p.000056: 3.13.C. Special considerations
p.000056: Sponsors typically give specific and binding guidance to research teams on how to determine and report physical harms
p.000056: as adverse events. It is good practice to define similarly stringent procedures for the determination, documentation,
p.000056: reporting, and manage- ment of social harms that trial participants may experience. Examples of social harms
...
p.000057: b. Procedures to encourage and facilitate reporting of social harms.
p.000057: c. Procedures to investigate events that have been reported indirectly, such as through a third party, taking
p.000057: confiden- tiality issues into account.
p.000057: d. Procedures for reporting social harms and whether these are to be reported to sponsors, ethics committees,
p.000057: and regulatory bodies, even if not specifically required by them.
p.000057: e. Procedures for ensuring optimal referrals to appropriate services for trial-related harms.
p.000057: f. Strategies to inform trial participants of the potential risks of engaging with media.
p.000057: g. Compensation or insurance policies, when applicable, for specific trial-related harms, coverage provided by
p.000057: the policies, how claims are made, and how participants are informed of their rights in relation to the policies.
p.000057: 3. Research teams and relevant stakeholders review follow-up strategies to reduce trial-related physical and social
p.000057: harms over the course of the trial.
p.000057: 4. Research teams maintain clear written records of discussions and agreements. This includes recommendations,
p.000057: actions taken by the research team, and any unresolved issues that require follow-up.
p.000057: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000057: ensure the effective management of physical and social harms related to participation in a trial.
p.000057:
p.000057: 3.13.E. Additional guidance
p.000057: 1. Ethical considerations in biomedical HIV prevention trials
p.000057: (Guidance Point 11, page 40, Potential Harms).1
p.000057:
p.000058: 58
p.000058:
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p.000058:
p.000058:
p.000058: 2. International Ethical Guidelines for Biomedical Research Involving Human Subjects (Guideline 19, page 78
p.000058: right of injured subjects to treatment and compensation).7
p.000058: 3.14 Trial accrual, follow-up, and exit
p.000058: 3.14.A. Definition
p.000058: Trial accrual, follow-up, and exit activities include the recruit- ment, screening, enrolment, follow-up, and exit of
p.000058: trial partici- pants in biomedical HIV prevention trials.
p.000058:
p.000058: 3.14.B. Relevance to good participatory practice
p.000058: Community stakeholders can provide the best information on how to design socially and culturally
p.000058: acceptable strate- gies for recruitment, screening, enrolment, follow-up, and exit. Community stakeholders included in
p.000058: the process of developing these strategies can play an important role in identifying and mitigating trial-related
p.000058: stigma, misconceptions, or miscommuni- cation.
p.000058:
p.000058: 3.14.C. Special considerations
p.000058: 1. Follow-up of participants after missed visits must respect agreements between the participant and research
p.000058: team about how to contact the participant.
p.000058: 2. Exiting a trial may present changes in what participants have become accustomed to with regard to clinical care and
p.000058: the impact of the trial on their social relationships. Anticipation and discussion of these issues between research
p.000058: teams and community stakeholders will help in the development of appropriate strategies to support participants
p.000058: upon trial exit.
p.000058: 3.14.D. Good participatory practices for trial accrual, follow-up, and exit
p.000058: 1. Research teams consult with relevant stakeholders about accrual, follow-up, and exit processes, taking
p.000058: account of the following:
p.000058:
p.000058:
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p.000059:
p.000059:
p.000059: a. Strategies and messages that are socially and culturally appropriate, meet the needs of specific
p.000059: stakeholders in terms of language and literacy, and draw on a range of communication modes, including written, oral,
p.000059: and visual.
p.000059: b. Procedures to anticipate, monitor, and mitigate trial- related stigma resulting from ineligibility to enrol
p.000059: or from enrolment itself.
p.000059: c. Procedures for training and supervising trial site staff on creating respectful relationships with participants
p.000059: and fostering an environment that is nonjudgmental and welcoming.
p.000059: d. Strategies to ensure the confidentiality of participants during trial visits, while following up participants
p.000059: outside of the trial clinic, and after trial exit.
p.000059: e. Procedures for informing participants about trial results and trial product assignment, when available.
p.000059: f. Procedures for transfer of care at the end of follow-up or trial closure, such as providing participants with
p.000059: referrals to HIV counselling and testing and to other supportive services.
p.000059: 2. Research teams provide relevant stakeholders with ongoing updates on trial accrual, follow-up, and trial exit.
p.000059: 3. Research teams seek advice from relevant stakeholders on how to improve accrual, follow-up and exit processes, and
p.000059: messages.
p.000059: 4. Research teams maintain clear written records of discussions and agreements, as well as ongoing discussions about
p.000059: ways to modify strategies.
p.000059: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000059: support stakeholder engagement in the development of locally accept- able trial procedures.
p.000059: 3.15 Trial closure and results dissemination
p.000059: 3.15.A. Definition
p.000059: Trial closure occurs when all participants have exited from the trial and all trial procedures are completed. Results
p.000059: dissemination
p.000059:
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p.000060:
p.000060:
p.000060: involves dissemination of trial results to participants, community stakeholders, and the public at large, as well as
p.000060: the unblinding of participants to trial group or arm assignment.
p.000060:
p.000060: 3.15.B. Relevance to good participatory practice
p.000060: Effectively engaging relevant stakeholders about trial closure and results dissemination in a transparent process
p.000060: is essential for building trust and lays a positive foundation for future research. In the event that a trial is
p.000060: stopped early or unexpectedly, research team-initiated dialogue with relevant stakeholders will minimise the risk of
p.000060: misinformation.
p.000060:
p.000060: 3.15.C. Special considerations
p.000060: 1. Trials may run to completion per protocol or may be stopped early. Reasons for stopping early may be evidence of a
p.000060: clear protective effect, evidence of harm, or evidence of futility. Trials may also stop early due to other unforeseen
p.000060: circum- stances, such as administrative or financial reasons, local objection, or sudden social unrest.
p.000060: 2. In multicountry or multisite trials, sites may complete partic- ipant follow-up at different times. Thus, while
p.000060: some sites might be closed for participant follow-up, research teams at other locations may continue to see
p.000060: participants.
p.000060: 3. Where trial product manufacturers are publicly traded companies, there may be legal requirements that affect
p.000060: the timing and methods for public announcement of a trial closure.
p.000060: 4. Ownership of data, issues of publication, and release of trial results vary by trial and may be strictly delineated
...
p.000061: 3. Research teams consult with relevant stakeholders to develop a results dissemination plan, detailing the following
p.000061: issues:
p.000061: a. Strategies to manage expectations about trial results, including by preparing participants and relevant
p.000061: stake- holders for all possible outcomes.
p.000061: b. Planned timelines for trial closure at the site and at other sites, completion of data analyses, and availability
p.000061: of results.
p.000061: c. Procedures and timelines for those who will be informed of trial results in confidence prior to public release and
p.000061: how results will be disseminated publicly.
p.000061: d. Development and piloting of key messages, how the messages will be finalised when the results are known, and
p.000061: the range of communication methods to be used.
p.000061: e. How the messages will explain implications of the results for the area where the trial was conducted, limitations
p.000061: of the trial, and its ability to generalise findings for specific aspects, such as by sex, behaviours, or location.
p.000061: f. How best to disseminate trial results that may be of a sensitive nature or that may put certain individuals
p.000061: or groups at risk of harm or stigmatisation.
p.000061: g. Procedures for contacting and informing trial participants of research results before they are announced publicly.
p.000061: h. Whether and how to disseminate additional findings that are not related to the primary trial question but may be of
p.000061: interest to some stakeholders, such as reported patterns
p.000061:
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p.000062:
p.000062:
p.000062: of sexual networks, rates of various infections, or demo- graphic data.
p.000062: i. How and when participants will be informed of their trial group assignment.
p.000062: j. How community stakeholder responses to the results will be systematically collected and documented. Although
p.000062: community stakeholder agreement may not be a prerequi- site for publishing or sharing research in a scientific forum,
p.000062: it is important that community stakeholder interpretations be noted, particularly if they differ from predominant
p.000062: scientific analyses.
p.000062: k. Issues around ownership of the data, data access, and publication, including how the research team will
p.000062: facili- tate community stakeholder access to published results of the trial.
p.000062: 4. Research teams maintain clear written records of discussions regarding trial closure and dissemination messages, as
p.000062: well as documentation of responses to the results.
p.000062: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000062: ensure comprehensive dissemination of results for participants, community stakeholders and other relevant
p.000062: stakeholders.
p.000062: 3.16 Post-trial access to trial products or procedures
p.000062: 3.16.A. Definition
p.000062: The term “post-trial access to trial products or procedures” refers to making the prevention product or procedure
p.000062: tested in the trial available to trial participants and local community stake- holders (1) should the new product or
p.000062: procedure be scientifically validated or approved by relevant authorities, and (2) in the form of follow-on, open
p.000062: label, or other such studies before product licensure or approval, should an efficacy or effectiveness trial have a
p.000062: compelling positive finding, with no safety concerns.
p.000062:
p.000062:
p.000062:
p.000062:
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p.000063:
p.000063:
p.000063: 3.16.B. Relevance to good participatory practice
p.000063: Research ethics call for maximising benefits to stakeholders who participate in research. Thus, local community
p.000063: stakeholders are to be among the first to gain access to new prevention products should they be found safe and
p.000063: effective. How trial sites commu- nicate and interact with community stakeholders about issues of access to the
p.000063: prevention product or procedure studied is likely to have a significant influence on community stakeholder percep-
p.000063: tions of a trial.
p.000063:
p.000063: 3.16.C. Special considerations
p.000063: 1. Availability of newly identified products or procedures to trial participants and other community stakeholders will
p.000063: depend on the biomedical HIV prevention strategy being tested.
p.000063: 2. After a trial is completed, other trials may be needed to corroborate findings.
p.000063: 3. After results from relevant trials are available, it may take time for normative agencies and appropriate
p.000063: regulatory authori- ties, including national governments, to approve the new product or procedure. Approval
p.000063: processes and timelines will differ by product or procedure and by country.
p.000063: 4. National regulatory authorities make the ultimate decision about whether a new product or procedure will be
p.000063: approved for use within a particular country.
p.000063: 5. Availability and pricing of new products or procedures may be affected by product-manufacturer parameters as well
p.000063: as by agreements with trial sponsors.
p.000063: 3.16.D. Good participatory practice practices for post-trial access to trial products or procedures
p.000063: 1. Research teams discuss with relevant stakeholders, early in the trial process, issues affecting future product or
p.000063: procedure availability, including the need for corroborated biomedical evidence, pursuit of licensure, production
p.000063: rights, and addi- tional marketing and distribution research.
p.000063:
p.000063:
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p.000064:
p.000064:
p.000064: 2. Trial funders, sponsors, and research teams conducting efficacy or effectiveness trials discuss with relevant
p.000064: stakeholders, early in the trial life-cycle, expectations about possible pre-licen- sure access, plans for follow-on,
p.000064: open label, or other such studies, and how such pre-licensure access will be funded, in the event that a compelling
p.000064: positive result, with no safety concerns, is observed.
p.000064: 3. Trial sponsors and research teams discuss, negotiate, and agree on responsibilities and funding requirements with
p.000064: national governments concerning licensure requirements and access issues, should the HIV prevention product or option
p.000064: under investigation be shown to be safe and effective.
p.000064: 4. Trial sponsors and research teams develop a clear strategy and funding mechanisms for how the HIV prevention
p.000064: product or procedure will be made available to participants (at a minimum) rapidly, affordably, and
p.000064: sustainably, should the HIV prevention product or procedure be shown to be safe and effective. Sponsors and research
p.000064: teams can collaborate with multiple stakeholders, such as UN organisations, develop- ment partners, local
p.000064: governments, and non-governmental organisations to design and support the overall access strategy.
p.000064: 5. Research teams inform community stakeholders of their rights, the access plan, and the factors that could
p.000064: postpone or prevent their gaining access to the new prevention product or procedure, such as the need to secure
p.000064: regulatory approvals or parameters related to the product manufacturer. Research teams give community stakeholders
p.000064: updates as they are available.
p.000064: 3.16.E. Additional guidance
p.000064: 1. Ethical considerations in biomedical HIV prevention trials
p.000064: (Guidance Point 19, page 60, Availability of Outcomes).1
p.000064: 2. Rethinking the Ethical Roadmap for ClinicalTesting of Microbicides: Report on an International Consultation
p.000064: (Chapter 10, After the trial: continued access and post-approval studies).37
p.000064: 3. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (Recommendation
p.000064: 4.1).38
p.000064:
p.000065: 65
p.000065:
p.000065: UNAIDS / AVAC
p.000065:
p.000065:
p.000065: Conclusion
p.000065: Well-conducted biomedical HIV prevention trials are essential to discov- ering additional options to reduce new HIV
p.000065: infections. The GPP guide- lines set global standard practices for stakeholder engagement. When applied during
p.000065: the entire life-cycle of a biomedical HIV prevention trial, they enhance both the quality and outcomes of research.
p.000065: While there is much guidance in the field on how to conduct trials, the GPP guide- lines are the only set of global
p.000065: guidelines that directly address how to engage stakeholders in the design, conduct, and outcome of biomedical HIV
p.000065: prevention trials.
p.000065:
p.000065: Adherence to good participatory practices is an investment that benefits the research process. These practices
p.000065: facilitate the engagement of relevant stakeholders to achieve mutual gains in local capacity building for biomed- ical
p.000065: HIV prevention research. Significant power imbalances exist between trial funders, sponsors, and implementers and
p.000065: community stakeholders— the GPP guidelines are a critical resource to help address and mitigate these disparities. A
p.000065: core aim of the guidelines is to enhance the skills of individ- uals and groups who are most vulnerable to both HIV and
p.000065: to exploitation. The GPP guidelines help build community stakeholder capacity for more robust engagement in the
p.000065: research process and improved decision-making abilities.
p.000065:
p.000065: Effective stakeholder engagement can exist only when appropriate funds and resources are made available to research
p.000065: teams so they may adhere to good participatory practice. Sponsors of biomedical HIV prevention trials are responsible
p.000065: for enabling GPP by ensuring ample budget allocations and staff time to facilitate participatory approaches.
p.000065:
p.000065: Investment in establishing mutually respectful relationships and building capacity of community stakeholders is a
p.000065: long-term process that extends throughout and beyond the life-cycle of any single clinical trial. Although it is highly
p.000065: beneficial to maintain and support key staff at trial sites and
p.000065:
p.000065:
p.000066: 66
p.000066:
p.000066: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: sustain relationships that have been developed with local partners during the course of a trial, sponsors of biomedical
p.000066: HIV prevention trials often only support implementation of specific clinical trials. Investing in collab- orative
p.000066: long-term, sustained relationships between research teams and relevant stakeholders, such as academic
p.000066: institutions, ministries of health, and non-governmental organisations, can improve research literacy, enhance the
p.000066: success of stakeholder engagement, and provide the foundation for future trials.
p.000066:
p.000066: The GPP guidelines are intended to provide trial funders, sponsors, and implementers with systematic guidance on how to
p.000066: effectively engage with relevant stakeholders in the design and conduct of biomedical HIV preven- tion trials.
p.000066: Developing participatory processes that balance the opinions of all stakeholders while achieving the scientific goals
p.000066: of a trial can ensure that the needs of both community stakeholders and the broader HIV preven- tion field are met.
p.000066:
p.000066: In a forward-looking approach, it is important to gather and analyse stake- holders’ experiences with the
p.000066: implementation of the GPP guidelines. Recommendations for modifications and refinements based on experience and
p.000066: reflection can be sent to gpp@unaids.org or avac@avac.org, where they will be gratefully received and considered in
p.000066: future updates of these guidelines.
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: UNAIDS / AVAC
p.000067:
p.000067:
p.000067: Annex 1. Acronyms and abbreviations
p.000067: AE – Adverse event
p.000067: AIDS – Acquired Immunodeficiency Syndrome
p.000067: ARV – Antiretroviral drug
p.000067: CAB – Community Advisory Board CAG – Community Advisory Group CBO – Community-Based Organisation
p.000067: CIOMS – Council for International Organizations of Medical Science
p.000067: EC – Ethics committee
p.000067: DSMB – Data safety monitoring board DSMC – Data safety monitoring committee GCLP– Good Clinical Laboratory Practice GCP
p.000067: – Good Clinical Practice
p.000067: GMP – Good Manufacturing Practice GPP – Good Participatory Practice HIV – Human Immunodeficiency Virus
p.000067: IDMC – Independent data monitoring committee
p.000067: IDU – Injecting drug use
p.000067: IRB – Institutional review board
p.000067: MSM – Men who have sex with men NGO – Non-governmental organisation PEP – Post-exposure prophylaxis
p.000067: PMTCT – Prevention of mother-to-child transmission
p.000067: PrEP – Pre-exposure prophylaxis REC – Research ethics committee SOP – Standard operating procedure STI – Sexually
p.000067: transmitted infection
p.000067: UNAIDS – Joint United Nations Programme on HIV/AIDS
p.000067: WHO – World Health Organization
p.000067:
p.000067:
p.000067:
p.000068: 68
p.000068: 68
p.000068:
p.000068: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000068:
p.000068:
p.000068: Annex 2. Glossary
p.000068: Accrual. The process of recruiting participants into a clinical trial in order to reach target participant
p.000068: numbers.
p.000068: Acquired immunodeficiency syndrome (AIDS). The most severe mani- festation of infection with human immunodeficiency
p.000068: virus (HIV), charac- terised by deterioration of the immune system and susceptibility to a range of opportunistic
p.000068: infections and cancers. (See human immunode- ficiency virus.)
p.000068: Activist. A person or group who acts on the behalf of a cause in order to bring about change.
p.000068: Adverse event (AE). An unwanted effect experienced by a partici- pant in a clinical trial. This may or may not
p.000068: be related to the product or procedure being studied.
p.000068: Advocate. A person or group who advocates on the behalf of indi- viduals, groups, or a specific cause.
p.000068: Antiretroviral (ARV) drug. A drug or medication that acts against or suppresses a retrovirus such as HIV.
p.000068: AVAC. An international, non-profit organisation that uses education, policy analysis, advocacy, and community
p.000068: mobilisation to accelerate the ethical development and eventual global delivery of AIDS vaccines and other new HIV
p.000068: prevention options as part of a comprehensive response to the pandemic.
p.000068: Biomedical HIV prevention trial. A clinical trial that aims to discover safe and effective products or procedures to
p.000068: prevent HIV transmission.
p.000068: Blinded trial or masked trial. A clinical trial designed to prevent the participants, research teams, or both, from
p.000068: knowing which participants are in the experimental arm or group and which are in the control arm or group of a trial,
p.000068: in order to reduce bias.
p.000068: Clinical trial. A research study that uses human volunteers to answer specific questions about the safety,
p.000068: efficacy or effectiveness, and medical effects of a specific procedure, medication, product, or treatment. A
p.000068: clinical trial process may include Phases I, II, IIb, III, and IV (post-marketing evaluation).
p.000068:
p.000069: 69
p.000069:
p.000069: UNAIDS / AVAC
p.000069:
p.000069:
p.000069: Community advisory boards (CABs) or community advisory groups (CAGs). Boards or groups composed of individuals
p.000069: or stakeholder representatives that act as an independent advisory voice and facilitate community stakeholder
p.000069: participation and involvement in the research process. They meet regularly with research team representatives, inform
p.000069: community stakeholders about proposed and ongoing research, and provide feedback to research teams about local norms
p.000069: and beliefs, as well as local views and concerns that arise in specific trials.
p.000069: Community groups. Groups of individuals who come together to act on behalf of common interests, goals, and values but
p.000069: whose organisa- tion does not require formal designation or registration.
p.000069: Community stakeholders (per the GPP guidelines). Individuals and groups who are ultimately representing the
p.000069: interests of people who would be recruited to or participate in a clinical trial, and others locally affected by
p.000069: a trial. Examples of “community stakeholders” are the population to be recruited, trial participants, people
p.000069: living in the area where the research is conducted, people living with HIV in the area, local HIV-positive groups or
p.000069: networks, people in the area affected by the HIV epidemic, local non-governmental organisations, community
p.000069: groups, and community-based organisations. (See stakeholders.)
p.000069: Confidentiality. The principle that protects the rights of trial partici- pants regarding prevention of
p.000069: unauthorised disclosure of personal information to third parties during data collection, storage, transfer,
p.000069: and use.
p.000069: Condom. A sheath or pouch that is worn either over the penis (male condom) or inside the vagina (female condom)
p.000069: during sexual inter- course, for the purpose of protecting against sexually transmitted infec- tions (including HIV)
p.000069: or preventing pregnancy. (See female condom or male condom.)
p.000069: Control arm or group. The group of participants in a clinical trial who receive the placebo or control product or
p.000069: procedure. (See placebo.)
p.000069: Data and safety monitoring board (DSMB) or independent data monitoring committee (IDMC). An independent
p.000069: committee estab- lished by a trial sponsor to assess, at intervals, the progress of a clinical trial, safety data, and
p.000069: critical efficacy or effectiveness endpoints. A data and safety monitoring board may recommend to the sponsor that a
p.000069:
p.000070: 70
p.000070:
p.000070: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000070:
p.000070:
p.000070: trial be stopped or modified if there are safety concerns, if trial objec- tives have been achieved, or if assessment
p.000070: of trial progress reveals that continuing the trial would be futile since it will no longer be possible to answer the
p.000070: research question that the trial is addressing.
p.000070: Ethics committee. See research ethics committee.
p.000070: Experimental arm or group. The group of participants in a clinical trial who receive the procedure, product, or drug
p.000070: being studied.
p.000070: Female condom. A pouch that when inserted in the vagina before vaginal intercourse, provides protection
p.000070: against most sexually trans- mitted infections, including HIV, and pregnancy. During anal sex, the female condom,
p.000070: when placed on the penis after removing the inner ring, provides protection against most sexually transmitted
p.000070: infections, including HIV. Currently made of polyurethane (female condom 1) or a synthetic latex (female condom 2), it
p.000070: is stronger than the natural latex used in male condoms, odourless, non-allergenic, and usable with oil-based
p.000070: and water-based lubricants. For vaginal intercourse, it can be inserted vaginally prior to intercourse, is not
p.000070: dependent on male erection, and does not require immediate withdrawal after ejaculation. (See also male condom.)
p.000070: Formative research activities. Activities that enable research teams to gain an informed understanding of local
p.000070: populations, socio-cultural norms and practices, local power dynamics, local perceptions, channels of communication and
p.000070: decision-making, and local history of research, as well as the needs and priorities of people locally affected by or
p.000070: able to influence a clinical trial. Formative research activities usually consti- tute the initial phase of stakeholder
p.000070: outreach and engagement.
p.000070: Futility. The inability of a clinical trial to achieve one or more of its objectives. This determination
p.000070: may be suggested, for example, during an interim analysis of a trial by a data safety monitoring board.
p.000070: Good Clinical Laboratory Practice (GCLP). Guidelines that set a standard for compliance by laboratories
p.000070: involved in the analysis of samples from clinical trials. These guidelines provide guidance to ensure that
p.000070: trial laboratory data are reliable, repeatable, auditable, and easily reconstructed in a research setting.
p.000070:
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071: UNAIDS / AVAC
p.000071:
p.000071:
p.000071: Good Clinical Practice (GCP). Internationally recognised guidelines for designing, conducting, recording, and reporting
p.000071: clinical trials in which humans participate. GCP provides guidance to ensure that trial data are credible and to
p.000071: protect the rights, safety, and well-being of trial partici- pants. The guidelines were issued by the
p.000071: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals
p.000071: for Human Use.
p.000071: Good Manufacturing Practice (GMP). Quality assurance practices that ensure that products are consistently produced and
p.000071: controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation.
p.000071: Good manufacturing practices are aimed primarily at diminishing the risks inherent in any pharmaceutical or
p.000071: medical device production.
p.000071: Good Participatory Practice (GPP). Guidelines that provide trial funders, sponsors, and implementers with
p.000071: systematic guidance on how to effectively engage with stakeholders in the design and conduct of biomedical HIV
p.000071: prevention trials.
p.000071: HIV vaccine (or AIDS vaccine). A vaccine designed to prevent HIV infection. (See vaccine.)
p.000071: Human immunodeficiency virus (HIV). The virus that weakens the immune system, ultimately leading to
p.000071: acquired immunodeficiency syndrome (AIDS).
p.000071: Implementer. See trial implementer.
p.000071: Informed consent. A process by which a competent individual volun- tarily confirms his or her willingness to
p.000071: participate in a particular clinical trial after having been informed of all aspects of the trial that are
p.000071: relevant to the individual’s decision to participate. Informed consent is an ongoing process throughout the course of a
p.000071: clinical trial.
p.000071: Institutional review board (IRB). See ethics committee.
p.000071: Male condom. A sheath designed to be worn over the penis during vaginal, anal, or oral intercourse as a means
p.000071: of preventing sexually transmitted infections, including HIV, or preventing pregnancy in the case of vaginal
p.000071: intercourse. (See also female condom.)
p.000071:
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000072:
p.000072:
p.000072: Medical male circumcision. The surgical removal of the entire foreskin of the penis. Three clinical trials conducted in
p.000072: sub-Saharan Africa have shown that medically performed male circumcision is safe and can reduce men’s risk
p.000072: of HIV infection during vaginal sex by about 60%. Prevalence of male circumcision varies by geography,
p.000072: religion, and cultural practices.
p.000072: Men who have sex with men (MSM). Men who have sexual contact with other men, regardless of whether or not they also
p.000072: have sex with women or have a personal or social gay or bisexual identity. This concept also includes men
p.000072: who self-identify as heterosexual but have sex with other men.
p.000072: Microbicides. A range of products that could be used vaginally or rectally (such as a gel, cream, ring, film,
p.000072: suppository or sponge) that are being tested to determine if they reduce or prevent the transmission of HIV and other
p.000072: disease-causing organisms during vaginal and anal intercourse.
p.000072: Network or research network. A cooperative of research institutions or centres conducting clinical trials under a
p.000072: common research agenda.
p.000072: Non-governmental organisation (NGO). A not-for-profit, registered entity or group that is organised on
p.000072: local, national, or international levels but is not an agency of local or national governments.
p.000072: Placebo. An inactive substance that is designed to appear like an exper- imental product being studied in all aspects
p.000072: except for the absence of the active ingredient under study. In clinical trials, the safety and effec- tiveness of an
p.000072: experimental product are assessed by comparing data from the experimental product trial arm to those from the placebo
p.000072: arm.
p.000072: Post-exposure prophylaxis (PEP). Antiretroviral medicines prescribed and taken after exposure or possible exposure to
p.000072: HIV, to reduce the risk of acquiring HIV. The exposure may be occupational, as in a needle stick injury, or
p.000072: non-occupational, as in the case of rape.
p.000072: Pre-exposure prophylaxis (PrEP). Antiretroviral drugs used by a person who does not have HIV infection to be taken
p.000072: before possible exposure to HIV in order to reduce the risk of acquiring HIV infection.
p.000072: Product or trial arm assignment. The specific study product or procedure, such as the experimental or ‘active’
p.000072: arm or the placebo arm,
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: UNAIDS / AVAC
p.000073:
p.000073:
p.000073: to which a participant is assigned for the designated follow-up period. (See placebo and experimental arm.)
p.000073: Protocol. A document that details the rationale, goals, design, method- ology, statistical considerations, and
p.000073: organisation of a study or clinical trial. A protocol describes a scientific study designed to answer specific research
p.000073: questions and describes how the health of the trial participants will be safeguarded.
p.000073: Randomisation. A method based on chance alone by which trial partic- ipants are assigned to a trial arm or group.
p.000073: Randomisation ensures that the only intended difference between trial arms or groups is which product or
p.000073: procedure a trial participant is exposed to during the trial.
p.000073: Randomised trial. A clinical trial in which participants are assigned by chance to one of the trial arms or groups.
p.000073: (See randomisation.)
p.000073: Regulatory authorities. Government agencies charged with carrying out the intent of legislation that constrains the
p.000073: actions of private indi- viduals, businesses, organisations, institutions, or government bodies. In most countries, one
p.000073: or more regulatory agency may be responsible for ensuring the safety and effectiveness of health products and the
p.000073: correct conduct of clinical trials.
p.000073: Research ethics committee (REC) or institutional review board (IRB). An independent body made up of medical,
p.000073: scientific, and non-scientific members whose responsibility is to protect the rights, safety, and well- being of human
p.000073: participants involved in a clinical trial. Research ethics committees review and approve the initial protocol, review
p.000073: materials to be used in recruiting and consenting trial participants, and provide continuing review of a trial protocol
p.000073: and any amendments. The term “institutional review board” is common in the United States of America, whereas other
p.000073: countries commonly use the term “research ethics committee” or “independent ethics committee”.
p.000073: Research network. See network.
p.000073: Research team. A group of investigators and staff involved in imple- menting biomedical HIV prevention trials. Research
p.000073: teams can include investigators and staff at a specific trial site as well as investigators and staff working at
p.000073: coordinating centres, institutions, or agencies.
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000074:
p.000074:
p.000074: Scientific process. A recognised systematic way to form and test hypotheses by designing controlled
p.000074: experiments to collect data, analyse results, and draw conclusions in order to acquire new knowledge or to correct,
p.000074: refine, and integrate previous knowledge.
p.000074: Seroconversion. The process by which a newly infected person develops antibodies that can be detected by
p.000074: an HIV antibody test. Development of antibodies may occur anywhere from weeks or months following HIV infection.
p.000074: Sexually transmitted infections (STIs). Infections caused by microor- ganisms that are transmitted from one person to
p.000074: another during sexual or intimate contact.
p.000074: Stakeholders or trial stakeholders. Individuals, groups, organisations, governments, or other entities that are
p.000074: affected by the outcome of a biomedical HIV prevention trial or that can influence proposed research through their
p.000074: input and actions. (See community stakeholders.)
p.000074: Standard operating procedure (SOP). A document that gives step- by-step instructions for how to conduct a procedure, in
p.000074: order to ensure that each staff member can perform the procedure in the same way.
p.000074: Stigma. AIDS-related stigma refers to a pattern of prejudice, discounting, discrediting, and discrimination directed at
p.000074: people perceived to have HIV or AIDS, their significant others and close associates or their social groups.
p.000074: Therapeutic HIV vaccine. A compound designed to stimulate the immune response to HIV in a person already
p.000074: infected with the virus, in order to control the infection. Also referred to as an immunotherapeutic vaccine. (See
p.000074: vaccine and HIV vaccine.)
p.000074: Trial arm or group. A group within a clinical trial formed of participants who have been assigned a particular product
p.000074: or procedure during a trial. (See control arm or group, experimental arm or group.)
p.000074: Trial funder. An individual or entity responsible for financing the cost of a trial.
p.000074: Trial implementer. Investigators, research staff, and all others specifi- cally responsible for executing
p.000074: biomedical HIV prevention trials. Implementers may be employed by governments, government-spon-
p.000074:
p.000075: 75
p.000075:
p.000075: UNAIDS / AVAC
p.000075:
p.000075:
p.000075: sored networks, non-governmental organisations, academic institu- tions, the pharmaceutical industry or other
p.000075: companies, foundations, or public–private partnerships.
p.000075: Trial life-cycle. The entire process of a trial, starting from developing the initial concept and writing the protocol
p.000075: and continuing through to the implementation and conduct of the trial to completion, exiting of participants, and
p.000075: dissemination and reporting of results.
p.000075: Trial participant. A competent individual who voluntarily provides informed consent to participate in a clinical
p.000075: trial. Trial participants are assigned to a particular trial arm or group, in which they receive a partic- ular product
p.000075: or procedure.
p.000075: Trial sponsor. An entity that is responsible for a trial but that does not actually conduct it. The sponsor may
p.000075: be a pharmaceutical company, governmental agency, academic institution, or private or other organi- sation.
p.000075: UNAIDS (Joint United Nations Programme on HIV/AIDS). UNAIDS brings together the resources of the UNAIDS Secretariat and
p.000075: 10 UN system organisations to lead and inspire the world in achieving universal access to HIV prevention, treatment,
p.000075: care, and support.
p.000075: Unblinding or unmasking. The process of revealing trial participants’ product or procedure assignments. Unblinding
p.000075: involves informing participants about which product they were assigned to during the trial.
p.000075: Vaccine. A compound that stimulates the body’s immune response in order to prevent or control an infection. A vaccine
p.000075: is typically made up of parts of a bacterium or virus that cannot itself cause an infection. (See HIV vaccine.)
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
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p.000076:
p.000076:
p.000076: Annex 3. Additional guidance
p.000076:
p.000076: International reference guidelines
p.000076:
p.000076: The Belmont Report, 1979
p.000076: This report was written by the United States National Commission for the Protection of Human Subjects of Biomedical and
p.000076: Behavioral Research, which was established after the public learned about the Tuskegee Syphilis Study. The Belmont
p.000076: Report established the foun- dational ethical principles of respect for persons, beneficence, and justice for research
p.000076: involving human volunteers.
p.000076: Citation: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont
p.000076: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC,
p.000076: Department of Health, Education and Welfare, 1979.
p.000076:
p.000076: Declaration of Helsinki, 1964
p.000076: This Declaration of the World Medical Association is often consid- ered to be the first document to set world
p.000076: standards for research involving human volunteers.
p.000076: Citation: World Medical Association General Assembly. World Medical Association Declaration of
p.000076: Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Helsinki, World Medical Association,
p.000076: 2008.
p.000076:
p.000076: Ethical Considerations in Biomedical HIV Prevention Trials, 2007
p.000076: This is an ethical guidance document, issued by UNAIDS and WHO, for biomedical HIV prevention trials. This document is
p.000076: a revision of Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document. Geneva, UNAIDS,
p.000076: 2000.
p.000076: Citation: UNAIDS and WHO. Ethical Considerations in Biomedical HIV Prevention Trials. Geneva, UNAIDS, 2007.
p.000076:
p.000077: 77
p.000077:
p.000077: UNAIDS / AVAC
p.000077:
p.000077:
p.000077: Guideline for Good Clinical Practice, 1996
p.000077: This guidance document was issued by the International Conference on Harmonisation of Technical Requirements for
p.000077: Registration of Pharmaceuticals for Human Use and outlines an international ethical and scientific quality standard
p.000077: for designing, conducting, recording, and reporting trials that involve human volunteers.
p.000077: Citation: Guideline for Good Clinical Practice: ICH Harmonised Tripartite Guideline. Geneva, International
p.000077: Conference on Harmoni- sation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.
p.000077:
p.000077: International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993
p.000077: These guidelines, published by the Council for International Organizations of Medical Sciences
p.000077: (CIOMS), added guidance on conducting research in developing countries to the body of ethical guidelines. The 2002
p.000077: version supersedes the 1982 and 1993 guidelines.
p.000077: Citation: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva,
p.000077: Council for International Organizations of Medical Sciences, 2002.
p.000077:
p.000077: Nuffield Council on Bioethics, 2002
p.000077: The 2002 Nuffield Council on Bioethics report on The Ethics of Research Related to Healthcare in
p.000077: Developing Countries provides an ethical framework for designing or conducting externally sponsored
p.000077: research in the developing world. The 2004 follow-up report, co-hosted with the Medical Research Council of
p.000077: South Africa, discusses how the guidelines could be applied in practice, particu- larly in light of conflicting ethical
p.000077: advice.
p.000077: Citation: The Ethics of Research Related to Healthcare in Developing Countries. London, Nuffield Council on
p.000077: Bioethics, 2002; and The Ethics of Healthcare Related Research in Developing Countries: A Follow-up
p.000077: Discussion Paper. London, Nuffield Council on Bioethics, 2005.
p.000077:
p.000077:
p.000078: 78
p.000078:
p.000078: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000078:
p.000078:
p.000078: Nuremberg Code, 1949
p.000078: This code of research ethics came out of the ruling of the International Military Tribunal that prosecuted Nazi war
p.000078: criminals at the end of the Second World War.
p.000078: Citation: Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10.
p.000078: Vol. 2. Washington, DC, United States Government Printing Office, 1949:181–182.
p.000078:
p.000078:
p.000078: Other references
p.000078: Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage Controversy, Convey Your
p.000078: Message, and Disseminate Results, 2010
p.000078: The Communications Handbook for Clinical Trials is a practical guide developed for site-level research teams,
p.000078: communicators, advocates, and others working on HIV prevention trials. It provides guidance on how to anticipate and
p.000078: respond to the special communication chal- lenges posed by the conduct of clinical research.
p.000078: Citation: Robinson ET et al. Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage
p.000078: Controversy, Convey Your Message, and Disseminate Results. Washington, DC, Microbicides Media Communications
p.000078: Initiative and Research Triangle Park, NC, FHI, 2010.
p.000078:
p.000078: Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, 2001
p.000078: This is a report and set of recommendations published by the United States National Bioethics Advisory Commission
p.000078: for United States policy on conducting clinical trials in developing countries.
p.000078: Citation: Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Vol. I. Report
p.000078: and Recommendations of the National Bioethics Advisory Commission. Washington, DC, United States National
p.000078: Bioethics Advisory Commission, 2001.
p.000078:
p.000078:
p.000079: 79
p.000079:
p.000079: UNAIDS / AVAC
p.000079:
p.000079:
p.000079: Mapping the Standards of Care at Microbicide Clinical Trial Sites, 2008
p.000079: The Global Campaign for Microbicides mapped the standard of care being provided across various microbicide
p.000079: clinical trial sites. The report resulted in a set of recommendations relating to the standard of care that is
p.000079: appropriate to provide to participants in microbicide clinical trials.
p.000079: Citation: Heise L, Shapiro K, West Slevin K. Mapping the Standards of Care at Microbicide Clinical Trial Sites.
p.000079: Washington, DC, Global Campaign for Microbicides, 2008.
p.000079:
p.000079: Recommendations for Community Involvement in National Institute of Allergy and Infectious Diseases,
p.000079: HIV/AIDS Clinical Trials Research, 2009
p.000079: The Division of AIDS of the United States National Institute of Allergy and Infectious Diseases and Community
p.000079: Partners (a global group of community representatives affiliated with the National Institute of Allergy and
p.000079: Infectious Diseases HIV/AIDS clinical trials networks) developed these recommendations as a tool for research teams and
p.000079: community representatives to further expand and deepen community involvement in HIV clinical trials research.
p.000079: Citation: Community Recommendations Working Group, Community Partners. Recommendations for Community Involvement in
p.000079: National Institute of Allergy and Infectious Diseases HIV/AIDS Clinical Trials Research. Bethesda, MD, 2009.
p.000079:
p.000079: Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International
p.000079: Consultation, 2005
p.000079: In 2003, the Global Campaign for Microbicides held a consultation to rethink the issues and ethical dilemmas facing the
p.000079: field of microbicide development. The report addresses ethical issues such as informed consent, standards of care, and
p.000079: post-trial access.
p.000079:
p.000079:
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p.000080: 80
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p.000080: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000080:
p.000080:
p.000080: Citation: Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International
p.000080: Consultation. Washington, DC, Global Campaign for Microbicides, 2005.
p.000080:
p.000080: Standards of Prevention in HIV Prevention Trials, 2010
p.000080: In March 2009, the Global Campaign for Microbicides, UNAIDS, and the United States Centers for Disease Control
p.000080: and Prevention jointly convened a consultation on the standards of prevention in HIV prevention trials in Kampala,
p.000080: Uganda. The resultant report summa- rises points of agreement and proposes a range of recommendations for standards of
p.000080: prevention in future HIV prevention clinical trials.
p.000080: Citation: Standards of Prevention at HIV Prevention Trials: Consultation Report and
p.000080: Recommendations. Seattle, Global Campaign for Microbicides, PATH, 2010; and Philpott S et al. The
p.000080: Challenge of Defining Standards of Prevention in HIV Prevention Trials. Journal of Medical Ethics, 2011,
p.000080: 37:244–248.
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p.000081:
p.000081:
p.000081: References
p.000081: 1 UNAIDS and WHO. Ethical Considerations in Biomedical HIV Prevention Trials. Geneva, UNAIDS, 2007.
p.000081: 2 Guideline for Good Clinical Practice: ICH Harmonised Tripartite Guideline. Geneva, International Conference on
p.000081: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.
p.000081: 3 Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation. Geneva,World Health
p.000081: Organization, 2002.
p.000081: 4 UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. Good Clinical
p.000081: Laboratory Practice (GCLP). Geneva, World Health Organization, 2009.
p.000081: 5 World Medical Association General Assembly. World Medical Association Declaration of Helsinki: Ethical Principles
p.000081: for Medical Research Involving Human Subjects. Helsinki, World Medical Association, 2008.
p.000081: 6 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report:
p.000081: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC, Department of
p.000081: Health, Education and Welfare, 1979.
p.000081: 7 International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Council for
p.000081: International Organizations of Medical Sciences, 2002.
p.000081: 8 The Ethics of Research Related to Healthcare in Developing Countries. London, Nuffield Council on
p.000081: Bioethics, 2002.
p.000081: 9 The Ethics of Healthcare Related Research in Developing Countries: A Follow-up Discussion Paper. London,
p.000081: Nuffield Council on Bioethics, 2005.
p.000081: 10 Creating Effective Partnerships for HIV Prevention Trials: Report of a UNAIDS Consultation. Geneva,
p.000081: UNAIDS, 2005.
p.000081: 11 Mills E et al. Media Reporting of Tenofovir Trials in Cambodia and Cameroon.
p.000081: BioMed Central International Health and Human Rights, 2005, 5:6.
p.000081: 12 Preventing Prevention Trial Failures:A Case Study and Lessons Learned for Future Trials from the 2004 Tenofovir
p.000081: Trial in Cambodia.Washington, DC, Global Campaign for Microbicides, 2009.
p.000081: 13 Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site. Washington, DC, Global
p.000081: Campaign for Microbicides, 2009.
p.000081:
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p.000082:
p.000082: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000082:
p.000082:
p.000082: 14 Guenter D et al. Ethical Considerations in International HIV Vaccine Trials: Summary of a Consultative Process by
p.000082: the Joint United National Programme on HIV/AIDS (UNAIDS). Journal of Medical Ethics, 2000, 26:37–43.
p.000082: 15 Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document. Geneva, UNAIDS, 2000.
p.000082: 16 Singh J et al.The Abandoned Trials of Pre-exposure Prophylaxis for HIV:What Went Wrong? PLoS Medicine, 2005,
p.000082: 2(9):e234.
p.000082: 17 Building Collaboration to Advance HIV Prevention Research: Global Consultation on Tenofovir Pre-exposure
p.000082: Prophylaxis Research. Geneva, International AIDS Society, 2005.
p.000082: 18 UNAIDS and AVAC. Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials. Geneva, UNAIDS,
p.000082: 2007.
p.000082: 19 MacQueen KM et al. What is Community? An Evidence-based Definition for Participatory Public Health. American
p.000082: Journal of Public Health, 2001, 91:1929–1937.
p.000082: 20 Cornwall A, Jewkes R.What is Participatory Research? Social Science and Medicine, 1995, 41:1667–1676.
p.000082: 21 Khanlou N, Peter E. Participatory Action Research: Considerations for Ethical Review. Social Science and Medicine,
p.000082: 2005, 60:2333–2340.
p.000082: 22 Macaulay AC et al. Participatory Research Maximises Community Lay Involvement. British Medical Journal,
p.000082: 1999, 319:774–778.
p.000082: 23 Israel BA et al. Review of Community-based Research: Assessing Partnership Approaches to Improve Public Health.
p.000082: Annual Review of Public Health, 1998, 19:173–202.
p.000082: 24 Green LW, Mercer SL. Can Public Health Researchers and Agencies Reconcile the Push from Funding Bodies and the Pull
p.000082: from Communities? American Journal of Public Health, 2001, 91:1926–1929.
p.000082: 25 Arnstein SR. A ladder of Citizen Participation. Journal of the American Institute of Planners, 1969, 35:216–224.
p.000082: 26 Quality Assurance of Pharmaceuticals:A Compendium of Guidelines and Related Materials. Vol. 2. Good Manufacturing
p.000082: Practices and Inspection. 2nd ed. Geneva,World Health Organization, 2007.
p.000082: 27 Community Recommendations Working Group, Community Partners. Recommendations for Community Involvement
p.000082: in National Institute of Allergy and Infectious Diseases HIV/AIDS Clinical Trials Research. Bethesda, MD, 2009.
p.000082:
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p.000083: 83
p.000083:
p.000083: UNAIDS / AVAC
p.000083:
p.000083:
p.000083: 28 Robinson ET et al. Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage
p.000083: Controversy, Convey Your Message, and Disseminate Results. Washington, DC, Microbicides Media Communications
p.000083: Initiative and Research Triangle Park, NC, FHI, 2010.
p.000083: 29 Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No.
p.000083: 10.Vol. 2, pp. 181–182. Washington, DC, United States Government Printing Office, 1949:181–182.
p.000083: 30 Molyneux CS, Peshu N, Marsh K. Understanding of Informed Consent in a Low-income Setting: Three Case Studies from
p.000083: the Kenyan Coast. Social Science and Medicine, 2004, 59:2547–2559.
p.000083: 31 Richter L et al. Guidelines for the Development of Culturally Sensitive Approaches to Obtaining Informed Consent
p.000083: for Participation in HIV Vaccine-related Trials. Geneva, UNAIDS, 1999.
p.000083: 32 Molyneux CS et al.“Even If They Ask You to Stand by a Tree All Day, You Will Have To Do It (laughter)...”:
p.000083: Community Voices on the Notion and Practice of Informed Consent for Biomedical Research in Developing Countries. Social
p.000083: Science and Medicine, 2005, 61:443–454.
p.000083: 33 Appelbaum PS, Lidz CW, Meisel A. Informed Consent: Legal Theory and Clinical Practice. New York, Oxford
p.000083: University Press, 1987.
p.000083: 34 Strauss RP et al. The Role of Community Advisory Boards: Involving Communities in the Informed Consent
p.000083: Process. American Journal of Public Health, 2001, 91:1938–1943.
p.000083: 35 Mapping the Standards of Care at Microbicide Clinical Trial Sites. Washington, DC, Global Campaign for
p.000083: Microbicides, PATH, 2008.
p.000083: 36 Philpott S et al. The Challenge of Defining Standards of Prevention in HIV Prevention Trials. Journal of Medical
p.000083: Ethics, 2011, 37:244–248.
p.000083: 37 Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International
p.000083: Consultation. Washington, DC, Global Campaign for Microbicides, 2005.
p.000083: 38 Ethical and Policy Issues in International Research:ClinicalTrials in Developing Countries. Vol. I. Report and
p.000083: Recommendations of the National Bioethics Advisory Commission. Washington, DC, United States National Bioethics
p.000083: Advisory Commission, 2001.
p.000083:
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p.000084:
p.000084: The Joint United Nations Programme on HIV/AIDS (UNAIDS) brings together ten UN agencies in a common
p.000084: effort to fight the epidemic: the Office of the United Nations High Commissioner for Refugees (UNHCR), the United
p.000084: Nations Children’s Fund (UNICEF), the World Food Programme (WFP), the United Nations Development Programme (UNDP),
p.000084: the United Nations Population Fund (UNFPA), the United Nations Office on Drugs and Crime (UNODC), the
p.000084: International Labour Organization (ILO), the United Nations Educational, Scientific and Cultural Organization
p.000084: (UNESCO), the World Health Organization (WHO), and the World Bank.
p.000084:
p.000084: Leveraging the AIDS response, UNAIDS works to build political action and to promote the rights of all people for better
p.000084: results for global health and development. Globally, it sets policy and is the source of HIV-related data. In
p.000084: countries, UNAIDS brings together the resources of the UNAIDS Secretariat and 10 UN system organizations for
p.000084: coordinated and accountable efforts to unite the world against AIDS.
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p.000084: UNAIDS
p.000084: 20 AVENUE APPIA
p.000084: CH-1211 GENEVA 27 SWITZERLAND
p.000084:
p.000084: Tel: (+41) 22 791 36 66
p.000084: Fax: (+41) 22 791 48 35
p.000084: e-mail: distribution@unaids.org www.unaids.org
p.000084:
...
Searching for indicator hiv/aids:
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Health / Healthy People
Searching for indicator volunteers:
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p.000015: participatory research approaches, which seek to engage community stakeholders as equal members who share control over
p.000015: all aspects of the research process.20,
p.000015: 21, 22, 23, 24
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000016:
p.000016:
p.000016: 1.3 The wider context of HIV
p.000016: There is an urgent need to develop additional strategies to address the HIV pandemic. Along with necessary behavioural
p.000016: and structural changes, a broad range of biomedical HIV prevention and treatment options is required to meet the
p.000016: diverse needs of individuals and populations. There are many inherent complexities in conducting biomedical HIV
p.000016: prevention trials. By acknowledging and under- standing these challenges and complexities, trial funders, sponsors,
p.000016: and implementers can more appropriately and effectively facilitate a mutually beneficial participatory approach to
p.000016: conducting biomedical HIV prevention trials.
p.000016:
p.000016: Biomedical HIV prevention research cannot succeed without mean- ingful stakeholder engagement, particularly given the
p.000016: need to involve large numbers of healthy, HIV-negative volunteers as trial partici- pants. It is optimal that
p.000016: experimental HIV prevention options are tested for safety and effectiveness in populations who need these interventions
p.000016: the most and are likely to use them should they prove effective. However, the very factors that increase HIV risk in
p.000016: such populations may contribute to increased vulnerability to exploitation. This underscores the importance of
p.000016: meaningful partnerships with community stakeholders.
p.000016:
p.000016: A wide range of factors creates, enhances, and perpetuates the risk of HIV infection. Structural determinants can
p.000016: increase vulnerability to HIV at an individual or population level by undermining ability to avoid HIV exposure.
p.000016: Underlying determinants of the HIV epidemic can be entrenched in the social, cultural, legal, institutional, or
p.000016: economic fabric of society. Examples of these determinants include gender and other power inequalities,
p.000016: gender-based violence, economic instability including poverty, migration, human rights
...
p.000068: Activist. A person or group who acts on the behalf of a cause in order to bring about change.
p.000068: Adverse event (AE). An unwanted effect experienced by a partici- pant in a clinical trial. This may or may not
p.000068: be related to the product or procedure being studied.
p.000068: Advocate. A person or group who advocates on the behalf of indi- viduals, groups, or a specific cause.
p.000068: Antiretroviral (ARV) drug. A drug or medication that acts against or suppresses a retrovirus such as HIV.
p.000068: AVAC. An international, non-profit organisation that uses education, policy analysis, advocacy, and community
p.000068: mobilisation to accelerate the ethical development and eventual global delivery of AIDS vaccines and other new HIV
p.000068: prevention options as part of a comprehensive response to the pandemic.
p.000068: Biomedical HIV prevention trial. A clinical trial that aims to discover safe and effective products or procedures to
p.000068: prevent HIV transmission.
p.000068: Blinded trial or masked trial. A clinical trial designed to prevent the participants, research teams, or both, from
p.000068: knowing which participants are in the experimental arm or group and which are in the control arm or group of a trial,
p.000068: in order to reduce bias.
p.000068: Clinical trial. A research study that uses human volunteers to answer specific questions about the safety,
p.000068: efficacy or effectiveness, and medical effects of a specific procedure, medication, product, or treatment. A
p.000068: clinical trial process may include Phases I, II, IIb, III, and IV (post-marketing evaluation).
p.000068:
p.000069: 69
p.000069:
p.000069: UNAIDS / AVAC
p.000069:
p.000069:
p.000069: Community advisory boards (CABs) or community advisory groups (CAGs). Boards or groups composed of individuals
p.000069: or stakeholder representatives that act as an independent advisory voice and facilitate community stakeholder
p.000069: participation and involvement in the research process. They meet regularly with research team representatives, inform
p.000069: community stakeholders about proposed and ongoing research, and provide feedback to research teams about local norms
p.000069: and beliefs, as well as local views and concerns that arise in specific trials.
p.000069: Community groups. Groups of individuals who come together to act on behalf of common interests, goals, and values but
p.000069: whose organisa- tion does not require formal designation or registration.
p.000069: Community stakeholders (per the GPP guidelines). Individuals and groups who are ultimately representing the
p.000069: interests of people who would be recruited to or participate in a clinical trial, and others locally affected by
p.000069: a trial. Examples of “community stakeholders” are the population to be recruited, trial participants, people
p.000069: living in the area where the research is conducted, people living with HIV in the area, local HIV-positive groups or
...
p.000075: care, and support.
p.000075: Unblinding or unmasking. The process of revealing trial participants’ product or procedure assignments. Unblinding
p.000075: involves informing participants about which product they were assigned to during the trial.
p.000075: Vaccine. A compound that stimulates the body’s immune response in order to prevent or control an infection. A vaccine
p.000075: is typically made up of parts of a bacterium or virus that cannot itself cause an infection. (See HIV vaccine.)
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000076: 76
p.000076:
p.000076: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000076:
p.000076:
p.000076: Annex 3. Additional guidance
p.000076:
p.000076: International reference guidelines
p.000076:
p.000076: The Belmont Report, 1979
p.000076: This report was written by the United States National Commission for the Protection of Human Subjects of Biomedical and
p.000076: Behavioral Research, which was established after the public learned about the Tuskegee Syphilis Study. The Belmont
p.000076: Report established the foun- dational ethical principles of respect for persons, beneficence, and justice for research
p.000076: involving human volunteers.
p.000076: Citation: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont
p.000076: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC,
p.000076: Department of Health, Education and Welfare, 1979.
p.000076:
p.000076: Declaration of Helsinki, 1964
p.000076: This Declaration of the World Medical Association is often consid- ered to be the first document to set world
p.000076: standards for research involving human volunteers.
p.000076: Citation: World Medical Association General Assembly. World Medical Association Declaration of
p.000076: Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Helsinki, World Medical Association,
p.000076: 2008.
p.000076:
p.000076: Ethical Considerations in Biomedical HIV Prevention Trials, 2007
p.000076: This is an ethical guidance document, issued by UNAIDS and WHO, for biomedical HIV prevention trials. This document is
p.000076: a revision of Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document. Geneva, UNAIDS,
p.000076: 2000.
p.000076: Citation: UNAIDS and WHO. Ethical Considerations in Biomedical HIV Prevention Trials. Geneva, UNAIDS, 2007.
p.000076:
p.000077: 77
p.000077:
p.000077: UNAIDS / AVAC
p.000077:
p.000077:
p.000077: Guideline for Good Clinical Practice, 1996
p.000077: This guidance document was issued by the International Conference on Harmonisation of Technical Requirements for
p.000077: Registration of Pharmaceuticals for Human Use and outlines an international ethical and scientific quality standard
p.000077: for designing, conducting, recording, and reporting trials that involve human volunteers.
p.000077: Citation: Guideline for Good Clinical Practice: ICH Harmonised Tripartite Guideline. Geneva, International
p.000077: Conference on Harmoni- sation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.
p.000077:
p.000077: International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993
p.000077: These guidelines, published by the Council for International Organizations of Medical Sciences
p.000077: (CIOMS), added guidance on conducting research in developing countries to the body of ethical guidelines. The 2002
p.000077: version supersedes the 1982 and 1993 guidelines.
p.000077: Citation: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva,
p.000077: Council for International Organizations of Medical Sciences, 2002.
p.000077:
p.000077: Nuffield Council on Bioethics, 2002
p.000077: The 2002 Nuffield Council on Bioethics report on The Ethics of Research Related to Healthcare in
p.000077: Developing Countries provides an ethical framework for designing or conducting externally sponsored
p.000077: research in the developing world. The 2004 follow-up report, co-hosted with the Medical Research Council of
p.000077: South Africa, discusses how the guidelines could be applied in practice, particu- larly in light of conflicting ethical
p.000077: advice.
...
Health / injured
Searching for indicator injured:
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p.000057: and regulatory bodies, even if not specifically required by them.
p.000057: e. Procedures for ensuring optimal referrals to appropriate services for trial-related harms.
p.000057: f. Strategies to inform trial participants of the potential risks of engaging with media.
p.000057: g. Compensation or insurance policies, when applicable, for specific trial-related harms, coverage provided by
p.000057: the policies, how claims are made, and how participants are informed of their rights in relation to the policies.
p.000057: 3. Research teams and relevant stakeholders review follow-up strategies to reduce trial-related physical and social
p.000057: harms over the course of the trial.
p.000057: 4. Research teams maintain clear written records of discussions and agreements. This includes recommendations,
p.000057: actions taken by the research team, and any unresolved issues that require follow-up.
p.000057: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000057: ensure the effective management of physical and social harms related to participation in a trial.
p.000057:
p.000057: 3.13.E. Additional guidance
p.000057: 1. Ethical considerations in biomedical HIV prevention trials
p.000057: (Guidance Point 11, page 40, Potential Harms).1
p.000057:
p.000058: 58
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p.000058: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000058:
p.000058:
p.000058: 2. International Ethical Guidelines for Biomedical Research Involving Human Subjects (Guideline 19, page 78
p.000058: right of injured subjects to treatment and compensation).7
p.000058: 3.14 Trial accrual, follow-up, and exit
p.000058: 3.14.A. Definition
p.000058: Trial accrual, follow-up, and exit activities include the recruit- ment, screening, enrolment, follow-up, and exit of
p.000058: trial partici- pants in biomedical HIV prevention trials.
p.000058:
p.000058: 3.14.B. Relevance to good participatory practice
p.000058: Community stakeholders can provide the best information on how to design socially and culturally
p.000058: acceptable strate- gies for recruitment, screening, enrolment, follow-up, and exit. Community stakeholders included in
p.000058: the process of developing these strategies can play an important role in identifying and mitigating trial-related
p.000058: stigma, misconceptions, or miscommuni- cation.
p.000058:
p.000058: 3.14.C. Special considerations
p.000058: 1. Follow-up of participants after missed visits must respect agreements between the participant and research
p.000058: team about how to contact the participant.
p.000058: 2. Exiting a trial may present changes in what participants have become accustomed to with regard to clinical care and
p.000058: the impact of the trial on their social relationships. Anticipation and discussion of these issues between research
p.000058: teams and community stakeholders will help in the development of appropriate strategies to support participants
p.000058: upon trial exit.
p.000058: 3.14.D. Good participatory practices for trial accrual, follow-up, and exit
p.000058: 1. Research teams consult with relevant stakeholders about accrual, follow-up, and exit processes, taking
p.000058: account of the following:
p.000058:
...
Health / sexually transmitted disases
Searching for indicator sexually transmitted:
(return to top)
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049: UNAIDS / AVAC
p.000049:
p.000049:
p.000049: 3.10.D. Good participatory practices for standard of HIV prevention
p.000049: 1. Research teams and relevant stakeholders negotiate the HIV prevention package during the protocol development phase
p.000049: of the trial.
p.000049: 2. Research teams determine which stakeholders already provide HIV prevention services, what types of
p.000049: services they provide, and their capacity to provide adequate services.This will enable research teams to provide
p.000049: optimal referrals and make linkages when necessary.
p.000049: 3. Research teams and relevant stakeholders discuss and negotiate the comprehensive HIV prevention package and
p.000049: consult local HIV prevention service providers when appro- priate. All scientifically validated methods are discussed,
p.000049: and their appropriateness for the trial design and population assessed, including:
p.000049: a. Risk assessment and risk-reduction counselling— including partner and couple counselling.
p.000049: b. Male and female condoms—with appropriate instructions and demonstrations.
p.000049: c. Testing for and treatment of sexually transmitted infec- tions.
p.000049: d. Sterile injecting equipment and drug substitution treatment.
p.000049: e. Medical male circumcision.
p.000049: f. Post-exposure prophylaxis.
p.000049: g. Other novel HIV risk-reduction strategies as they become available.
p.000049: 4. Research teams and relevant stakeholders discuss and negotiate the comprehensive HIV prevention package,
p.000049: taking account of the following:
p.000049: a. The HIV prevention package required as a minimum for the trial protocol.
p.000049: b. Current HIV prevention standards and services available nationally and locally.
p.000049:
p.000050: 50
p.000050:
p.000050: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000050:
p.000050:
p.000050: c. Current national laws on HIV prevention strategies and services, as well as national ethical guidance on research.
p.000050: d. The trial’s funding source, any implications this may have for the prevention package, and how these will be
p.000050: addressed to ensure participants are offered a comprehen- sive package.
p.000050: e. The HIV prevention services and options that will be offered through referral mechanisms.
p.000050: f. The HIV prevention services that will be available to partners of trial participants.
...
p.000069: community stakeholders about proposed and ongoing research, and provide feedback to research teams about local norms
p.000069: and beliefs, as well as local views and concerns that arise in specific trials.
p.000069: Community groups. Groups of individuals who come together to act on behalf of common interests, goals, and values but
p.000069: whose organisa- tion does not require formal designation or registration.
p.000069: Community stakeholders (per the GPP guidelines). Individuals and groups who are ultimately representing the
p.000069: interests of people who would be recruited to or participate in a clinical trial, and others locally affected by
p.000069: a trial. Examples of “community stakeholders” are the population to be recruited, trial participants, people
p.000069: living in the area where the research is conducted, people living with HIV in the area, local HIV-positive groups or
p.000069: networks, people in the area affected by the HIV epidemic, local non-governmental organisations, community
p.000069: groups, and community-based organisations. (See stakeholders.)
p.000069: Confidentiality. The principle that protects the rights of trial partici- pants regarding prevention of
p.000069: unauthorised disclosure of personal information to third parties during data collection, storage, transfer,
p.000069: and use.
p.000069: Condom. A sheath or pouch that is worn either over the penis (male condom) or inside the vagina (female condom)
p.000069: during sexual inter- course, for the purpose of protecting against sexually transmitted infec- tions (including HIV)
p.000069: or preventing pregnancy. (See female condom or male condom.)
p.000069: Control arm or group. The group of participants in a clinical trial who receive the placebo or control product or
p.000069: procedure. (See placebo.)
p.000069: Data and safety monitoring board (DSMB) or independent data monitoring committee (IDMC). An independent
p.000069: committee estab- lished by a trial sponsor to assess, at intervals, the progress of a clinical trial, safety data, and
p.000069: critical efficacy or effectiveness endpoints. A data and safety monitoring board may recommend to the sponsor that a
p.000069:
p.000070: 70
p.000070:
p.000070: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000070:
p.000070:
p.000070: trial be stopped or modified if there are safety concerns, if trial objec- tives have been achieved, or if assessment
p.000070: of trial progress reveals that continuing the trial would be futile since it will no longer be possible to answer the
p.000070: research question that the trial is addressing.
p.000070: Ethics committee. See research ethics committee.
p.000070: Experimental arm or group. The group of participants in a clinical trial who receive the procedure, product, or drug
p.000070: being studied.
p.000070: Female condom. A pouch that when inserted in the vagina before vaginal intercourse, provides protection
p.000070: against most sexually trans- mitted infections, including HIV, and pregnancy. During anal sex, the female condom,
p.000070: when placed on the penis after removing the inner ring, provides protection against most sexually transmitted
p.000070: infections, including HIV. Currently made of polyurethane (female condom 1) or a synthetic latex (female condom 2), it
p.000070: is stronger than the natural latex used in male condoms, odourless, non-allergenic, and usable with oil-based
p.000070: and water-based lubricants. For vaginal intercourse, it can be inserted vaginally prior to intercourse, is not
p.000070: dependent on male erection, and does not require immediate withdrawal after ejaculation. (See also male condom.)
p.000070: Formative research activities. Activities that enable research teams to gain an informed understanding of local
p.000070: populations, socio-cultural norms and practices, local power dynamics, local perceptions, channels of communication and
p.000070: decision-making, and local history of research, as well as the needs and priorities of people locally affected by or
p.000070: able to influence a clinical trial. Formative research activities usually consti- tute the initial phase of stakeholder
p.000070: outreach and engagement.
p.000070: Futility. The inability of a clinical trial to achieve one or more of its objectives. This determination
p.000070: may be suggested, for example, during an interim analysis of a trial by a data safety monitoring board.
p.000070: Good Clinical Laboratory Practice (GCLP). Guidelines that set a standard for compliance by laboratories
p.000070: involved in the analysis of samples from clinical trials. These guidelines provide guidance to ensure that
p.000070: trial laboratory data are reliable, repeatable, auditable, and easily reconstructed in a research setting.
p.000070:
p.000070:
p.000070:
p.000071: 71
...
p.000071: Good manufacturing practices are aimed primarily at diminishing the risks inherent in any pharmaceutical or
p.000071: medical device production.
p.000071: Good Participatory Practice (GPP). Guidelines that provide trial funders, sponsors, and implementers with
p.000071: systematic guidance on how to effectively engage with stakeholders in the design and conduct of biomedical HIV
p.000071: prevention trials.
p.000071: HIV vaccine (or AIDS vaccine). A vaccine designed to prevent HIV infection. (See vaccine.)
p.000071: Human immunodeficiency virus (HIV). The virus that weakens the immune system, ultimately leading to
p.000071: acquired immunodeficiency syndrome (AIDS).
p.000071: Implementer. See trial implementer.
p.000071: Informed consent. A process by which a competent individual volun- tarily confirms his or her willingness to
p.000071: participate in a particular clinical trial after having been informed of all aspects of the trial that are
p.000071: relevant to the individual’s decision to participate. Informed consent is an ongoing process throughout the course of a
p.000071: clinical trial.
p.000071: Institutional review board (IRB). See ethics committee.
p.000071: Male condom. A sheath designed to be worn over the penis during vaginal, anal, or oral intercourse as a means
p.000071: of preventing sexually transmitted infections, including HIV, or preventing pregnancy in the case of vaginal
p.000071: intercourse. (See also female condom.)
p.000071:
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000072:
p.000072:
p.000072: Medical male circumcision. The surgical removal of the entire foreskin of the penis. Three clinical trials conducted in
p.000072: sub-Saharan Africa have shown that medically performed male circumcision is safe and can reduce men’s risk
p.000072: of HIV infection during vaginal sex by about 60%. Prevalence of male circumcision varies by geography,
p.000072: religion, and cultural practices.
p.000072: Men who have sex with men (MSM). Men who have sexual contact with other men, regardless of whether or not they also
p.000072: have sex with women or have a personal or social gay or bisexual identity. This concept also includes men
p.000072: who self-identify as heterosexual but have sex with other men.
p.000072: Microbicides. A range of products that could be used vaginally or rectally (such as a gel, cream, ring, film,
p.000072: suppository or sponge) that are being tested to determine if they reduce or prevent the transmission of HIV and other
p.000072: disease-causing organisms during vaginal and anal intercourse.
p.000072: Network or research network. A cooperative of research institutions or centres conducting clinical trials under a
...
p.000073: materials to be used in recruiting and consenting trial participants, and provide continuing review of a trial protocol
p.000073: and any amendments. The term “institutional review board” is common in the United States of America, whereas other
p.000073: countries commonly use the term “research ethics committee” or “independent ethics committee”.
p.000073: Research network. See network.
p.000073: Research team. A group of investigators and staff involved in imple- menting biomedical HIV prevention trials. Research
p.000073: teams can include investigators and staff at a specific trial site as well as investigators and staff working at
p.000073: coordinating centres, institutions, or agencies.
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000074:
p.000074:
p.000074: Scientific process. A recognised systematic way to form and test hypotheses by designing controlled
p.000074: experiments to collect data, analyse results, and draw conclusions in order to acquire new knowledge or to correct,
p.000074: refine, and integrate previous knowledge.
p.000074: Seroconversion. The process by which a newly infected person develops antibodies that can be detected by
p.000074: an HIV antibody test. Development of antibodies may occur anywhere from weeks or months following HIV infection.
p.000074: Sexually transmitted infections (STIs). Infections caused by microor- ganisms that are transmitted from one person to
p.000074: another during sexual or intimate contact.
p.000074: Stakeholders or trial stakeholders. Individuals, groups, organisations, governments, or other entities that are
p.000074: affected by the outcome of a biomedical HIV prevention trial or that can influence proposed research through their
p.000074: input and actions. (See community stakeholders.)
p.000074: Standard operating procedure (SOP). A document that gives step- by-step instructions for how to conduct a procedure, in
p.000074: order to ensure that each staff member can perform the procedure in the same way.
p.000074: Stigma. AIDS-related stigma refers to a pattern of prejudice, discounting, discrediting, and discrimination directed at
p.000074: people perceived to have HIV or AIDS, their significant others and close associates or their social groups.
p.000074: Therapeutic HIV vaccine. A compound designed to stimulate the immune response to HIV in a person already
p.000074: infected with the virus, in order to control the infection. Also referred to as an immunotherapeutic vaccine. (See
p.000074: vaccine and HIV vaccine.)
p.000074: Trial arm or group. A group within a clinical trial formed of participants who have been assigned a particular product
p.000074: or procedure during a trial. (See control arm or group, experimental arm or group.)
...
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p.000066: reflection can be sent to gpp@unaids.org or avac@avac.org, where they will be gratefully received and considered in
p.000066: future updates of these guidelines.
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: UNAIDS / AVAC
p.000067:
p.000067:
p.000067: Annex 1. Acronyms and abbreviations
p.000067: AE – Adverse event
p.000067: AIDS – Acquired Immunodeficiency Syndrome
p.000067: ARV – Antiretroviral drug
p.000067: CAB – Community Advisory Board CAG – Community Advisory Group CBO – Community-Based Organisation
p.000067: CIOMS – Council for International Organizations of Medical Science
p.000067: EC – Ethics committee
p.000067: DSMB – Data safety monitoring board DSMC – Data safety monitoring committee GCLP– Good Clinical Laboratory Practice GCP
p.000067: – Good Clinical Practice
p.000067: GMP – Good Manufacturing Practice GPP – Good Participatory Practice HIV – Human Immunodeficiency Virus
p.000067: IDMC – Independent data monitoring committee
p.000067: IDU – Injecting drug use
p.000067: IRB – Institutional review board
p.000067: MSM – Men who have sex with men NGO – Non-governmental organisation PEP – Post-exposure prophylaxis
p.000067: PMTCT – Prevention of mother-to-child transmission
p.000067: PrEP – Pre-exposure prophylaxis REC – Research ethics committee SOP – Standard operating procedure STI – Sexually
p.000067: transmitted infection
p.000067: UNAIDS – Joint United Nations Programme on HIV/AIDS
p.000067: WHO – World Health Organization
p.000067:
p.000067:
p.000067:
p.000068: 68
p.000068: 68
p.000068:
p.000068: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000068:
p.000068:
p.000068: Annex 2. Glossary
p.000068: Accrual. The process of recruiting participants into a clinical trial in order to reach target participant
p.000068: numbers.
p.000068: Acquired immunodeficiency syndrome (AIDS). The most severe mani- festation of infection with human immunodeficiency
p.000068: virus (HIV), charac- terised by deterioration of the immune system and susceptibility to a range of opportunistic
p.000068: infections and cancers. (See human immunode- ficiency virus.)
p.000068: Activist. A person or group who acts on the behalf of a cause in order to bring about change.
p.000068: Adverse event (AE). An unwanted effect experienced by a partici- pant in a clinical trial. This may or may not
p.000068: be related to the product or procedure being studied.
p.000068: Advocate. A person or group who advocates on the behalf of indi- viduals, groups, or a specific cause.
p.000068: Antiretroviral (ARV) drug. A drug or medication that acts against or suppresses a retrovirus such as HIV.
p.000068: AVAC. An international, non-profit organisation that uses education, policy analysis, advocacy, and community
...
Health / visual impairment
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p.000068: numbers.
p.000068: Acquired immunodeficiency syndrome (AIDS). The most severe mani- festation of infection with human immunodeficiency
p.000068: virus (HIV), charac- terised by deterioration of the immune system and susceptibility to a range of opportunistic
p.000068: infections and cancers. (See human immunode- ficiency virus.)
p.000068: Activist. A person or group who acts on the behalf of a cause in order to bring about change.
p.000068: Adverse event (AE). An unwanted effect experienced by a partici- pant in a clinical trial. This may or may not
p.000068: be related to the product or procedure being studied.
p.000068: Advocate. A person or group who advocates on the behalf of indi- viduals, groups, or a specific cause.
p.000068: Antiretroviral (ARV) drug. A drug or medication that acts against or suppresses a retrovirus such as HIV.
p.000068: AVAC. An international, non-profit organisation that uses education, policy analysis, advocacy, and community
p.000068: mobilisation to accelerate the ethical development and eventual global delivery of AIDS vaccines and other new HIV
p.000068: prevention options as part of a comprehensive response to the pandemic.
p.000068: Biomedical HIV prevention trial. A clinical trial that aims to discover safe and effective products or procedures to
p.000068: prevent HIV transmission.
p.000068: Blinded trial or masked trial. A clinical trial designed to prevent the participants, research teams, or both, from
p.000068: knowing which participants are in the experimental arm or group and which are in the control arm or group of a trial,
p.000068: in order to reduce bias.
p.000068: Clinical trial. A research study that uses human volunteers to answer specific questions about the safety,
p.000068: efficacy or effectiveness, and medical effects of a specific procedure, medication, product, or treatment. A
p.000068: clinical trial process may include Phases I, II, IIb, III, and IV (post-marketing evaluation).
p.000068:
p.000069: 69
p.000069:
p.000069: UNAIDS / AVAC
p.000069:
p.000069:
p.000069: Community advisory boards (CABs) or community advisory groups (CAGs). Boards or groups composed of individuals
p.000069: or stakeholder representatives that act as an independent advisory voice and facilitate community stakeholder
p.000069: participation and involvement in the research process. They meet regularly with research team representatives, inform
p.000069: community stakeholders about proposed and ongoing research, and provide feedback to research teams about local norms
p.000069: and beliefs, as well as local views and concerns that arise in specific trials.
p.000069: Community groups. Groups of individuals who come together to act on behalf of common interests, goals, and values but
p.000069: whose organisa- tion does not require formal designation or registration.
p.000069: Community stakeholders (per the GPP guidelines). Individuals and groups who are ultimately representing the
p.000069: interests of people who would be recruited to or participate in a clinical trial, and others locally affected by
...
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p.000002: 2.4 Transparency 24
p.000002: 2.5 Accountability 24
p.000002: 2.6 Community stakeholder autonomy 25
p.000002: 3. Good participatory practices in biomedical HIV prevention trials 26
p.000002: Introduction to good participatory practices 26
p.000002: 3.1 Formative research activities 27
p.000002: 3.2 Stakeholder advisory mechanisms 29
p.000002: 3.3 Stakeholder engagement plan 35
p.000002: 3.4 Stakeholder education plan 37
p.000002: 2
p.000002:
p.000002: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 3.5 Communications plan 39
p.000002: 3.6 Issues management plan 41
p.000002: 3.7 Site selection 43
p.000002: 3.8 Protocol development 44
p.000002: 3.9 Informed consent process 45
p.000002: 3.10 Standard of HIV prevention 48
p.000002: 3.11 Access to HIV care and treatment 52
p.000002: 3.12 Non HIV-related care 55
p.000002: 3.13 Policies on trial-related harms 57
p.000002: 3.14 Trial accrual, follow-up, and exit 59
p.000002: 3.15 Trial closure and results dissemination 60
p.000002: 3.16 Post-trial access to trial products or procedures 63
p.000002: Conclusion 66
p.000002: Annex 1. Acronyms and abbreviations 68
p.000002: Annex 2. Glossary 69
p.000002: Annex 3. Additional guidance 77
p.000002: References 82
p.000002:
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p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: UNAIDS / AVAC
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Section 1:
p.000003: The Importance of Good Participatory Practice
p.000003:
p.000003: Section 2:
p.000003: Guiding Principles
p.000003: of GPP in Biomedical HIV Prevention Trials
p.000003:
p.000003: Section 3:
p.000003: Good Participatory Practices in Biomedical HIV Prevention Trials
p.000003:
p.000003:
p.000003:
p.000003: Who are Stakeholders?
p.000003:
p.000003:
p.000003: What is Stakeholder Engagement?
p.000003:
p.000003:
p.000003: The Wider Context of HIV
p.000003:
p.000003: The Dynamics of Biomedical HIV Prevention Trials
p.000003:
p.000003: Rationale for GPP Guidelines
p.000003:
p.000003:
p.000003: Applying GPP
p.000003:
p.000003: Respect
p.000003:
p.000003:
p.000003: Mutual Understanding
p.000003:
p.000003:
p.000003: Integrity
p.000003:
p.000003:
p.000003: Transparency
p.000003:
p.000003:
p.000003: Accountability
p.000003:
p.000003:
p.000003: Community Stakeholder Autonomy
p.000003: Formative Research Activities
p.000003: Stakeholder
p.000003: Advisory Mechanisms
p.000003: Stakeholder Engagement Plan
p.000003: Stakeholder Education Plan
p.000003:
p.000003: Communications Plan Issues Management Plan Site Selection
p.000003: Protocol Development
p.000003:
p.000003: Informed Consent Process
p.000003: Standard of HIV Prevention
p.000003: Access to HIV Care and Treatment
p.000003:
p.000003: Non HIV-Related Care
p.000003:
p.000003: Policies on
p.000003: Trial-Related Harms
p.000003: Trial Accrual, Follow-Up, and Exit
p.000003: Trial Closure and Results Dissemination
p.000003: Post-trial Access to Trial Products or Procedures
p.000003:
p.000004: 4
p.000004:
p.000004: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000004:
p.000004:
p.000004: Introduction
p.000004:
p.000004: Objective of the good participatory practice (GPP) guidelines
p.000004: The good participatory practice (GPP) guidelines provide trial funders, sponsors, and implementers with systematic
p.000004: guidance on how to effec- tively engage with stakeholders in the design and conduct of biomedical HIV prevention
p.000004: trials.
p.000004: In the GPP guidelines,“design and conduct of biomedical HIV prevention trials” refers to activities required for the
p.000004: development, planning, imple- mentation, and conclusion of a trial, including dissemination of trial results.
p.000004:
p.000004: Intended audience of the GPP guidelines
p.000004: The GPP guidelines are primarily written for trial funders, trial sponsors, and trial implementers. Trial funders,
p.000004: sponsors, and implementers include investigators, research staff, and all others involved in designing, financing, and
p.000004: executing biomedical HIV prevention trials.They can include govern- ments, government-sponsored research networks,
p.000004: non-governmental organisations, academic institutions, foundations, public–private partner- ships, and pharmaceutical
p.000004: or other companies.
p.000004: Stakeholders not directly involved in funding, sponsoring, or implementing trials can use the guidelines to better
p.000004: understand the objectives, expectations, and methods of stakeholder engagement and to better evaluate such efforts.
...
p.000009: document:
p.000009:
p.000009: Section 1: The importance of good participatory practice defines the key terms used in the document and describes the
p.000009: realities and the underlying determinants of the HIV epidemic, the context of conducting biomedical HIV prevention
p.000009: trials, and why a participatory approach is necessary to effectively conduct trials.
p.000009:
p.000009: Section 2: Guiding principles of GPP in biomedical HIV preven- tion trials outlines the set of principles that serve
p.000009: as the foundation of the relationships among trial funders, sponsors, and implementers and other stakeholders.These
p.000009: principles include respect, mutual under- standing, integrity, transparency, accountability, and community stake-
p.000009: holder autonomy.
p.000009:
p.000009: Section 3: Good participatory practices in biomedical HIV prevention trials describes optimal practices
p.000009: to follow when designing and conducting biomedical HIV prevention trials. Under 16 topic areas, this section outlines
p.000009: expected stakeholder engagement activities that take place at each stage of the research life-cycle.The topic areas
p.000009: are:
p.000009:
p.000009: 1. Formative research activities 9. Informed consent process
p.000009: 2. Stakeholder advisory mechanisms 10. Standard of HIV prevention
p.000009: 3. Stakeholder engagement plan 11. Access to HIV care and treatment
p.000009: 4. Stakeholder education plan 12. Non HIV-related care
p.000009: 5. Communications plan 13. Policies on trial-related harms
p.000009: 6. Issues management plan 14. Trial accrual, follow-up, and exit
p.000009: 7. Site selection 15. Trial closure and results dissemination
p.000009: 8. Protocol development 16. Post-trial access to trial products or
p.000009: procedures
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000010:
p.000010:
p.000010: Topic areas in the good participatory practices section are divided into the following subsections:
p.000010: A. Definition.
p.000010: B. Relevance to good participatory practice.
p.000010: C. Special considerations.
p.000010: D. Good participatory practices.
p.000010: E. Additional guidance.
p.000010:
p.000010: After the Conclusion (pages 66-67), the reader will find three useful annexes:
p.000010:
p.000010: Annex 1 presents the acronyms and abbreviations used in this document. Annex 2 is a glossary of the essential terms
p.000010: used throughout the GPP guidelines. Annex 3 introduces other international reference guidelines and key documents,
p.000010: for further reading.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
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p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
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p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: UNAIDS / AVAC
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Section 1:
p.000011: The Importance of Good Participatory Practice
p.000011: Section 2:
p.000011: Guiding Principles
p.000011: of GPP in Biomedical HIV Prevention Trials
p.000011: Section 3:
p.000011: Good Participatory Practices in Biomedical HIV Prevention Trials
p.000011:
p.000011:
p.000011: The Importance of Good Participatory Practice defines the key terms used in the document and describes the realities
...
p.000012:
p.000012:
p.000012: Who are Stakeholders?
p.000012:
p.000012:
p.000012: What is Stakeholder Engagement?
p.000012:
p.000012:
p.000012: The Wider Context of HIV
p.000012:
p.000012: The Dynamics of Biomedical HIV Prevention Trials
p.000012:
p.000012: Rationale for GPP Guidelines
p.000012:
p.000012:
p.000012: Applying GPP
p.000012: Use this section to understand the principles that guide the foundation of the relationships among biomedical HIV
p.000012: preven- tion stakeholders
p.000012:
p.000012:
p.000012: Respect
p.000012:
p.000012:
p.000012: Mutual Understanding
p.000012:
p.000012:
p.000012: Integrity
p.000012:
p.000012:
p.000012: Transparency
p.000012:
p.000012:
p.000012: Accountability
p.000012:
p.000012:
p.000012: Community Stakeholder Autonomy
p.000012: Use this section and its optimal practices to guide specific stakeholder engagement activities when conducting
p.000012: biomedical HIV prevention trials
p.000012:
p.000012: Formative Research Activities
p.000012: Stakeholder
p.000012: Advisory Mechanisms
p.000012: Stakeholder Engagement Plan
p.000012: Stakeholder Education Plan
p.000012:
p.000012: Communications Plan Issues Management Plan Site Selection
p.000012: Protocol Development
p.000012:
p.000012: Informed Consent Process
p.000012: Standard of HIV Prevention
p.000012: Access to HIV Care and Treatment
p.000012:
p.000012: Non HIV-Related Care
p.000012:
p.000012: Policies on
p.000012: Trial-Related Harms
p.000012: Trial Accrual, Follow-Up, and Exit
p.000012: Trial Closure and Results Dissemination
p.000012: Post-trial Access to Trial Products or Procedures
p.000012:
p.000013: 13
p.000013:
p.000013: UNAIDS / AVAC
p.000013:
p.000013:
p.000013: 1. The importance of good participatory practice
p.000013:
p.000013: 1.1 Who are stakeholders?
p.000013: The starting point of good participatory practice is the identification of key stakeholders in the conduct of a
p.000013: biomedical HIV prevention trial. Stakeholders are individuals, groups, organisations, government bodies, or any other
p.000013: individuals or collections of individuals who can influence or are affected by the conduct or outcome of a biomedical
p.000013: HIV prevention trial. In this guidance document, the term “stake- holders” is all-encompassing. It describes any
p.000013: individual or collection of individuals who have a stake in a biomedical HIV prevention trial.
p.000013:
p.000013: Examples of stakeholders are illustrated in Figure 2 and can include trial participants, families of trial
p.000013: participants, prospective trial partic- ipants, individuals resident within, or surrounding, the area where research is
p.000013: conducted, people living with HIV or affected by HIV, prevention and treatment advocates and activists,
p.000013: non-governmental organisations (NGOs), community-based organisations (CBOs), community groups, religious leaders,
p.000013: opinion leaders, media, govern- ment bodies, national and local health-care authorities, service providers,
...
p.000043: procedures are locally appro- priate, are acceptable to the trial population, and optimise successful
p.000043: implementation of the trial.
p.000043:
p.000043: 3.8.C. Special considerations
p.000043: 1. Opportunities for protocol review and input by local research teams and relevant stakeholders vary by trial. In
p.000043: some circum- stances, particularly multicountry or multisite trials, protocol development may be largely centralised.
p.000043: It is good practice in the protocol development process to incorporate mecha- nisms to facilitate stakeholder input
p.000043: early in the process.
p.000043: 2. Research teams can consider documenting community stake- holder input into protocol development and sharing these
p.000043: recommendations with protocol review bodies, even when not explicitly required by such bodies.
p.000043: 3.8.D. Good participatory practices for protocol development
p.000043: 1. Trial sponsors and network leadership provide opportuni- ties and time for local research teams to contribute to
p.000043: trial protocol development.
p.000043:
p.000044: 44
p.000044:
p.000044: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000044:
p.000044:
p.000044: 2. Trial sponsors, network leadership, and local research teams provide opportunities and time for local
p.000044: stakeholders, in particular community stakeholders, to contribute to trial design issues and procedures such as
p.000044: products to be tested, trial objectives, recruitment strategies, informed consent materials and procedures,
p.000044: reimbursement policies, counsel- ling approaches, follow-up procedures, and post-trial access to trial products or
p.000044: procedures.
p.000044: 3. Research teams maintain clear and transparent communica- tion about the protocol development process with relevant
p.000044: stakeholders, in particular, formal stakeholder advisory mech- anisms.
p.000044: 4. Research teams provide relevant stakeholders with draft versions of the protocol and make technical
p.000044: information as accessible as possible by providing protocol summaries and translated materials, or by facilitating
p.000044: workshops, as necessary.
p.000044: 5. Research teams inform relevant stakeholders of protocol reviews and approval processes and provide regular
p.000044: updates.
p.000044: 6. Trial sponsors or implementers make full, final protocols of trials available and easily accessible to
p.000044: stakeholders.
p.000044: 7. Research teams maintain clear written records of discussions and agreements. This includes relevant stakeholders’
p.000044: recom- mendations, actions taken by the research team, and any unre- solved issues that require follow-up.
p.000044: 8. Trial sponsors ensure sufficient funding and research teams allocate resources and time to support stakeholder
p.000044: engage- ment in the protocol development process.
p.000044: 3.9 Informed consent process
p.000044: 3.9.A. Definition
p.000044: Informed consent is a process by which a competent individual is provided with enough information about a trial to make
p.000044: an independent decision whether or not to participate in the trial. In this process, research staff members educate the
p.000044: prospective participant about the trial, including about the potential risks and benefits, trial procedures, and what
p.000044: is expected of the participant.
p.000044:
p.000045: 45
p.000045:
p.000045: UNAIDS / AVAC
p.000045:
p.000045:
p.000045: When an individual provides consent, this is documented on the informed consent form. Informed consent is an ongoing
p.000045: process. Participants may decide to drop out of the trial at any point, even after providing consent to enrol in the
p.000045: trial.
p.000045:
p.000045: 3.9.B. Relevance to good participatory practice
p.000045: The informed consent process is relevant to good participatory practice because a wide range of stakeholders can help
p.000045: research teams develop locally acceptable and effective informed consent procedures and materials.
p.000045:
p.000045: 3.9.C. Special considerations
p.000045: Community stakeholders can provide research teams with invaluable advice to improve the informed consent process
p.000045: and materials. However, the actual implementation of the informed consent process between an individual and the
p.000045: research staff is confidential. Only designated research staff members have access to confidential information about
p.000045: the identity of trial participants. The informed consent process itself is conducted in accordance with Good Clinical
p.000045: Practice.2
p.000045:
p.000045: 3.9.D. Good participatory practices for the informed consent process
p.000045: 1. Research teams discuss the following topics with community stakeholders during development of the informed consent
p.000045: materials and procedures:
p.000045: a. Who needs to be consulted locally to enable research teams to invite individuals to join the trial.
p.000045: b. What local cultural practices may affect individual deci- sion-making ability, and how working within these struc-
p.000045: tures can be facilitated while ensuring protection of indi- vidual autonomy to provide informed consent.
p.000045: c. The general literacy level of the population to be recruited and how to assess the literacy level of prospective
p.000045: partici- pants.
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000046:
p.000046:
p.000046: d. Considerations and requirements for illiterate participants, including discussion of possibilities of who may
...
p.000047: contexts, including a range of innovative approaches to measure and assess participant understanding, to address
p.000047: literacy issues, and to accommodate the desire of participants to consult with families and friends. 30, 31, 32, 33, 34
p.000047: 3.10 Standard of HIV prevention
p.000047: 3.10.A. Definition
p.000047: The term “standard of HIV prevention” refers to the package of comprehensive counselling and state-of-the-art HIV
p.000047: risk reduction methods provided or made available to participants in biomedical HIV prevention trials.
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000048:
p.000048:
p.000048: 3.10.B. Relevance to good participatory practice
p.000048: Helping trial participants reduce their risk of acquiring HIV is a key ethical obligation of research teams.
p.000048: Determining the components of the HIV prevention package is a joint effort between research teams and relevant
p.000048: stakeholders. Trial sponsors and implementers must work with relevant stakeholders in establishing the type,
p.000048: scope, and process by which participants are provided with, or referred to, services to access the full HIV prevention
p.000048: package. How trial sites help participants prevent HIV acquisition is often at the forefront of community stakeholder
p.000048: concerns. Therefore, successful negotiation with stakeholders about the prevention package to be provided to trial
p.000048: participants is likely to have a significant influence on community stakeholder perceptions of a trial.
p.000048:
p.000048: 3.10.C. Special considerations
p.000048: 1. Deviations from expected standard HIV prevention packages at a trial site or among trial sites in multisite studies
p.000048: may be caused by national legal restrictions.
p.000048: 2. When funding-body restrictions limit which prevention methods can be paid for by trial funds, research teams
p.000048: have the responsibility to find other ways to provide these methods, such as through alternative funding streams or
p.000048: linkages with non-governmental organisations or community-based organ- isations.
p.000048: 3. Research teams may need to review the HIV prevention package regularly, taking into consideration new HIV coun-
p.000048: selling models and risk reduction methods that are scientifi- cally validated and, when appropriate, approved by
p.000048: national bodies for use.
p.000048: 4. To improve relevant stakeholder understanding of the preven- tion package offered and the clinical trial process,
...
p.000050: g. The impact that any services offered by the trial, as well as those to which participants will be referred by the
p.000050: trial, could have on local services.
p.000050: 5. Research teams and relevant stakeholders discuss how the HIV prevention package will be implemented and monitored,
p.000050: including uptake and standards of referral services.
p.000050: 6. Research teams maintain clear written records of discussions and agreements. This includes recommendations,
p.000050: actions taken by the research team, and any unresolved issues that require follow-up.
p.000050: 7. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000050: ensure provision of the comprehensive HIV prevention package.
p.000050: 3.10.E. Additional guidance
p.000050: 1. Ethical considerations in biomedical HIV prevention trials
p.000050: (Guidance Point 13, page 45, Standard of HIV Prevention).1
p.000050: 2. Ethical considerations in biomedical HIV prevention trials (page 13, selected circumstances in which biomedical HIV
p.000050: prevention trials should not be conducted).1
p.000050: 3. Mapping the Standards of Care at Microbicide Clinical Trial Sites.35
p.000050: 4. The challenge of defining standards of prevention in HIV prevention trials.36
p.000050:
p.000050:
p.000050:
p.000050:
p.000051: 51
p.000051:
p.000051: UNAIDS / AVAC
p.000051:
p.000051:
p.000051: 3.11 Access to HIV care and treatment
p.000051: 3.11.A. Definition
p.000051: Access to comprehensive HIV care and treatment refers to care and treatment services made available to
p.000051: individuals who are identified as HIV-positive during the screening process and to trial participants who acquire HIV
p.000051: infection during the trial. Comprehensive HIV care includes all preventive, psychoso- cial, psychological, and
p.000051: clinical components of HIV care. HIV treatment refers to antiretroviral therapy regimens internationally recognised as
p.000051: optimal for the management of HIV.
p.000051:
p.000051: 3.11.B. Relevance to good participatory practice
p.000051: Trial sponsors and implementers are ethically obligated to ensure that participants who acquire HIV during trial
p.000051: participation have access to clinical evaluation, and stage-appropriate HIV care and treatment.This issue is often at
p.000051: the forefront of community stake- holder concerns.Therefore, how access to HIV care and treatment is negotiated with
p.000051: relevant stakeholders and how it is provided to trial participants are likely to have a significant influence on
p.000051: community stakeholder perceptions of a trial.
p.000051:
p.000051: 3.11.C. Special considerations
p.000051: 1. HIV care and treatment guidelines vary by country.
p.000051: 2. Treatment options may improve over time and research teams may need to modify their HIV care and treatment access
p.000051: plans in line with updated national guidelines.
p.000051: 3. Mechanisms to provide HIV care and treatment require long-term logistics planning as people living
p.000051: with HIV require lifelong care and treatment, and, for some participants, HIV treatment may begin after trial exit or
p.000051: completion.
p.000051: 3.11.D. Good participatory practices for access to HIV care and treatment
p.000051: 1. Research teams identify local HIV care and treatment services, local HIV non-governmental organisations or
p.000051: community- based organisations, and HIV support groups, determine
p.000051:
p.000052: 52
p.000052:
p.000052: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000052:
p.000052:
p.000052: their capacities, and seek their views and perspectives. This enables research teams to design optimal referral
p.000052: mechanisms in consultation with service providers.
p.000052: 2. During protocol development, research teams and relevant stakeholders discuss access to HIV care and treatment for
p.000052: the following:
p.000052: a. Individuals who are identified as HIV-positive during the screening process.
p.000052: b. Individuals who become HIV-positive during the trial.
p.000052: c. Women who are identified as HIV-positive during the screening process or who acquire HIV during the trial, and when
p.000052: appropriate HIV-positive men, for provision of information about the risk of mother-to-child HIV trans- mission and the
p.000052: benefits of vertical transmission preven- tion services.
p.000052: 3. Research teams and relevant stakeholders discuss the HIV care and treatment package, taking account of the
p.000052: following:
p.000052: a. The HIV care and treatment package required as a minimum for the trial protocol.
p.000052: b. Current national HIV care and treatment guidelines and policies and local provision of HIV care and treatment
p.000052: services.
p.000052: c. Anticipated numbers of people likely to be found HIV-positive during screening and the anticipated
p.000052: numbers of participants likely to seroconvert during the trial.
p.000052: d. Current national laws that could affect a person’s right or ability to access HIV care and treatment.
p.000052: e. HIV care and treatment services that will be offered through referral mechanisms.
p.000052: f. The possibility of negotiating provisions for priority access to national care and treatment programmes, at the
p.000052: time needed, for individuals who become HIV-positive during a trial.
p.000052:
p.000052:
p.000052:
p.000053: 53
p.000053:
p.000053: UNAIDS / AVAC
p.000053:
p.000053:
p.000053: g. Treatment regimens that will be available if the technology under study has the potential to give rise to
p.000053: antiretroviral resistance.
p.000053: h. Local health institution responsibilities and proposed trial sponsor and implementer commitments regarding:
p.000053: • Who will finance and who will deliver specific HIV care and treatment services.
p.000053: • The duration of HIV care and treatment services being provided by each partnering stakeholder.
p.000053: i. The impact that any services offered by the trial, or to which participants will be referred, could have on local
p.000053: services.
p.000053: 4. Research teams include a description of the HIV care and treatment package in informed consent forms for screening
p.000053: and enrolment.
p.000053: 5. Research teams and relevant stakeholders discuss optimal referral procedures and the most appropriate way to
p.000053: ensure that all individuals screened and enrolled are aware of how to access the HIV care and treatment services.
p.000053: 6. Research teams and relevant stakeholders discuss how to monitor access to HIV care and treatment
p.000053: services. They consider how to gather and analyse information on numbers of seroconverters who access HIV care,
p.000053: barriers to accessing HIV care and treatment programmes and other issues that may arise.
p.000053: 7. Research teams maintain clear written records of discussions and agreements. This includes relevant stakeholder
p.000053: recom- mendations, actions taken by the research team, aspects of HIV care and treatment that will not be offered and
p.000053: why, and any unresolved issues that require follow-up.
p.000053: 8. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000053: ensure that the locally agreed HIV care and treatment package can be effectively delivered.
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000054:
p.000054:
p.000054: 3.11.E. Additional guidance
p.000054: 1. The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.5
p.000054: 2. Ethical considerations in biomedical HIV prevention trials
p.000054: (Guidance Point 14, page 48, Care and Treatment).1
p.000054: 3. Ethical considerations in biomedical HIV prevention trials (page 13, selected circumstances in which biomedical HIV
p.000054: prevention trials should not be conducted).1
p.000054: 4. Mapping the Standards of Care at Microbicide Clinical Trial Sites.35
p.000054: 3.12 Non HIV-related care
p.000054: 3.12.A. Definition
p.000054: Non HIV-related care refers to health and social care services provided or made available to trial participants
p.000054: that are not directly related to HIV prevention, HIV care and treatment, or trial-related harm.The non HIV-related
p.000054: care services appropriate for trial participants will depend on the trial population and local health priorities.
p.000054: Examples could include provision of female or male sexual and reproductive health care, management of infec- tious
p.000054: diseases, nutritional health, psychiatric care, and psychoso- cial services.
p.000054:
p.000054: 3.12.B. Relevance to good participatory practice
p.000054: Access to non HIV-related care can provide benefits for partici- pants, contribute to their welfare, and improve
p.000054: clinical trial outcomes. Negotiating the range of non HIV-related services available to participants at the trial site
p.000054: or via referral will assist in ensuring that relevant stakeholders clearly understand the breadth of services available
p.000054: and reasons for inclusion and exclusion of certain services.
p.000054:
p.000054: 3.12.C. Special considerations
p.000054: Non HIV-related care packages may vary from site to site, depending on local health priorities and local
p.000054: standards of care.
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: UNAIDS / AVAC
p.000055:
p.000055:
p.000055: 3.12.D. Good participatory practices for non HIV-related care
p.000055: 1. Research teams identify the existence and capacity of local social care and primary health-care services and of
p.000055: secondary and tertiary diagnostic and treatment services. This enables the provision of appropriate referrals and
p.000055: linkages, should the need arise.
p.000055: 2. Research teams and relevant stakeholders discuss access to non HIV-related care services during the trial’s
p.000055: protocol development phase.
p.000055: 3. Research teams and relevant stakeholders discuss non HIV-related care services to be offered to participants
p.000055: and consult with local social and health-care service providers when appropriate. Discussions take account of the
p.000055: following:
p.000055: a. Non HIV-related care services required by the trial protocol.
p.000055: b. Additional non HIV-related care services that community stakeholders would like to see the trial site offer to
p.000055: partici- pants.
p.000055: c. Services that will be offered through referral.
p.000055: d. Whether any non HIV-related services will be available to partners of trial participants.
p.000055: e. The impact on local service delivery of any services offered or referred to by the trial.
p.000055: 4. Research teams maintain clear written records of discussions and agreements. This includes relevant stakeholder
p.000055: recom- mendations, actions taken by the research team, and any unre- solved issues.
p.000055: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds to ensure provision
p.000055: of the locally discussed, non HIV-related care package.
p.000055: 3.12.E. Additional guidance
p.000055: See Mapping the Standards of Care at Microbicide Clinical Trial Sites.35
p.000055:
p.000056: 56
p.000056:
...
p.000061: the range of communication methods to be used.
p.000061: e. How the messages will explain implications of the results for the area where the trial was conducted, limitations
p.000061: of the trial, and its ability to generalise findings for specific aspects, such as by sex, behaviours, or location.
p.000061: f. How best to disseminate trial results that may be of a sensitive nature or that may put certain individuals
p.000061: or groups at risk of harm or stigmatisation.
p.000061: g. Procedures for contacting and informing trial participants of research results before they are announced publicly.
p.000061: h. Whether and how to disseminate additional findings that are not related to the primary trial question but may be of
p.000061: interest to some stakeholders, such as reported patterns
p.000061:
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p.000062:
p.000062: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000062:
p.000062:
p.000062: of sexual networks, rates of various infections, or demo- graphic data.
p.000062: i. How and when participants will be informed of their trial group assignment.
p.000062: j. How community stakeholder responses to the results will be systematically collected and documented. Although
p.000062: community stakeholder agreement may not be a prerequi- site for publishing or sharing research in a scientific forum,
p.000062: it is important that community stakeholder interpretations be noted, particularly if they differ from predominant
p.000062: scientific analyses.
p.000062: k. Issues around ownership of the data, data access, and publication, including how the research team will
p.000062: facili- tate community stakeholder access to published results of the trial.
p.000062: 4. Research teams maintain clear written records of discussions regarding trial closure and dissemination messages, as
p.000062: well as documentation of responses to the results.
p.000062: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000062: ensure comprehensive dissemination of results for participants, community stakeholders and other relevant
p.000062: stakeholders.
p.000062: 3.16 Post-trial access to trial products or procedures
p.000062: 3.16.A. Definition
p.000062: The term “post-trial access to trial products or procedures” refers to making the prevention product or procedure
p.000062: tested in the trial available to trial participants and local community stake- holders (1) should the new product or
p.000062: procedure be scientifically validated or approved by relevant authorities, and (2) in the form of follow-on, open
p.000062: label, or other such studies before product licensure or approval, should an efficacy or effectiveness trial have a
p.000062: compelling positive finding, with no safety concerns.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: UNAIDS / AVAC
p.000063:
p.000063:
p.000063: 3.16.B. Relevance to good participatory practice
p.000063: Research ethics call for maximising benefits to stakeholders who participate in research. Thus, local community
p.000063: stakeholders are to be among the first to gain access to new prevention products should they be found safe and
p.000063: effective. How trial sites commu- nicate and interact with community stakeholders about issues of access to the
p.000063: prevention product or procedure studied is likely to have a significant influence on community stakeholder percep-
p.000063: tions of a trial.
p.000063:
p.000063: 3.16.C. Special considerations
p.000063: 1. Availability of newly identified products or procedures to trial participants and other community stakeholders will
p.000063: depend on the biomedical HIV prevention strategy being tested.
p.000063: 2. After a trial is completed, other trials may be needed to corroborate findings.
p.000063: 3. After results from relevant trials are available, it may take time for normative agencies and appropriate
p.000063: regulatory authori- ties, including national governments, to approve the new product or procedure. Approval
p.000063: processes and timelines will differ by product or procedure and by country.
p.000063: 4. National regulatory authorities make the ultimate decision about whether a new product or procedure will be
p.000063: approved for use within a particular country.
p.000063: 5. Availability and pricing of new products or procedures may be affected by product-manufacturer parameters as well
p.000063: as by agreements with trial sponsors.
p.000063: 3.16.D. Good participatory practice practices for post-trial access to trial products or procedures
p.000063: 1. Research teams discuss with relevant stakeholders, early in the trial process, issues affecting future product or
p.000063: procedure availability, including the need for corroborated biomedical evidence, pursuit of licensure, production
p.000063: rights, and addi- tional marketing and distribution research.
p.000063:
p.000063:
p.000064: 64
p.000064:
p.000064: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000064:
p.000064:
p.000064: 2. Trial funders, sponsors, and research teams conducting efficacy or effectiveness trials discuss with relevant
p.000064: stakeholders, early in the trial life-cycle, expectations about possible pre-licen- sure access, plans for follow-on,
p.000064: open label, or other such studies, and how such pre-licensure access will be funded, in the event that a compelling
p.000064: positive result, with no safety concerns, is observed.
p.000064: 3. Trial sponsors and research teams discuss, negotiate, and agree on responsibilities and funding requirements with
p.000064: national governments concerning licensure requirements and access issues, should the HIV prevention product or option
p.000064: under investigation be shown to be safe and effective.
p.000064: 4. Trial sponsors and research teams develop a clear strategy and funding mechanisms for how the HIV prevention
p.000064: product or procedure will be made available to participants (at a minimum) rapidly, affordably, and
p.000064: sustainably, should the HIV prevention product or procedure be shown to be safe and effective. Sponsors and research
p.000064: teams can collaborate with multiple stakeholders, such as UN organisations, develop- ment partners, local
p.000064: governments, and non-governmental organisations to design and support the overall access strategy.
p.000064: 5. Research teams inform community stakeholders of their rights, the access plan, and the factors that could
p.000064: postpone or prevent their gaining access to the new prevention product or procedure, such as the need to secure
p.000064: regulatory approvals or parameters related to the product manufacturer. Research teams give community stakeholders
p.000064: updates as they are available.
p.000064: 3.16.E. Additional guidance
p.000064: 1. Ethical considerations in biomedical HIV prevention trials
p.000064: (Guidance Point 19, page 60, Availability of Outcomes).1
p.000064: 2. Rethinking the Ethical Roadmap for ClinicalTesting of Microbicides: Report on an International Consultation
p.000064: (Chapter 10, After the trial: continued access and post-approval studies).37
p.000064: 3. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (Recommendation
p.000064: 4.1).38
p.000064:
p.000065: 65
p.000065:
p.000065: UNAIDS / AVAC
p.000065:
p.000065:
p.000065: Conclusion
p.000065: Well-conducted biomedical HIV prevention trials are essential to discov- ering additional options to reduce new HIV
p.000065: infections. The GPP guide- lines set global standard practices for stakeholder engagement. When applied during
p.000065: the entire life-cycle of a biomedical HIV prevention trial, they enhance both the quality and outcomes of research.
p.000065: While there is much guidance in the field on how to conduct trials, the GPP guide- lines are the only set of global
p.000065: guidelines that directly address how to engage stakeholders in the design, conduct, and outcome of biomedical HIV
p.000065: prevention trials.
p.000065:
p.000065: Adherence to good participatory practices is an investment that benefits the research process. These practices
p.000065: facilitate the engagement of relevant stakeholders to achieve mutual gains in local capacity building for biomed- ical
p.000065: HIV prevention research. Significant power imbalances exist between trial funders, sponsors, and implementers and
p.000065: community stakeholders— the GPP guidelines are a critical resource to help address and mitigate these disparities. A
...
p.000074: Trial implementer. Investigators, research staff, and all others specifi- cally responsible for executing
p.000074: biomedical HIV prevention trials. Implementers may be employed by governments, government-spon-
p.000074:
p.000075: 75
p.000075:
p.000075: UNAIDS / AVAC
p.000075:
p.000075:
p.000075: sored networks, non-governmental organisations, academic institu- tions, the pharmaceutical industry or other
p.000075: companies, foundations, or public–private partnerships.
p.000075: Trial life-cycle. The entire process of a trial, starting from developing the initial concept and writing the protocol
p.000075: and continuing through to the implementation and conduct of the trial to completion, exiting of participants, and
p.000075: dissemination and reporting of results.
p.000075: Trial participant. A competent individual who voluntarily provides informed consent to participate in a clinical
p.000075: trial. Trial participants are assigned to a particular trial arm or group, in which they receive a partic- ular product
p.000075: or procedure.
p.000075: Trial sponsor. An entity that is responsible for a trial but that does not actually conduct it. The sponsor may
p.000075: be a pharmaceutical company, governmental agency, academic institution, or private or other organi- sation.
p.000075: UNAIDS (Joint United Nations Programme on HIV/AIDS). UNAIDS brings together the resources of the UNAIDS Secretariat and
p.000075: 10 UN system organisations to lead and inspire the world in achieving universal access to HIV prevention, treatment,
p.000075: care, and support.
p.000075: Unblinding or unmasking. The process of revealing trial participants’ product or procedure assignments. Unblinding
p.000075: involves informing participants about which product they were assigned to during the trial.
p.000075: Vaccine. A compound that stimulates the body’s immune response in order to prevent or control an infection. A vaccine
p.000075: is typically made up of parts of a bacterium or virus that cannot itself cause an infection. (See HIV vaccine.)
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
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p.000076:
p.000076:
p.000076: Annex 3. Additional guidance
p.000076:
p.000076: International reference guidelines
p.000076:
p.000076: The Belmont Report, 1979
p.000076: This report was written by the United States National Commission for the Protection of Human Subjects of Biomedical and
p.000076: Behavioral Research, which was established after the public learned about the Tuskegee Syphilis Study. The Belmont
p.000076: Report established the foun- dational ethical principles of respect for persons, beneficence, and justice for research
p.000076: involving human volunteers.
...
p.000079: Citation: Heise L, Shapiro K, West Slevin K. Mapping the Standards of Care at Microbicide Clinical Trial Sites.
p.000079: Washington, DC, Global Campaign for Microbicides, 2008.
p.000079:
p.000079: Recommendations for Community Involvement in National Institute of Allergy and Infectious Diseases,
p.000079: HIV/AIDS Clinical Trials Research, 2009
p.000079: The Division of AIDS of the United States National Institute of Allergy and Infectious Diseases and Community
p.000079: Partners (a global group of community representatives affiliated with the National Institute of Allergy and
p.000079: Infectious Diseases HIV/AIDS clinical trials networks) developed these recommendations as a tool for research teams and
p.000079: community representatives to further expand and deepen community involvement in HIV clinical trials research.
p.000079: Citation: Community Recommendations Working Group, Community Partners. Recommendations for Community Involvement in
p.000079: National Institute of Allergy and Infectious Diseases HIV/AIDS Clinical Trials Research. Bethesda, MD, 2009.
p.000079:
p.000079: Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International
p.000079: Consultation, 2005
p.000079: In 2003, the Global Campaign for Microbicides held a consultation to rethink the issues and ethical dilemmas facing the
p.000079: field of microbicide development. The report addresses ethical issues such as informed consent, standards of care, and
p.000079: post-trial access.
p.000079:
p.000079:
p.000079:
p.000079:
p.000080: 80
p.000080:
p.000080: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000080:
p.000080:
p.000080: Citation: Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International
p.000080: Consultation. Washington, DC, Global Campaign for Microbicides, 2005.
p.000080:
p.000080: Standards of Prevention in HIV Prevention Trials, 2010
p.000080: In March 2009, the Global Campaign for Microbicides, UNAIDS, and the United States Centers for Disease Control
p.000080: and Prevention jointly convened a consultation on the standards of prevention in HIV prevention trials in Kampala,
p.000080: Uganda. The resultant report summa- rises points of agreement and proposes a range of recommendations for standards of
p.000080: prevention in future HIV prevention clinical trials.
p.000080: Citation: Standards of Prevention at HIV Prevention Trials: Consultation Report and
p.000080: Recommendations. Seattle, Global Campaign for Microbicides, PATH, 2010; and Philpott S et al. The
p.000080: Challenge of Defining Standards of Prevention in HIV Prevention Trials. Journal of Medical Ethics, 2011,
p.000080: 37:244–248.
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
...
Social / Age
Searching for indicator age:
(return to top)
p.000045: materials and procedures:
p.000045: a. Who needs to be consulted locally to enable research teams to invite individuals to join the trial.
p.000045: b. What local cultural practices may affect individual deci- sion-making ability, and how working within these struc-
p.000045: tures can be facilitated while ensuring protection of indi- vidual autonomy to provide informed consent.
p.000045: c. The general literacy level of the population to be recruited and how to assess the literacy level of prospective
p.000045: partici- pants.
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000046:
p.000046:
p.000046: d. Considerations and requirements for illiterate participants, including discussion of possibilities of who may
p.000046: serve appropriately as a witness to the informed consent process.
p.000046: e. The prevalence of different languages in the area and which languages are required for obtaining
p.000046: informed consent from individuals.
p.000046: f. Local and legal forms of identity (name and age) verifica- tion and local practices around the use of names.
p.000046: g. The legal, local, and trial sponsor definitions of a “minor” and consideration of legal and local
p.000046: determinations of who can serve as a minor’s guardian.
p.000046: h. Locally appropriate reimbursement and compensation.
p.000046: i. Appropriate strategies to ensure participant rights are protected, including voluntariness of
p.000046: participation, ensuring undue inducement is avoided, and mitigating the influence of social desirability in influencing
p.000046: individual agreement to enrol.
p.000046: j. Strategies to ensure comprehension of informed consent materials and critical trial-related terms and
p.000046: concepts, including the use of visual or audio formats, flipcharts, props, analogies, and other supportive
p.000046: materials and methods.
p.000046: k. Techniques to assess comprehension of trial participation and the frequency with which they are to be used.
p.000046: l. Explanation of potential trial-related harms and how such harms will be addressed (see Section 3.13).
p.000046: m. Strategies to ensure that follow-up of participants after missed visits respects agreements between the participant
p.000046: and research team about how to contact the participant.
p.000046: n. Consideration of the length of informed consent forms and the estimated time required to complete the informed
p.000046: consent process.
p.000046: o. Preferred ways for participants to contact research teams and stakeholders independent from the research team to
...
Social / Child
Searching for indicator child:
(return to top)
p.000051: 1. Research teams identify local HIV care and treatment services, local HIV non-governmental organisations or
p.000051: community- based organisations, and HIV support groups, determine
p.000051:
p.000052: 52
p.000052:
p.000052: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000052:
p.000052:
p.000052: their capacities, and seek their views and perspectives. This enables research teams to design optimal referral
p.000052: mechanisms in consultation with service providers.
p.000052: 2. During protocol development, research teams and relevant stakeholders discuss access to HIV care and treatment for
p.000052: the following:
p.000052: a. Individuals who are identified as HIV-positive during the screening process.
p.000052: b. Individuals who become HIV-positive during the trial.
p.000052: c. Women who are identified as HIV-positive during the screening process or who acquire HIV during the trial, and when
p.000052: appropriate HIV-positive men, for provision of information about the risk of mother-to-child HIV trans- mission and the
p.000052: benefits of vertical transmission preven- tion services.
p.000052: 3. Research teams and relevant stakeholders discuss the HIV care and treatment package, taking account of the
p.000052: following:
p.000052: a. The HIV care and treatment package required as a minimum for the trial protocol.
p.000052: b. Current national HIV care and treatment guidelines and policies and local provision of HIV care and treatment
p.000052: services.
p.000052: c. Anticipated numbers of people likely to be found HIV-positive during screening and the anticipated
p.000052: numbers of participants likely to seroconvert during the trial.
p.000052: d. Current national laws that could affect a person’s right or ability to access HIV care and treatment.
p.000052: e. HIV care and treatment services that will be offered through referral mechanisms.
p.000052: f. The possibility of negotiating provisions for priority access to national care and treatment programmes, at the
p.000052: time needed, for individuals who become HIV-positive during a trial.
p.000052:
p.000052:
p.000052:
p.000053: 53
p.000053:
p.000053: UNAIDS / AVAC
p.000053:
p.000053:
...
p.000066:
p.000066: In a forward-looking approach, it is important to gather and analyse stake- holders’ experiences with the
p.000066: implementation of the GPP guidelines. Recommendations for modifications and refinements based on experience and
p.000066: reflection can be sent to gpp@unaids.org or avac@avac.org, where they will be gratefully received and considered in
p.000066: future updates of these guidelines.
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: UNAIDS / AVAC
p.000067:
p.000067:
p.000067: Annex 1. Acronyms and abbreviations
p.000067: AE – Adverse event
p.000067: AIDS – Acquired Immunodeficiency Syndrome
p.000067: ARV – Antiretroviral drug
p.000067: CAB – Community Advisory Board CAG – Community Advisory Group CBO – Community-Based Organisation
p.000067: CIOMS – Council for International Organizations of Medical Science
p.000067: EC – Ethics committee
p.000067: DSMB – Data safety monitoring board DSMC – Data safety monitoring committee GCLP– Good Clinical Laboratory Practice GCP
p.000067: – Good Clinical Practice
p.000067: GMP – Good Manufacturing Practice GPP – Good Participatory Practice HIV – Human Immunodeficiency Virus
p.000067: IDMC – Independent data monitoring committee
p.000067: IDU – Injecting drug use
p.000067: IRB – Institutional review board
p.000067: MSM – Men who have sex with men NGO – Non-governmental organisation PEP – Post-exposure prophylaxis
p.000067: PMTCT – Prevention of mother-to-child transmission
p.000067: PrEP – Pre-exposure prophylaxis REC – Research ethics committee SOP – Standard operating procedure STI – Sexually
p.000067: transmitted infection
p.000067: UNAIDS – Joint United Nations Programme on HIV/AIDS
p.000067: WHO – World Health Organization
p.000067:
p.000067:
p.000067:
p.000068: 68
p.000068: 68
p.000068:
p.000068: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000068:
p.000068:
p.000068: Annex 2. Glossary
p.000068: Accrual. The process of recruiting participants into a clinical trial in order to reach target participant
p.000068: numbers.
p.000068: Acquired immunodeficiency syndrome (AIDS). The most severe mani- festation of infection with human immunodeficiency
p.000068: virus (HIV), charac- terised by deterioration of the immune system and susceptibility to a range of opportunistic
p.000068: infections and cancers. (See human immunode- ficiency virus.)
p.000068: Activist. A person or group who acts on the behalf of a cause in order to bring about change.
p.000068: Adverse event (AE). An unwanted effect experienced by a partici- pant in a clinical trial. This may or may not
p.000068: be related to the product or procedure being studied.
p.000068: Advocate. A person or group who advocates on the behalf of indi- viduals, groups, or a specific cause.
p.000068: Antiretroviral (ARV) drug. A drug or medication that acts against or suppresses a retrovirus such as HIV.
...
Searching for indicator children:
(return to top)
p.000083: Process. American Journal of Public Health, 2001, 91:1938–1943.
p.000083: 35 Mapping the Standards of Care at Microbicide Clinical Trial Sites. Washington, DC, Global Campaign for
p.000083: Microbicides, PATH, 2008.
p.000083: 36 Philpott S et al. The Challenge of Defining Standards of Prevention in HIV Prevention Trials. Journal of Medical
p.000083: Ethics, 2011, 37:244–248.
p.000083: 37 Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International
p.000083: Consultation. Washington, DC, Global Campaign for Microbicides, 2005.
p.000083: 38 Ethical and Policy Issues in International Research:ClinicalTrials in Developing Countries. Vol. I. Report and
p.000083: Recommendations of the National Bioethics Advisory Commission. Washington, DC, United States National Bioethics
p.000083: Advisory Commission, 2001.
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000084: 84
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: The Joint United Nations Programme on HIV/AIDS (UNAIDS) brings together ten UN agencies in a common
p.000084: effort to fight the epidemic: the Office of the United Nations High Commissioner for Refugees (UNHCR), the United
p.000084: Nations Children’s Fund (UNICEF), the World Food Programme (WFP), the United Nations Development Programme (UNDP),
p.000084: the United Nations Population Fund (UNFPA), the United Nations Office on Drugs and Crime (UNODC), the
p.000084: International Labour Organization (ILO), the United Nations Educational, Scientific and Cultural Organization
p.000084: (UNESCO), the World Health Organization (WHO), and the World Bank.
p.000084:
p.000084: Leveraging the AIDS response, UNAIDS works to build political action and to promote the rights of all people for better
p.000084: results for global health and development. Globally, it sets policy and is the source of HIV-related data. In
p.000084: countries, UNAIDS brings together the resources of the UNAIDS Secretariat and 10 UN system organizations for
p.000084: coordinated and accountable efforts to unite the world against AIDS.
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: UNAIDS
p.000084: 20 AVENUE APPIA
p.000084: CH-1211 GENEVA 27 SWITZERLAND
p.000084:
p.000084: Tel: (+41) 22 791 36 66
p.000084: Fax: (+41) 22 791 48 35
p.000084: e-mail: distribution@unaids.org www.unaids.org
p.000084:
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000017:
p.000017: 1.4 The dynamics of biomedical HIV prevention trials
p.000017: Power inequalities always exist between funders and funding recipients with respect to a range of issues, such as
p.000017: decision-making processes, priority setting, control of resources, and equitable recognition of input. Biomedical HIV
p.000017: prevention trials are often funded by institu- tions in developed countries and conducted with multiple partner
p.000017: institutions worldwide, including those in developing countries. Disparities among these institutions and
p.000017: partners can introduce or reinforce power inequalities between and among trial implementers and the funders or sponsors
p.000017: of trials. This can then translate into inequalities between trial implementers and other stakeholders.
p.000017:
p.000017: The fact that many biomedical HIV prevention trials are conducted in multiple settings and countries introduces another
p.000017: level of complexity. Variation in cultures, physical environments, infrastructure, research experience, health
p.000017: policies, and national laws can introduce inequali- ties among research teams and between research teams and site-level
p.000017: community stakeholders. Power inequalities between research teams and community stakeholders can include
p.000017: imbalances in literacy, education, and economic resources, as well as those inherent in patient–provider
p.000017: relationships. National, racial, ethnic, and linguistic differences between members of research teams and
p.000017: community stakeholders can also exacerbate inequalities.
p.000017:
p.000017: In order to achieve meaningful community stakeholder participa- tion and partnership, it is essential to recognise
p.000017: these various power inequalities and address them.
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000018:
p.000018:
p.000018: Figure 3. Example of a Trial Network
p.000018:
p.000018: Funding From One or More Sources
p.000018:
p.000018:
p.000018: Sponsors
p.000018:
p.000018:
p.000018: Coordinating Centre
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Data Laboratory
p.000018:
p.000018: Clinical Safety
p.000018:
p.000018: Pharmacy
p.000018: Social Science Stakeholder
p.000018:
p.000018:
p.000018:
p.000018: Implementing Institution
p.000018:
p.000018: Trial Sites Trial Sites
p.000018:
p.000018:
p.000018: Basic structure of a typical biomedical HIV prevention trial network. Funding from one or more sources is distributed
p.000018: through a network coordinating centre directly to trial sites or to implementing institutions such as universities that
p.000018: then send funds to trial sites. Trial networks may have several centres responsible for different aspects of trial
p.000018: conduct: data management, laboratory, pharmacy, clinical, safety, social science, and stakeholder engagement.
p.000018: Monitoring of trial conduct may be executed through the coordinating centre or outsourced to an independent
p.000018: monitoring organisation.
p.000018:
p.000018:
...
Social / Laboratory Staff
Searching for indicator research staff:
(return to top)
p.000003: Standard of HIV Prevention
p.000003: Access to HIV Care and Treatment
p.000003:
p.000003: Non HIV-Related Care
p.000003:
p.000003: Policies on
p.000003: Trial-Related Harms
p.000003: Trial Accrual, Follow-Up, and Exit
p.000003: Trial Closure and Results Dissemination
p.000003: Post-trial Access to Trial Products or Procedures
p.000003:
p.000004: 4
p.000004:
p.000004: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000004:
p.000004:
p.000004: Introduction
p.000004:
p.000004: Objective of the good participatory practice (GPP) guidelines
p.000004: The good participatory practice (GPP) guidelines provide trial funders, sponsors, and implementers with systematic
p.000004: guidance on how to effec- tively engage with stakeholders in the design and conduct of biomedical HIV prevention
p.000004: trials.
p.000004: In the GPP guidelines,“design and conduct of biomedical HIV prevention trials” refers to activities required for the
p.000004: development, planning, imple- mentation, and conclusion of a trial, including dissemination of trial results.
p.000004:
p.000004: Intended audience of the GPP guidelines
p.000004: The GPP guidelines are primarily written for trial funders, trial sponsors, and trial implementers. Trial funders,
p.000004: sponsors, and implementers include investigators, research staff, and all others involved in designing, financing, and
p.000004: executing biomedical HIV prevention trials.They can include govern- ments, government-sponsored research networks,
p.000004: non-governmental organisations, academic institutions, foundations, public–private partner- ships, and pharmaceutical
p.000004: or other companies.
p.000004: Stakeholders not directly involved in funding, sponsoring, or implementing trials can use the guidelines to better
p.000004: understand the objectives, expectations, and methods of stakeholder engagement and to better evaluate such efforts.
p.000004:
p.000004: Scope of the GPP guidelines
p.000004: The GPP guidelines provide a framework for development of effective stakeholder engagement programmes. The goal of
p.000004: effective stakeholder engagement programmes is to build mutually beneficial, sustained rela- tionships between trial
p.000004: funders, sponsors, and implementers and other stakeholders that are transparent and respectful, that address
p.000004: interests of community stakeholders, and that support the conduct of scientifically rigorous and ethical biomedical HIV
p.000004: prevention trials.
p.000004:
p.000005: 5
p.000005:
p.000005: UNAIDS / AVAC
p.000005:
p.000005:
p.000005: This GPP guidelines publication is a companion document to the UNAIDS/ WHO Ethical considerations in biomedical
p.000005: HIV prevention trials,1 which contains explicit guidance on community participation, capacity building,
p.000005: monitoring, informed consent, standard of prevention, and other key ethical issues.The GPP guidelines were developed to
...
p.000030: biomedical HIV prevention research and specific trials.
p.000030:
p.000030: 3.2.C. Special considerations
p.000030: 1. Community advisory boards or groups were first developed in the context of HIV research in the United States of
p.000030: America and Europe. Over the past two decades, they have become a standard element of HIV research worldwide.
p.000030: Nonetheless, the establishment of a community advisory board or group may not always translate as best practice
p.000030: in all locations globally. In many settings, they are necessary but not sufficient for gaining adequate and
p.000030: appropriate community stakeholder input. Careful consideration needs to be given to the range of stakeholder advisory
p.000030: mechanisms that are required to best support effective participatory practices.
p.000030: 2. The need to identify and establish new stakeholder advisory mechanisms may vary from site to site and within a
p.000030: single site, over time. Stakeholder identification and inclusion considers the dynamic stakeholder landscape, as well
p.000030: as whether a trial is conducted in a research-naïve area or at a well-established research facility.
p.000030: 3. Formative research activities (see Section 3.1) help research teams to comprehensively identify which groups or
p.000030: individ- uals are relevant stakeholders and why.
p.000030: 4. While community advisory boards or groups can assist research teams in thinking about best strategies
p.000030: for trial recruitment, individual members of community advisory boards or groups are not research staff and do
p.000030: not participate in implementing actual trial procedures such as recruitment of prospective participants.
p.000030: 5. While community advisory boards or groups are often funded by research networks or trial sites, they are intended
p.000030: to be an independent advisory voice that is free to express concerns about proposed or ongoing research.
p.000030:
p.000031: 31
p.000031:
p.000031:
p.000031:
p.000031: UNAIDS / AVAC
p.000031:
p.000031:
p.000031: Figure 6. The Role of Community Advisory Boards
p.000031:
p.000031: y
p.000031:
p.000031:
p.000031:
p.000031: Research Team
p.000031: CAB
p.000031: Stakeholders
p.000031:
p.000031:
p.000031: y
p.000031:
p.000031:
p.000031: Community advisory boards (CABs) can play an important role in translating infor- mation between research teams and
p.000031: stakeholders. While community advisory boards are a key mechanism by which research teams inform stakeholders and
p.000031: receive their feedback, research teams are responsible for using other advisory mechanisms in addition to
p.000031: CABs to reach a broader range of stakeholders.
p.000031:
p.000031:
p.000031:
p.000031: Figure 7. Examples of How Research Teams can Engage with Stakeholders
p.000031:
p.000031: Ongoing dialogue with CBOs
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Research Team
p.000031:
p.000031: NGO advisory group
p.000031:
p.000031: Focus group discussions
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Stakeholders
p.000031:
p.000031: Local meetings or events
p.000031:
p.000031: CABs
p.000031:
p.000031:
p.000031: Examples of advisory mechanisms that research teams may use to engage with stake- holders to facilitate ongoing
p.000031: communication and collaboration.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
...
p.000044: reimbursement policies, counsel- ling approaches, follow-up procedures, and post-trial access to trial products or
p.000044: procedures.
p.000044: 3. Research teams maintain clear and transparent communica- tion about the protocol development process with relevant
p.000044: stakeholders, in particular, formal stakeholder advisory mech- anisms.
p.000044: 4. Research teams provide relevant stakeholders with draft versions of the protocol and make technical
p.000044: information as accessible as possible by providing protocol summaries and translated materials, or by facilitating
p.000044: workshops, as necessary.
p.000044: 5. Research teams inform relevant stakeholders of protocol reviews and approval processes and provide regular
p.000044: updates.
p.000044: 6. Trial sponsors or implementers make full, final protocols of trials available and easily accessible to
p.000044: stakeholders.
p.000044: 7. Research teams maintain clear written records of discussions and agreements. This includes relevant stakeholders’
p.000044: recom- mendations, actions taken by the research team, and any unre- solved issues that require follow-up.
p.000044: 8. Trial sponsors ensure sufficient funding and research teams allocate resources and time to support stakeholder
p.000044: engage- ment in the protocol development process.
p.000044: 3.9 Informed consent process
p.000044: 3.9.A. Definition
p.000044: Informed consent is a process by which a competent individual is provided with enough information about a trial to make
p.000044: an independent decision whether or not to participate in the trial. In this process, research staff members educate the
p.000044: prospective participant about the trial, including about the potential risks and benefits, trial procedures, and what
p.000044: is expected of the participant.
p.000044:
p.000045: 45
p.000045:
p.000045: UNAIDS / AVAC
p.000045:
p.000045:
p.000045: When an individual provides consent, this is documented on the informed consent form. Informed consent is an ongoing
p.000045: process. Participants may decide to drop out of the trial at any point, even after providing consent to enrol in the
p.000045: trial.
p.000045:
p.000045: 3.9.B. Relevance to good participatory practice
p.000045: The informed consent process is relevant to good participatory practice because a wide range of stakeholders can help
p.000045: research teams develop locally acceptable and effective informed consent procedures and materials.
p.000045:
p.000045: 3.9.C. Special considerations
p.000045: Community stakeholders can provide research teams with invaluable advice to improve the informed consent process
p.000045: and materials. However, the actual implementation of the informed consent process between an individual and the
p.000045: research staff is confidential. Only designated research staff members have access to confidential information about
p.000045: the identity of trial participants. The informed consent process itself is conducted in accordance with Good Clinical
p.000045: Practice.2
p.000045:
p.000045: 3.9.D. Good participatory practices for the informed consent process
p.000045: 1. Research teams discuss the following topics with community stakeholders during development of the informed consent
p.000045: materials and procedures:
p.000045: a. Who needs to be consulted locally to enable research teams to invite individuals to join the trial.
p.000045: b. What local cultural practices may affect individual deci- sion-making ability, and how working within these struc-
p.000045: tures can be facilitated while ensuring protection of indi- vidual autonomy to provide informed consent.
p.000045: c. The general literacy level of the population to be recruited and how to assess the literacy level of prospective
p.000045: partici- pants.
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000046:
p.000046:
...
p.000074: Stakeholders or trial stakeholders. Individuals, groups, organisations, governments, or other entities that are
p.000074: affected by the outcome of a biomedical HIV prevention trial or that can influence proposed research through their
p.000074: input and actions. (See community stakeholders.)
p.000074: Standard operating procedure (SOP). A document that gives step- by-step instructions for how to conduct a procedure, in
p.000074: order to ensure that each staff member can perform the procedure in the same way.
p.000074: Stigma. AIDS-related stigma refers to a pattern of prejudice, discounting, discrediting, and discrimination directed at
p.000074: people perceived to have HIV or AIDS, their significant others and close associates or their social groups.
p.000074: Therapeutic HIV vaccine. A compound designed to stimulate the immune response to HIV in a person already
p.000074: infected with the virus, in order to control the infection. Also referred to as an immunotherapeutic vaccine. (See
p.000074: vaccine and HIV vaccine.)
p.000074: Trial arm or group. A group within a clinical trial formed of participants who have been assigned a particular product
p.000074: or procedure during a trial. (See control arm or group, experimental arm or group.)
p.000074: Trial funder. An individual or entity responsible for financing the cost of a trial.
p.000074: Trial implementer. Investigators, research staff, and all others specifi- cally responsible for executing
p.000074: biomedical HIV prevention trials. Implementers may be employed by governments, government-spon-
p.000074:
p.000075: 75
p.000075:
p.000075: UNAIDS / AVAC
p.000075:
p.000075:
p.000075: sored networks, non-governmental organisations, academic institu- tions, the pharmaceutical industry or other
p.000075: companies, foundations, or public–private partnerships.
p.000075: Trial life-cycle. The entire process of a trial, starting from developing the initial concept and writing the protocol
p.000075: and continuing through to the implementation and conduct of the trial to completion, exiting of participants, and
p.000075: dissemination and reporting of results.
p.000075: Trial participant. A competent individual who voluntarily provides informed consent to participate in a clinical
p.000075: trial. Trial participants are assigned to a particular trial arm or group, in which they receive a partic- ular product
p.000075: or procedure.
p.000075: Trial sponsor. An entity that is responsible for a trial but that does not actually conduct it. The sponsor may
p.000075: be a pharmaceutical company, governmental agency, academic institution, or private or other organi- sation.
p.000075: UNAIDS (Joint United Nations Programme on HIV/AIDS). UNAIDS brings together the resources of the UNAIDS Secretariat and
p.000075: 10 UN system organisations to lead and inspire the world in achieving universal access to HIV prevention, treatment,
p.000075: care, and support.
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000038:
p.000038: 3.5.D. Good participatory practices for communications planning
p.000038: 1. Research teams and relevant stakeholders comprehensively identify potential audiences within and
p.000038: surrounding the research area as well as regionally, nationally, and internationally.
p.000038: 2. Research teams and relevant stakeholders discuss and negotiate a communications plan to support open channels
p.000038:
p.000038: c Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000038: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000038: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000038: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000038: clear.
p.000038:
p.000039: 39
p.000039:
p.000039: UNAIDS / AVAC
p.000039:
p.000039:
p.000039: of communication about the trial throughout its life-cycle. The plan describes the following:
p.000039: a. The information needs of the different stakeholders at various stages of the research life-cycle, from early phases
p.000039: of stakeholder engagement to recruitment, enrolment, trial closure, and results dissemination.
p.000039: b. The key messages to be communicated about the trial, such as the purpose, risks, benefits, ongoing progress,
p.000039: closure, and results dissemination.
p.000039: c. The various communication methods that will be used for specific stakeholders, taking into account literacy levels
p.000039: and language needs.
p.000039: d. Local stakeholders who could deliver or facilitate commu- nications activities.
p.000039: e. Specific training needs necessary to effectively deliver messages.
p.000039: f. Procedures and timelines for disseminating information and procedures for actively addressing inquiries about the
p.000039: trial or HIV prevention research.
p.000039: g. The frequency with which the communications plan will be reviewed.
p.000039: h. The criteria by which to review the success of the commu- nications plan.
p.000039: 3. Research teams develop communication materials in under- standable language and translate them as needed,
p.000039: seeking input from relevant stakeholders.
p.000039: 4. Research teams implement the plan and maintain clear written records of discussions, agreements, and
p.000039: communica- tion activities.This includes relevant stakeholder recommen- dations, actions taken by the research team,
p.000039: and any unre- solved issues that require further follow-up.
p.000039: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000039: support activities outlined in the communications plan.
p.000039:
p.000039:
p.000039:
p.000040: 40
p.000040:
p.000040: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000040:
p.000040:
p.000040: 3.5.E. Additional guidance
p.000040: See Communications Handbook for Clinical Trials: Strategies, tips, and tools to manage controversy, convey your
p.000040: message, and dissemi- nate results.28
p.000040: 3.6 Issues management pland
p.000040: 3.6.A. Definition
p.000040: The issues management plan describes how research teams intend to manage issues of concern or any unexpected
p.000040: developments that may emerge before, during, or after the trial, including those that could limit the support for, or
p.000040: success of, the specific trial or future biomedical HIV prevention trials.
p.000040: Examples of the types of issues that may emerge are negative media coverage, rumours about the trial, socio-cultural
p.000040: taboos around certain trial procedures, developments in other HIV prevention trials, premature closure of a trial
...
p.000058:
p.000058: 3.14.B. Relevance to good participatory practice
p.000058: Community stakeholders can provide the best information on how to design socially and culturally
p.000058: acceptable strate- gies for recruitment, screening, enrolment, follow-up, and exit. Community stakeholders included in
p.000058: the process of developing these strategies can play an important role in identifying and mitigating trial-related
p.000058: stigma, misconceptions, or miscommuni- cation.
p.000058:
p.000058: 3.14.C. Special considerations
p.000058: 1. Follow-up of participants after missed visits must respect agreements between the participant and research
p.000058: team about how to contact the participant.
p.000058: 2. Exiting a trial may present changes in what participants have become accustomed to with regard to clinical care and
p.000058: the impact of the trial on their social relationships. Anticipation and discussion of these issues between research
p.000058: teams and community stakeholders will help in the development of appropriate strategies to support participants
p.000058: upon trial exit.
p.000058: 3.14.D. Good participatory practices for trial accrual, follow-up, and exit
p.000058: 1. Research teams consult with relevant stakeholders about accrual, follow-up, and exit processes, taking
p.000058: account of the following:
p.000058:
p.000058:
p.000059: 59
p.000059:
p.000059: UNAIDS / AVAC
p.000059:
p.000059:
p.000059: a. Strategies and messages that are socially and culturally appropriate, meet the needs of specific
p.000059: stakeholders in terms of language and literacy, and draw on a range of communication modes, including written, oral,
p.000059: and visual.
p.000059: b. Procedures to anticipate, monitor, and mitigate trial- related stigma resulting from ineligibility to enrol
p.000059: or from enrolment itself.
p.000059: c. Procedures for training and supervising trial site staff on creating respectful relationships with participants
p.000059: and fostering an environment that is nonjudgmental and welcoming.
p.000059: d. Strategies to ensure the confidentiality of participants during trial visits, while following up participants
p.000059: outside of the trial clinic, and after trial exit.
p.000059: e. Procedures for informing participants about trial results and trial product assignment, when available.
p.000059: f. Procedures for transfer of care at the end of follow-up or trial closure, such as providing participants with
p.000059: referrals to HIV counselling and testing and to other supportive services.
p.000059: 2. Research teams provide relevant stakeholders with ongoing updates on trial accrual, follow-up, and trial exit.
p.000059: 3. Research teams seek advice from relevant stakeholders on how to improve accrual, follow-up and exit processes, and
p.000059: messages.
p.000059: 4. Research teams maintain clear written records of discussions and agreements, as well as ongoing discussions about
p.000059: ways to modify strategies.
p.000059: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000059: support stakeholder engagement in the development of locally accept- able trial procedures.
p.000059: 3.15 Trial closure and results dissemination
p.000059: 3.15.A. Definition
...
Searching for indicator linguistic:
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p.000017: Power inequalities always exist between funders and funding recipients with respect to a range of issues, such as
p.000017: decision-making processes, priority setting, control of resources, and equitable recognition of input. Biomedical HIV
p.000017: prevention trials are often funded by institu- tions in developed countries and conducted with multiple partner
p.000017: institutions worldwide, including those in developing countries. Disparities among these institutions and
p.000017: partners can introduce or reinforce power inequalities between and among trial implementers and the funders or sponsors
p.000017: of trials. This can then translate into inequalities between trial implementers and other stakeholders.
p.000017:
p.000017: The fact that many biomedical HIV prevention trials are conducted in multiple settings and countries introduces another
p.000017: level of complexity. Variation in cultures, physical environments, infrastructure, research experience, health
p.000017: policies, and national laws can introduce inequali- ties among research teams and between research teams and site-level
p.000017: community stakeholders. Power inequalities between research teams and community stakeholders can include
p.000017: imbalances in literacy, education, and economic resources, as well as those inherent in patient–provider
p.000017: relationships. National, racial, ethnic, and linguistic differences between members of research teams and
p.000017: community stakeholders can also exacerbate inequalities.
p.000017:
p.000017: In order to achieve meaningful community stakeholder participa- tion and partnership, it is essential to recognise
p.000017: these various power inequalities and address them.
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000018:
p.000018:
p.000018: Figure 3. Example of a Trial Network
p.000018:
p.000018: Funding From One or More Sources
p.000018:
p.000018:
p.000018: Sponsors
p.000018:
p.000018:
p.000018: Coordinating Centre
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Data Laboratory
p.000018:
p.000018: Clinical Safety
p.000018:
p.000018: Pharmacy
p.000018: Social Science Stakeholder
p.000018:
p.000018:
p.000018:
p.000018: Implementing Institution
p.000018:
p.000018: Trial Sites Trial Sites
p.000018:
p.000018:
p.000018: Basic structure of a typical biomedical HIV prevention trial network. Funding from one or more sources is distributed
p.000018: through a network coordinating centre directly to trial sites or to implementing institutions such as universities that
p.000018: then send funds to trial sites. Trial networks may have several centres responsible for different aspects of trial
p.000018: conduct: data management, laboratory, pharmacy, clinical, safety, social science, and stakeholder engagement.
p.000018: Monitoring of trial conduct may be executed through the coordinating centre or outsourced to an independent
p.000018: monitoring organisation.
p.000018:
p.000018:
p.000018: 1.5 Rationale for GPP guidelines
...
Social / Literacy
Searching for indicator illiterate:
(return to top)
p.000045: the identity of trial participants. The informed consent process itself is conducted in accordance with Good Clinical
p.000045: Practice.2
p.000045:
p.000045: 3.9.D. Good participatory practices for the informed consent process
p.000045: 1. Research teams discuss the following topics with community stakeholders during development of the informed consent
p.000045: materials and procedures:
p.000045: a. Who needs to be consulted locally to enable research teams to invite individuals to join the trial.
p.000045: b. What local cultural practices may affect individual deci- sion-making ability, and how working within these struc-
p.000045: tures can be facilitated while ensuring protection of indi- vidual autonomy to provide informed consent.
p.000045: c. The general literacy level of the population to be recruited and how to assess the literacy level of prospective
p.000045: partici- pants.
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000046:
p.000046:
p.000046: d. Considerations and requirements for illiterate participants, including discussion of possibilities of who may
p.000046: serve appropriately as a witness to the informed consent process.
p.000046: e. The prevalence of different languages in the area and which languages are required for obtaining
p.000046: informed consent from individuals.
p.000046: f. Local and legal forms of identity (name and age) verifica- tion and local practices around the use of names.
p.000046: g. The legal, local, and trial sponsor definitions of a “minor” and consideration of legal and local
p.000046: determinations of who can serve as a minor’s guardian.
p.000046: h. Locally appropriate reimbursement and compensation.
p.000046: i. Appropriate strategies to ensure participant rights are protected, including voluntariness of
p.000046: participation, ensuring undue inducement is avoided, and mitigating the influence of social desirability in influencing
p.000046: individual agreement to enrol.
p.000046: j. Strategies to ensure comprehension of informed consent materials and critical trial-related terms and
p.000046: concepts, including the use of visual or audio formats, flipcharts, props, analogies, and other supportive
p.000046: materials and methods.
p.000046: k. Techniques to assess comprehension of trial participation and the frequency with which they are to be used.
p.000046: l. Explanation of potential trial-related harms and how such harms will be addressed (see Section 3.13).
...
Searching for indicator literacy:
(return to top)
p.000017: trials.While stakeholder engagement helps empower and equip community stakeholders to engage in the research
p.000017: process in a meaningful fashion, it also harnesses the expertise that community stakeholders can contribute to the
p.000017: design and conduct of research.
p.000017:
p.000017: 1.4 The dynamics of biomedical HIV prevention trials
p.000017: Power inequalities always exist between funders and funding recipients with respect to a range of issues, such as
p.000017: decision-making processes, priority setting, control of resources, and equitable recognition of input. Biomedical HIV
p.000017: prevention trials are often funded by institu- tions in developed countries and conducted with multiple partner
p.000017: institutions worldwide, including those in developing countries. Disparities among these institutions and
p.000017: partners can introduce or reinforce power inequalities between and among trial implementers and the funders or sponsors
p.000017: of trials. This can then translate into inequalities between trial implementers and other stakeholders.
p.000017:
p.000017: The fact that many biomedical HIV prevention trials are conducted in multiple settings and countries introduces another
p.000017: level of complexity. Variation in cultures, physical environments, infrastructure, research experience, health
p.000017: policies, and national laws can introduce inequali- ties among research teams and between research teams and site-level
p.000017: community stakeholders. Power inequalities between research teams and community stakeholders can include
p.000017: imbalances in literacy, education, and economic resources, as well as those inherent in patient–provider
p.000017: relationships. National, racial, ethnic, and linguistic differences between members of research teams and
p.000017: community stakeholders can also exacerbate inequalities.
p.000017:
p.000017: In order to achieve meaningful community stakeholder participa- tion and partnership, it is essential to recognise
p.000017: these various power inequalities and address them.
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000018:
p.000018:
p.000018: Figure 3. Example of a Trial Network
p.000018:
p.000018: Funding From One or More Sources
p.000018:
p.000018:
p.000018: Sponsors
p.000018:
p.000018:
p.000018: Coordinating Centre
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Data Laboratory
p.000018:
p.000018: Clinical Safety
p.000018:
p.000018: Pharmacy
p.000018: Social Science Stakeholder
p.000018:
p.000018:
p.000018:
p.000018: Implementing Institution
p.000018:
p.000018: Trial Sites Trial Sites
p.000018:
p.000018:
p.000018: Basic structure of a typical biomedical HIV prevention trial network. Funding from one or more sources is distributed
p.000018: through a network coordinating centre directly to trial sites or to implementing institutions such as universities that
p.000018: then send funds to trial sites. Trial networks may have several centres responsible for different aspects of trial
p.000018: conduct: data management, laboratory, pharmacy, clinical, safety, social science, and stakeholder engagement.
p.000018: Monitoring of trial conduct may be executed through the coordinating centre or outsourced to an independent
p.000018: monitoring organisation.
p.000018:
p.000018:
p.000018: 1.5 Rationale for GPP guidelines
p.000018: Constructive long-term stakeholder engagement helps ensure the ethical and scientific quality of research as well
p.000018: as its relevance to community stakeholders.1,25 Stakeholders, in particular community stakeholders, have unique
p.000018: expertise to contribute to the research process. They possess critical knowledge and understandings of local
p.000018: cultures and perspectives, languages, dynamics of the local HIV epidemic, concerns of vulnerable or marginalised
p.000018: populations, and local priorities that trial funders, sponsors, and implementers may lack.
p.000018:
p.000019: 19
p.000019:
p.000019: UNAIDS / AVAC
p.000019:
p.000019:
p.000019: Stakeholder collaboration can help ensure that research questions and procedures are culturally sensitive and
p.000019: appropriate, thus improving recruitment, retention, adherence, and other trial outcomes. It can help avoid reinforcing
p.000019: existing inequalities and increase sensitivity to the needs of vulnerable populations. An essential component of
p.000019: stakeholder engagement is improving stakeholder knowledge and understanding of the research process, building
p.000019: research literacy and competencies. This, in turn, enables stakeholders to contribute more effectively to the process
p.000019: of guiding research and helps to address the power imbalance between research teams and community stake- holders.
p.000019:
p.000019: Strengthening meaningful collaboration among stakeholders fosters greater trust and respect between trial funders,
p.000019: sponsors, and imple- menters, and other stakeholders. Stakeholder engagement that is trans- parent and mutually
p.000019: respectful can minimise misunderstandings and reduce the chances of unnecessary conflict or controversy. Following good
p.000019: participatory practices through the entire research life-cycle helps facilitate local ownership of research, enables
p.000019: more equitable relationships, and increases the likelihood of successful research conduct, trial completion, and
p.000019: application of research results.
p.000019:
p.000019: 1.6 Applying GPP
p.000019: The GPP guidelines broadly describe systematic ways to establish and maintain effective stakeholder engagement that can
p.000019: be applied in diverse locations globally. The specificity of the content of the GPP guidelines enables monitoring of
p.000019: stakeholder engagement activities.
p.000019:
p.000019: The most effective way for the GPP guidelines to be implemented is for trial sponsors to adopt them as a requirement in
p.000019: trial conduct and to monitor their implementation and evaluate their effectiveness. As an essential element of
p.000019: successful trial implementation, effective
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000020:
p.000020:
...
p.000035: with, or empowered to make decisions.
p.000035: c. The frequency and type of engagement methods to be used, such as public meetings, workshops, joint decision- making
p.000035: models, or delegated decision-making.
p.000035: d. The process by which new relevant stakeholders will be identified and engaged.
p.000035: e. The frequency with which the engagement plan will be reviewed.
p.000035: f. The criteria by which to review the success of the engage- ment plan.
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000036:
p.000036:
p.000036: 4. Research teams implement the plan and maintain clear written records of discussions and agreements, as
p.000036: well as stakeholder engagement activities. This includes stakeholder recommendations, actions taken by the research
p.000036: team, and any unresolved issues that require follow-up.
p.000036: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000036: manage activities and relationships involved in stakeholder engage- ment plans.
p.000036: 3.4 Stakeholder education planb
p.000036: 3.4.A. Definition
p.000036: The stakeholder education plan describes strategies and mecha- nisms for providing relevant education about a specific
p.000036: planned trial—and about biomedical HIV prevention research in general—in order to enhance research
p.000036: literacy.
p.000036:
p.000036: 3.4.B. Relevance to good participatory practice
p.000036: Effective stakeholder education is key to building research literacy and, ultimately, empowering community
p.000036: stakeholders as decision-making agents. Building research literacy lays the foun- dation for a supportive environment
p.000036: for research that extends beyond the lifespan of a specific biomedical HIV prevention trial.
p.000036:
p.000036: 3.4.C. Special considerations
p.000036: 1. While it is important that all relevant stakeholders improve their knowledge of research processes, enhancing
p.000036: research literacy for community stakeholders will foster more equitable relationships.
p.000036: 2. The goals and outcomes of stakeholder education are different from those of recruitment activities. While
p.000036: stakeholder
p.000036:
p.000036: b Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000036: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000036: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000036: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000036: clear.
p.000037: 37
p.000037:
p.000037: UNAIDS / AVAC
p.000037:
p.000037:
p.000037: education can positively influence trial recruitment activities, a stakeholder education plan can help clarify the
p.000037: differences between participant recruitment and stakeholder education.
p.000037: 3.4.D. Good participatory practices for stakeholder education planning
p.000037: 1. Research teams, with input from relevant stakeholders, determine what education is needed in order to enhance
p.000037: stakeholder understanding of, and engagement with, a specific planned trial and biomedical HIV prevention
p.000037: research more generally.
p.000037: 2. Research teams and relevant stakeholders discuss and negotiate a stakeholder education plan to cover the
p.000037: life-cycle of the trial.The plan defines the following:
p.000037: a. The range of different stakeholders that could benefit from specific education about HIV, HIV prevention
p.000037: options, and general research literacy.
p.000037: b. The level of knowledge that is optimal and desired by stakeholders to support effective engagement. This will be
p.000037: influenced by the type of engagement defined for each stakeholder in the stakeholder engagement plan (see
p.000037: Section 3.3).
p.000037: c. The methods and frequency of educational activities.
p.000037: d. The stakeholders who could also deliver or facilitate the delivery of activities in the stakeholder education plan.
p.000037: e. The frequency with which the stakeholder education plan will be reviewed.
p.000037: f. The criteria by which to review the success of the stake- holder education plan.
p.000037: 3. Research teams implement the plan and document stake- holder education activities, including questions that
p.000037: arise, topics that cause confusion, and suggestions for future educa- tional activities.
p.000037: 4. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000037: support activities outlined in the stakeholder education plan.
p.000037:
p.000038: 38
p.000038:
p.000038: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000038:
p.000038:
p.000038: 3.5 Communications planc
p.000038: 3.5.A. Definition
p.000038: The communications plan describes policies and strategies that will increase broad awareness of the trial, facilitate
p.000038: dissemina- tion and understanding of correct information about trial design, conduct, and results, and coordinate
...
p.000038: especially across multidisciplinary teams, is a prerequisite to attaining effective external communications.
p.000038:
p.000038: 3.5.D. Good participatory practices for communications planning
p.000038: 1. Research teams and relevant stakeholders comprehensively identify potential audiences within and
p.000038: surrounding the research area as well as regionally, nationally, and internationally.
p.000038: 2. Research teams and relevant stakeholders discuss and negotiate a communications plan to support open channels
p.000038:
p.000038: c Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000038: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000038: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000038: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000038: clear.
p.000038:
p.000039: 39
p.000039:
p.000039: UNAIDS / AVAC
p.000039:
p.000039:
p.000039: of communication about the trial throughout its life-cycle. The plan describes the following:
p.000039: a. The information needs of the different stakeholders at various stages of the research life-cycle, from early phases
p.000039: of stakeholder engagement to recruitment, enrolment, trial closure, and results dissemination.
p.000039: b. The key messages to be communicated about the trial, such as the purpose, risks, benefits, ongoing progress,
p.000039: closure, and results dissemination.
p.000039: c. The various communication methods that will be used for specific stakeholders, taking into account literacy levels
p.000039: and language needs.
p.000039: d. Local stakeholders who could deliver or facilitate commu- nications activities.
p.000039: e. Specific training needs necessary to effectively deliver messages.
p.000039: f. Procedures and timelines for disseminating information and procedures for actively addressing inquiries about the
p.000039: trial or HIV prevention research.
p.000039: g. The frequency with which the communications plan will be reviewed.
p.000039: h. The criteria by which to review the success of the commu- nications plan.
p.000039: 3. Research teams develop communication materials in under- standable language and translate them as needed,
p.000039: seeking input from relevant stakeholders.
p.000039: 4. Research teams implement the plan and maintain clear written records of discussions, agreements, and
p.000039: communica- tion activities.This includes relevant stakeholder recommen- dations, actions taken by the research team,
p.000039: and any unre- solved issues that require further follow-up.
p.000039: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000039: support activities outlined in the communications plan.
p.000039:
p.000039:
p.000039:
p.000040: 40
p.000040:
p.000040: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000040:
p.000040:
p.000040: 3.5.E. Additional guidance
p.000040: See Communications Handbook for Clinical Trials: Strategies, tips, and tools to manage controversy, convey your
p.000040: message, and dissemi- nate results.28
p.000040: 3.6 Issues management pland
p.000040: 3.6.A. Definition
...
p.000045: 3.9.C. Special considerations
p.000045: Community stakeholders can provide research teams with invaluable advice to improve the informed consent process
p.000045: and materials. However, the actual implementation of the informed consent process between an individual and the
p.000045: research staff is confidential. Only designated research staff members have access to confidential information about
p.000045: the identity of trial participants. The informed consent process itself is conducted in accordance with Good Clinical
p.000045: Practice.2
p.000045:
p.000045: 3.9.D. Good participatory practices for the informed consent process
p.000045: 1. Research teams discuss the following topics with community stakeholders during development of the informed consent
p.000045: materials and procedures:
p.000045: a. Who needs to be consulted locally to enable research teams to invite individuals to join the trial.
p.000045: b. What local cultural practices may affect individual deci- sion-making ability, and how working within these struc-
p.000045: tures can be facilitated while ensuring protection of indi- vidual autonomy to provide informed consent.
p.000045: c. The general literacy level of the population to be recruited and how to assess the literacy level of prospective
p.000045: partici- pants.
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000046:
p.000046:
p.000046: d. Considerations and requirements for illiterate participants, including discussion of possibilities of who may
p.000046: serve appropriately as a witness to the informed consent process.
p.000046: e. The prevalence of different languages in the area and which languages are required for obtaining
p.000046: informed consent from individuals.
p.000046: f. Local and legal forms of identity (name and age) verifica- tion and local practices around the use of names.
p.000046: g. The legal, local, and trial sponsor definitions of a “minor” and consideration of legal and local
p.000046: determinations of who can serve as a minor’s guardian.
p.000046: h. Locally appropriate reimbursement and compensation.
p.000046: i. Appropriate strategies to ensure participant rights are protected, including voluntariness of
p.000046: participation, ensuring undue inducement is avoided, and mitigating the influence of social desirability in influencing
p.000046: individual agreement to enrol.
p.000046: j. Strategies to ensure comprehension of informed consent materials and critical trial-related terms and
...
p.000047: stakeholder recommendations, actions taken by the research team, and any unresolved issues that require follow-up.
p.000047: 3. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000047: allow informed consent materials to be properly developed, piloted, translated, and implemented, including materials
p.000047: to assess participants’ ongoing consent.
p.000047: 3.9.E. Additional guidance
p.000047: 1. Informed consent is the cornerstone of ethically conducted research and is explicitly discussed in guidance
p.000047: documents that address the overall ethical conduct of research, such as the Declaration of Helsinki,5 CIOMS
p.000047: guidelines,7 The Belmont Report,6 Good Clinical Practice,2 the World Health Organization Handbook for Good Clinical
p.000047: Research Practice,3 the Nuremberg Code,29 the Nuffield Council Guidance on health research in devel- oping
p.000047: countries,8, 9 and UNAIDS/WHO Ethical considerations in biomedical HIV prevention trials,10 and in relevant
p.000047: national guidelines.
p.000047: 2. There are extensive literature and other resources on the devel- opment of informed consent processes in multiple
p.000047: contexts, including a range of innovative approaches to measure and assess participant understanding, to address
p.000047: literacy issues, and to accommodate the desire of participants to consult with families and friends. 30, 31, 32, 33, 34
p.000047: 3.10 Standard of HIV prevention
p.000047: 3.10.A. Definition
p.000047: The term “standard of HIV prevention” refers to the package of comprehensive counselling and state-of-the-art HIV
p.000047: risk reduction methods provided or made available to participants in biomedical HIV prevention trials.
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000048:
p.000048:
p.000048: 3.10.B. Relevance to good participatory practice
p.000048: Helping trial participants reduce their risk of acquiring HIV is a key ethical obligation of research teams.
p.000048: Determining the components of the HIV prevention package is a joint effort between research teams and relevant
p.000048: stakeholders. Trial sponsors and implementers must work with relevant stakeholders in establishing the type,
p.000048: scope, and process by which participants are provided with, or referred to, services to access the full HIV prevention
...
p.000058: Community stakeholders can provide the best information on how to design socially and culturally
p.000058: acceptable strate- gies for recruitment, screening, enrolment, follow-up, and exit. Community stakeholders included in
p.000058: the process of developing these strategies can play an important role in identifying and mitigating trial-related
p.000058: stigma, misconceptions, or miscommuni- cation.
p.000058:
p.000058: 3.14.C. Special considerations
p.000058: 1. Follow-up of participants after missed visits must respect agreements between the participant and research
p.000058: team about how to contact the participant.
p.000058: 2. Exiting a trial may present changes in what participants have become accustomed to with regard to clinical care and
p.000058: the impact of the trial on their social relationships. Anticipation and discussion of these issues between research
p.000058: teams and community stakeholders will help in the development of appropriate strategies to support participants
p.000058: upon trial exit.
p.000058: 3.14.D. Good participatory practices for trial accrual, follow-up, and exit
p.000058: 1. Research teams consult with relevant stakeholders about accrual, follow-up, and exit processes, taking
p.000058: account of the following:
p.000058:
p.000058:
p.000059: 59
p.000059:
p.000059: UNAIDS / AVAC
p.000059:
p.000059:
p.000059: a. Strategies and messages that are socially and culturally appropriate, meet the needs of specific
p.000059: stakeholders in terms of language and literacy, and draw on a range of communication modes, including written, oral,
p.000059: and visual.
p.000059: b. Procedures to anticipate, monitor, and mitigate trial- related stigma resulting from ineligibility to enrol
p.000059: or from enrolment itself.
p.000059: c. Procedures for training and supervising trial site staff on creating respectful relationships with participants
p.000059: and fostering an environment that is nonjudgmental and welcoming.
p.000059: d. Strategies to ensure the confidentiality of participants during trial visits, while following up participants
p.000059: outside of the trial clinic, and after trial exit.
p.000059: e. Procedures for informing participants about trial results and trial product assignment, when available.
p.000059: f. Procedures for transfer of care at the end of follow-up or trial closure, such as providing participants with
p.000059: referrals to HIV counselling and testing and to other supportive services.
p.000059: 2. Research teams provide relevant stakeholders with ongoing updates on trial accrual, follow-up, and trial exit.
p.000059: 3. Research teams seek advice from relevant stakeholders on how to improve accrual, follow-up and exit processes, and
p.000059: messages.
p.000059: 4. Research teams maintain clear written records of discussions and agreements, as well as ongoing discussions about
p.000059: ways to modify strategies.
p.000059: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000059: support stakeholder engagement in the development of locally accept- able trial procedures.
p.000059: 3.15 Trial closure and results dissemination
p.000059: 3.15.A. Definition
...
p.000065: research process and improved decision-making abilities.
p.000065:
p.000065: Effective stakeholder engagement can exist only when appropriate funds and resources are made available to research
p.000065: teams so they may adhere to good participatory practice. Sponsors of biomedical HIV prevention trials are responsible
p.000065: for enabling GPP by ensuring ample budget allocations and staff time to facilitate participatory approaches.
p.000065:
p.000065: Investment in establishing mutually respectful relationships and building capacity of community stakeholders is a
p.000065: long-term process that extends throughout and beyond the life-cycle of any single clinical trial. Although it is highly
p.000065: beneficial to maintain and support key staff at trial sites and
p.000065:
p.000065:
p.000066: 66
p.000066:
p.000066: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: sustain relationships that have been developed with local partners during the course of a trial, sponsors of biomedical
p.000066: HIV prevention trials often only support implementation of specific clinical trials. Investing in collab- orative
p.000066: long-term, sustained relationships between research teams and relevant stakeholders, such as academic
p.000066: institutions, ministries of health, and non-governmental organisations, can improve research literacy, enhance the
p.000066: success of stakeholder engagement, and provide the foundation for future trials.
p.000066:
p.000066: The GPP guidelines are intended to provide trial funders, sponsors, and implementers with systematic guidance on how to
p.000066: effectively engage with relevant stakeholders in the design and conduct of biomedical HIV preven- tion trials.
p.000066: Developing participatory processes that balance the opinions of all stakeholders while achieving the scientific goals
p.000066: of a trial can ensure that the needs of both community stakeholders and the broader HIV preven- tion field are met.
p.000066:
p.000066: In a forward-looking approach, it is important to gather and analyse stake- holders’ experiences with the
p.000066: implementation of the GPP guidelines. Recommendations for modifications and refinements based on experience and
p.000066: reflection can be sent to gpp@unaids.org or avac@avac.org, where they will be gratefully received and considered in
p.000066: future updates of these guidelines.
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: UNAIDS / AVAC
p.000067:
p.000067:
p.000067: Annex 1. Acronyms and abbreviations
p.000067: AE – Adverse event
p.000067: AIDS – Acquired Immunodeficiency Syndrome
p.000067: ARV – Antiretroviral drug
p.000067: CAB – Community Advisory Board CAG – Community Advisory Group CBO – Community-Based Organisation
p.000067: CIOMS – Council for International Organizations of Medical Science
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000029: mechanism, there are many other ways that research teams can effectively engage with stakeholders.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000030:
p.000030:
p.000030: 3.2.B. Relevance to good participatory practice
p.000030: Establishment, maintenance, and engagement of stakeholder advisory mechanisms throughout the research process are
p.000030: key to establishing meaningful partnerships with community stake- holders and to ensuring continuous dialogue about
p.000030: biomedical HIV prevention research and specific trials.
p.000030:
p.000030: 3.2.C. Special considerations
p.000030: 1. Community advisory boards or groups were first developed in the context of HIV research in the United States of
p.000030: America and Europe. Over the past two decades, they have become a standard element of HIV research worldwide.
p.000030: Nonetheless, the establishment of a community advisory board or group may not always translate as best practice
p.000030: in all locations globally. In many settings, they are necessary but not sufficient for gaining adequate and
p.000030: appropriate community stakeholder input. Careful consideration needs to be given to the range of stakeholder advisory
p.000030: mechanisms that are required to best support effective participatory practices.
p.000030: 2. The need to identify and establish new stakeholder advisory mechanisms may vary from site to site and within a
p.000030: single site, over time. Stakeholder identification and inclusion considers the dynamic stakeholder landscape, as well
p.000030: as whether a trial is conducted in a research-naïve area or at a well-established research facility.
p.000030: 3. Formative research activities (see Section 3.1) help research teams to comprehensively identify which groups or
p.000030: individ- uals are relevant stakeholders and why.
p.000030: 4. While community advisory boards or groups can assist research teams in thinking about best strategies
p.000030: for trial recruitment, individual members of community advisory boards or groups are not research staff and do
p.000030: not participate in implementing actual trial procedures such as recruitment of prospective participants.
p.000030: 5. While community advisory boards or groups are often funded by research networks or trial sites, they are intended
p.000030: to be an independent advisory voice that is free to express concerns about proposed or ongoing research.
p.000030:
p.000031: 31
p.000031:
p.000031:
p.000031:
p.000031: UNAIDS / AVAC
p.000031:
p.000031:
p.000031: Figure 6. The Role of Community Advisory Boards
p.000031:
p.000031: y
p.000031:
p.000031:
p.000031:
p.000031: Research Team
p.000031: CAB
p.000031: Stakeholders
p.000031:
p.000031:
p.000031: y
p.000031:
p.000031:
p.000031: Community advisory boards (CABs) can play an important role in translating infor- mation between research teams and
p.000031: stakeholders. While community advisory boards are a key mechanism by which research teams inform stakeholders and
p.000031: receive their feedback, research teams are responsible for using other advisory mechanisms in addition to
p.000031: CABs to reach a broader range of stakeholders.
p.000031:
p.000031:
p.000031:
...
p.000065: prevention trials.
p.000065:
p.000065: Adherence to good participatory practices is an investment that benefits the research process. These practices
p.000065: facilitate the engagement of relevant stakeholders to achieve mutual gains in local capacity building for biomed- ical
p.000065: HIV prevention research. Significant power imbalances exist between trial funders, sponsors, and implementers and
p.000065: community stakeholders— the GPP guidelines are a critical resource to help address and mitigate these disparities. A
p.000065: core aim of the guidelines is to enhance the skills of individ- uals and groups who are most vulnerable to both HIV and
p.000065: to exploitation. The GPP guidelines help build community stakeholder capacity for more robust engagement in the
p.000065: research process and improved decision-making abilities.
p.000065:
p.000065: Effective stakeholder engagement can exist only when appropriate funds and resources are made available to research
p.000065: teams so they may adhere to good participatory practice. Sponsors of biomedical HIV prevention trials are responsible
p.000065: for enabling GPP by ensuring ample budget allocations and staff time to facilitate participatory approaches.
p.000065:
p.000065: Investment in establishing mutually respectful relationships and building capacity of community stakeholders is a
p.000065: long-term process that extends throughout and beyond the life-cycle of any single clinical trial. Although it is highly
p.000065: beneficial to maintain and support key staff at trial sites and
p.000065:
p.000065:
p.000066: 66
p.000066:
p.000066: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: sustain relationships that have been developed with local partners during the course of a trial, sponsors of biomedical
p.000066: HIV prevention trials often only support implementation of specific clinical trials. Investing in collab- orative
p.000066: long-term, sustained relationships between research teams and relevant stakeholders, such as academic
p.000066: institutions, ministries of health, and non-governmental organisations, can improve research literacy, enhance the
p.000066: success of stakeholder engagement, and provide the foundation for future trials.
p.000066:
p.000066: The GPP guidelines are intended to provide trial funders, sponsors, and implementers with systematic guidance on how to
p.000066: effectively engage with relevant stakeholders in the design and conduct of biomedical HIV preven- tion trials.
p.000066: Developing participatory processes that balance the opinions of all stakeholders while achieving the scientific goals
p.000066: of a trial can ensure that the needs of both community stakeholders and the broader HIV preven- tion field are met.
p.000066:
p.000066: In a forward-looking approach, it is important to gather and analyse stake- holders’ experiences with the
...
Social / Racial Minority
Searching for indicator racial:
(return to top)
p.000017: design and conduct of research.
p.000017:
p.000017: 1.4 The dynamics of biomedical HIV prevention trials
p.000017: Power inequalities always exist between funders and funding recipients with respect to a range of issues, such as
p.000017: decision-making processes, priority setting, control of resources, and equitable recognition of input. Biomedical HIV
p.000017: prevention trials are often funded by institu- tions in developed countries and conducted with multiple partner
p.000017: institutions worldwide, including those in developing countries. Disparities among these institutions and
p.000017: partners can introduce or reinforce power inequalities between and among trial implementers and the funders or sponsors
p.000017: of trials. This can then translate into inequalities between trial implementers and other stakeholders.
p.000017:
p.000017: The fact that many biomedical HIV prevention trials are conducted in multiple settings and countries introduces another
p.000017: level of complexity. Variation in cultures, physical environments, infrastructure, research experience, health
p.000017: policies, and national laws can introduce inequali- ties among research teams and between research teams and site-level
p.000017: community stakeholders. Power inequalities between research teams and community stakeholders can include
p.000017: imbalances in literacy, education, and economic resources, as well as those inherent in patient–provider
p.000017: relationships. National, racial, ethnic, and linguistic differences between members of research teams and
p.000017: community stakeholders can also exacerbate inequalities.
p.000017:
p.000017: In order to achieve meaningful community stakeholder participa- tion and partnership, it is essential to recognise
p.000017: these various power inequalities and address them.
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000018:
p.000018:
p.000018: Figure 3. Example of a Trial Network
p.000018:
p.000018: Funding From One or More Sources
p.000018:
p.000018:
p.000018: Sponsors
p.000018:
p.000018:
p.000018: Coordinating Centre
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Data Laboratory
p.000018:
p.000018: Clinical Safety
p.000018:
p.000018: Pharmacy
p.000018: Social Science Stakeholder
p.000018:
p.000018:
p.000018:
p.000018: Implementing Institution
p.000018:
p.000018: Trial Sites Trial Sites
p.000018:
p.000018:
p.000018: Basic structure of a typical biomedical HIV prevention trial network. Funding from one or more sources is distributed
p.000018: through a network coordinating centre directly to trial sites or to implementing institutions such as universities that
p.000018: then send funds to trial sites. Trial networks may have several centres responsible for different aspects of trial
p.000018: conduct: data management, laboratory, pharmacy, clinical, safety, social science, and stakeholder engagement.
...
Social / Religion
Searching for indicator religion:
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p.000071: acquired immunodeficiency syndrome (AIDS).
p.000071: Implementer. See trial implementer.
p.000071: Informed consent. A process by which a competent individual volun- tarily confirms his or her willingness to
p.000071: participate in a particular clinical trial after having been informed of all aspects of the trial that are
p.000071: relevant to the individual’s decision to participate. Informed consent is an ongoing process throughout the course of a
p.000071: clinical trial.
p.000071: Institutional review board (IRB). See ethics committee.
p.000071: Male condom. A sheath designed to be worn over the penis during vaginal, anal, or oral intercourse as a means
p.000071: of preventing sexually transmitted infections, including HIV, or preventing pregnancy in the case of vaginal
p.000071: intercourse. (See also female condom.)
p.000071:
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000072:
p.000072:
p.000072: Medical male circumcision. The surgical removal of the entire foreskin of the penis. Three clinical trials conducted in
p.000072: sub-Saharan Africa have shown that medically performed male circumcision is safe and can reduce men’s risk
p.000072: of HIV infection during vaginal sex by about 60%. Prevalence of male circumcision varies by geography,
p.000072: religion, and cultural practices.
p.000072: Men who have sex with men (MSM). Men who have sexual contact with other men, regardless of whether or not they also
p.000072: have sex with women or have a personal or social gay or bisexual identity. This concept also includes men
p.000072: who self-identify as heterosexual but have sex with other men.
p.000072: Microbicides. A range of products that could be used vaginally or rectally (such as a gel, cream, ring, film,
p.000072: suppository or sponge) that are being tested to determine if they reduce or prevent the transmission of HIV and other
p.000072: disease-causing organisms during vaginal and anal intercourse.
p.000072: Network or research network. A cooperative of research institutions or centres conducting clinical trials under a
p.000072: common research agenda.
p.000072: Non-governmental organisation (NGO). A not-for-profit, registered entity or group that is organised on
p.000072: local, national, or international levels but is not an agency of local or national governments.
p.000072: Placebo. An inactive substance that is designed to appear like an exper- imental product being studied in all aspects
p.000072: except for the absence of the active ingredient under study. In clinical trials, the safety and effec- tiveness of an
p.000072: experimental product are assessed by comparing data from the experimental product trial arm to those from the placebo
p.000072: arm.
p.000072: Post-exposure prophylaxis (PEP). Antiretroviral medicines prescribed and taken after exposure or possible exposure to
...
Searching for indicator religious:
(return to top)
p.000012: Policies on
p.000012: Trial-Related Harms
p.000012: Trial Accrual, Follow-Up, and Exit
p.000012: Trial Closure and Results Dissemination
p.000012: Post-trial Access to Trial Products or Procedures
p.000012:
p.000013: 13
p.000013:
p.000013: UNAIDS / AVAC
p.000013:
p.000013:
p.000013: 1. The importance of good participatory practice
p.000013:
p.000013: 1.1 Who are stakeholders?
p.000013: The starting point of good participatory practice is the identification of key stakeholders in the conduct of a
p.000013: biomedical HIV prevention trial. Stakeholders are individuals, groups, organisations, government bodies, or any other
p.000013: individuals or collections of individuals who can influence or are affected by the conduct or outcome of a biomedical
p.000013: HIV prevention trial. In this guidance document, the term “stake- holders” is all-encompassing. It describes any
p.000013: individual or collection of individuals who have a stake in a biomedical HIV prevention trial.
p.000013:
p.000013: Examples of stakeholders are illustrated in Figure 2 and can include trial participants, families of trial
p.000013: participants, prospective trial partic- ipants, individuals resident within, or surrounding, the area where research is
p.000013: conducted, people living with HIV or affected by HIV, prevention and treatment advocates and activists,
p.000013: non-governmental organisations (NGOs), community-based organisations (CBOs), community groups, religious leaders,
p.000013: opinion leaders, media, govern- ment bodies, national and local health-care authorities, service providers,
p.000013: trial funders, trial sponsors, and trial implementers.
p.000013:
p.000013: The definition of “community” is more complicated, as it is a dynamic term that has different meanings to
p.000013: different people.19 This term is often used to refer to a group of people who have a common set of interests, share a
p.000013: common set of characteristics, or live in a common area. Individuals can be a part of multiple “communities” at the
p.000013: same time. The term “community” is also used to refer to the public at large or to a physical location.
p.000013:
p.000013: In the GPP guidelines, the preferred term is “community stake- holders”, rather than “community”, and refers to both
p.000013: individuals and groups that are ultimately representing the interests of people who would be recruited to or
p.000013: participate in a trial, and others locally
p.000013:
p.000014: 14
p.000014:
p.000014:
p.000014:
p.000014: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000014:
p.000014:
p.000014: affected by a trial. Examples of “community stakeholders” are the population to be recruited, trial participants,
p.000014: people living in the area where the research is conducted, people living with HIV in the area, local HIV-positive
p.000014: groups or networks, people in the area who are affected by the HIV epidemic, local non-governmental organisa-
...
p.000027: conduct formative research activities.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000028:
p.000028:
p.000028: 3.2 Stakeholder advisory mechanisms
p.000028: 3.2.A. Definition
p.000028: The term “stakeholder advisory mechanisms” refers to strategies or approaches that facilitate meaningful dialogue among
p.000028: research teams and relevant stakeholders about planned or ongoing clinical trials. Stakeholder advisory
p.000028: mechanisms provide research teams with information about relevant stakeholders’ perspectives on the design, planning,
p.000028: and implementation of a specific clinical trial and facilitate open communication about research goals,
p.000028: processes, and results. These mechanisms also provide relevant stakeholders with the opportunity to engage with
p.000028: research teams during the life-cycle of a trial.
p.000028: Stakeholder advisory mechanisms may be informal or formal. They can be built and sustained by the trial site or may
p.000028: already exist in the area.
p.000028: 1. Informal stakeholder advisory mechanisms may be events or less formal means by which research teams seek
p.000028: relevant stakeholders’ views on proposed or ongoing research. Examples include stakeholder meetings, local
p.000028: events, focus group discussions, interviews, consultations, and suggestion boxes. They may involve individuals,
p.000028: existing organisations, local employer associations, local government or traditional committees, or other advocacy,
p.000028: charitable, cultural, political, religious, or social groups.
p.000028: 2. Formal stakeholder advisory mechanisms typically involve established groups that develop an ongoing
p.000028: relationship with the research team at a particular trial site. Examples are trial participant groups (former or
p.000028: current participants),professional groups (local scientists, service providers, media, or experts on local
p.000028: socio-cultural issues), non-governmental organisation advisory groups (with representatives from different non-
p.000028: governmental organisations or community-based organisa- tions), and community advisory boards (see definition
p.000028: below).
p.000028: 3. Community advisory boards (CABs), also referred to as community advisory groups (CAGs), are a common
p.000028: example of a formal stakeholder advisory mechanism. They are composed of individuals or stakeholder representatives
p.000028:
p.000029: 29
p.000029:
p.000029: UNAIDS / AVAC
p.000029:
p.000029:
p.000029: and provide an independent advisory voice. They facili- tate community stakeholder participation and involvement
p.000029: in the research process. They meet regularly with research team representatives, inform community stakeholders about
p.000029: proposed and ongoing research, and provide feedback to research teams about local norms and beliefs, as well as
p.000029: local views and concerns that arise during specific trials.
p.000029: The composition of community advisory boards or groups varies from site to site but is intended to reflect the
p.000029: diversity of community stakeholder interests and needs. They may include members or representatives of the
p.000029: surrounding area, individuals in the population from which participants will be recruited, people living with or
p.000029: affected by HIV, current or former trial participants, religious or opinion leaders, and representatives of other
p.000029: sections of society as determined by the trial’s location and eligibility criteria.
p.000029:
p.000029:
p.000029: Figure 5. Examples of Stakeholder Advisory Mechanisms
p.000029:
p.000029: Stakeholder Advisory Mechanisms
p.000029:
p.000029:
p.000029: Informal Formal
p.000029:
p.000029: E x a m p l e s o f M e c h a n i s m s
p.000029:
p.000029: Stakeholder meetings
p.000029: Local events
p.000029: Ongoing dialogue with CBOs
p.000029: Focus group discussions
p.000029: Call in radio shows
p.000029: CABs NGO
p.000029: advisory groups
p.000029: Participant groups
p.000029: Groups already established in the area
p.000029:
p.000029:
p.000029: Stakeholder advisory mechanisms can include informal and formal stakeholder advisory mechanisms (see definition 3.2.A).
p.000029: All of these mechanisms, as well as others, may be used to facilitate important dialogue between research teams and
p.000029: other stakeholders. While community advisory boards (CABs) are one example of a stakeholder advisory
p.000029: mechanism, there are many other ways that research teams can effectively engage with stakeholders.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000030:
p.000030:
p.000030: 3.2.B. Relevance to good participatory practice
p.000030: Establishment, maintenance, and engagement of stakeholder advisory mechanisms throughout the research process are
p.000030: key to establishing meaningful partnerships with community stake- holders and to ensuring continuous dialogue about
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000077: Citation: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva,
p.000077: Council for International Organizations of Medical Sciences, 2002.
p.000077:
p.000077: Nuffield Council on Bioethics, 2002
p.000077: The 2002 Nuffield Council on Bioethics report on The Ethics of Research Related to Healthcare in
p.000077: Developing Countries provides an ethical framework for designing or conducting externally sponsored
p.000077: research in the developing world. The 2004 follow-up report, co-hosted with the Medical Research Council of
p.000077: South Africa, discusses how the guidelines could be applied in practice, particu- larly in light of conflicting ethical
p.000077: advice.
p.000077: Citation: The Ethics of Research Related to Healthcare in Developing Countries. London, Nuffield Council on
p.000077: Bioethics, 2002; and The Ethics of Healthcare Related Research in Developing Countries: A Follow-up
p.000077: Discussion Paper. London, Nuffield Council on Bioethics, 2005.
p.000077:
p.000077:
p.000078: 78
p.000078:
p.000078: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000078:
p.000078:
p.000078: Nuremberg Code, 1949
p.000078: This code of research ethics came out of the ruling of the International Military Tribunal that prosecuted Nazi war
p.000078: criminals at the end of the Second World War.
p.000078: Citation: Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10.
p.000078: Vol. 2. Washington, DC, United States Government Printing Office, 1949:181–182.
p.000078:
p.000078:
p.000078: Other references
p.000078: Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage Controversy, Convey Your
p.000078: Message, and Disseminate Results, 2010
p.000078: The Communications Handbook for Clinical Trials is a practical guide developed for site-level research teams,
p.000078: communicators, advocates, and others working on HIV prevention trials. It provides guidance on how to anticipate and
p.000078: respond to the special communication chal- lenges posed by the conduct of clinical research.
p.000078: Citation: Robinson ET et al. Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage
p.000078: Controversy, Convey Your Message, and Disseminate Results. Washington, DC, Microbicides Media Communications
p.000078: Initiative and Research Triangle Park, NC, FHI, 2010.
p.000078:
p.000078: Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, 2001
p.000078: This is a report and set of recommendations published by the United States National Bioethics Advisory Commission
p.000078: for United States policy on conducting clinical trials in developing countries.
p.000078: Citation: Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Vol. I. Report
p.000078: and Recommendations of the National Bioethics Advisory Commission. Washington, DC, United States National
p.000078: Bioethics Advisory Commission, 2001.
p.000078:
p.000078:
p.000079: 79
p.000079:
...
p.000082: 21 Khanlou N, Peter E. Participatory Action Research: Considerations for Ethical Review. Social Science and Medicine,
p.000082: 2005, 60:2333–2340.
p.000082: 22 Macaulay AC et al. Participatory Research Maximises Community Lay Involvement. British Medical Journal,
p.000082: 1999, 319:774–778.
p.000082: 23 Israel BA et al. Review of Community-based Research: Assessing Partnership Approaches to Improve Public Health.
p.000082: Annual Review of Public Health, 1998, 19:173–202.
p.000082: 24 Green LW, Mercer SL. Can Public Health Researchers and Agencies Reconcile the Push from Funding Bodies and the Pull
p.000082: from Communities? American Journal of Public Health, 2001, 91:1926–1929.
p.000082: 25 Arnstein SR. A ladder of Citizen Participation. Journal of the American Institute of Planners, 1969, 35:216–224.
p.000082: 26 Quality Assurance of Pharmaceuticals:A Compendium of Guidelines and Related Materials. Vol. 2. Good Manufacturing
p.000082: Practices and Inspection. 2nd ed. Geneva,World Health Organization, 2007.
p.000082: 27 Community Recommendations Working Group, Community Partners. Recommendations for Community Involvement
p.000082: in National Institute of Allergy and Infectious Diseases HIV/AIDS Clinical Trials Research. Bethesda, MD, 2009.
p.000082:
p.000082:
p.000082:
p.000082:
p.000083: 83
p.000083:
p.000083: UNAIDS / AVAC
p.000083:
p.000083:
p.000083: 28 Robinson ET et al. Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage
p.000083: Controversy, Convey Your Message, and Disseminate Results. Washington, DC, Microbicides Media Communications
p.000083: Initiative and Research Triangle Park, NC, FHI, 2010.
p.000083: 29 Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No.
p.000083: 10.Vol. 2, pp. 181–182. Washington, DC, United States Government Printing Office, 1949:181–182.
p.000083: 30 Molyneux CS, Peshu N, Marsh K. Understanding of Informed Consent in a Low-income Setting: Three Case Studies from
p.000083: the Kenyan Coast. Social Science and Medicine, 2004, 59:2547–2559.
p.000083: 31 Richter L et al. Guidelines for the Development of Culturally Sensitive Approaches to Obtaining Informed Consent
p.000083: for Participation in HIV Vaccine-related Trials. Geneva, UNAIDS, 1999.
p.000083: 32 Molyneux CS et al.“Even If They Ask You to Stand by a Tree All Day, You Will Have To Do It (laughter)...”:
p.000083: Community Voices on the Notion and Practice of Informed Consent for Biomedical Research in Developing Countries. Social
p.000083: Science and Medicine, 2005, 61:443–454.
p.000083: 33 Appelbaum PS, Lidz CW, Meisel A. Informed Consent: Legal Theory and Clinical Practice. New York, Oxford
p.000083: University Press, 1987.
p.000083: 34 Strauss RP et al. The Role of Community Advisory Boards: Involving Communities in the Informed Consent
p.000083: Process. American Journal of Public Health, 2001, 91:1938–1943.
p.000083: 35 Mapping the Standards of Care at Microbicide Clinical Trial Sites. Washington, DC, Global Campaign for
p.000083: Microbicides, PATH, 2008.
...
Social / Threat of Stigma
Searching for indicator stigma:
(return to top)
p.000016: the most and are likely to use them should they prove effective. However, the very factors that increase HIV risk in
p.000016: such populations may contribute to increased vulnerability to exploitation. This underscores the importance of
p.000016: meaningful partnerships with community stakeholders.
p.000016:
p.000016: A wide range of factors creates, enhances, and perpetuates the risk of HIV infection. Structural determinants can
p.000016: increase vulnerability to HIV at an individual or population level by undermining ability to avoid HIV exposure.
p.000016: Underlying determinants of the HIV epidemic can be entrenched in the social, cultural, legal, institutional, or
p.000016: economic fabric of society. Examples of these determinants include gender and other power inequalities,
p.000016: gender-based violence, economic instability including poverty, migration, human rights
p.000016: violations,homophobia,discriminatory practices,HIV-related stigma, social marginalisation, and criminalisation of
p.000016: HIV transmission. Recognition of these factors is the first step in developing practices
p.000016:
p.000017: 17
p.000017:
p.000017: UNAIDS / AVAC
p.000017:
p.000017:
p.000017: that avoid inadvertently replicating or reinforcing them in the design and conduct of biomedical HIV prevention
p.000017: trials.While stakeholder engagement helps empower and equip community stakeholders to engage in the research
p.000017: process in a meaningful fashion, it also harnesses the expertise that community stakeholders can contribute to the
p.000017: design and conduct of research.
p.000017:
p.000017: 1.4 The dynamics of biomedical HIV prevention trials
p.000017: Power inequalities always exist between funders and funding recipients with respect to a range of issues, such as
p.000017: decision-making processes, priority setting, control of resources, and equitable recognition of input. Biomedical HIV
p.000017: prevention trials are often funded by institu- tions in developed countries and conducted with multiple partner
p.000017: institutions worldwide, including those in developing countries. Disparities among these institutions and
p.000017: partners can introduce or reinforce power inequalities between and among trial implementers and the funders or sponsors
p.000017: of trials. This can then translate into inequalities between trial implementers and other stakeholders.
p.000017:
...
p.000056: 3.13.A. Definition
p.000056: Policies on trial-related harms describe how research teams will treat and compensate trial participants should they
p.000056: experience physical or social harms that are determined to be associated with trial participation, as well as how such
p.000056: harms will be addressed and mitigated.
p.000056:
p.000056: 3.13.B. Relevance to good participatory practice
p.000056: A key ethical obligation of research teams is to maximise benefits and minimise harms for trial participants. Relevant
p.000056: stakeholders can provide valuable input about possible social harms of trial participation. These are of particular
p.000056: concern for individuals or groups who may be vulnerable, marginalised, stigmatised, or who have less power in society.
p.000056: Relevant stakeholders can also provide advice about local expectations of research team obligations to address
p.000056: trial-related physical and social harms. Discussing with stakeholders before a trial starts and clearly explaining how
p.000056: trial- related harms will be addressed and mitigated can significantly influence community stakeholder perceptions of
p.000056: the trial and of how well community stakeholder concerns will be addressed.
p.000056:
p.000056: 3.13.C. Special considerations
p.000056: Sponsors typically give specific and binding guidance to research teams on how to determine and report physical harms
p.000056: as adverse events. It is good practice to define similarly stringent procedures for the determination, documentation,
p.000056: reporting, and manage- ment of social harms that trial participants may experience. Examples of social harms
p.000056: due to trial participation include stigma, discrimination, and verbal, emotional, physical, or sexual abuse.
p.000056:
p.000056: 3.13.D. Good participatory practices for policies on trial- related harms
p.000056: 1. Research teams and relevant stakeholders list anticipated physical and social harms that might occur due to
p.000056: trial partic- ipation.
p.000056:
p.000057: 57
p.000057:
p.000057: UNAIDS / AVAC
p.000057:
p.000057:
p.000057: 2. Research teams and relevant stakeholders discuss and develop policies on trial-related physical and social harms,
p.000057: considering the following issues:
p.000057: a. Strategies to prevent or reduce the risk of trial-related harms.
p.000057: b. Procedures to encourage and facilitate reporting of social harms.
p.000057: c. Procedures to investigate events that have been reported indirectly, such as through a third party, taking
p.000057: confiden- tiality issues into account.
p.000057: d. Procedures for reporting social harms and whether these are to be reported to sponsors, ethics committees,
p.000057: and regulatory bodies, even if not specifically required by them.
p.000057: e. Procedures for ensuring optimal referrals to appropriate services for trial-related harms.
p.000057: f. Strategies to inform trial participants of the potential risks of engaging with media.
p.000057: g. Compensation or insurance policies, when applicable, for specific trial-related harms, coverage provided by
p.000057: the policies, how claims are made, and how participants are informed of their rights in relation to the policies.
p.000057: 3. Research teams and relevant stakeholders review follow-up strategies to reduce trial-related physical and social
...
p.000057: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000057: ensure the effective management of physical and social harms related to participation in a trial.
p.000057:
p.000057: 3.13.E. Additional guidance
p.000057: 1. Ethical considerations in biomedical HIV prevention trials
p.000057: (Guidance Point 11, page 40, Potential Harms).1
p.000057:
p.000058: 58
p.000058:
p.000058: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000058:
p.000058:
p.000058: 2. International Ethical Guidelines for Biomedical Research Involving Human Subjects (Guideline 19, page 78
p.000058: right of injured subjects to treatment and compensation).7
p.000058: 3.14 Trial accrual, follow-up, and exit
p.000058: 3.14.A. Definition
p.000058: Trial accrual, follow-up, and exit activities include the recruit- ment, screening, enrolment, follow-up, and exit of
p.000058: trial partici- pants in biomedical HIV prevention trials.
p.000058:
p.000058: 3.14.B. Relevance to good participatory practice
p.000058: Community stakeholders can provide the best information on how to design socially and culturally
p.000058: acceptable strate- gies for recruitment, screening, enrolment, follow-up, and exit. Community stakeholders included in
p.000058: the process of developing these strategies can play an important role in identifying and mitigating trial-related
p.000058: stigma, misconceptions, or miscommuni- cation.
p.000058:
p.000058: 3.14.C. Special considerations
p.000058: 1. Follow-up of participants after missed visits must respect agreements between the participant and research
p.000058: team about how to contact the participant.
p.000058: 2. Exiting a trial may present changes in what participants have become accustomed to with regard to clinical care and
p.000058: the impact of the trial on their social relationships. Anticipation and discussion of these issues between research
p.000058: teams and community stakeholders will help in the development of appropriate strategies to support participants
p.000058: upon trial exit.
p.000058: 3.14.D. Good participatory practices for trial accrual, follow-up, and exit
p.000058: 1. Research teams consult with relevant stakeholders about accrual, follow-up, and exit processes, taking
p.000058: account of the following:
p.000058:
p.000058:
p.000059: 59
p.000059:
p.000059: UNAIDS / AVAC
p.000059:
p.000059:
p.000059: a. Strategies and messages that are socially and culturally appropriate, meet the needs of specific
p.000059: stakeholders in terms of language and literacy, and draw on a range of communication modes, including written, oral,
p.000059: and visual.
p.000059: b. Procedures to anticipate, monitor, and mitigate trial- related stigma resulting from ineligibility to enrol
p.000059: or from enrolment itself.
p.000059: c. Procedures for training and supervising trial site staff on creating respectful relationships with participants
p.000059: and fostering an environment that is nonjudgmental and welcoming.
p.000059: d. Strategies to ensure the confidentiality of participants during trial visits, while following up participants
p.000059: outside of the trial clinic, and after trial exit.
p.000059: e. Procedures for informing participants about trial results and trial product assignment, when available.
p.000059: f. Procedures for transfer of care at the end of follow-up or trial closure, such as providing participants with
p.000059: referrals to HIV counselling and testing and to other supportive services.
p.000059: 2. Research teams provide relevant stakeholders with ongoing updates on trial accrual, follow-up, and trial exit.
p.000059: 3. Research teams seek advice from relevant stakeholders on how to improve accrual, follow-up and exit processes, and
p.000059: messages.
p.000059: 4. Research teams maintain clear written records of discussions and agreements, as well as ongoing discussions about
p.000059: ways to modify strategies.
p.000059: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000059: support stakeholder engagement in the development of locally accept- able trial procedures.
p.000059: 3.15 Trial closure and results dissemination
p.000059: 3.15.A. Definition
p.000059: Trial closure occurs when all participants have exited from the trial and all trial procedures are completed. Results
p.000059: dissemination
p.000059:
p.000060: 60
p.000060:
...
p.000073: coordinating centres, institutions, or agencies.
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000074:
p.000074:
p.000074: Scientific process. A recognised systematic way to form and test hypotheses by designing controlled
p.000074: experiments to collect data, analyse results, and draw conclusions in order to acquire new knowledge or to correct,
p.000074: refine, and integrate previous knowledge.
p.000074: Seroconversion. The process by which a newly infected person develops antibodies that can be detected by
p.000074: an HIV antibody test. Development of antibodies may occur anywhere from weeks or months following HIV infection.
p.000074: Sexually transmitted infections (STIs). Infections caused by microor- ganisms that are transmitted from one person to
p.000074: another during sexual or intimate contact.
p.000074: Stakeholders or trial stakeholders. Individuals, groups, organisations, governments, or other entities that are
p.000074: affected by the outcome of a biomedical HIV prevention trial or that can influence proposed research through their
p.000074: input and actions. (See community stakeholders.)
p.000074: Standard operating procedure (SOP). A document that gives step- by-step instructions for how to conduct a procedure, in
p.000074: order to ensure that each staff member can perform the procedure in the same way.
p.000074: Stigma. AIDS-related stigma refers to a pattern of prejudice, discounting, discrediting, and discrimination directed at
p.000074: people perceived to have HIV or AIDS, their significant others and close associates or their social groups.
p.000074: Therapeutic HIV vaccine. A compound designed to stimulate the immune response to HIV in a person already
p.000074: infected with the virus, in order to control the infection. Also referred to as an immunotherapeutic vaccine. (See
p.000074: vaccine and HIV vaccine.)
p.000074: Trial arm or group. A group within a clinical trial formed of participants who have been assigned a particular product
p.000074: or procedure during a trial. (See control arm or group, experimental arm or group.)
p.000074: Trial funder. An individual or entity responsible for financing the cost of a trial.
p.000074: Trial implementer. Investigators, research staff, and all others specifi- cally responsible for executing
p.000074: biomedical HIV prevention trials. Implementers may be employed by governments, government-spon-
p.000074:
p.000075: 75
p.000075:
p.000075: UNAIDS / AVAC
p.000075:
p.000075:
p.000075: sored networks, non-governmental organisations, academic institu- tions, the pharmaceutical industry or other
p.000075: companies, foundations, or public–private partnerships.
p.000075: Trial life-cycle. The entire process of a trial, starting from developing the initial concept and writing the protocol
...
Social / Threat of Violence
Searching for indicator violence:
(return to top)
p.000016: experimental HIV prevention options are tested for safety and effectiveness in populations who need these interventions
p.000016: the most and are likely to use them should they prove effective. However, the very factors that increase HIV risk in
p.000016: such populations may contribute to increased vulnerability to exploitation. This underscores the importance of
p.000016: meaningful partnerships with community stakeholders.
p.000016:
p.000016: A wide range of factors creates, enhances, and perpetuates the risk of HIV infection. Structural determinants can
p.000016: increase vulnerability to HIV at an individual or population level by undermining ability to avoid HIV exposure.
p.000016: Underlying determinants of the HIV epidemic can be entrenched in the social, cultural, legal, institutional, or
p.000016: economic fabric of society. Examples of these determinants include gender and other power inequalities,
p.000016: gender-based violence, economic instability including poverty, migration, human rights
p.000016: violations,homophobia,discriminatory practices,HIV-related stigma, social marginalisation, and criminalisation of
p.000016: HIV transmission. Recognition of these factors is the first step in developing practices
p.000016:
p.000017: 17
p.000017:
p.000017: UNAIDS / AVAC
p.000017:
p.000017:
p.000017: that avoid inadvertently replicating or reinforcing them in the design and conduct of biomedical HIV prevention
p.000017: trials.While stakeholder engagement helps empower and equip community stakeholders to engage in the research
p.000017: process in a meaningful fashion, it also harnesses the expertise that community stakeholders can contribute to the
p.000017: design and conduct of research.
p.000017:
p.000017: 1.4 The dynamics of biomedical HIV prevention trials
p.000017: Power inequalities always exist between funders and funding recipients with respect to a range of issues, such as
p.000017: decision-making processes, priority setting, control of resources, and equitable recognition of input. Biomedical HIV
p.000017: prevention trials are often funded by institu- tions in developed countries and conducted with multiple partner
p.000017: institutions worldwide, including those in developing countries. Disparities among these institutions and
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000056: experience physical or social harms that are determined to be associated with trial participation, as well as how such
p.000056: harms will be addressed and mitigated.
p.000056:
p.000056: 3.13.B. Relevance to good participatory practice
p.000056: A key ethical obligation of research teams is to maximise benefits and minimise harms for trial participants. Relevant
p.000056: stakeholders can provide valuable input about possible social harms of trial participation. These are of particular
p.000056: concern for individuals or groups who may be vulnerable, marginalised, stigmatised, or who have less power in society.
p.000056: Relevant stakeholders can also provide advice about local expectations of research team obligations to address
p.000056: trial-related physical and social harms. Discussing with stakeholders before a trial starts and clearly explaining how
p.000056: trial- related harms will be addressed and mitigated can significantly influence community stakeholder perceptions of
p.000056: the trial and of how well community stakeholder concerns will be addressed.
p.000056:
p.000056: 3.13.C. Special considerations
p.000056: Sponsors typically give specific and binding guidance to research teams on how to determine and report physical harms
p.000056: as adverse events. It is good practice to define similarly stringent procedures for the determination, documentation,
p.000056: reporting, and manage- ment of social harms that trial participants may experience. Examples of social harms
p.000056: due to trial participation include stigma, discrimination, and verbal, emotional, physical, or sexual abuse.
p.000056:
p.000056: 3.13.D. Good participatory practices for policies on trial- related harms
p.000056: 1. Research teams and relevant stakeholders list anticipated physical and social harms that might occur due to
p.000056: trial partic- ipation.
p.000056:
p.000057: 57
p.000057:
p.000057: UNAIDS / AVAC
p.000057:
p.000057:
p.000057: 2. Research teams and relevant stakeholders discuss and develop policies on trial-related physical and social harms,
p.000057: considering the following issues:
p.000057: a. Strategies to prevent or reduce the risk of trial-related harms.
p.000057: b. Procedures to encourage and facilitate reporting of social harms.
p.000057: c. Procedures to investigate events that have been reported indirectly, such as through a third party, taking
p.000057: confiden- tiality issues into account.
p.000057: d. Procedures for reporting social harms and whether these are to be reported to sponsors, ethics committees,
p.000057: and regulatory bodies, even if not specifically required by them.
p.000057: e. Procedures for ensuring optimal referrals to appropriate services for trial-related harms.
p.000057: f. Strategies to inform trial participants of the potential risks of engaging with media.
p.000057: g. Compensation or insurance policies, when applicable, for specific trial-related harms, coverage provided by
p.000057: the policies, how claims are made, and how participants are informed of their rights in relation to the policies.
p.000057: 3. Research teams and relevant stakeholders review follow-up strategies to reduce trial-related physical and social
p.000057: harms over the course of the trial.
...
Social / Women
Searching for indicator women:
(return to top)
p.000051: with HIV require lifelong care and treatment, and, for some participants, HIV treatment may begin after trial exit or
p.000051: completion.
p.000051: 3.11.D. Good participatory practices for access to HIV care and treatment
p.000051: 1. Research teams identify local HIV care and treatment services, local HIV non-governmental organisations or
p.000051: community- based organisations, and HIV support groups, determine
p.000051:
p.000052: 52
p.000052:
p.000052: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000052:
p.000052:
p.000052: their capacities, and seek their views and perspectives. This enables research teams to design optimal referral
p.000052: mechanisms in consultation with service providers.
p.000052: 2. During protocol development, research teams and relevant stakeholders discuss access to HIV care and treatment for
p.000052: the following:
p.000052: a. Individuals who are identified as HIV-positive during the screening process.
p.000052: b. Individuals who become HIV-positive during the trial.
p.000052: c. Women who are identified as HIV-positive during the screening process or who acquire HIV during the trial, and when
p.000052: appropriate HIV-positive men, for provision of information about the risk of mother-to-child HIV trans- mission and the
p.000052: benefits of vertical transmission preven- tion services.
p.000052: 3. Research teams and relevant stakeholders discuss the HIV care and treatment package, taking account of the
p.000052: following:
p.000052: a. The HIV care and treatment package required as a minimum for the trial protocol.
p.000052: b. Current national HIV care and treatment guidelines and policies and local provision of HIV care and treatment
p.000052: services.
p.000052: c. Anticipated numbers of people likely to be found HIV-positive during screening and the anticipated
p.000052: numbers of participants likely to seroconvert during the trial.
p.000052: d. Current national laws that could affect a person’s right or ability to access HIV care and treatment.
p.000052: e. HIV care and treatment services that will be offered through referral mechanisms.
...
p.000071: relevant to the individual’s decision to participate. Informed consent is an ongoing process throughout the course of a
p.000071: clinical trial.
p.000071: Institutional review board (IRB). See ethics committee.
p.000071: Male condom. A sheath designed to be worn over the penis during vaginal, anal, or oral intercourse as a means
p.000071: of preventing sexually transmitted infections, including HIV, or preventing pregnancy in the case of vaginal
p.000071: intercourse. (See also female condom.)
p.000071:
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000072:
p.000072:
p.000072: Medical male circumcision. The surgical removal of the entire foreskin of the penis. Three clinical trials conducted in
p.000072: sub-Saharan Africa have shown that medically performed male circumcision is safe and can reduce men’s risk
p.000072: of HIV infection during vaginal sex by about 60%. Prevalence of male circumcision varies by geography,
p.000072: religion, and cultural practices.
p.000072: Men who have sex with men (MSM). Men who have sexual contact with other men, regardless of whether or not they also
p.000072: have sex with women or have a personal or social gay or bisexual identity. This concept also includes men
p.000072: who self-identify as heterosexual but have sex with other men.
p.000072: Microbicides. A range of products that could be used vaginally or rectally (such as a gel, cream, ring, film,
p.000072: suppository or sponge) that are being tested to determine if they reduce or prevent the transmission of HIV and other
p.000072: disease-causing organisms during vaginal and anal intercourse.
p.000072: Network or research network. A cooperative of research institutions or centres conducting clinical trials under a
p.000072: common research agenda.
p.000072: Non-governmental organisation (NGO). A not-for-profit, registered entity or group that is organised on
p.000072: local, national, or international levels but is not an agency of local or national governments.
p.000072: Placebo. An inactive substance that is designed to appear like an exper- imental product being studied in all aspects
p.000072: except for the absence of the active ingredient under study. In clinical trials, the safety and effec- tiveness of an
p.000072: experimental product are assessed by comparing data from the experimental product trial arm to those from the placebo
p.000072: arm.
p.000072: Post-exposure prophylaxis (PEP). Antiretroviral medicines prescribed and taken after exposure or possible exposure to
p.000072: HIV, to reduce the risk of acquiring HIV. The exposure may be occupational, as in a needle stick injury, or
...
Social / Youth/Minors
Searching for indicator minor:
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p.000045: a. Who needs to be consulted locally to enable research teams to invite individuals to join the trial.
p.000045: b. What local cultural practices may affect individual deci- sion-making ability, and how working within these struc-
p.000045: tures can be facilitated while ensuring protection of indi- vidual autonomy to provide informed consent.
p.000045: c. The general literacy level of the population to be recruited and how to assess the literacy level of prospective
p.000045: partici- pants.
p.000045:
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p.000045:
p.000046: 46
p.000046:
p.000046: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000046:
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p.000046: d. Considerations and requirements for illiterate participants, including discussion of possibilities of who may
p.000046: serve appropriately as a witness to the informed consent process.
p.000046: e. The prevalence of different languages in the area and which languages are required for obtaining
p.000046: informed consent from individuals.
p.000046: f. Local and legal forms of identity (name and age) verifica- tion and local practices around the use of names.
p.000046: g. The legal, local, and trial sponsor definitions of a “minor” and consideration of legal and local
p.000046: determinations of who can serve as a minor’s guardian.
p.000046: h. Locally appropriate reimbursement and compensation.
p.000046: i. Appropriate strategies to ensure participant rights are protected, including voluntariness of
p.000046: participation, ensuring undue inducement is avoided, and mitigating the influence of social desirability in influencing
p.000046: individual agreement to enrol.
p.000046: j. Strategies to ensure comprehension of informed consent materials and critical trial-related terms and
p.000046: concepts, including the use of visual or audio formats, flipcharts, props, analogies, and other supportive
p.000046: materials and methods.
p.000046: k. Techniques to assess comprehension of trial participation and the frequency with which they are to be used.
p.000046: l. Explanation of potential trial-related harms and how such harms will be addressed (see Section 3.13).
p.000046: m. Strategies to ensure that follow-up of participants after missed visits respects agreements between the participant
p.000046: and research team about how to contact the participant.
p.000046: n. Consideration of the length of informed consent forms and the estimated time required to complete the informed
p.000046: consent process.
p.000046: o. Preferred ways for participants to contact research teams and stakeholders independent from the research team to
p.000046: ask questions or express concerns about trial participation.
p.000046: p. Ways to pilot informed consent materials.
p.000046:
p.000047: 47
p.000047:
p.000047: UNAIDS / AVAC
p.000047:
p.000047:
...
Social / education
Searching for indicator education:
(return to top)
p.000002: 1.1 Who are stakeholders? 14
p.000002: 1.2 What is stakeholder engagement? 16
p.000002: 1.3 The wider context of HIV 17
p.000002: 1.4 The dynamics of biomedical HIV prevention trials 18
p.000002: 1.5 Rationale for GPP guidelines 19
p.000002: 1.6 Applying GPP 20
p.000002: 2. Guiding principles of GPP in biomedical HIV prevention trials 22
p.000002: 2.1 Respect 22
p.000002: 2.2 Mutual understanding 22
p.000002: 2.3 Integrity 24
p.000002: 2.4 Transparency 24
p.000002: 2.5 Accountability 24
p.000002: 2.6 Community stakeholder autonomy 25
p.000002: 3. Good participatory practices in biomedical HIV prevention trials 26
p.000002: Introduction to good participatory practices 26
p.000002: 3.1 Formative research activities 27
p.000002: 3.2 Stakeholder advisory mechanisms 29
p.000002: 3.3 Stakeholder engagement plan 35
p.000002: 3.4 Stakeholder education plan 37
p.000002: 2
p.000002:
p.000002: Good participatory practice guidelines for biomedical HIV prevention trials 2011
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p.000002: 3.5 Communications plan 39
p.000002: 3.6 Issues management plan 41
p.000002: 3.7 Site selection 43
p.000002: 3.8 Protocol development 44
p.000002: 3.9 Informed consent process 45
p.000002: 3.10 Standard of HIV prevention 48
p.000002: 3.11 Access to HIV care and treatment 52
p.000002: 3.12 Non HIV-related care 55
p.000002: 3.13 Policies on trial-related harms 57
p.000002: 3.14 Trial accrual, follow-up, and exit 59
p.000002: 3.15 Trial closure and results dissemination 60
p.000002: 3.16 Post-trial access to trial products or procedures 63
p.000002: Conclusion 66
p.000002: Annex 1. Acronyms and abbreviations 68
...
p.000002: References 82
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p.000003: 3
p.000003:
p.000003: UNAIDS / AVAC
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Section 1:
p.000003: The Importance of Good Participatory Practice
p.000003:
p.000003: Section 2:
p.000003: Guiding Principles
p.000003: of GPP in Biomedical HIV Prevention Trials
p.000003:
p.000003: Section 3:
p.000003: Good Participatory Practices in Biomedical HIV Prevention Trials
p.000003:
p.000003:
p.000003:
p.000003: Who are Stakeholders?
p.000003:
p.000003:
p.000003: What is Stakeholder Engagement?
p.000003:
p.000003:
p.000003: The Wider Context of HIV
p.000003:
p.000003: The Dynamics of Biomedical HIV Prevention Trials
p.000003:
p.000003: Rationale for GPP Guidelines
p.000003:
p.000003:
p.000003: Applying GPP
p.000003:
p.000003: Respect
p.000003:
p.000003:
p.000003: Mutual Understanding
p.000003:
p.000003:
p.000003: Integrity
p.000003:
p.000003:
p.000003: Transparency
p.000003:
p.000003:
p.000003: Accountability
p.000003:
p.000003:
p.000003: Community Stakeholder Autonomy
p.000003: Formative Research Activities
p.000003: Stakeholder
p.000003: Advisory Mechanisms
p.000003: Stakeholder Engagement Plan
p.000003: Stakeholder Education Plan
p.000003:
p.000003: Communications Plan Issues Management Plan Site Selection
p.000003: Protocol Development
p.000003:
p.000003: Informed Consent Process
p.000003: Standard of HIV Prevention
p.000003: Access to HIV Care and Treatment
p.000003:
p.000003: Non HIV-Related Care
p.000003:
p.000003: Policies on
p.000003: Trial-Related Harms
p.000003: Trial Accrual, Follow-Up, and Exit
p.000003: Trial Closure and Results Dissemination
p.000003: Post-trial Access to Trial Products or Procedures
p.000003:
p.000004: 4
p.000004:
p.000004: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000004:
p.000004:
p.000004: Introduction
p.000004:
p.000004: Objective of the good participatory practice (GPP) guidelines
p.000004: The good participatory practice (GPP) guidelines provide trial funders, sponsors, and implementers with systematic
p.000004: guidance on how to effec- tively engage with stakeholders in the design and conduct of biomedical HIV prevention
p.000004: trials.
p.000004: In the GPP guidelines,“design and conduct of biomedical HIV prevention trials” refers to activities required for the
p.000004: development, planning, imple- mentation, and conclusion of a trial, including dissemination of trial results.
p.000004:
p.000004: Intended audience of the GPP guidelines
...
p.000009: trials, and why a participatory approach is necessary to effectively conduct trials.
p.000009:
p.000009: Section 2: Guiding principles of GPP in biomedical HIV preven- tion trials outlines the set of principles that serve
p.000009: as the foundation of the relationships among trial funders, sponsors, and implementers and other stakeholders.These
p.000009: principles include respect, mutual under- standing, integrity, transparency, accountability, and community stake-
p.000009: holder autonomy.
p.000009:
p.000009: Section 3: Good participatory practices in biomedical HIV prevention trials describes optimal practices
p.000009: to follow when designing and conducting biomedical HIV prevention trials. Under 16 topic areas, this section outlines
p.000009: expected stakeholder engagement activities that take place at each stage of the research life-cycle.The topic areas
p.000009: are:
p.000009:
p.000009: 1. Formative research activities 9. Informed consent process
p.000009: 2. Stakeholder advisory mechanisms 10. Standard of HIV prevention
p.000009: 3. Stakeholder engagement plan 11. Access to HIV care and treatment
p.000009: 4. Stakeholder education plan 12. Non HIV-related care
p.000009: 5. Communications plan 13. Policies on trial-related harms
p.000009: 6. Issues management plan 14. Trial accrual, follow-up, and exit
p.000009: 7. Site selection 15. Trial closure and results dissemination
p.000009: 8. Protocol development 16. Post-trial access to trial products or
p.000009: procedures
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000010:
p.000010:
p.000010: Topic areas in the good participatory practices section are divided into the following subsections:
p.000010: A. Definition.
p.000010: B. Relevance to good participatory practice.
p.000010: C. Special considerations.
p.000010: D. Good participatory practices.
p.000010: E. Additional guidance.
p.000010:
p.000010: After the Conclusion (pages 66-67), the reader will find three useful annexes:
p.000010:
p.000010: Annex 1 presents the acronyms and abbreviations used in this document. Annex 2 is a glossary of the essential terms
p.000010: used throughout the GPP guidelines. Annex 3 introduces other international reference guidelines and key documents,
p.000010: for further reading.
p.000010:
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p.000010:
p.000011: 11
p.000011:
p.000011: UNAIDS / AVAC
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Section 1:
...
p.000012: Section 3:
p.000012: Good Participatory Practices in Biomedical HIV Prevention Trials
p.000012:
p.000012:
p.000012: Use this section to understand the meaning of stakeholder engage- ment, the context of biomedical HIV prevention
p.000012: trials, and why a participatory approach is necessary to effectively conduct trials
p.000012:
p.000012:
p.000012: Who are Stakeholders?
p.000012:
p.000012:
p.000012: What is Stakeholder Engagement?
p.000012:
p.000012:
p.000012: The Wider Context of HIV
p.000012:
p.000012: The Dynamics of Biomedical HIV Prevention Trials
p.000012:
p.000012: Rationale for GPP Guidelines
p.000012:
p.000012:
p.000012: Applying GPP
p.000012: Use this section to understand the principles that guide the foundation of the relationships among biomedical HIV
p.000012: preven- tion stakeholders
p.000012:
p.000012:
p.000012: Respect
p.000012:
p.000012:
p.000012: Mutual Understanding
p.000012:
p.000012:
p.000012: Integrity
p.000012:
p.000012:
p.000012: Transparency
p.000012:
p.000012:
p.000012: Accountability
p.000012:
p.000012:
p.000012: Community Stakeholder Autonomy
p.000012: Use this section and its optimal practices to guide specific stakeholder engagement activities when conducting
p.000012: biomedical HIV prevention trials
p.000012:
p.000012: Formative Research Activities
p.000012: Stakeholder
p.000012: Advisory Mechanisms
p.000012: Stakeholder Engagement Plan
p.000012: Stakeholder Education Plan
p.000012:
p.000012: Communications Plan Issues Management Plan Site Selection
p.000012: Protocol Development
p.000012:
p.000012: Informed Consent Process
p.000012: Standard of HIV Prevention
p.000012: Access to HIV Care and Treatment
p.000012:
p.000012: Non HIV-Related Care
p.000012:
p.000012: Policies on
p.000012: Trial-Related Harms
p.000012: Trial Accrual, Follow-Up, and Exit
p.000012: Trial Closure and Results Dissemination
p.000012: Post-trial Access to Trial Products or Procedures
p.000012:
p.000013: 13
p.000013:
p.000013: UNAIDS / AVAC
p.000013:
p.000013:
p.000013: 1. The importance of good participatory practice
p.000013:
p.000013: 1.1 Who are stakeholders?
p.000013: The starting point of good participatory practice is the identification of key stakeholders in the conduct of a
p.000013: biomedical HIV prevention trial. Stakeholders are individuals, groups, organisations, government bodies, or any other
p.000013: individuals or collections of individuals who can influence or are affected by the conduct or outcome of a biomedical
p.000013: HIV prevention trial. In this guidance document, the term “stake- holders” is all-encompassing. It describes any
p.000013: individual or collection of individuals who have a stake in a biomedical HIV prevention trial.
p.000013:
...
p.000017: process in a meaningful fashion, it also harnesses the expertise that community stakeholders can contribute to the
p.000017: design and conduct of research.
p.000017:
p.000017: 1.4 The dynamics of biomedical HIV prevention trials
p.000017: Power inequalities always exist between funders and funding recipients with respect to a range of issues, such as
p.000017: decision-making processes, priority setting, control of resources, and equitable recognition of input. Biomedical HIV
p.000017: prevention trials are often funded by institu- tions in developed countries and conducted with multiple partner
p.000017: institutions worldwide, including those in developing countries. Disparities among these institutions and
p.000017: partners can introduce or reinforce power inequalities between and among trial implementers and the funders or sponsors
p.000017: of trials. This can then translate into inequalities between trial implementers and other stakeholders.
p.000017:
p.000017: The fact that many biomedical HIV prevention trials are conducted in multiple settings and countries introduces another
p.000017: level of complexity. Variation in cultures, physical environments, infrastructure, research experience, health
p.000017: policies, and national laws can introduce inequali- ties among research teams and between research teams and site-level
p.000017: community stakeholders. Power inequalities between research teams and community stakeholders can include
p.000017: imbalances in literacy, education, and economic resources, as well as those inherent in patient–provider
p.000017: relationships. National, racial, ethnic, and linguistic differences between members of research teams and
p.000017: community stakeholders can also exacerbate inequalities.
p.000017:
p.000017: In order to achieve meaningful community stakeholder participa- tion and partnership, it is essential to recognise
p.000017: these various power inequalities and address them.
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000018:
p.000018:
p.000018: Figure 3. Example of a Trial Network
p.000018:
p.000018: Funding From One or More Sources
p.000018:
p.000018:
p.000018: Sponsors
p.000018:
p.000018:
p.000018: Coordinating Centre
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Data Laboratory
p.000018:
p.000018: Clinical Safety
p.000018:
p.000018: Pharmacy
p.000018: Social Science Stakeholder
p.000018:
p.000018:
p.000018:
p.000018: Implementing Institution
p.000018:
p.000018: Trial Sites Trial Sites
p.000018:
p.000018:
p.000018: Basic structure of a typical biomedical HIV prevention trial network. Funding from one or more sources is distributed
p.000018: through a network coordinating centre directly to trial sites or to implementing institutions such as universities that
p.000018: then send funds to trial sites. Trial networks may have several centres responsible for different aspects of trial
...
p.000034:
p.000034:
p.000034: 3.3 Stakeholder engagement plana
p.000034: 3.3.A. Definition
p.000034: The stakeholder engagement plan describes strategies and mecha- nisms for building relationships and constructively
p.000034: engaging with a broad range of local, national, and international stakeholders.
p.000034:
p.000034: 3.3.B. Relevance to good participatory practice
p.000034: A comprehensive stakeholder engagement plan enables research teams to collaborate with stakeholders and
p.000034: facilitate a more participatory approach to biomedical HIV prevention research. An effective stakeholder
p.000034: engagement plan will help research teams design and implement research that is effective and locally acceptable,
p.000034: and also lays the foundation for a supportive environ- ment for research that extends beyond the lifespan of a specific
p.000034: biomedical HIV prevention trial.
p.000034:
p.000034:
p.000034:
p.000034: Figure 8. Stakeholder Engagement through the Research Life-cycle
p.000034:
p.000034: Stakeholder Input and Engagement
p.000034:
p.000034:
p.000034: Research questions Protocol Recruitment Enrolment Follow-up Results Dissemination of results
p.000034: Resear c h Life-cycle
p.000034:
p.000034:
p.000034: Robust stakeholder engagement occurs at all stages of the research life-cycle, including during trial design,
p.000034: recruitment, implementation, trial closure, results dissemination, negotiations of next steps, and development of
p.000034: future research questions.
p.000034:
p.000034:
p.000034:
p.000034: a Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000034: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000034: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000034: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000034: clear.
p.000034:
p.000035: 35
p.000035:
p.000035: UNAIDS / AVAC
p.000035:
p.000035:
p.000035: 3.3.C. Special considerations
p.000035: Being familiar with and appreciating the relationship dynamics among different stakeholders increases the research
p.000035: team’s ability to effectively and constructively engage with a broad range of relevant stakeholders, deepens
p.000035: understanding of local context, and will inform the development of the stakeholder engagement plan.
p.000035:
p.000035: 3.3.D. Good participatory practices for stakeholder engagement planning
p.000035: 1. Research teams comprehensively identify relevant stake- holders (see Section 1.2 and Section 3.1)
p.000035: within and surrounding the research area as well as regionally, nationally, and internationally.
p.000035: 2. Research teams designate trial site staff responsible for managing activities and relationships involving
p.000035: stakeholder engagement planning.
p.000035: 3. Research teams and relevant stakeholders discuss and negotiate a stakeholder engagement plan to cover the
p.000035: life- cycle of the trial.The plan defines the following:
p.000035: a. The range of different stakeholders to be engaged, specifi- cally ensuring inclusion of relevant
p.000035: non-governmental organisations and community-based organisations and groups.
p.000035: b. The type of engagement that is appropriate for each stake- holder, such as being informed, consulted, collaborated
p.000035: with, or empowered to make decisions.
p.000035: c. The frequency and type of engagement methods to be used, such as public meetings, workshops, joint decision- making
p.000035: models, or delegated decision-making.
p.000035: d. The process by which new relevant stakeholders will be identified and engaged.
p.000035: e. The frequency with which the engagement plan will be reviewed.
p.000035: f. The criteria by which to review the success of the engage- ment plan.
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000036:
p.000036:
p.000036: 4. Research teams implement the plan and maintain clear written records of discussions and agreements, as
p.000036: well as stakeholder engagement activities. This includes stakeholder recommendations, actions taken by the research
p.000036: team, and any unresolved issues that require follow-up.
p.000036: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000036: manage activities and relationships involved in stakeholder engage- ment plans.
p.000036: 3.4 Stakeholder education planb
p.000036: 3.4.A. Definition
p.000036: The stakeholder education plan describes strategies and mecha- nisms for providing relevant education about a specific
p.000036: planned trial—and about biomedical HIV prevention research in general—in order to enhance research
p.000036: literacy.
p.000036:
p.000036: 3.4.B. Relevance to good participatory practice
p.000036: Effective stakeholder education is key to building research literacy and, ultimately, empowering community
p.000036: stakeholders as decision-making agents. Building research literacy lays the foun- dation for a supportive environment
p.000036: for research that extends beyond the lifespan of a specific biomedical HIV prevention trial.
p.000036:
p.000036: 3.4.C. Special considerations
p.000036: 1. While it is important that all relevant stakeholders improve their knowledge of research processes, enhancing
p.000036: research literacy for community stakeholders will foster more equitable relationships.
p.000036: 2. The goals and outcomes of stakeholder education are different from those of recruitment activities. While
p.000036: stakeholder
p.000036:
p.000036: b Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000036: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000036: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000036: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000036: clear.
p.000037: 37
p.000037:
p.000037: UNAIDS / AVAC
p.000037:
p.000037:
p.000037: education can positively influence trial recruitment activities, a stakeholder education plan can help clarify the
p.000037: differences between participant recruitment and stakeholder education.
p.000037: 3.4.D. Good participatory practices for stakeholder education planning
p.000037: 1. Research teams, with input from relevant stakeholders, determine what education is needed in order to enhance
p.000037: stakeholder understanding of, and engagement with, a specific planned trial and biomedical HIV prevention
p.000037: research more generally.
p.000037: 2. Research teams and relevant stakeholders discuss and negotiate a stakeholder education plan to cover the
p.000037: life-cycle of the trial.The plan defines the following:
p.000037: a. The range of different stakeholders that could benefit from specific education about HIV, HIV prevention
p.000037: options, and general research literacy.
p.000037: b. The level of knowledge that is optimal and desired by stakeholders to support effective engagement. This will be
p.000037: influenced by the type of engagement defined for each stakeholder in the stakeholder engagement plan (see
p.000037: Section 3.3).
p.000037: c. The methods and frequency of educational activities.
p.000037: d. The stakeholders who could also deliver or facilitate the delivery of activities in the stakeholder education plan.
p.000037: e. The frequency with which the stakeholder education plan will be reviewed.
p.000037: f. The criteria by which to review the success of the stake- holder education plan.
p.000037: 3. Research teams implement the plan and document stake- holder education activities, including questions that
p.000037: arise, topics that cause confusion, and suggestions for future educa- tional activities.
p.000037: 4. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000037: support activities outlined in the stakeholder education plan.
p.000037:
p.000038: 38
p.000038:
p.000038: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000038:
p.000038:
p.000038: 3.5 Communications planc
p.000038: 3.5.A. Definition
p.000038: The communications plan describes policies and strategies that will increase broad awareness of the trial, facilitate
p.000038: dissemina- tion and understanding of correct information about trial design, conduct, and results, and coordinate
p.000038: communication between the research team and relevant stakeholders.
p.000038:
p.000038: 3.5.B. Relevance to good participatory practice
p.000038: Ongoing, transparent, and accurate communication with relevant stakeholders about proposed and ongoing research is
p.000038: essential for respectful, transparent relationships and builds trust among stake- holders.Additionally, consultation
p.000038: with relevant stakeholders will help research teams design communications strategies that are effective and help create
p.000038: a supportive and conducive environ- ment for trial initiation and implementation.
p.000038:
p.000038: 3.5.C. Special considerations
p.000038: The communications plan exclusively addresses external commu- nication. However, effective internal communication,
p.000038: especially across multidisciplinary teams, is a prerequisite to attaining effective external communications.
p.000038:
p.000038: 3.5.D. Good participatory practices for communications planning
p.000038: 1. Research teams and relevant stakeholders comprehensively identify potential audiences within and
p.000038: surrounding the research area as well as regionally, nationally, and internationally.
p.000038: 2. Research teams and relevant stakeholders discuss and negotiate a communications plan to support open channels
p.000038:
p.000038: c Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000038: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000038: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000038: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000038: clear.
p.000038:
p.000039: 39
p.000039:
p.000039: UNAIDS / AVAC
p.000039:
p.000039:
p.000039: of communication about the trial throughout its life-cycle. The plan describes the following:
p.000039: a. The information needs of the different stakeholders at various stages of the research life-cycle, from early phases
p.000039: of stakeholder engagement to recruitment, enrolment, trial closure, and results dissemination.
p.000039: b. The key messages to be communicated about the trial, such as the purpose, risks, benefits, ongoing progress,
p.000039: closure, and results dissemination.
p.000039: c. The various communication methods that will be used for specific stakeholders, taking into account literacy levels
p.000039: and language needs.
p.000039: d. Local stakeholders who could deliver or facilitate commu- nications activities.
p.000039: e. Specific training needs necessary to effectively deliver messages.
p.000039: f. Procedures and timelines for disseminating information and procedures for actively addressing inquiries about the
p.000039: trial or HIV prevention research.
p.000039: g. The frequency with which the communications plan will be reviewed.
p.000039: h. The criteria by which to review the success of the commu- nications plan.
...
p.000040: message, and dissemi- nate results.28
p.000040: 3.6 Issues management pland
p.000040: 3.6.A. Definition
p.000040: The issues management plan describes how research teams intend to manage issues of concern or any unexpected
p.000040: developments that may emerge before, during, or after the trial, including those that could limit the support for, or
p.000040: success of, the specific trial or future biomedical HIV prevention trials.
p.000040: Examples of the types of issues that may emerge are negative media coverage, rumours about the trial, socio-cultural
p.000040: taboos around certain trial procedures, developments in other HIV prevention trials, premature closure of a trial
p.000040: for reasons of harm, futility, or proven efficacy in interim analyses, recruitment chal- lenges, or protocol issues.
p.000040:
p.000040: 3.6.B. Relevance to good participatory practice
p.000040: The risk that unexpected developments will negatively affect a trial can be mitigated if research teams work closely
p.000040: with relevant stakeholders to identify and plan for such risks and if relevant stakeholders provide advice and
p.000040: direction on how to resolve issues when they do arise. By developing an issues management plan prior to trial
p.000040: implementation, research teams are better equipped to deal with issues or risks as they arise and are more likely to
p.000040: avert a crisis.
p.000040:
p.000040:
p.000040: d Stakeholder engagement, education, communications, and issues management (see Sections 3.3, 3.4, 3.5, and
p.000040: 3.6) are four different areas of planning to be addressed during the trial planning phase. Research teams may decide to
p.000040: create separate plans for each of these topic areas, or may decide to combine some or all of these plans as needed.The
p.000040: plans are described separately in the GPP guidelines so that the unique objectives and activities of each plan are
p.000040: clear.
p.000040:
p.000040:
p.000041: 41
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p.000041: UNAIDS / AVAC
p.000041:
p.000041:
p.000041: 3.6.C. Special considerations
p.000041: Research teams may find it helpful to participate in communica- tions networks of biomedical HIV prevention trials to
p.000041: share and discuss emerging issues and their potential management.
p.000041:
p.000041: 3.6.D. Good participatory practices for issues management planning
p.000041: 1. Research teams identify and list all known issues that could emerge and undermine the success of the trial before,
p.000041: during, or after trial completion.
p.000041: 2. Research teams and relevant stakeholders discuss and negotiate an issues management plan to cover the
p.000041: life-cycle of the trial.The plan defines the following:
p.000041: a. A site-level strategy to manage unexpected developments and emerging concerns.
p.000041: b. Key trial site staff who are responsible for addressing emerging issues.
p.000041: c. A chain of communication within the research team and with relevant stakeholders for emerging issues.
p.000041: d. Relevant stakeholders who can act as advisers and help implement steps of the issues management plan.
p.000041: e. Key messages created to address anticipated concerns.
p.000041: f. Clear processes by which media reports and media requests will be addressed.
...
p.000067: transmitted infection
p.000067: UNAIDS – Joint United Nations Programme on HIV/AIDS
p.000067: WHO – World Health Organization
p.000067:
p.000067:
p.000067:
p.000068: 68
p.000068: 68
p.000068:
p.000068: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000068:
p.000068:
p.000068: Annex 2. Glossary
p.000068: Accrual. The process of recruiting participants into a clinical trial in order to reach target participant
p.000068: numbers.
p.000068: Acquired immunodeficiency syndrome (AIDS). The most severe mani- festation of infection with human immunodeficiency
p.000068: virus (HIV), charac- terised by deterioration of the immune system and susceptibility to a range of opportunistic
p.000068: infections and cancers. (See human immunode- ficiency virus.)
p.000068: Activist. A person or group who acts on the behalf of a cause in order to bring about change.
p.000068: Adverse event (AE). An unwanted effect experienced by a partici- pant in a clinical trial. This may or may not
p.000068: be related to the product or procedure being studied.
p.000068: Advocate. A person or group who advocates on the behalf of indi- viduals, groups, or a specific cause.
p.000068: Antiretroviral (ARV) drug. A drug or medication that acts against or suppresses a retrovirus such as HIV.
p.000068: AVAC. An international, non-profit organisation that uses education, policy analysis, advocacy, and community
p.000068: mobilisation to accelerate the ethical development and eventual global delivery of AIDS vaccines and other new HIV
p.000068: prevention options as part of a comprehensive response to the pandemic.
p.000068: Biomedical HIV prevention trial. A clinical trial that aims to discover safe and effective products or procedures to
p.000068: prevent HIV transmission.
p.000068: Blinded trial or masked trial. A clinical trial designed to prevent the participants, research teams, or both, from
p.000068: knowing which participants are in the experimental arm or group and which are in the control arm or group of a trial,
p.000068: in order to reduce bias.
p.000068: Clinical trial. A research study that uses human volunteers to answer specific questions about the safety,
p.000068: efficacy or effectiveness, and medical effects of a specific procedure, medication, product, or treatment. A
p.000068: clinical trial process may include Phases I, II, IIb, III, and IV (post-marketing evaluation).
p.000068:
p.000069: 69
p.000069:
p.000069: UNAIDS / AVAC
p.000069:
p.000069:
p.000069: Community advisory boards (CABs) or community advisory groups (CAGs). Boards or groups composed of individuals
p.000069: or stakeholder representatives that act as an independent advisory voice and facilitate community stakeholder
p.000069: participation and involvement in the research process. They meet regularly with research team representatives, inform
p.000069: community stakeholders about proposed and ongoing research, and provide feedback to research teams about local norms
...
p.000075: is typically made up of parts of a bacterium or virus that cannot itself cause an infection. (See HIV vaccine.)
p.000075:
p.000075:
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p.000076: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000076:
p.000076:
p.000076: Annex 3. Additional guidance
p.000076:
p.000076: International reference guidelines
p.000076:
p.000076: The Belmont Report, 1979
p.000076: This report was written by the United States National Commission for the Protection of Human Subjects of Biomedical and
p.000076: Behavioral Research, which was established after the public learned about the Tuskegee Syphilis Study. The Belmont
p.000076: Report established the foun- dational ethical principles of respect for persons, beneficence, and justice for research
p.000076: involving human volunteers.
p.000076: Citation: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont
p.000076: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC,
p.000076: Department of Health, Education and Welfare, 1979.
p.000076:
p.000076: Declaration of Helsinki, 1964
p.000076: This Declaration of the World Medical Association is often consid- ered to be the first document to set world
p.000076: standards for research involving human volunteers.
p.000076: Citation: World Medical Association General Assembly. World Medical Association Declaration of
p.000076: Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Helsinki, World Medical Association,
p.000076: 2008.
p.000076:
p.000076: Ethical Considerations in Biomedical HIV Prevention Trials, 2007
p.000076: This is an ethical guidance document, issued by UNAIDS and WHO, for biomedical HIV prevention trials. This document is
p.000076: a revision of Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document. Geneva, UNAIDS,
p.000076: 2000.
p.000076: Citation: UNAIDS and WHO. Ethical Considerations in Biomedical HIV Prevention Trials. Geneva, UNAIDS, 2007.
p.000076:
p.000077: 77
p.000077:
p.000077: UNAIDS / AVAC
p.000077:
p.000077:
p.000077: Guideline for Good Clinical Practice, 1996
p.000077: This guidance document was issued by the International Conference on Harmonisation of Technical Requirements for
p.000077: Registration of Pharmaceuticals for Human Use and outlines an international ethical and scientific quality standard
...
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p.000080:
p.000080:
p.000081: 81
p.000081:
p.000081: UNAIDS / AVAC
p.000081:
p.000081:
p.000081: References
p.000081: 1 UNAIDS and WHO. Ethical Considerations in Biomedical HIV Prevention Trials. Geneva, UNAIDS, 2007.
p.000081: 2 Guideline for Good Clinical Practice: ICH Harmonised Tripartite Guideline. Geneva, International Conference on
p.000081: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.
p.000081: 3 Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation. Geneva,World Health
p.000081: Organization, 2002.
p.000081: 4 UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. Good Clinical
p.000081: Laboratory Practice (GCLP). Geneva, World Health Organization, 2009.
p.000081: 5 World Medical Association General Assembly. World Medical Association Declaration of Helsinki: Ethical Principles
p.000081: for Medical Research Involving Human Subjects. Helsinki, World Medical Association, 2008.
p.000081: 6 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report:
p.000081: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC, Department of
p.000081: Health, Education and Welfare, 1979.
p.000081: 7 International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Council for
p.000081: International Organizations of Medical Sciences, 2002.
p.000081: 8 The Ethics of Research Related to Healthcare in Developing Countries. London, Nuffield Council on
p.000081: Bioethics, 2002.
p.000081: 9 The Ethics of Healthcare Related Research in Developing Countries: A Follow-up Discussion Paper. London,
p.000081: Nuffield Council on Bioethics, 2005.
p.000081: 10 Creating Effective Partnerships for HIV Prevention Trials: Report of a UNAIDS Consultation. Geneva,
p.000081: UNAIDS, 2005.
p.000081: 11 Mills E et al. Media Reporting of Tenofovir Trials in Cambodia and Cameroon.
p.000081: BioMed Central International Health and Human Rights, 2005, 5:6.
p.000081: 12 Preventing Prevention Trial Failures:A Case Study and Lessons Learned for Future Trials from the 2004 Tenofovir
p.000081: Trial in Cambodia.Washington, DC, Global Campaign for Microbicides, 2009.
p.000081: 13 Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site. Washington, DC, Global
p.000081: Campaign for Microbicides, 2009.
p.000081:
p.000081:
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p.000082: 82
p.000082:
p.000082: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000082:
p.000082:
...
Searching for indicator educational:
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p.000037: 3.4.D. Good participatory practices for stakeholder education planning
p.000037: 1. Research teams, with input from relevant stakeholders, determine what education is needed in order to enhance
p.000037: stakeholder understanding of, and engagement with, a specific planned trial and biomedical HIV prevention
p.000037: research more generally.
p.000037: 2. Research teams and relevant stakeholders discuss and negotiate a stakeholder education plan to cover the
p.000037: life-cycle of the trial.The plan defines the following:
p.000037: a. The range of different stakeholders that could benefit from specific education about HIV, HIV prevention
p.000037: options, and general research literacy.
p.000037: b. The level of knowledge that is optimal and desired by stakeholders to support effective engagement. This will be
p.000037: influenced by the type of engagement defined for each stakeholder in the stakeholder engagement plan (see
p.000037: Section 3.3).
p.000037: c. The methods and frequency of educational activities.
p.000037: d. The stakeholders who could also deliver or facilitate the delivery of activities in the stakeholder education plan.
p.000037: e. The frequency with which the stakeholder education plan will be reviewed.
p.000037: f. The criteria by which to review the success of the stake- holder education plan.
p.000037: 3. Research teams implement the plan and document stake- holder education activities, including questions that
p.000037: arise, topics that cause confusion, and suggestions for future educa- tional activities.
p.000037: 4. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000037: support activities outlined in the stakeholder education plan.
p.000037:
p.000038: 38
p.000038:
p.000038: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000038:
p.000038:
p.000038: 3.5 Communications planc
p.000038: 3.5.A. Definition
p.000038: The communications plan describes policies and strategies that will increase broad awareness of the trial, facilitate
p.000038: dissemina- tion and understanding of correct information about trial design, conduct, and results, and coordinate
p.000038: communication between the research team and relevant stakeholders.
p.000038:
...
p.000083: Ethics, 2011, 37:244–248.
p.000083: 37 Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International
p.000083: Consultation. Washington, DC, Global Campaign for Microbicides, 2005.
p.000083: 38 Ethical and Policy Issues in International Research:ClinicalTrials in Developing Countries. Vol. I. Report and
p.000083: Recommendations of the National Bioethics Advisory Commission. Washington, DC, United States National Bioethics
p.000083: Advisory Commission, 2001.
p.000083:
p.000083:
p.000083:
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p.000084: 84
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p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: The Joint United Nations Programme on HIV/AIDS (UNAIDS) brings together ten UN agencies in a common
p.000084: effort to fight the epidemic: the Office of the United Nations High Commissioner for Refugees (UNHCR), the United
p.000084: Nations Children’s Fund (UNICEF), the World Food Programme (WFP), the United Nations Development Programme (UNDP),
p.000084: the United Nations Population Fund (UNFPA), the United Nations Office on Drugs and Crime (UNODC), the
p.000084: International Labour Organization (ILO), the United Nations Educational, Scientific and Cultural Organization
p.000084: (UNESCO), the World Health Organization (WHO), and the World Bank.
p.000084:
p.000084: Leveraging the AIDS response, UNAIDS works to build political action and to promote the rights of all people for better
p.000084: results for global health and development. Globally, it sets policy and is the source of HIV-related data. In
p.000084: countries, UNAIDS brings together the resources of the UNAIDS Secretariat and 10 UN system organizations for
p.000084: coordinated and accountable efforts to unite the world against AIDS.
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p.000084:
p.000084:
p.000084: UNAIDS
p.000084: 20 AVENUE APPIA
p.000084: CH-1211 GENEVA 27 SWITZERLAND
p.000084:
p.000084: Tel: (+41) 22 791 36 66
p.000084: Fax: (+41) 22 791 48 35
p.000084: e-mail: distribution@unaids.org www.unaids.org
p.000084:
...
Social / gender
Searching for indicator gender:
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p.000014:
p.000015: 15
p.000015:
p.000015: UNAIDS / AVAC
p.000015:
p.000015:
p.000015: 1.2 What is stakeholder engagement?
p.000015: Of key importance in good participatory practice is sustained, collab- orative partnering with stakeholders. In the GPP
p.000015: guidelines, the term “stakeholder engagement” refers to processes through which trial funders, sponsors, and
p.000015: implementers build transparent, meaningful, collaborative, and mutually beneficial relationships with interested or
p.000015: affected individuals, groups of individuals, or organisations, with the ultimate goal of shaping research collectively.
p.000015:
p.000015: Successful stakeholder engagement requires a broad, inclusive, and multifaceted understanding of the context in
p.000015: which a biomed- ical HIV prevention trial is conducted. It begins with an inclusive perspective for identification of
p.000015: potential stakeholders. Stakeholder identification is a dynamic process, as stakeholders, interests, priorities,
p.000015: perspectives, and aspects of culture may change over time. Research teams are responsible for identifying stakeholders,
p.000015: a process which begins by determining the trial population to be recruited, consid- ering those who are affected by the
p.000015: trial in the local area, consulting with already known stakeholders, and building on that expertise to develop a richer
p.000015: understanding of potential and known stakeholders.
p.000015:
p.000015: Different stakeholders will have different perspectives. Some stake- holders will have competing interests or
p.000015: power imbalances within groups, as well as differences in social organisation, hierarchies, gender issues, and
p.000015: relative social and economic status that may then create division and disagreement during the course of a trial. If
p.000015: there is oppo- sition or disagreement among stakeholders, then those issues must be addressed in a way that is honest,
p.000015: transparent, and respectful to all parties.
p.000015:
p.000015: Stakeholders in biomedical HIV prevention research can learn from other fields that have successfully adopted
p.000015: participatory research approaches, which seek to engage community stakeholders as equal members who share control over
p.000015: all aspects of the research process.20,
p.000015: 21, 22, 23, 24
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000016:
p.000016:
p.000016: 1.3 The wider context of HIV
p.000016: There is an urgent need to develop additional strategies to address the HIV pandemic. Along with necessary behavioural
p.000016: and structural changes, a broad range of biomedical HIV prevention and treatment options is required to meet the
p.000016: diverse needs of individuals and populations. There are many inherent complexities in conducting biomedical HIV
p.000016: prevention trials. By acknowledging and under- standing these challenges and complexities, trial funders, sponsors,
p.000016: and implementers can more appropriately and effectively facilitate a mutually beneficial participatory approach to
...
p.000016: need to involve large numbers of healthy, HIV-negative volunteers as trial partici- pants. It is optimal that
p.000016: experimental HIV prevention options are tested for safety and effectiveness in populations who need these interventions
p.000016: the most and are likely to use them should they prove effective. However, the very factors that increase HIV risk in
p.000016: such populations may contribute to increased vulnerability to exploitation. This underscores the importance of
p.000016: meaningful partnerships with community stakeholders.
p.000016:
p.000016: A wide range of factors creates, enhances, and perpetuates the risk of HIV infection. Structural determinants can
p.000016: increase vulnerability to HIV at an individual or population level by undermining ability to avoid HIV exposure.
p.000016: Underlying determinants of the HIV epidemic can be entrenched in the social, cultural, legal, institutional, or
p.000016: economic fabric of society. Examples of these determinants include gender and other power inequalities,
p.000016: gender-based violence, economic instability including poverty, migration, human rights
p.000016: violations,homophobia,discriminatory practices,HIV-related stigma, social marginalisation, and criminalisation of
p.000016: HIV transmission. Recognition of these factors is the first step in developing practices
p.000016:
p.000017: 17
p.000017:
p.000017: UNAIDS / AVAC
p.000017:
p.000017:
p.000017: that avoid inadvertently replicating or reinforcing them in the design and conduct of biomedical HIV prevention
p.000017: trials.While stakeholder engagement helps empower and equip community stakeholders to engage in the research
p.000017: process in a meaningful fashion, it also harnesses the expertise that community stakeholders can contribute to the
p.000017: design and conduct of research.
p.000017:
p.000017: 1.4 The dynamics of biomedical HIV prevention trials
p.000017: Power inequalities always exist between funders and funding recipients with respect to a range of issues, such as
p.000017: decision-making processes, priority setting, control of resources, and equitable recognition of input. Biomedical HIV
p.000017: prevention trials are often funded by institu- tions in developed countries and conducted with multiple partner
p.000017: institutions worldwide, including those in developing countries. Disparities among these institutions and
...
Social / parents
Searching for indicator parent:
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p.000018: as its relevance to community stakeholders.1,25 Stakeholders, in particular community stakeholders, have unique
p.000018: expertise to contribute to the research process. They possess critical knowledge and understandings of local
p.000018: cultures and perspectives, languages, dynamics of the local HIV epidemic, concerns of vulnerable or marginalised
p.000018: populations, and local priorities that trial funders, sponsors, and implementers may lack.
p.000018:
p.000019: 19
p.000019:
p.000019: UNAIDS / AVAC
p.000019:
p.000019:
p.000019: Stakeholder collaboration can help ensure that research questions and procedures are culturally sensitive and
p.000019: appropriate, thus improving recruitment, retention, adherence, and other trial outcomes. It can help avoid reinforcing
p.000019: existing inequalities and increase sensitivity to the needs of vulnerable populations. An essential component of
p.000019: stakeholder engagement is improving stakeholder knowledge and understanding of the research process, building
p.000019: research literacy and competencies. This, in turn, enables stakeholders to contribute more effectively to the process
p.000019: of guiding research and helps to address the power imbalance between research teams and community stake- holders.
p.000019:
p.000019: Strengthening meaningful collaboration among stakeholders fosters greater trust and respect between trial funders,
p.000019: sponsors, and imple- menters, and other stakeholders. Stakeholder engagement that is trans- parent and mutually
p.000019: respectful can minimise misunderstandings and reduce the chances of unnecessary conflict or controversy. Following good
p.000019: participatory practices through the entire research life-cycle helps facilitate local ownership of research, enables
p.000019: more equitable relationships, and increases the likelihood of successful research conduct, trial completion, and
p.000019: application of research results.
p.000019:
p.000019: 1.6 Applying GPP
p.000019: The GPP guidelines broadly describe systematic ways to establish and maintain effective stakeholder engagement that can
p.000019: be applied in diverse locations globally. The specificity of the content of the GPP guidelines enables monitoring of
p.000019: stakeholder engagement activities.
p.000019:
p.000019: The most effective way for the GPP guidelines to be implemented is for trial sponsors to adopt them as a requirement in
p.000019: trial conduct and to monitor their implementation and evaluate their effectiveness. As an essential element of
p.000019: successful trial implementation, effective
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000020:
p.000020:
p.000020: stakeholder engagement requires that trial sponsors provide ample time allocation, adequate human resources, and
p.000020: sufficient funds in site budgets for implementation of Section 3 of the GPP guidelines.
p.000020:
p.000020: Other stakeholders, such as national authorities, institutions, ethics committees, institutional review boards, and
p.000020: community stakeholders can also require that the GPP guidelines be followed when research is conducted in their
p.000020: country, institution, or area.
p.000020:
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000002:
p.000002: Good participatory practice
p.000002: Guidelines for biomedical HIV prevention trials 2011
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: UNAIDS / JC1853E (Second edition, June 2011)
p.000002:
p.000002: © Joint United Nations Programme on HIV/AIDS (UNAIDS) 2011. All rights reserved
p.000002: The designations employed and the presentation of the material in this publication do not imply the expression of any
p.000002: opinion whatsoever on the part of UNAIDS concerning the legal status of any country, territory, city or area or of its
p.000002: authorities, or concerning the delimitation of its frontiers or boundaries.
p.000002: UNAIDS does not warrant that the information published in this publication is complete and correct and shall not be
p.000002: liable for any damages incurred as a result of its use.
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p.000002:
p.000002: UNAIDS – 20 avenue Appia – 1211 Geneva 27 – Switzerland Telephone: (+41) 22 791 36 66 – Fax: (+41) 22 791 48 35
p.000002: E-mail: distribution@unaids.org – Internet: http://www.unaids.org
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Good participatory practice
p.000002: Guidelines for biomedical HIV prevention trials 2011
p.000002:
p.000002: UNAIDS / AVAC
p.000002:
p.000002:
p.000002: Contents
p.000002: Introduction 5
p.000002: Objective of the good participatory practice (GPP) guidelines 5
p.000002: Intended audience of the GPP guidelines 5
p.000002: Scope of the GPP guidelines 5
p.000002: Development of the GPP guidelines 7
p.000002: Organisation and how to use the GPP guidelines 10
p.000002: 1. The importance of good participatory practice 14
p.000002: 1.1 Who are stakeholders? 14
...
p.000012: Trial Closure and Results Dissemination
p.000012: Post-trial Access to Trial Products or Procedures
p.000012:
p.000013: 13
p.000013:
p.000013: UNAIDS / AVAC
p.000013:
p.000013:
p.000013: 1. The importance of good participatory practice
p.000013:
p.000013: 1.1 Who are stakeholders?
p.000013: The starting point of good participatory practice is the identification of key stakeholders in the conduct of a
p.000013: biomedical HIV prevention trial. Stakeholders are individuals, groups, organisations, government bodies, or any other
p.000013: individuals or collections of individuals who can influence or are affected by the conduct or outcome of a biomedical
p.000013: HIV prevention trial. In this guidance document, the term “stake- holders” is all-encompassing. It describes any
p.000013: individual or collection of individuals who have a stake in a biomedical HIV prevention trial.
p.000013:
p.000013: Examples of stakeholders are illustrated in Figure 2 and can include trial participants, families of trial
p.000013: participants, prospective trial partic- ipants, individuals resident within, or surrounding, the area where research is
p.000013: conducted, people living with HIV or affected by HIV, prevention and treatment advocates and activists,
p.000013: non-governmental organisations (NGOs), community-based organisations (CBOs), community groups, religious leaders,
p.000013: opinion leaders, media, govern- ment bodies, national and local health-care authorities, service providers,
p.000013: trial funders, trial sponsors, and trial implementers.
p.000013:
p.000013: The definition of “community” is more complicated, as it is a dynamic term that has different meanings to
p.000013: different people.19 This term is often used to refer to a group of people who have a common set of interests, share a
p.000013: common set of characteristics, or live in a common area. Individuals can be a part of multiple “communities” at the
p.000013: same time. The term “community” is also used to refer to the public at large or to a physical location.
p.000013:
p.000013: In the GPP guidelines, the preferred term is “community stake- holders”, rather than “community”, and refers to both
p.000013: individuals and groups that are ultimately representing the interests of people who would be recruited to or
p.000013: participate in a trial, and others locally
p.000013:
p.000014: 14
p.000014:
p.000014:
p.000014:
p.000014: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000014:
p.000014:
p.000014: affected by a trial. Examples of “community stakeholders” are the population to be recruited, trial participants,
p.000014: people living in the area where the research is conducted, people living with HIV in the area, local HIV-positive
p.000014: groups or networks, people in the area who are affected by the HIV epidemic, local non-governmental organisa-
p.000014: tions, community groups, and community-based organisations. Trial funders, sponsors, and implementers, as well as
...
p.000028: current participants),professional groups (local scientists, service providers, media, or experts on local
p.000028: socio-cultural issues), non-governmental organisation advisory groups (with representatives from different non-
p.000028: governmental organisations or community-based organisa- tions), and community advisory boards (see definition
p.000028: below).
p.000028: 3. Community advisory boards (CABs), also referred to as community advisory groups (CAGs), are a common
p.000028: example of a formal stakeholder advisory mechanism. They are composed of individuals or stakeholder representatives
p.000028:
p.000029: 29
p.000029:
p.000029: UNAIDS / AVAC
p.000029:
p.000029:
p.000029: and provide an independent advisory voice. They facili- tate community stakeholder participation and involvement
p.000029: in the research process. They meet regularly with research team representatives, inform community stakeholders about
p.000029: proposed and ongoing research, and provide feedback to research teams about local norms and beliefs, as well as
p.000029: local views and concerns that arise during specific trials.
p.000029: The composition of community advisory boards or groups varies from site to site but is intended to reflect the
p.000029: diversity of community stakeholder interests and needs. They may include members or representatives of the
p.000029: surrounding area, individuals in the population from which participants will be recruited, people living with or
p.000029: affected by HIV, current or former trial participants, religious or opinion leaders, and representatives of other
p.000029: sections of society as determined by the trial’s location and eligibility criteria.
p.000029:
p.000029:
p.000029: Figure 5. Examples of Stakeholder Advisory Mechanisms
p.000029:
p.000029: Stakeholder Advisory Mechanisms
p.000029:
p.000029:
p.000029: Informal Formal
p.000029:
p.000029: E x a m p l e s o f M e c h a n i s m s
p.000029:
p.000029: Stakeholder meetings
p.000029: Local events
p.000029: Ongoing dialogue with CBOs
p.000029: Focus group discussions
p.000029: Call in radio shows
p.000029: CABs NGO
p.000029: advisory groups
p.000029: Participant groups
p.000029: Groups already established in the area
p.000029:
p.000029:
p.000029: Stakeholder advisory mechanisms can include informal and formal stakeholder advisory mechanisms (see definition 3.2.A).
p.000029: All of these mechanisms, as well as others, may be used to facilitate important dialogue between research teams and
p.000029: other stakeholders. While community advisory boards (CABs) are one example of a stakeholder advisory
p.000029: mechanism, there are many other ways that research teams can effectively engage with stakeholders.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000030:
p.000030:
p.000030: 3.2.B. Relevance to good participatory practice
p.000030: Establishment, maintenance, and engagement of stakeholder advisory mechanisms throughout the research process are
p.000030: key to establishing meaningful partnerships with community stake- holders and to ensuring continuous dialogue about
...
Economic / Economic/Poverty
Searching for indicator poverty:
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p.000016: experimental HIV prevention options are tested for safety and effectiveness in populations who need these interventions
p.000016: the most and are likely to use them should they prove effective. However, the very factors that increase HIV risk in
p.000016: such populations may contribute to increased vulnerability to exploitation. This underscores the importance of
p.000016: meaningful partnerships with community stakeholders.
p.000016:
p.000016: A wide range of factors creates, enhances, and perpetuates the risk of HIV infection. Structural determinants can
p.000016: increase vulnerability to HIV at an individual or population level by undermining ability to avoid HIV exposure.
p.000016: Underlying determinants of the HIV epidemic can be entrenched in the social, cultural, legal, institutional, or
p.000016: economic fabric of society. Examples of these determinants include gender and other power inequalities,
p.000016: gender-based violence, economic instability including poverty, migration, human rights
p.000016: violations,homophobia,discriminatory practices,HIV-related stigma, social marginalisation, and criminalisation of
p.000016: HIV transmission. Recognition of these factors is the first step in developing practices
p.000016:
p.000017: 17
p.000017:
p.000017: UNAIDS / AVAC
p.000017:
p.000017:
p.000017: that avoid inadvertently replicating or reinforcing them in the design and conduct of biomedical HIV prevention
p.000017: trials.While stakeholder engagement helps empower and equip community stakeholders to engage in the research
p.000017: process in a meaningful fashion, it also harnesses the expertise that community stakeholders can contribute to the
p.000017: design and conduct of research.
p.000017:
p.000017: 1.4 The dynamics of biomedical HIV prevention trials
p.000017: Power inequalities always exist between funders and funding recipients with respect to a range of issues, such as
p.000017: decision-making processes, priority setting, control of resources, and equitable recognition of input. Biomedical HIV
p.000017: prevention trials are often funded by institu- tions in developed countries and conducted with multiple partner
p.000017: institutions worldwide, including those in developing countries. Disparities among these institutions and
p.000017: partners can introduce or reinforce power inequalities between and among trial implementers and the funders or sponsors
...
Searching for indicator low-income:
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p.000082: Annual Review of Public Health, 1998, 19:173–202.
p.000082: 24 Green LW, Mercer SL. Can Public Health Researchers and Agencies Reconcile the Push from Funding Bodies and the Pull
p.000082: from Communities? American Journal of Public Health, 2001, 91:1926–1929.
p.000082: 25 Arnstein SR. A ladder of Citizen Participation. Journal of the American Institute of Planners, 1969, 35:216–224.
p.000082: 26 Quality Assurance of Pharmaceuticals:A Compendium of Guidelines and Related Materials. Vol. 2. Good Manufacturing
p.000082: Practices and Inspection. 2nd ed. Geneva,World Health Organization, 2007.
p.000082: 27 Community Recommendations Working Group, Community Partners. Recommendations for Community Involvement
p.000082: in National Institute of Allergy and Infectious Diseases HIV/AIDS Clinical Trials Research. Bethesda, MD, 2009.
p.000082:
p.000082:
p.000082:
p.000082:
p.000083: 83
p.000083:
p.000083: UNAIDS / AVAC
p.000083:
p.000083:
p.000083: 28 Robinson ET et al. Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage
p.000083: Controversy, Convey Your Message, and Disseminate Results. Washington, DC, Microbicides Media Communications
p.000083: Initiative and Research Triangle Park, NC, FHI, 2010.
p.000083: 29 Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No.
p.000083: 10.Vol. 2, pp. 181–182. Washington, DC, United States Government Printing Office, 1949:181–182.
p.000083: 30 Molyneux CS, Peshu N, Marsh K. Understanding of Informed Consent in a Low-income Setting: Three Case Studies from
p.000083: the Kenyan Coast. Social Science and Medicine, 2004, 59:2547–2559.
p.000083: 31 Richter L et al. Guidelines for the Development of Culturally Sensitive Approaches to Obtaining Informed Consent
p.000083: for Participation in HIV Vaccine-related Trials. Geneva, UNAIDS, 1999.
p.000083: 32 Molyneux CS et al.“Even If They Ask You to Stand by a Tree All Day, You Will Have To Do It (laughter)...”:
p.000083: Community Voices on the Notion and Practice of Informed Consent for Biomedical Research in Developing Countries. Social
p.000083: Science and Medicine, 2005, 61:443–454.
p.000083: 33 Appelbaum PS, Lidz CW, Meisel A. Informed Consent: Legal Theory and Clinical Practice. New York, Oxford
p.000083: University Press, 1987.
p.000083: 34 Strauss RP et al. The Role of Community Advisory Boards: Involving Communities in the Informed Consent
p.000083: Process. American Journal of Public Health, 2001, 91:1938–1943.
p.000083: 35 Mapping the Standards of Care at Microbicide Clinical Trial Sites. Washington, DC, Global Campaign for
p.000083: Microbicides, PATH, 2008.
p.000083: 36 Philpott S et al. The Challenge of Defining Standards of Prevention in HIV Prevention Trials. Journal of Medical
p.000083: Ethics, 2011, 37:244–248.
...
General/Other / Dependent
Searching for indicator dependent:
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p.000070:
p.000070:
p.000070: trial be stopped or modified if there are safety concerns, if trial objec- tives have been achieved, or if assessment
p.000070: of trial progress reveals that continuing the trial would be futile since it will no longer be possible to answer the
p.000070: research question that the trial is addressing.
p.000070: Ethics committee. See research ethics committee.
p.000070: Experimental arm or group. The group of participants in a clinical trial who receive the procedure, product, or drug
p.000070: being studied.
p.000070: Female condom. A pouch that when inserted in the vagina before vaginal intercourse, provides protection
p.000070: against most sexually trans- mitted infections, including HIV, and pregnancy. During anal sex, the female condom,
p.000070: when placed on the penis after removing the inner ring, provides protection against most sexually transmitted
p.000070: infections, including HIV. Currently made of polyurethane (female condom 1) or a synthetic latex (female condom 2), it
p.000070: is stronger than the natural latex used in male condoms, odourless, non-allergenic, and usable with oil-based
p.000070: and water-based lubricants. For vaginal intercourse, it can be inserted vaginally prior to intercourse, is not
p.000070: dependent on male erection, and does not require immediate withdrawal after ejaculation. (See also male condom.)
p.000070: Formative research activities. Activities that enable research teams to gain an informed understanding of local
p.000070: populations, socio-cultural norms and practices, local power dynamics, local perceptions, channels of communication and
p.000070: decision-making, and local history of research, as well as the needs and priorities of people locally affected by or
p.000070: able to influence a clinical trial. Formative research activities usually consti- tute the initial phase of stakeholder
p.000070: outreach and engagement.
p.000070: Futility. The inability of a clinical trial to achieve one or more of its objectives. This determination
p.000070: may be suggested, for example, during an interim analysis of a trial by a data safety monitoring board.
p.000070: Good Clinical Laboratory Practice (GCLP). Guidelines that set a standard for compliance by laboratories
p.000070: involved in the analysis of samples from clinical trials. These guidelines provide guidance to ensure that
p.000070: trial laboratory data are reliable, repeatable, auditable, and easily reconstructed in a research setting.
p.000070:
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071: UNAIDS / AVAC
p.000071:
p.000071:
p.000071: Good Clinical Practice (GCP). Internationally recognised guidelines for designing, conducting, recording, and reporting
p.000071: clinical trials in which humans participate. GCP provides guidance to ensure that trial data are credible and to
p.000071: protect the rights, safety, and well-being of trial partici- pants. The guidelines were issued by the
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000002: Objective of the good participatory practice (GPP) guidelines 5
p.000002: Intended audience of the GPP guidelines 5
p.000002: Scope of the GPP guidelines 5
p.000002: Development of the GPP guidelines 7
p.000002: Organisation and how to use the GPP guidelines 10
p.000002: 1. The importance of good participatory practice 14
p.000002: 1.1 Who are stakeholders? 14
p.000002: 1.2 What is stakeholder engagement? 16
p.000002: 1.3 The wider context of HIV 17
p.000002: 1.4 The dynamics of biomedical HIV prevention trials 18
p.000002: 1.5 Rationale for GPP guidelines 19
p.000002: 1.6 Applying GPP 20
p.000002: 2. Guiding principles of GPP in biomedical HIV prevention trials 22
p.000002: 2.1 Respect 22
p.000002: 2.2 Mutual understanding 22
p.000002: 2.3 Integrity 24
p.000002: 2.4 Transparency 24
p.000002: 2.5 Accountability 24
p.000002: 2.6 Community stakeholder autonomy 25
p.000002: 3. Good participatory practices in biomedical HIV prevention trials 26
p.000002: Introduction to good participatory practices 26
p.000002: 3.1 Formative research activities 27
p.000002: 3.2 Stakeholder advisory mechanisms 29
p.000002: 3.3 Stakeholder engagement plan 35
p.000002: 3.4 Stakeholder education plan 37
p.000002: 2
p.000002:
p.000002: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 3.5 Communications plan 39
p.000002: 3.6 Issues management plan 41
p.000002: 3.7 Site selection 43
p.000002: 3.8 Protocol development 44
p.000002: 3.9 Informed consent process 45
p.000002: 3.10 Standard of HIV prevention 48
p.000002: 3.11 Access to HIV care and treatment 52
p.000002: 3.12 Non HIV-related care 55
...
p.000002: Annex 2. Glossary 69
p.000002: Annex 3. Additional guidance 77
p.000002: References 82
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: UNAIDS / AVAC
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Section 1:
p.000003: The Importance of Good Participatory Practice
p.000003:
p.000003: Section 2:
p.000003: Guiding Principles
p.000003: of GPP in Biomedical HIV Prevention Trials
p.000003:
p.000003: Section 3:
p.000003: Good Participatory Practices in Biomedical HIV Prevention Trials
p.000003:
p.000003:
p.000003:
p.000003: Who are Stakeholders?
p.000003:
p.000003:
p.000003: What is Stakeholder Engagement?
p.000003:
p.000003:
p.000003: The Wider Context of HIV
p.000003:
p.000003: The Dynamics of Biomedical HIV Prevention Trials
p.000003:
p.000003: Rationale for GPP Guidelines
p.000003:
p.000003:
p.000003: Applying GPP
p.000003:
p.000003: Respect
p.000003:
p.000003:
p.000003: Mutual Understanding
p.000003:
p.000003:
p.000003: Integrity
p.000003:
p.000003:
p.000003: Transparency
p.000003:
p.000003:
p.000003: Accountability
p.000003:
p.000003:
p.000003: Community Stakeholder Autonomy
p.000003: Formative Research Activities
p.000003: Stakeholder
p.000003: Advisory Mechanisms
p.000003: Stakeholder Engagement Plan
p.000003: Stakeholder Education Plan
p.000003:
p.000003: Communications Plan Issues Management Plan Site Selection
p.000003: Protocol Development
p.000003:
p.000003: Informed Consent Process
p.000003: Standard of HIV Prevention
p.000003: Access to HIV Care and Treatment
p.000003:
p.000003: Non HIV-Related Care
p.000003:
p.000003: Policies on
p.000003: Trial-Related Harms
p.000003: Trial Accrual, Follow-Up, and Exit
p.000003: Trial Closure and Results Dissemination
p.000003: Post-trial Access to Trial Products or Procedures
p.000003:
p.000004: 4
p.000004:
p.000004: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000004:
p.000004:
p.000004: Introduction
p.000004:
p.000004: Objective of the good participatory practice (GPP) guidelines
p.000004: The good participatory practice (GPP) guidelines provide trial funders, sponsors, and implementers with systematic
p.000004: guidance on how to effec- tively engage with stakeholders in the design and conduct of biomedical HIV prevention
p.000004: trials.
p.000004: In the GPP guidelines,“design and conduct of biomedical HIV prevention trials” refers to activities required for the
...
p.000008: published in 2007. It was developed as a companion to the UNAIDS/WHO guidance document Ethical considerations that
p.000008: addresses key ethical issues in a set of guidance points with commentaries.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: UNAIDS / AVAC
p.000009:
p.000009:
p.000009: Organisation and how to use the GPP guidelines
p.000009: The GPP guidelines are presented in three main sections that are colour- coded to enable users to easily navigate the
p.000009: document:
p.000009:
p.000009: Section 1: The importance of good participatory practice defines the key terms used in the document and describes the
p.000009: realities and the underlying determinants of the HIV epidemic, the context of conducting biomedical HIV prevention
p.000009: trials, and why a participatory approach is necessary to effectively conduct trials.
p.000009:
p.000009: Section 2: Guiding principles of GPP in biomedical HIV preven- tion trials outlines the set of principles that serve
p.000009: as the foundation of the relationships among trial funders, sponsors, and implementers and other stakeholders.These
p.000009: principles include respect, mutual under- standing, integrity, transparency, accountability, and community stake-
p.000009: holder autonomy.
p.000009:
p.000009: Section 3: Good participatory practices in biomedical HIV prevention trials describes optimal practices
p.000009: to follow when designing and conducting biomedical HIV prevention trials. Under 16 topic areas, this section outlines
p.000009: expected stakeholder engagement activities that take place at each stage of the research life-cycle.The topic areas
p.000009: are:
p.000009:
p.000009: 1. Formative research activities 9. Informed consent process
p.000009: 2. Stakeholder advisory mechanisms 10. Standard of HIV prevention
p.000009: 3. Stakeholder engagement plan 11. Access to HIV care and treatment
p.000009: 4. Stakeholder education plan 12. Non HIV-related care
p.000009: 5. Communications plan 13. Policies on trial-related harms
p.000009: 6. Issues management plan 14. Trial accrual, follow-up, and exit
p.000009: 7. Site selection 15. Trial closure and results dissemination
p.000009: 8. Protocol development 16. Post-trial access to trial products or
p.000009: procedures
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000010:
p.000010:
...
p.000012: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Section 1:
p.000012: The Importance of Good Participatory Practice
p.000012:
p.000012: Section 2:
p.000012: Guiding Principles
p.000012: of GPP in Biomedical HIV Prevention Trials
p.000012:
p.000012: Section 3:
p.000012: Good Participatory Practices in Biomedical HIV Prevention Trials
p.000012:
p.000012:
p.000012: Use this section to understand the meaning of stakeholder engage- ment, the context of biomedical HIV prevention
p.000012: trials, and why a participatory approach is necessary to effectively conduct trials
p.000012:
p.000012:
p.000012: Who are Stakeholders?
p.000012:
p.000012:
p.000012: What is Stakeholder Engagement?
p.000012:
p.000012:
p.000012: The Wider Context of HIV
p.000012:
p.000012: The Dynamics of Biomedical HIV Prevention Trials
p.000012:
p.000012: Rationale for GPP Guidelines
p.000012:
p.000012:
p.000012: Applying GPP
p.000012: Use this section to understand the principles that guide the foundation of the relationships among biomedical HIV
p.000012: preven- tion stakeholders
p.000012:
p.000012:
p.000012: Respect
p.000012:
p.000012:
p.000012: Mutual Understanding
p.000012:
p.000012:
p.000012: Integrity
p.000012:
p.000012:
p.000012: Transparency
p.000012:
p.000012:
p.000012: Accountability
p.000012:
p.000012:
p.000012: Community Stakeholder Autonomy
p.000012: Use this section and its optimal practices to guide specific stakeholder engagement activities when conducting
p.000012: biomedical HIV prevention trials
p.000012:
p.000012: Formative Research Activities
p.000012: Stakeholder
p.000012: Advisory Mechanisms
p.000012: Stakeholder Engagement Plan
p.000012: Stakeholder Education Plan
p.000012:
p.000012: Communications Plan Issues Management Plan Site Selection
p.000012: Protocol Development
p.000012:
p.000012: Informed Consent Process
p.000012: Standard of HIV Prevention
p.000012: Access to HIV Care and Treatment
p.000012:
p.000012: Non HIV-Related Care
p.000012:
p.000012: Policies on
p.000012: Trial-Related Harms
p.000012: Trial Accrual, Follow-Up, and Exit
p.000012: Trial Closure and Results Dissemination
p.000012: Post-trial Access to Trial Products or Procedures
p.000012:
p.000013: 13
p.000013:
p.000013: UNAIDS / AVAC
p.000013:
p.000013:
p.000013: 1. The importance of good participatory practice
p.000013:
p.000013: 1.1 Who are stakeholders?
p.000013: The starting point of good participatory practice is the identification of key stakeholders in the conduct of a
p.000013: biomedical HIV prevention trial. Stakeholders are individuals, groups, organisations, government bodies, or any other
...
p.000023: trial-related decisions. Adherence to the principle of transparency means that stakeholders communicate about
p.000023: circumstances that may affect previously agreed levels of consultation, involvement, collaboration, and
p.000023: decision-making.
p.000023:
p.000023: 2.5 Accountability
p.000023: Accountability is fundamental to sustaining relationships built on trust and mutual respect.
p.000023:
p.000024: 24
p.000024:
p.000024: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000024:
p.000024:
p.000024: Trial funders, sponsors, and implementers are accountable to the society at large for conducting scientifically
p.000024: valid and ethical research. They are accountable to all research stakeholders for the use of partic- ipatory practices
p.000024: and for responding to input from relevant stake- holders as mutually agreed. They are also accountable for ensuring
p.000024: that funding is adequate to enable optimal engagement between research teams and other stakeholders.
p.000024: Community stakeholders and other relevant stakeholders are accountable for ensuring that their input into
p.000024: the research process is fair and constructive, respects the scientific process, and is in the best self-identified
p.000024: interests of community stakeholders.Where stake- holders accept the responsibility to act as liaisons or
p.000024: representatives between research teams and other stakeholders, they are accountable for representing the interests of
p.000024: those they represent, sharing informa- tion about planned or ongoing trials with them, and expressing their needs and
p.000024: concerns to research teams.
p.000024:
p.000024: 2.6 Community stakeholder autonomy
p.000024: Community stakeholder autonomy describes the community stake- holders’ right to support or refuse proposals to conduct
p.000024: research in a particular area, depending on the community stakeholders’ self-iden- tified interests and desires.
p.000024: Different stakeholder groups may well have different perspectives on the relevance or appropriateness of a specific
p.000024: trial, adding complexity to the situation.
p.000024: Good participatory practice strives to maximise the opportunity for stakeholders to understand the local, national, and
p.000024: global benefits of a specific trial and to make informed decisions regarding the appropri- ateness of a proposed trial.
p.000024: While a wide range of stakeholders generally participates in the design, approval, and implementation of a
p.000024: particular trial protocol, the self-identified interests of community stakeholders ultimately determine whether
p.000024: or not a trial is conducted in a particular area.
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: UNAIDS / AVAC
p.000025:
p.000025:
p.000025: 3. Good participatory practices in biomedical HIV prevention trials
p.000025:
p.000025: Introduction to good participatory practices
p.000025: The design, planning, and implementation of biomedical HIV preven- tion trials are guided by a range of standards such
p.000025: as Good Clinical Practice,2,3 Good Clinical Laboratory Practice,4 and Good Manufacturing Practice.26 This
p.000025: section describes a systematic framework that trial funders, sponsors, and implementers can use to develop
p.000025: meaningful and sustained partnerships with relevant stakeholders in the planning and conduct of biomedical HIV
...
p.000045: research teams develop locally acceptable and effective informed consent procedures and materials.
p.000045:
p.000045: 3.9.C. Special considerations
p.000045: Community stakeholders can provide research teams with invaluable advice to improve the informed consent process
p.000045: and materials. However, the actual implementation of the informed consent process between an individual and the
p.000045: research staff is confidential. Only designated research staff members have access to confidential information about
p.000045: the identity of trial participants. The informed consent process itself is conducted in accordance with Good Clinical
p.000045: Practice.2
p.000045:
p.000045: 3.9.D. Good participatory practices for the informed consent process
p.000045: 1. Research teams discuss the following topics with community stakeholders during development of the informed consent
p.000045: materials and procedures:
p.000045: a. Who needs to be consulted locally to enable research teams to invite individuals to join the trial.
p.000045: b. What local cultural practices may affect individual deci- sion-making ability, and how working within these struc-
p.000045: tures can be facilitated while ensuring protection of indi- vidual autonomy to provide informed consent.
p.000045: c. The general literacy level of the population to be recruited and how to assess the literacy level of prospective
p.000045: partici- pants.
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000046:
p.000046:
p.000046: d. Considerations and requirements for illiterate participants, including discussion of possibilities of who may
p.000046: serve appropriately as a witness to the informed consent process.
p.000046: e. The prevalence of different languages in the area and which languages are required for obtaining
p.000046: informed consent from individuals.
p.000046: f. Local and legal forms of identity (name and age) verifica- tion and local practices around the use of names.
p.000046: g. The legal, local, and trial sponsor definitions of a “minor” and consideration of legal and local
p.000046: determinations of who can serve as a minor’s guardian.
p.000046: h. Locally appropriate reimbursement and compensation.
p.000046: i. Appropriate strategies to ensure participant rights are protected, including voluntariness of
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000013: trial funders, trial sponsors, and trial implementers.
p.000013:
p.000013: The definition of “community” is more complicated, as it is a dynamic term that has different meanings to
p.000013: different people.19 This term is often used to refer to a group of people who have a common set of interests, share a
p.000013: common set of characteristics, or live in a common area. Individuals can be a part of multiple “communities” at the
p.000013: same time. The term “community” is also used to refer to the public at large or to a physical location.
p.000013:
p.000013: In the GPP guidelines, the preferred term is “community stake- holders”, rather than “community”, and refers to both
p.000013: individuals and groups that are ultimately representing the interests of people who would be recruited to or
p.000013: participate in a trial, and others locally
p.000013:
p.000014: 14
p.000014:
p.000014:
p.000014:
p.000014: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000014:
p.000014:
p.000014: affected by a trial. Examples of “community stakeholders” are the population to be recruited, trial participants,
p.000014: people living in the area where the research is conducted, people living with HIV in the area, local HIV-positive
p.000014: groups or networks, people in the area who are affected by the HIV epidemic, local non-governmental organisa-
p.000014: tions, community groups, and community-based organisations. Trial funders, sponsors, and implementers, as well as
p.000014: government bodies or representatives of high-level authority structures, are explicitly excluded from the term
p.000014: “community stakeholders” but are clearly considered trial stakeholders.
p.000014:
p.000014: Figure 2. Layers of Biomedical HIV Prevention Trial Stakeholders
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Examples
p.000014:
p.000014:
p.000014: Trial Participant
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: m
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Various stakeholders may influence or be affected by a biomedical HIV prevention trial. Stakeholders include trial
p.000014: participants and other community stakeholders as well as a broader range of national and international stakeholders.
p.000014:
p.000015: 15
p.000015:
p.000015: UNAIDS / AVAC
p.000015:
p.000015:
p.000015: 1.2 What is stakeholder engagement?
p.000015: Of key importance in good participatory practice is sustained, collab- orative partnering with stakeholders. In the GPP
p.000015: guidelines, the term “stakeholder engagement” refers to processes through which trial funders, sponsors, and
p.000015: implementers build transparent, meaningful, collaborative, and mutually beneficial relationships with interested or
p.000015: affected individuals, groups of individuals, or organisations, with the ultimate goal of shaping research collectively.
p.000015:
p.000015: Successful stakeholder engagement requires a broad, inclusive, and multifaceted understanding of the context in
p.000015: which a biomed- ical HIV prevention trial is conducted. It begins with an inclusive perspective for identification of
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p.000005:
p.000005:
p.000005: This GPP guidelines publication is a companion document to the UNAIDS/ WHO Ethical considerations in biomedical
p.000005: HIV prevention trials,1 which contains explicit guidance on community participation, capacity building,
p.000005: monitoring, informed consent, standard of prevention, and other key ethical issues.The GPP guidelines were developed to
p.000005: enable trial funders, sponsors, and implementers to adhere to Guidance Point 2 of Ethical considerations, “Community
p.000005: Participation”, which states:“To ensure the ethical and scien- tific quality and outcome of proposed research, its
p.000005: relevance to the affected community, and its acceptance by the affected community, researchers and trial sponsors
p.000005: should consult communities through a transparent and mean- ingful participatory process which involves them in an early
p.000005: and sustained manner in the design, development, implementation, monitoring, and distribution of results of
p.000005: biomedical HIV prevention trials”.
p.000005: The GPP guidelines provide comprehensive guidance on the participa- tory conduct of biomedical HIV prevention trials
p.000005: and are not intended to provide guidance on all scientific and ethical aspects of these trials. Multiple guidance
p.000005: documents already exist that address overall scientific and ethical trial conduct, such as Good Clinical
p.000005: Practice,2, 3 Good Clinical Laboratory Practice,4 the Declaration of Helsinki,5 The Belmont Report,6 Guidelines
p.000005: of the Council for International Organizations of Medical Sciences (CIOMS),7 the Nuffield Council Guidance
p.000005: on ethics of research related to health care in devel- oping countries,8,9 the UNAIDS/WHO Ethical
p.000005: considerations in biomedical HIV prevention trials,1 and various national guidelines.
p.000005: GPP is unique, as it is the only global guidance document to provide guidance about the relationship between a trial’s
p.000005: funders, sponsors, and implementers, and other stakeholders in the context of biomedical HIV prevention trials. Good
p.000005: Clinical Practice (GCP), in contrast, provides ethical guidance specifically for the relationship between investigators
p.000005: and trial participants and for ensuring the integrity of trial data.
p.000005: The principles of GPP in Section 2 apply to all biomedical HIV preven- tion trials, as they outline expectations and
p.000005: the foundations for building meaningful partnerships among stakeholders in biomedical HIV preven- tion research.
p.000005: The good participatory practices outlined in the 16 topic areas of Section 3 of these guidelines are applicable to all
p.000005: large-scale effectiveness and efficacy trials.
p.000005:
p.000006: 6
p.000006:
p.000006: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000006:
p.000006:
p.000006: The complete GPP guidelines are most relevant for trials that are larger and have substantial impacts on
...
p.000046: and research team about how to contact the participant.
p.000046: n. Consideration of the length of informed consent forms and the estimated time required to complete the informed
p.000046: consent process.
p.000046: o. Preferred ways for participants to contact research teams and stakeholders independent from the research team to
p.000046: ask questions or express concerns about trial participation.
p.000046: p. Ways to pilot informed consent materials.
p.000046:
p.000047: 47
p.000047:
p.000047: UNAIDS / AVAC
p.000047:
p.000047:
p.000047: 2. Research teams maintain clear written records of discus- sions and agreements. This includes community
p.000047: stakeholder recommendations, actions taken by the research team, and any unresolved issues that require follow-up.
p.000047: 3. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000047: allow informed consent materials to be properly developed, piloted, translated, and implemented, including materials
p.000047: to assess participants’ ongoing consent.
p.000047: 3.9.E. Additional guidance
p.000047: 1. Informed consent is the cornerstone of ethically conducted research and is explicitly discussed in guidance
p.000047: documents that address the overall ethical conduct of research, such as the Declaration of Helsinki,5 CIOMS
p.000047: guidelines,7 The Belmont Report,6 Good Clinical Practice,2 the World Health Organization Handbook for Good Clinical
p.000047: Research Practice,3 the Nuremberg Code,29 the Nuffield Council Guidance on health research in devel- oping
p.000047: countries,8, 9 and UNAIDS/WHO Ethical considerations in biomedical HIV prevention trials,10 and in relevant
p.000047: national guidelines.
p.000047: 2. There are extensive literature and other resources on the devel- opment of informed consent processes in multiple
p.000047: contexts, including a range of innovative approaches to measure and assess participant understanding, to address
p.000047: literacy issues, and to accommodate the desire of participants to consult with families and friends. 30, 31, 32, 33, 34
p.000047: 3.10 Standard of HIV prevention
p.000047: 3.10.A. Definition
p.000047: The term “standard of HIV prevention” refers to the package of comprehensive counselling and state-of-the-art HIV
p.000047: risk reduction methods provided or made available to participants in biomedical HIV prevention trials.
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000048:
p.000048:
p.000048: 3.10.B. Relevance to good participatory practice
...
p.000075: trial. Trial participants are assigned to a particular trial arm or group, in which they receive a partic- ular product
p.000075: or procedure.
p.000075: Trial sponsor. An entity that is responsible for a trial but that does not actually conduct it. The sponsor may
p.000075: be a pharmaceutical company, governmental agency, academic institution, or private or other organi- sation.
p.000075: UNAIDS (Joint United Nations Programme on HIV/AIDS). UNAIDS brings together the resources of the UNAIDS Secretariat and
p.000075: 10 UN system organisations to lead and inspire the world in achieving universal access to HIV prevention, treatment,
p.000075: care, and support.
p.000075: Unblinding or unmasking. The process of revealing trial participants’ product or procedure assignments. Unblinding
p.000075: involves informing participants about which product they were assigned to during the trial.
p.000075: Vaccine. A compound that stimulates the body’s immune response in order to prevent or control an infection. A vaccine
p.000075: is typically made up of parts of a bacterium or virus that cannot itself cause an infection. (See HIV vaccine.)
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000076: 76
p.000076:
p.000076: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000076:
p.000076:
p.000076: Annex 3. Additional guidance
p.000076:
p.000076: International reference guidelines
p.000076:
p.000076: The Belmont Report, 1979
p.000076: This report was written by the United States National Commission for the Protection of Human Subjects of Biomedical and
p.000076: Behavioral Research, which was established after the public learned about the Tuskegee Syphilis Study. The Belmont
p.000076: Report established the foun- dational ethical principles of respect for persons, beneficence, and justice for research
p.000076: involving human volunteers.
p.000076: Citation: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont
p.000076: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC,
p.000076: Department of Health, Education and Welfare, 1979.
p.000076:
p.000076: Declaration of Helsinki, 1964
p.000076: This Declaration of the World Medical Association is often consid- ered to be the first document to set world
p.000076: standards for research involving human volunteers.
p.000076: Citation: World Medical Association General Assembly. World Medical Association Declaration of
p.000076: Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Helsinki, World Medical Association,
p.000076: 2008.
p.000076:
p.000076: Ethical Considerations in Biomedical HIV Prevention Trials, 2007
p.000076: This is an ethical guidance document, issued by UNAIDS and WHO, for biomedical HIV prevention trials. This document is
p.000076: a revision of Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document. Geneva, UNAIDS,
p.000076: 2000.
p.000076: Citation: UNAIDS and WHO. Ethical Considerations in Biomedical HIV Prevention Trials. Geneva, UNAIDS, 2007.
p.000076:
p.000077: 77
p.000077:
p.000077: UNAIDS / AVAC
p.000077:
p.000077:
p.000077: Guideline for Good Clinical Practice, 1996
...
p.000080: 37:244–248.
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000081: 81
p.000081:
p.000081: UNAIDS / AVAC
p.000081:
p.000081:
p.000081: References
p.000081: 1 UNAIDS and WHO. Ethical Considerations in Biomedical HIV Prevention Trials. Geneva, UNAIDS, 2007.
p.000081: 2 Guideline for Good Clinical Practice: ICH Harmonised Tripartite Guideline. Geneva, International Conference on
p.000081: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.
p.000081: 3 Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation. Geneva,World Health
p.000081: Organization, 2002.
p.000081: 4 UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. Good Clinical
p.000081: Laboratory Practice (GCLP). Geneva, World Health Organization, 2009.
p.000081: 5 World Medical Association General Assembly. World Medical Association Declaration of Helsinki: Ethical Principles
p.000081: for Medical Research Involving Human Subjects. Helsinki, World Medical Association, 2008.
p.000081: 6 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report:
p.000081: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC, Department of
p.000081: Health, Education and Welfare, 1979.
p.000081: 7 International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Council for
p.000081: International Organizations of Medical Sciences, 2002.
p.000081: 8 The Ethics of Research Related to Healthcare in Developing Countries. London, Nuffield Council on
p.000081: Bioethics, 2002.
p.000081: 9 The Ethics of Healthcare Related Research in Developing Countries: A Follow-up Discussion Paper. London,
p.000081: Nuffield Council on Bioethics, 2005.
p.000081: 10 Creating Effective Partnerships for HIV Prevention Trials: Report of a UNAIDS Consultation. Geneva,
p.000081: UNAIDS, 2005.
p.000081: 11 Mills E et al. Media Reporting of Tenofovir Trials in Cambodia and Cameroon.
p.000081: BioMed Central International Health and Human Rights, 2005, 5:6.
p.000081: 12 Preventing Prevention Trial Failures:A Case Study and Lessons Learned for Future Trials from the 2004 Tenofovir
p.000081: Trial in Cambodia.Washington, DC, Global Campaign for Microbicides, 2009.
p.000081: 13 Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site. Washington, DC, Global
p.000081: Campaign for Microbicides, 2009.
p.000081:
p.000081:
p.000081:
p.000081:
p.000082: 82
p.000082:
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000005: monitoring, informed consent, standard of prevention, and other key ethical issues.The GPP guidelines were developed to
p.000005: enable trial funders, sponsors, and implementers to adhere to Guidance Point 2 of Ethical considerations, “Community
p.000005: Participation”, which states:“To ensure the ethical and scien- tific quality and outcome of proposed research, its
p.000005: relevance to the affected community, and its acceptance by the affected community, researchers and trial sponsors
p.000005: should consult communities through a transparent and mean- ingful participatory process which involves them in an early
p.000005: and sustained manner in the design, development, implementation, monitoring, and distribution of results of
p.000005: biomedical HIV prevention trials”.
p.000005: The GPP guidelines provide comprehensive guidance on the participa- tory conduct of biomedical HIV prevention trials
p.000005: and are not intended to provide guidance on all scientific and ethical aspects of these trials. Multiple guidance
p.000005: documents already exist that address overall scientific and ethical trial conduct, such as Good Clinical
p.000005: Practice,2, 3 Good Clinical Laboratory Practice,4 the Declaration of Helsinki,5 The Belmont Report,6 Guidelines
p.000005: of the Council for International Organizations of Medical Sciences (CIOMS),7 the Nuffield Council Guidance
p.000005: on ethics of research related to health care in devel- oping countries,8,9 the UNAIDS/WHO Ethical
p.000005: considerations in biomedical HIV prevention trials,1 and various national guidelines.
p.000005: GPP is unique, as it is the only global guidance document to provide guidance about the relationship between a trial’s
p.000005: funders, sponsors, and implementers, and other stakeholders in the context of biomedical HIV prevention trials. Good
p.000005: Clinical Practice (GCP), in contrast, provides ethical guidance specifically for the relationship between investigators
p.000005: and trial participants and for ensuring the integrity of trial data.
p.000005: The principles of GPP in Section 2 apply to all biomedical HIV preven- tion trials, as they outline expectations and
p.000005: the foundations for building meaningful partnerships among stakeholders in biomedical HIV preven- tion research.
p.000005: The good participatory practices outlined in the 16 topic areas of Section 3 of these guidelines are applicable to all
p.000005: large-scale effectiveness and efficacy trials.
p.000005:
p.000006: 6
p.000006:
p.000006: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000006:
p.000006:
p.000006: The complete GPP guidelines are most relevant for trials that are larger and have substantial impacts on
p.000006: individuals and areas where trials are conducted. However, the GPP guidelines can also serve as a guide for other
...
p.000046: and research team about how to contact the participant.
p.000046: n. Consideration of the length of informed consent forms and the estimated time required to complete the informed
p.000046: consent process.
p.000046: o. Preferred ways for participants to contact research teams and stakeholders independent from the research team to
p.000046: ask questions or express concerns about trial participation.
p.000046: p. Ways to pilot informed consent materials.
p.000046:
p.000047: 47
p.000047:
p.000047: UNAIDS / AVAC
p.000047:
p.000047:
p.000047: 2. Research teams maintain clear written records of discus- sions and agreements. This includes community
p.000047: stakeholder recommendations, actions taken by the research team, and any unresolved issues that require follow-up.
p.000047: 3. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000047: allow informed consent materials to be properly developed, piloted, translated, and implemented, including materials
p.000047: to assess participants’ ongoing consent.
p.000047: 3.9.E. Additional guidance
p.000047: 1. Informed consent is the cornerstone of ethically conducted research and is explicitly discussed in guidance
p.000047: documents that address the overall ethical conduct of research, such as the Declaration of Helsinki,5 CIOMS
p.000047: guidelines,7 The Belmont Report,6 Good Clinical Practice,2 the World Health Organization Handbook for Good Clinical
p.000047: Research Practice,3 the Nuremberg Code,29 the Nuffield Council Guidance on health research in devel- oping
p.000047: countries,8, 9 and UNAIDS/WHO Ethical considerations in biomedical HIV prevention trials,10 and in relevant
p.000047: national guidelines.
p.000047: 2. There are extensive literature and other resources on the devel- opment of informed consent processes in multiple
p.000047: contexts, including a range of innovative approaches to measure and assess participant understanding, to address
p.000047: literacy issues, and to accommodate the desire of participants to consult with families and friends. 30, 31, 32, 33, 34
p.000047: 3.10 Standard of HIV prevention
p.000047: 3.10.A. Definition
p.000047: The term “standard of HIV prevention” refers to the package of comprehensive counselling and state-of-the-art HIV
p.000047: risk reduction methods provided or made available to participants in biomedical HIV prevention trials.
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000048:
p.000048:
p.000048: 3.10.B. Relevance to good participatory practice
...
p.000066: success of stakeholder engagement, and provide the foundation for future trials.
p.000066:
p.000066: The GPP guidelines are intended to provide trial funders, sponsors, and implementers with systematic guidance on how to
p.000066: effectively engage with relevant stakeholders in the design and conduct of biomedical HIV preven- tion trials.
p.000066: Developing participatory processes that balance the opinions of all stakeholders while achieving the scientific goals
p.000066: of a trial can ensure that the needs of both community stakeholders and the broader HIV preven- tion field are met.
p.000066:
p.000066: In a forward-looking approach, it is important to gather and analyse stake- holders’ experiences with the
p.000066: implementation of the GPP guidelines. Recommendations for modifications and refinements based on experience and
p.000066: reflection can be sent to gpp@unaids.org or avac@avac.org, where they will be gratefully received and considered in
p.000066: future updates of these guidelines.
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: UNAIDS / AVAC
p.000067:
p.000067:
p.000067: Annex 1. Acronyms and abbreviations
p.000067: AE – Adverse event
p.000067: AIDS – Acquired Immunodeficiency Syndrome
p.000067: ARV – Antiretroviral drug
p.000067: CAB – Community Advisory Board CAG – Community Advisory Group CBO – Community-Based Organisation
p.000067: CIOMS – Council for International Organizations of Medical Science
p.000067: EC – Ethics committee
p.000067: DSMB – Data safety monitoring board DSMC – Data safety monitoring committee GCLP– Good Clinical Laboratory Practice GCP
p.000067: – Good Clinical Practice
p.000067: GMP – Good Manufacturing Practice GPP – Good Participatory Practice HIV – Human Immunodeficiency Virus
p.000067: IDMC – Independent data monitoring committee
p.000067: IDU – Injecting drug use
p.000067: IRB – Institutional review board
p.000067: MSM – Men who have sex with men NGO – Non-governmental organisation PEP – Post-exposure prophylaxis
p.000067: PMTCT – Prevention of mother-to-child transmission
p.000067: PrEP – Pre-exposure prophylaxis REC – Research ethics committee SOP – Standard operating procedure STI – Sexually
p.000067: transmitted infection
p.000067: UNAIDS – Joint United Nations Programme on HIV/AIDS
p.000067: WHO – World Health Organization
p.000067:
p.000067:
p.000067:
p.000068: 68
p.000068: 68
p.000068:
p.000068: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000068:
p.000068:
p.000068: Annex 2. Glossary
p.000068: Accrual. The process of recruiting participants into a clinical trial in order to reach target participant
p.000068: numbers.
p.000068: Acquired immunodeficiency syndrome (AIDS). The most severe mani- festation of infection with human immunodeficiency
...
p.000076: 2008.
p.000076:
p.000076: Ethical Considerations in Biomedical HIV Prevention Trials, 2007
p.000076: This is an ethical guidance document, issued by UNAIDS and WHO, for biomedical HIV prevention trials. This document is
p.000076: a revision of Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document. Geneva, UNAIDS,
p.000076: 2000.
p.000076: Citation: UNAIDS and WHO. Ethical Considerations in Biomedical HIV Prevention Trials. Geneva, UNAIDS, 2007.
p.000076:
p.000077: 77
p.000077:
p.000077: UNAIDS / AVAC
p.000077:
p.000077:
p.000077: Guideline for Good Clinical Practice, 1996
p.000077: This guidance document was issued by the International Conference on Harmonisation of Technical Requirements for
p.000077: Registration of Pharmaceuticals for Human Use and outlines an international ethical and scientific quality standard
p.000077: for designing, conducting, recording, and reporting trials that involve human volunteers.
p.000077: Citation: Guideline for Good Clinical Practice: ICH Harmonised Tripartite Guideline. Geneva, International
p.000077: Conference on Harmoni- sation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.
p.000077:
p.000077: International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993
p.000077: These guidelines, published by the Council for International Organizations of Medical Sciences
p.000077: (CIOMS), added guidance on conducting research in developing countries to the body of ethical guidelines. The 2002
p.000077: version supersedes the 1982 and 1993 guidelines.
p.000077: Citation: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva,
p.000077: Council for International Organizations of Medical Sciences, 2002.
p.000077:
p.000077: Nuffield Council on Bioethics, 2002
p.000077: The 2002 Nuffield Council on Bioethics report on The Ethics of Research Related to Healthcare in
p.000077: Developing Countries provides an ethical framework for designing or conducting externally sponsored
p.000077: research in the developing world. The 2004 follow-up report, co-hosted with the Medical Research Council of
p.000077: South Africa, discusses how the guidelines could be applied in practice, particu- larly in light of conflicting ethical
p.000077: advice.
p.000077: Citation: The Ethics of Research Related to Healthcare in Developing Countries. London, Nuffield Council on
p.000077: Bioethics, 2002; and The Ethics of Healthcare Related Research in Developing Countries: A Follow-up
p.000077: Discussion Paper. London, Nuffield Council on Bioethics, 2005.
p.000077:
p.000077:
p.000078: 78
p.000078:
p.000078: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000078:
p.000078:
...
General/Other / cultural difference
Searching for indicator culturally:
(return to top)
p.000018:
p.000018:
p.000018:
p.000018: Implementing Institution
p.000018:
p.000018: Trial Sites Trial Sites
p.000018:
p.000018:
p.000018: Basic structure of a typical biomedical HIV prevention trial network. Funding from one or more sources is distributed
p.000018: through a network coordinating centre directly to trial sites or to implementing institutions such as universities that
p.000018: then send funds to trial sites. Trial networks may have several centres responsible for different aspects of trial
p.000018: conduct: data management, laboratory, pharmacy, clinical, safety, social science, and stakeholder engagement.
p.000018: Monitoring of trial conduct may be executed through the coordinating centre or outsourced to an independent
p.000018: monitoring organisation.
p.000018:
p.000018:
p.000018: 1.5 Rationale for GPP guidelines
p.000018: Constructive long-term stakeholder engagement helps ensure the ethical and scientific quality of research as well
p.000018: as its relevance to community stakeholders.1,25 Stakeholders, in particular community stakeholders, have unique
p.000018: expertise to contribute to the research process. They possess critical knowledge and understandings of local
p.000018: cultures and perspectives, languages, dynamics of the local HIV epidemic, concerns of vulnerable or marginalised
p.000018: populations, and local priorities that trial funders, sponsors, and implementers may lack.
p.000018:
p.000019: 19
p.000019:
p.000019: UNAIDS / AVAC
p.000019:
p.000019:
p.000019: Stakeholder collaboration can help ensure that research questions and procedures are culturally sensitive and
p.000019: appropriate, thus improving recruitment, retention, adherence, and other trial outcomes. It can help avoid reinforcing
p.000019: existing inequalities and increase sensitivity to the needs of vulnerable populations. An essential component of
p.000019: stakeholder engagement is improving stakeholder knowledge and understanding of the research process, building
p.000019: research literacy and competencies. This, in turn, enables stakeholders to contribute more effectively to the process
p.000019: of guiding research and helps to address the power imbalance between research teams and community stake- holders.
p.000019:
p.000019: Strengthening meaningful collaboration among stakeholders fosters greater trust and respect between trial funders,
p.000019: sponsors, and imple- menters, and other stakeholders. Stakeholder engagement that is trans- parent and mutually
p.000019: respectful can minimise misunderstandings and reduce the chances of unnecessary conflict or controversy. Following good
p.000019: participatory practices through the entire research life-cycle helps facilitate local ownership of research, enables
p.000019: more equitable relationships, and increases the likelihood of successful research conduct, trial completion, and
p.000019: application of research results.
p.000019:
p.000019: 1.6 Applying GPP
p.000019: The GPP guidelines broadly describe systematic ways to establish and maintain effective stakeholder engagement that can
p.000019: be applied in diverse locations globally. The specificity of the content of the GPP guidelines enables monitoring of
p.000019: stakeholder engagement activities.
p.000019:
...
p.000057: 3. Research teams and relevant stakeholders review follow-up strategies to reduce trial-related physical and social
p.000057: harms over the course of the trial.
p.000057: 4. Research teams maintain clear written records of discussions and agreements. This includes recommendations,
p.000057: actions taken by the research team, and any unresolved issues that require follow-up.
p.000057: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000057: ensure the effective management of physical and social harms related to participation in a trial.
p.000057:
p.000057: 3.13.E. Additional guidance
p.000057: 1. Ethical considerations in biomedical HIV prevention trials
p.000057: (Guidance Point 11, page 40, Potential Harms).1
p.000057:
p.000058: 58
p.000058:
p.000058: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000058:
p.000058:
p.000058: 2. International Ethical Guidelines for Biomedical Research Involving Human Subjects (Guideline 19, page 78
p.000058: right of injured subjects to treatment and compensation).7
p.000058: 3.14 Trial accrual, follow-up, and exit
p.000058: 3.14.A. Definition
p.000058: Trial accrual, follow-up, and exit activities include the recruit- ment, screening, enrolment, follow-up, and exit of
p.000058: trial partici- pants in biomedical HIV prevention trials.
p.000058:
p.000058: 3.14.B. Relevance to good participatory practice
p.000058: Community stakeholders can provide the best information on how to design socially and culturally
p.000058: acceptable strate- gies for recruitment, screening, enrolment, follow-up, and exit. Community stakeholders included in
p.000058: the process of developing these strategies can play an important role in identifying and mitigating trial-related
p.000058: stigma, misconceptions, or miscommuni- cation.
p.000058:
p.000058: 3.14.C. Special considerations
p.000058: 1. Follow-up of participants after missed visits must respect agreements between the participant and research
p.000058: team about how to contact the participant.
p.000058: 2. Exiting a trial may present changes in what participants have become accustomed to with regard to clinical care and
p.000058: the impact of the trial on their social relationships. Anticipation and discussion of these issues between research
p.000058: teams and community stakeholders will help in the development of appropriate strategies to support participants
p.000058: upon trial exit.
p.000058: 3.14.D. Good participatory practices for trial accrual, follow-up, and exit
p.000058: 1. Research teams consult with relevant stakeholders about accrual, follow-up, and exit processes, taking
p.000058: account of the following:
p.000058:
p.000058:
p.000059: 59
p.000059:
p.000059: UNAIDS / AVAC
p.000059:
p.000059:
p.000059: a. Strategies and messages that are socially and culturally appropriate, meet the needs of specific
p.000059: stakeholders in terms of language and literacy, and draw on a range of communication modes, including written, oral,
p.000059: and visual.
p.000059: b. Procedures to anticipate, monitor, and mitigate trial- related stigma resulting from ineligibility to enrol
p.000059: or from enrolment itself.
p.000059: c. Procedures for training and supervising trial site staff on creating respectful relationships with participants
p.000059: and fostering an environment that is nonjudgmental and welcoming.
p.000059: d. Strategies to ensure the confidentiality of participants during trial visits, while following up participants
p.000059: outside of the trial clinic, and after trial exit.
p.000059: e. Procedures for informing participants about trial results and trial product assignment, when available.
p.000059: f. Procedures for transfer of care at the end of follow-up or trial closure, such as providing participants with
p.000059: referrals to HIV counselling and testing and to other supportive services.
p.000059: 2. Research teams provide relevant stakeholders with ongoing updates on trial accrual, follow-up, and trial exit.
p.000059: 3. Research teams seek advice from relevant stakeholders on how to improve accrual, follow-up and exit processes, and
p.000059: messages.
p.000059: 4. Research teams maintain clear written records of discussions and agreements, as well as ongoing discussions about
p.000059: ways to modify strategies.
p.000059: 5. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
...
p.000082: from Communities? American Journal of Public Health, 2001, 91:1926–1929.
p.000082: 25 Arnstein SR. A ladder of Citizen Participation. Journal of the American Institute of Planners, 1969, 35:216–224.
p.000082: 26 Quality Assurance of Pharmaceuticals:A Compendium of Guidelines and Related Materials. Vol. 2. Good Manufacturing
p.000082: Practices and Inspection. 2nd ed. Geneva,World Health Organization, 2007.
p.000082: 27 Community Recommendations Working Group, Community Partners. Recommendations for Community Involvement
p.000082: in National Institute of Allergy and Infectious Diseases HIV/AIDS Clinical Trials Research. Bethesda, MD, 2009.
p.000082:
p.000082:
p.000082:
p.000082:
p.000083: 83
p.000083:
p.000083: UNAIDS / AVAC
p.000083:
p.000083:
p.000083: 28 Robinson ET et al. Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage
p.000083: Controversy, Convey Your Message, and Disseminate Results. Washington, DC, Microbicides Media Communications
p.000083: Initiative and Research Triangle Park, NC, FHI, 2010.
p.000083: 29 Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No.
p.000083: 10.Vol. 2, pp. 181–182. Washington, DC, United States Government Printing Office, 1949:181–182.
p.000083: 30 Molyneux CS, Peshu N, Marsh K. Understanding of Informed Consent in a Low-income Setting: Three Case Studies from
p.000083: the Kenyan Coast. Social Science and Medicine, 2004, 59:2547–2559.
p.000083: 31 Richter L et al. Guidelines for the Development of Culturally Sensitive Approaches to Obtaining Informed Consent
p.000083: for Participation in HIV Vaccine-related Trials. Geneva, UNAIDS, 1999.
p.000083: 32 Molyneux CS et al.“Even If They Ask You to Stand by a Tree All Day, You Will Have To Do It (laughter)...”:
p.000083: Community Voices on the Notion and Practice of Informed Consent for Biomedical Research in Developing Countries. Social
p.000083: Science and Medicine, 2005, 61:443–454.
p.000083: 33 Appelbaum PS, Lidz CW, Meisel A. Informed Consent: Legal Theory and Clinical Practice. New York, Oxford
p.000083: University Press, 1987.
p.000083: 34 Strauss RP et al. The Role of Community Advisory Boards: Involving Communities in the Informed Consent
p.000083: Process. American Journal of Public Health, 2001, 91:1938–1943.
p.000083: 35 Mapping the Standards of Care at Microbicide Clinical Trial Sites. Washington, DC, Global Campaign for
p.000083: Microbicides, PATH, 2008.
p.000083: 36 Philpott S et al. The Challenge of Defining Standards of Prevention in HIV Prevention Trials. Journal of Medical
p.000083: Ethics, 2011, 37:244–248.
p.000083: 37 Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International
p.000083: Consultation. Washington, DC, Global Campaign for Microbicides, 2005.
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000004:
p.000005: 5
p.000005:
p.000005: UNAIDS / AVAC
p.000005:
p.000005:
p.000005: This GPP guidelines publication is a companion document to the UNAIDS/ WHO Ethical considerations in biomedical
p.000005: HIV prevention trials,1 which contains explicit guidance on community participation, capacity building,
p.000005: monitoring, informed consent, standard of prevention, and other key ethical issues.The GPP guidelines were developed to
p.000005: enable trial funders, sponsors, and implementers to adhere to Guidance Point 2 of Ethical considerations, “Community
p.000005: Participation”, which states:“To ensure the ethical and scien- tific quality and outcome of proposed research, its
p.000005: relevance to the affected community, and its acceptance by the affected community, researchers and trial sponsors
p.000005: should consult communities through a transparent and mean- ingful participatory process which involves them in an early
p.000005: and sustained manner in the design, development, implementation, monitoring, and distribution of results of
p.000005: biomedical HIV prevention trials”.
p.000005: The GPP guidelines provide comprehensive guidance on the participa- tory conduct of biomedical HIV prevention trials
p.000005: and are not intended to provide guidance on all scientific and ethical aspects of these trials. Multiple guidance
p.000005: documents already exist that address overall scientific and ethical trial conduct, such as Good Clinical
p.000005: Practice,2, 3 Good Clinical Laboratory Practice,4 the Declaration of Helsinki,5 The Belmont Report,6 Guidelines
p.000005: of the Council for International Organizations of Medical Sciences (CIOMS),7 the Nuffield Council Guidance
p.000005: on ethics of research related to health care in devel- oping countries,8,9 the UNAIDS/WHO Ethical
p.000005: considerations in biomedical HIV prevention trials,1 and various national guidelines.
p.000005: GPP is unique, as it is the only global guidance document to provide guidance about the relationship between a trial’s
p.000005: funders, sponsors, and implementers, and other stakeholders in the context of biomedical HIV prevention trials. Good
p.000005: Clinical Practice (GCP), in contrast, provides ethical guidance specifically for the relationship between investigators
p.000005: and trial participants and for ensuring the integrity of trial data.
p.000005: The principles of GPP in Section 2 apply to all biomedical HIV preven- tion trials, as they outline expectations and
p.000005: the foundations for building meaningful partnerships among stakeholders in biomedical HIV preven- tion research.
p.000005: The good participatory practices outlined in the 16 topic areas of Section 3 of these guidelines are applicable to all
p.000005: large-scale effectiveness and efficacy trials.
p.000005:
p.000006: 6
p.000006:
p.000006: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000006:
p.000006:
...
p.000046: m. Strategies to ensure that follow-up of participants after missed visits respects agreements between the participant
p.000046: and research team about how to contact the participant.
p.000046: n. Consideration of the length of informed consent forms and the estimated time required to complete the informed
p.000046: consent process.
p.000046: o. Preferred ways for participants to contact research teams and stakeholders independent from the research team to
p.000046: ask questions or express concerns about trial participation.
p.000046: p. Ways to pilot informed consent materials.
p.000046:
p.000047: 47
p.000047:
p.000047: UNAIDS / AVAC
p.000047:
p.000047:
p.000047: 2. Research teams maintain clear written records of discus- sions and agreements. This includes community
p.000047: stakeholder recommendations, actions taken by the research team, and any unresolved issues that require follow-up.
p.000047: 3. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000047: allow informed consent materials to be properly developed, piloted, translated, and implemented, including materials
p.000047: to assess participants’ ongoing consent.
p.000047: 3.9.E. Additional guidance
p.000047: 1. Informed consent is the cornerstone of ethically conducted research and is explicitly discussed in guidance
p.000047: documents that address the overall ethical conduct of research, such as the Declaration of Helsinki,5 CIOMS
p.000047: guidelines,7 The Belmont Report,6 Good Clinical Practice,2 the World Health Organization Handbook for Good Clinical
p.000047: Research Practice,3 the Nuremberg Code,29 the Nuffield Council Guidance on health research in devel- oping
p.000047: countries,8, 9 and UNAIDS/WHO Ethical considerations in biomedical HIV prevention trials,10 and in relevant
p.000047: national guidelines.
p.000047: 2. There are extensive literature and other resources on the devel- opment of informed consent processes in multiple
p.000047: contexts, including a range of innovative approaches to measure and assess participant understanding, to address
p.000047: literacy issues, and to accommodate the desire of participants to consult with families and friends. 30, 31, 32, 33, 34
p.000047: 3.10 Standard of HIV prevention
p.000047: 3.10.A. Definition
p.000047: The term “standard of HIV prevention” refers to the package of comprehensive counselling and state-of-the-art HIV
p.000047: risk reduction methods provided or made available to participants in biomedical HIV prevention trials.
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000048:
p.000048:
...
p.000053: ensure that all individuals screened and enrolled are aware of how to access the HIV care and treatment services.
p.000053: 6. Research teams and relevant stakeholders discuss how to monitor access to HIV care and treatment
p.000053: services. They consider how to gather and analyse information on numbers of seroconverters who access HIV care,
p.000053: barriers to accessing HIV care and treatment programmes and other issues that may arise.
p.000053: 7. Research teams maintain clear written records of discussions and agreements. This includes relevant stakeholder
p.000053: recom- mendations, actions taken by the research team, aspects of HIV care and treatment that will not be offered and
p.000053: why, and any unresolved issues that require follow-up.
p.000053: 8. Trial sponsors ensure sufficient funding and research teams create a budget and allocate funds and staff time to
p.000053: ensure that the locally agreed HIV care and treatment package can be effectively delivered.
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000054:
p.000054:
p.000054: 3.11.E. Additional guidance
p.000054: 1. The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.5
p.000054: 2. Ethical considerations in biomedical HIV prevention trials
p.000054: (Guidance Point 14, page 48, Care and Treatment).1
p.000054: 3. Ethical considerations in biomedical HIV prevention trials (page 13, selected circumstances in which biomedical HIV
p.000054: prevention trials should not be conducted).1
p.000054: 4. Mapping the Standards of Care at Microbicide Clinical Trial Sites.35
p.000054: 3.12 Non HIV-related care
p.000054: 3.12.A. Definition
p.000054: Non HIV-related care refers to health and social care services provided or made available to trial participants
p.000054: that are not directly related to HIV prevention, HIV care and treatment, or trial-related harm.The non HIV-related
p.000054: care services appropriate for trial participants will depend on the trial population and local health priorities.
p.000054: Examples could include provision of female or male sexual and reproductive health care, management of infec- tious
p.000054: diseases, nutritional health, psychiatric care, and psychoso- cial services.
p.000054:
p.000054: 3.12.B. Relevance to good participatory practice
...
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000076: 76
p.000076:
p.000076: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000076:
p.000076:
p.000076: Annex 3. Additional guidance
p.000076:
p.000076: International reference guidelines
p.000076:
p.000076: The Belmont Report, 1979
p.000076: This report was written by the United States National Commission for the Protection of Human Subjects of Biomedical and
p.000076: Behavioral Research, which was established after the public learned about the Tuskegee Syphilis Study. The Belmont
p.000076: Report established the foun- dational ethical principles of respect for persons, beneficence, and justice for research
p.000076: involving human volunteers.
p.000076: Citation: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont
p.000076: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC,
p.000076: Department of Health, Education and Welfare, 1979.
p.000076:
p.000076: Declaration of Helsinki, 1964
p.000076: This Declaration of the World Medical Association is often consid- ered to be the first document to set world
p.000076: standards for research involving human volunteers.
p.000076: Citation: World Medical Association General Assembly. World Medical Association Declaration of
p.000076: Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Helsinki, World Medical Association,
p.000076: 2008.
p.000076:
p.000076: Ethical Considerations in Biomedical HIV Prevention Trials, 2007
p.000076: This is an ethical guidance document, issued by UNAIDS and WHO, for biomedical HIV prevention trials. This document is
p.000076: a revision of Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document. Geneva, UNAIDS,
p.000076: 2000.
p.000076: Citation: UNAIDS and WHO. Ethical Considerations in Biomedical HIV Prevention Trials. Geneva, UNAIDS, 2007.
p.000076:
p.000077: 77
p.000077:
p.000077: UNAIDS / AVAC
p.000077:
p.000077:
p.000077: Guideline for Good Clinical Practice, 1996
p.000077: This guidance document was issued by the International Conference on Harmonisation of Technical Requirements for
p.000077: Registration of Pharmaceuticals for Human Use and outlines an international ethical and scientific quality standard
p.000077: for designing, conducting, recording, and reporting trials that involve human volunteers.
p.000077: Citation: Guideline for Good Clinical Practice: ICH Harmonised Tripartite Guideline. Geneva, International
p.000077: Conference on Harmoni- sation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.
p.000077:
p.000077: International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993
p.000077: These guidelines, published by the Council for International Organizations of Medical Sciences
...
p.000080: Citation: Standards of Prevention at HIV Prevention Trials: Consultation Report and
p.000080: Recommendations. Seattle, Global Campaign for Microbicides, PATH, 2010; and Philpott S et al. The
p.000080: Challenge of Defining Standards of Prevention in HIV Prevention Trials. Journal of Medical Ethics, 2011,
p.000080: 37:244–248.
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000081: 81
p.000081:
p.000081: UNAIDS / AVAC
p.000081:
p.000081:
p.000081: References
p.000081: 1 UNAIDS and WHO. Ethical Considerations in Biomedical HIV Prevention Trials. Geneva, UNAIDS, 2007.
p.000081: 2 Guideline for Good Clinical Practice: ICH Harmonised Tripartite Guideline. Geneva, International Conference on
p.000081: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.
p.000081: 3 Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation. Geneva,World Health
p.000081: Organization, 2002.
p.000081: 4 UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. Good Clinical
p.000081: Laboratory Practice (GCLP). Geneva, World Health Organization, 2009.
p.000081: 5 World Medical Association General Assembly. World Medical Association Declaration of Helsinki: Ethical Principles
p.000081: for Medical Research Involving Human Subjects. Helsinki, World Medical Association, 2008.
p.000081: 6 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report:
p.000081: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC, Department of
p.000081: Health, Education and Welfare, 1979.
p.000081: 7 International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Council for
p.000081: International Organizations of Medical Sciences, 2002.
p.000081: 8 The Ethics of Research Related to Healthcare in Developing Countries. London, Nuffield Council on
p.000081: Bioethics, 2002.
p.000081: 9 The Ethics of Healthcare Related Research in Developing Countries: A Follow-up Discussion Paper. London,
p.000081: Nuffield Council on Bioethics, 2005.
p.000081: 10 Creating Effective Partnerships for HIV Prevention Trials: Report of a UNAIDS Consultation. Geneva,
p.000081: UNAIDS, 2005.
p.000081: 11 Mills E et al. Media Reporting of Tenofovir Trials in Cambodia and Cameroon.
p.000081: BioMed Central International Health and Human Rights, 2005, 5:6.
p.000081: 12 Preventing Prevention Trial Failures:A Case Study and Lessons Learned for Future Trials from the 2004 Tenofovir
p.000081: Trial in Cambodia.Washington, DC, Global Campaign for Microbicides, 2009.
...
General/Other / participants in a control group
Searching for indicator placebo:
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p.000048: concerns. Therefore, successful negotiation with stakeholders about the prevention package to be provided to trial
p.000048: participants is likely to have a significant influence on community stakeholder perceptions of a trial.
p.000048:
p.000048: 3.10.C. Special considerations
p.000048: 1. Deviations from expected standard HIV prevention packages at a trial site or among trial sites in multisite studies
p.000048: may be caused by national legal restrictions.
p.000048: 2. When funding-body restrictions limit which prevention methods can be paid for by trial funds, research teams
p.000048: have the responsibility to find other ways to provide these methods, such as through alternative funding streams or
p.000048: linkages with non-governmental organisations or community-based organ- isations.
p.000048: 3. Research teams may need to review the HIV prevention package regularly, taking into consideration new HIV coun-
p.000048: selling models and risk reduction methods that are scientifi- cally validated and, when appropriate, approved by
p.000048: national bodies for use.
p.000048: 4. To improve relevant stakeholder understanding of the preven- tion package offered and the clinical trial process,
p.000048: research teams can describe the trial as comparing the study product plus the HIV prevention package, with the
p.000048: placebo (or comparator arm) plus the HIV prevention package.
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049: UNAIDS / AVAC
p.000049:
p.000049:
p.000049: 3.10.D. Good participatory practices for standard of HIV prevention
p.000049: 1. Research teams and relevant stakeholders negotiate the HIV prevention package during the protocol development phase
p.000049: of the trial.
p.000049: 2. Research teams determine which stakeholders already provide HIV prevention services, what types of
p.000049: services they provide, and their capacity to provide adequate services.This will enable research teams to provide
p.000049: optimal referrals and make linkages when necessary.
p.000049: 3. Research teams and relevant stakeholders discuss and negotiate the comprehensive HIV prevention package and
p.000049: consult local HIV prevention service providers when appro- priate. All scientifically validated methods are discussed,
p.000049: and their appropriateness for the trial design and population assessed, including:
p.000049: a. Risk assessment and risk-reduction counselling— including partner and couple counselling.
p.000049: b. Male and female condoms—with appropriate instructions and demonstrations.
p.000049: c. Testing for and treatment of sexually transmitted infec- tions.
...
p.000069: Community groups. Groups of individuals who come together to act on behalf of common interests, goals, and values but
p.000069: whose organisa- tion does not require formal designation or registration.
p.000069: Community stakeholders (per the GPP guidelines). Individuals and groups who are ultimately representing the
p.000069: interests of people who would be recruited to or participate in a clinical trial, and others locally affected by
p.000069: a trial. Examples of “community stakeholders” are the population to be recruited, trial participants, people
p.000069: living in the area where the research is conducted, people living with HIV in the area, local HIV-positive groups or
p.000069: networks, people in the area affected by the HIV epidemic, local non-governmental organisations, community
p.000069: groups, and community-based organisations. (See stakeholders.)
p.000069: Confidentiality. The principle that protects the rights of trial partici- pants regarding prevention of
p.000069: unauthorised disclosure of personal information to third parties during data collection, storage, transfer,
p.000069: and use.
p.000069: Condom. A sheath or pouch that is worn either over the penis (male condom) or inside the vagina (female condom)
p.000069: during sexual inter- course, for the purpose of protecting against sexually transmitted infec- tions (including HIV)
p.000069: or preventing pregnancy. (See female condom or male condom.)
p.000069: Control arm or group. The group of participants in a clinical trial who receive the placebo or control product or
p.000069: procedure. (See placebo.)
p.000069: Data and safety monitoring board (DSMB) or independent data monitoring committee (IDMC). An independent
p.000069: committee estab- lished by a trial sponsor to assess, at intervals, the progress of a clinical trial, safety data, and
p.000069: critical efficacy or effectiveness endpoints. A data and safety monitoring board may recommend to the sponsor that a
p.000069:
p.000070: 70
p.000070:
p.000070: Good participatory practice guidelines for biomedical HIV prevention trials 2011
p.000070:
p.000070:
p.000070: trial be stopped or modified if there are safety concerns, if trial objec- tives have been achieved, or if assessment
p.000070: of trial progress reveals that continuing the trial would be futile since it will no longer be possible to answer the
p.000070: research question that the trial is addressing.
p.000070: Ethics committee. See research ethics committee.
p.000070: Experimental arm or group. The group of participants in a clinical trial who receive the procedure, product, or drug
p.000070: being studied.
p.000070: Female condom. A pouch that when inserted in the vagina before vaginal intercourse, provides protection
p.000070: against most sexually trans- mitted infections, including HIV, and pregnancy. During anal sex, the female condom,
p.000070: when placed on the penis after removing the inner ring, provides protection against most sexually transmitted
...
p.000072:
p.000072:
p.000072: Medical male circumcision. The surgical removal of the entire foreskin of the penis. Three clinical trials conducted in
p.000072: sub-Saharan Africa have shown that medically performed male circumcision is safe and can reduce men’s risk
p.000072: of HIV infection during vaginal sex by about 60%. Prevalence of male circumcision varies by geography,
p.000072: religion, and cultural practices.
p.000072: Men who have sex with men (MSM). Men who have sexual contact with other men, regardless of whether or not they also
p.000072: have sex with women or have a personal or social gay or bisexual identity. This concept also includes men
p.000072: who self-identify as heterosexual but have sex with other men.
p.000072: Microbicides. A range of products that could be used vaginally or rectally (such as a gel, cream, ring, film,
p.000072: suppository or sponge) that are being tested to determine if they reduce or prevent the transmission of HIV and other
p.000072: disease-causing organisms during vaginal and anal intercourse.
p.000072: Network or research network. A cooperative of research institutions or centres conducting clinical trials under a
p.000072: common research agenda.
p.000072: Non-governmental organisation (NGO). A not-for-profit, registered entity or group that is organised on
p.000072: local, national, or international levels but is not an agency of local or national governments.
p.000072: Placebo. An inactive substance that is designed to appear like an exper- imental product being studied in all aspects
p.000072: except for the absence of the active ingredient under study. In clinical trials, the safety and effec- tiveness of an
p.000072: experimental product are assessed by comparing data from the experimental product trial arm to those from the placebo
p.000072: arm.
p.000072: Post-exposure prophylaxis (PEP). Antiretroviral medicines prescribed and taken after exposure or possible exposure to
p.000072: HIV, to reduce the risk of acquiring HIV. The exposure may be occupational, as in a needle stick injury, or
p.000072: non-occupational, as in the case of rape.
p.000072: Pre-exposure prophylaxis (PrEP). Antiretroviral drugs used by a person who does not have HIV infection to be taken
p.000072: before possible exposure to HIV in order to reduce the risk of acquiring HIV infection.
p.000072: Product or trial arm assignment. The specific study product or procedure, such as the experimental or ‘active’
p.000072: arm or the placebo arm,
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: UNAIDS / AVAC
p.000073:
p.000073:
p.000073: to which a participant is assigned for the designated follow-up period. (See placebo and experimental arm.)
p.000073: Protocol. A document that details the rationale, goals, design, method- ology, statistical considerations, and
p.000073: organisation of a study or clinical trial. A protocol describes a scientific study designed to answer specific research
p.000073: questions and describes how the health of the trial participants will be safeguarded.
p.000073: Randomisation. A method based on chance alone by which trial partic- ipants are assigned to a trial arm or group.
p.000073: Randomisation ensures that the only intended difference between trial arms or groups is which product or
p.000073: procedure a trial participant is exposed to during the trial.
p.000073: Randomised trial. A clinical trial in which participants are assigned by chance to one of the trial arms or groups.
p.000073: (See randomisation.)
p.000073: Regulatory authorities. Government agencies charged with carrying out the intent of legislation that constrains the
p.000073: actions of private indi- viduals, businesses, organisations, institutions, or government bodies. In most countries, one
p.000073: or more regulatory agency may be responsible for ensuring the safety and effectiveness of health products and the
p.000073: correct conduct of clinical trials.
p.000073: Research ethics committee (REC) or institutional review board (IRB). An independent body made up of medical,
p.000073: scientific, and non-scientific members whose responsibility is to protect the rights, safety, and well- being of human
p.000073: participants involved in a clinical trial. Research ethics committees review and approve the initial protocol, review
p.000073: materials to be used in recruiting and consenting trial participants, and provide continuing review of a trial protocol
...
Orphaned Trigger Words
p.000060: stopped early or unexpectedly, research team-initiated dialogue with relevant stakeholders will minimise the risk of
p.000060: misinformation.
p.000060:
p.000060: 3.15.C. Special considerations
p.000060: 1. Trials may run to completion per protocol or may be stopped early. Reasons for stopping early may be evidence of a
p.000060: clear protective effect, evidence of harm, or evidence of futility. Trials may also stop early due to other unforeseen
p.000060: circum- stances, such as administrative or financial reasons, local objection, or sudden social unrest.
p.000060: 2. In multicountry or multisite trials, sites may complete partic- ipant follow-up at different times. Thus, while
p.000060: some sites might be closed for participant follow-up, research teams at other locations may continue to see
p.000060: participants.
p.000060: 3. Where trial product manufacturers are publicly traded companies, there may be legal requirements that affect
p.000060: the timing and methods for public announcement of a trial closure.
p.000060: 4. Ownership of data, issues of publication, and release of trial results vary by trial and may be strictly delineated
p.000060: in non- negotiable terms by sponsors or product manufacturers.
p.000060: 3.15.D. Good participatory practices for trial closure and results dissemination
p.000060: 1. Research teams consult with relevant stakeholders early in the research life-cycle to develop a trial closure
p.000060: plan.The plan addresses a range of possible closure scenarios, including:
p.000060: a. Trial closure as scheduled per protocol.
p.000060:
p.000061: 61
p.000061:
p.000061: UNAIDS / AVAC
p.000061:
p.000061:
p.000061: b. Early closure due to evidence of harm, futility, or clear protective benefit in interim analyses of trial data.
p.000061: c. Early closure because of evidence of harm or of clear protective benefit from a different trial evaluating
p.000061: the same product.
p.000061: d. Early closure due to unforeseen circumstances, such as administrative or financial reasons, stakeholder objection,
p.000061: or sudden social unrest.
p.000061: 2. Research teams ensure that trial participants are provided opportunities to learn trial results before they
p.000061: are announced publicly.
p.000061: 3. Research teams consult with relevant stakeholders to develop a results dissemination plan, detailing the following
p.000061: issues:
p.000061: a. Strategies to manage expectations about trial results, including by preparing participants and relevant
p.000061: stake- holders for all possible outcomes.
p.000061: b. Planned timelines for trial closure at the site and at other sites, completion of data analyses, and availability
p.000061: of results.
p.000061: c. Procedures and timelines for those who will be informed of trial results in confidence prior to public release and
p.000061: how results will be disseminated publicly.
p.000061: d. Development and piloting of key messages, how the messages will be finalised when the results are known, and
p.000061: the range of communication methods to be used.
p.000061: e. How the messages will explain implications of the results for the area where the trial was conducted, limitations
p.000061: of the trial, and its ability to generalise findings for specific aspects, such as by sex, behaviours, or location.
p.000061: f. How best to disseminate trial results that may be of a sensitive nature or that may put certain individuals
p.000061: or groups at risk of harm or stigmatisation.
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belmont | belmont |
| blinded | visual impairment |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| crime | Illegal Activity |
| culturally | cultural difference |
| dependent | Dependent |
| drug | Drug Usage |
| education | education |
| educational | education |
| ethnic | Ethnicity |
| gender | gender |
| helsinki | declaration of helsinki |
| hiv/aids | HIV/AIDS |
| illiterate | Literacy |
| influence | Drug Usage |
| injured | injured |
| language | Linguistic Proficiency |
| linguistic | Linguistic Proficiency |
| literacy | Literacy |
| low-income | Economic/Poverty |
| military | Soldier |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| party | political affiliation |
| placebo | participants in a control group |
| political | political affiliation |
| poverty | Economic/Poverty |
| prosecuted | Prosecuted |
| racial | Racial Minority |
| religion | Religion |
| religious | Religion |
| research staff | Laboratory Staff |
| sexually transmitted | sexually transmitted disases |
| single | Marital Status |
| sti | sexually transmitted disases |
| stigma | Threat of Stigma |
| substance | Drug Usage |
| violence | Threat of Violence |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| HIV | ['hiv/aids'] |
| child | ['children'] |
| children | ['child'] |
| drug | ['influence', 'substance'] |
| education | ['educational'] |
| educational | ['education'] |
| hiv/aids | ['HIV'] |
| illiterate | ['literacy'] |
| influence | ['drug', 'substance'] |
| language | ['linguistic'] |
| linguistic | ['language'] |
| literacy | ['illiterate'] |
| low-income | ['poverty'] |
| party | ['political'] |
| political | ['party'] |
| poverty | ['low-income'] |
| religion | ['religious'] |
| religious | ['religion'] |
| sexually transmitted | ['sti'] |
| sti | ['sexuallyXtransmitted'] |
| substance | ['drug', 'influence'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input