Book 5: Community participation

To ensure the ethical and scientific quality of the proposed research and its relevance and acceptability to the participating community, community representatives should be involved in an early and sustained manner in relevant aspects of HIV vaccine research, including the design, development, implementation, and distribution of results of HIV vaccine research.

5.1 In South Africa differences exist in status, knowledge and power between investigators and research participants, especially where participating individuals and communities are vulnerable because of socio-economic and other factors (see Points 7 and 13).

5.2 The meaningful involvement of communities in research can serve to offset the vulnerability of communities and promote their rights and welfare. Furthermore, communities have the right and responsibility to take decisions regarding the nature of their participation in HIV vaccine research (see Point 3.1).

5.3 Communities should be empowered to participate meaningfully in HIV vaccine development and research (see Points 3 and 7). Sponsors and investigators must commit the necessary time and resources required for such capacity development, and community participation.

5.4 There should be community participation in all relevant aspects of HIV vaccine research. These include the design of HIV vaccine research, the development of HIV vaccine trial protocols, the implementation of the research and the distribution of research results.

5.4.1 Investigators must clearly justify and explain those aspects of the research that are essential to a scientifically valid and ethically sound research design. Community participation should enhance the scientific quality or ethical soundness of the proposed research.

5.4.2 Community participation should involve the review of ethical aspects of HIV vaccine research (see Point 6) and communities should be empowered in this regard (see Point 3).

5.4.3 Community participation could include, but not be limited to, input into an appropriate informed consent process (Points 12.2 and 12.5.2), appropriate risk reduction interventions (Points 14.2 and 14.5), and decisions regarding treatment and care linked to the research (see Point 16).

5.5 Community participation should:

1. Enable community members to become genuine and active partners in the research process;
2. Be orientated towards mutual education and consensus-building regarding the research; and
3. Be an ongoing and bi-directional communication process. Community involvement should not be seen as a single encounter, or as unidirectional.

5.6 Community representatives should be chosen through a process of broad consultation.

5.6.1 In this process, representative participation by community members and structures should be facilitated.

5.6.2 Representation should encompass diverse sets of values and groups in the community, and be endorsed by primary socio-political structures. It should encourage the inclusion of relevant representatives from the following constituencies, for example:

1. The population eligible to serve as research participants;
2. Relevant community-based and non-governmental organisations;
3. Persons living with HIV/ AIDS; iv. Community leaders and public health officials;
4. Those who provide health care and other services to people living with and affected by HIV; and vi. Other community members who would be among intended beneficiaries of a developed vaccine.

5.7 Participants in the investigator-community partnership should develop a mutually respectful and evaluative ethos regarding their respective norms, conventions, values and expectations.

5.7.1 Investigator and community representatives are encouraged to engage in a process of ethical reflection to develop a mutually agreed upon frame of reference that can be used to resolve disputes in a manner that protects the integrity of both partners.

5.8 A continuing forum for communication and problem solving should be in place. Mechanisms for community participation include representation on existing structures, and/ or the formation of new structures.

5.8.1 There should be appropriate representation of the community on committees charged with the review and approval of the HIV vaccine research (see Point 6).

5.8.2 The formation of new structures such as Community Advisory Boards (CABs) should be encouraged. A CAB consisting of community representatives could serve a number of critical functions. These include:

1. Information flow between investigators and participating communities;
2. Education of the research team on community expectations, needs and values;
3. Education of the community on aspects of the research;
4. Evaluation of the impact of the research on the community; and
5. Voicing of community concerns.

5.9 The expectations and hopes of the community should be identified early and the research team should explicitly address these expectations by clarifying which expectations can be met and to what extent.

5.10 The potential benefits of community participation include:

1. Enhanced cultural appropriateness and quality of research questions;
2. Forum to communicate and resolve concerns;
3. Fairness and equity in a range of research decisions;
4. Promotion of trust between investigators and community;
5. Effective dissemination of information to the community-at-large on the proposed research;
6. Provision of information to investigators about health beliefs and norms of the community;
7. Exchange of information about respective values and practices; and
8. Facilitation of recruitment, retention and support of trial participants.

5.11 In some instances it may be difficult to identify a 'community' or existing community structures and organisations (e. g. in informal settlements). However, investigators are encouraged to make every effort to identify and facilitate the development of structures and processes for community participation (see Point 7.8.1).

5.12 The quality of community participation should be evaluated.