The relations between the investigators and the community change with the path of time. Currently, to listen to those beneficiaries of the researches, their families and organized patient groups is an excellent practice within people who conduct researches. The active participation of the community in clinical research is a relatively new area that is in full development among the actors that are part of this process. This advance undoubtedly constitutes a significant and fundamental innovation in the clinical research process.
In this sense, what CIOMS proposes in its seventh guideline is:
COMMUNITY INVOLVEMENT: “Researchers, sponsors, health authorities and relevant institutions should work together with potential participants and communities in a meaningful participatory process that includes them in an early and sustained way in the design, development, execution, design of the informed consent process and monitoring of the research, as well as the dissemination of its results "
From CICAL we carry out two tasks in relation to this guideline:
- The Community Advisory Committee:
The way of interchanging opinions with the Community is by means of Community Advisory Boards, known as CABs. CICAL organizes and sponsors the CAB of Argentina for IMPAACT, INSIGHT D2EFT, HPTN 083 y MOSAICO HVTN 706 studies.
What is a CAB?
The CAB is a group of people belonging to the Community summoned by the investigators to give their opinion as regards to the different phases of a clinical research, its methods and its way of information disclosure. Moreover, the CAB coaches other community members in relation to the research.
In order to activate a CAB, this CAB needs to be located in the place where the clinical research is developed. The CAB has a specific function. It works nor freely neither independently from a research structure.
What is a Community Representative?
It is a person who due to the personal, historic and social features can express the ideas of others who are in the similar personal, historic and social conditions. This is an inductive way of identifying concerns, necessities and desires of a bigger population.
How do we do it?
Our function is to allow the participation in the development and idea-sharing of clinical research priorities and the balance within the priorities of the research, the community and the investigator (HANC HIV/AIDS Network Coordination, DAIDS).
CAB in Argentina.
It was born in 2005 by an initiative of the Net of Clinical Essays INSIGHT and in 2009 IMPAACT was incorporated. From that moment on, it has been working continuously.
Worldwide CAB
In the 80´s, a group of people infected with HIV imposed their research and development agenda before public and private entities, making their voice to be heard. This fighting experience has turned into a collaborative society that includes hundreds of people worldwide through international nets of clinical essays.
What elements are involved in a CAB?
Population, those for which the research is conducted; investigators interested in their tasks and in the Community with whom they will work,people able to interpret and conduct the ideas from one side to the other.) - The educational platform Academy of Community Representatives ACERCA:
ACERCA is a platform where through simple cartoons and interactive classes we provide tools for community education about clinical research, its processes, risks and benefits, among other topics.
This is a free-to-use platform, anyone can access and use it to learn more about the research process. ACERCA is very useful for community educators when it comes to informing the community about how to get involved in the research process, following the ethical guidelines proposed by CIOMS.
This platform is developed by the CEI IRB with the contributions of CICAL and UNSW.