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Every protocol is aim at addressing gap in knowledge which will accumulate evidence that will inform policy decision. We engaged policy decision makers and top government functionaries through a process called administrative approval. We usually write and get to make presentation to them on the protocol synopsis (too busy to read ) and require that they officially flag-off activities for the protocol implementation. This usually lead to the involvement of their technical team and create a sense of ownership. It’s slow the process but in a long run it’s helps because both the IRB approval and the administrative approval issued are view as instruments of government authority.
Addressing a finished protocol, I will organize protocol review meeting with key stakeholders including an existing CAB.
@Erica, This just happened to us at the site. The best way is to identify the authentic success of information for any community and saturate that source or sources with accurate and up to date information such that the opinion of a negative deviant will be investigated by the people who are gate keepers and have the influence to speak in your favour.
If the population is an urban heterogeneous environment, the media will be the best place to saturate with quality and up to date information. If the community is homogeneous then you need to saturate the leadership with saturate with accurate and up to date information.
We only interviewed the people within his circle of influence and saturated them with accurate information and the situation was addressed naturally.
Safety first. First to place a call to any of the members and find out about their safety. The PI should be informed to immediately convene CAB at a secured place to initiate the process of investigation and issue management planing.
Most often the staff at the facility are also at risk so safety SOP need to implemented immediately with security doors at the entrance.
Before starting the study, the team is suppose to do community mapping and establish code of conduct in public places to avoid unnecessary attraction.
What surprise me from the learning on this course is about ISSUE MANAGEMENT. In our design of research implementation plan, we never thought of documented approach to handling conflict through an issue management. We rather focused on conflict mitigation which has helped prevent any major issue. I now know better that we have to plan for these unforeseen events if they does happen.
Stakeholders engagement is about relationship building ultimately establish trust. Human beings psychologically get connected to people and groups that over delivery on their promises. In the instance the CAPRISA team brought more that research. The ensure development of the entire community and eliminated any barrier to community and access. One way to sustain relationship is designate the community as a research centre and in between research provide social amenities as much as resource can permit. We provided mosquito nets and borehole to our designated research village which was well celebrated.
Formative research to some extend could be said to be a feasibility study and involve in several ways the element of community engagement especially the qualitative approach. Focus group discuss (FGD), In depth interviews, Key Information Interviews (KII-Interviewing people who are in position to know) and community mapping are formative research (qualitative) methods and at the same time community engagement strategies that yield quality information about study feasibility. Both are similar in so many ways and what differentiate both is the intention of the research team.
Our current effort (Ebola) was very sensitive in nature so community engagement and consultation was done as an informal formative research. Key informant interviews, stakeholders consultative meetings and focus group discussions yielded quality information for planning.
Respect for the research team. Somehow stakeholders in their wisdom tends to respect researchers who carry them along in study design because it is a learning opportunity for them and as custodians of social, political and leadership mandate, they fill a sense of responsibility and fulfillment.
In one instance the CAB requested for a toll-free line and we immediate got that set up. They were excited that we are transparent in our operations and willing to answer questions from the public.
For CAB, the main indicator is meeting attendance.
We all know that research is actually the process of taking a path that is unknown and unforeseen so we must prepare our mind for rejection and accept rejection as part of the process. When we work with this mind set everything became easy to handle because we make everything “foreseeable” and anticipate worst scenarios. We need to design a conflict mitigation plan. For instance, in an event of strike what immediate actions should the participant take? Who should participants call, how should they protect themselves etc, What actions should the staff take, security doors must be lock at all times, who should they call, who should be reported to, what changes need to be instituted in recruitment/follow up, who should draft press briefing materials, who should address the media etc. It is the confusion associated with crisis management that have huge negative impact on trials.
Our research team as constituted at the moment place priority on stakeholders engagement because of the country’s (Nigeria) experience with Pfizer litigation in the past.
Our protocols are reviewed by the ethical review board before commencing any form of implementation.
Relevant national stakeholders are officially communicated for administrative approvals and paid advocacy visits to brief them and share the protocol in acceptable format.
The broader stakeholders which involve associations of medical doctors, nurses and laboratory personnel are engaged during their continue professional education (CPE) sessions.
Community stakeholder engagement is based on two strategies namely demand creation which is focus on potential volunteers and conflict mitigation which deals with individuals and groups that could potentially oppose the trial. The media is involve from the beginning with key message development that is usually reviewed by a broad based Community Advisory Committee constituted for the specific research.
The composition of the team for each assignment is based on team members who have competence, social connection and understanding of the working of the groups and individuals.
Best of weekend
It is even best to engagement in the key message development workshop or get them to review the key messages before moving ahead with the process.
Those who do not support the trial are usually very vocal. It is very important to seek and involve them at the design stage or as early as it is practically possible. Their opposition may lead to distractions that may be difficult to manage, Our team usually segment our community engagement process in to two namely demand creation and conflict mitigation. It is important to actively identify such people or groups and pay them advocacy visit as part of the process of conflict mitigation.
