Give an example of successful stakeholder engagement in protocol and/or IC development. What changes were made as a result of the input gathered?
At our site a few years ago, the members from DAIDS visited our unit and discussed the length of ICs in microbicide trials with peer educators and members from the community (CWG members). This was a useful exercise as the members explained that the length of the ICs in English was long and when translated in the local language it is even longer making it difficult for participants to internalise all the information. After a day of discussions and consultations with the community members, it was agreed that a short form of the IC will be a way forward. However, the process of implementing a short IC with key information is ongoing and we continue to have lengthy ICs in biomedical clinical trials. Fortunately. the use of graphic tools and various material to explain the study to participants and community members has contributed to better understanding of the research procedures. There is discussion on ensuring that ICs have relevant information for decision making among participants and their family members and relatives. This engagement also helped community members understand the purpose of providing the key information to participants thus achieving mutual understanding of the IC information and length of the forms.
2) If a protocol gets sent to your trial site in final form, how would you address the GPP recommendation for stakeholder involvement in protocol development?
This is a common practice within projects where it is not always feasible to engage the community at the trial site but there was community engagement at national or network level. Thus, we explain that although the site community may not have been engaged on the protocol, there was community input by a national or international CAB member. We also invite the site community members to share their feedback and concerns which may not always in changes but it is possible to amend protocol. To be honest and transparent with the community about the process helps with understanding that it is not always feasible to engage the community when the protocol is being drafted as this is dependent on sponsors, resources and logistics. The GPP and other community guidelines must be explained and shared with the stakeholders so that they know their roles in the research process.
