Since there is no previous experience with this kind of malaria control strategy, the possibility that the project could lead to counterproductive outcomes, or to other undesired consequences, should be considered.
For example, improper use of the rapid test with a false negative result could lead to the decision not to take the antimalarial medication, whereas if no intervention had taken place, even an incomplete treatment course could have been lifesaving.
Therefore, strong quality monitoring is required.
- A Data Safety Monitoring Board (DSMB) has been set up. This independent board is composed of four international malaria experts: Prof. Philippe Guérin, Prof. Léopoldo Villegas, Dr. Gustavo Bretas, and Dr. Jordi Landier. The DSMB has access to data from the study and immediately notifies the study coordinators if any irregularity regarding the safety of the participants is observed.
- Potential project side effects can be notified through different channels:
- Active notification by gold miners themselves using the phone app
- By facilitators during follow-up visits to distribution sites
- Passive notification through health centers
- Patient advocacy: As in any clinical study, it should be clear to participants that they are free to take part in the study and that their decision not to participate will not have any consequences, especially since participation is requested in an environment where the participant may not feel free to say no or to withdraw.
The facilitators must be ethically irreproachable. A toll-free phone number to contact an independent Portuguese- speaking person has thus been set up to allow participants to express any doubts about the way study staff is acting.
- A clinical research assistant (CRA) outside the Malakit project carries out regular monitoring of the ethical aspects of the project in each country. In particular, the CRA monitors the informed consent forms and the Clinical Trial Master File.