Informed consent
- Participants must give informed consent before any trial procedures are undertaken. The trial information sheet and informed consent form must be approved together with the protocol by an ethics committee. See our template information and consent form in the drop down menu below which can form the basis of your own form for a malaria efficacy trial. We've included some suggested text to cover the relatively new area of data sharing (in anticipation for secondary data analysis).
- In malaria-endemic settings where some participants cannot write, a finger print may be used instead of a signature, as long as a literate witness is there to assure the information given was accurate.
- Consent is an on-going process, participants should continuously be asked for their willingness to continue taking part in the trial and assured that withdrawal will not mean that they will not be treated for their illness. Changes to the trial protocol affecting the participants should be communicated to them in a new approved informed consent process.
- In certain circumstances, such as with children (minors) or for incapacitated persons, a legal representative (a person who is able to consent to treatment) can give consent. In some studies older children may also need to give their assent.
View the related resources
Procedure
AD06
A suggested process for how informed consent may be obtained from competent adults in a typical antimalarial clinical trial
Version: 2.0 Author: WWARN