Table 6 Considering ways of countering burdens and maximising benefits in malaria HIS

 Physical and psychological burdens during and after the challenge event

• Important to recognise that this is a specific time when volunteers will feel very anxious. Clinical staff may also feel anxious; this is the time they are watching carefully for reactions and have equipment ready for resuscitation if needed. Both groups may need particular support, and staff must be able to communicate clearly and in ways that are trust building with volunteers.

• Skilled counselling support for volunteers may be particularly needed at this stage and should be available throughout residency.

• Informed consent processes should include more realistic information about this stage, ideally drawing on the account of past volunteers, so that there are no surprises for new volunteers.

• There is a need for openness and careful communication around all study procedures, and nothing should be done ‘behind closed doors’. Clinical staff should be aware of the kinds of concerns that volunteers typically have.

• Laboratory tours conducted later in residency period created a lot of trust; consider doing this and other similar trust-building activities earlier.

 Social, psychological and economic burdens associated with residency

• Skilled counselling support should be available to volunteers throughout residency.

• Informed consent processes should include more realistic information about this stage, ideally drawing on the account of past volunteers, so that there are no surprises for current volunteers. This might include video material used as part of engagement with potential volunteers.

• Residency should be kept to an absolute minimum period and alternatives considered where possible/meet safety requirements (for example, facilitating more open residency arrangements in local hotels to facilitate follow-up and safety checks; considering the provision of same gender accommodation).

• As much movement in and out of a research-run residency as can be managed and is safe (including third party risks) should be allowed, to include volunteers having time ‘out’ and families having time ‘in’.

• Compensation payments should be made on a regular basis, not as a lumpsum, at intervals to be determined through community engagement.

• Additional support should be given for mobile phone communication with families during residency (not part of compensation).

• Consider setting up capacity strengthening activities during residency that would maximise benefits of participation e.g. financial/business management training, and other practical skills.

 Preparing for residency and psychological burdens linked to taking contraceptives

• More support needed to individuals and their families in preparing for long residency periods, particularly when volunteers need to travel long distances from home to reach the residency. Particular need to limit repeated health checks or conducting these after travel to the research site, where this is involved.

• Clearer communication/engagement and ongoing support around the need for contraception in women volunteers.

 Preparing study staff, especially field workers to manage challenges arising from recruitment and post-study community dynamics

• Consider developing and undertaking targeted training of fieldworkers on basic problem solving, conflict resolution and effective communication skills.

• Consider providing counselling support for study staff, especially fieldworkers, prior to study commencement.

• Consider developing a standard response to study staff, especially clinicians responsible for consenting on the need and importance of the study requirement of mandatory enrolment on an effective contraceptive for female volunteers.

 Institutional readiness to respond to potential study-related crisis

• The study team and institution should consider developing a crisis response plan in the event of a crisis emanating about the study in the community or broader public.

• Consider targeted engagement with specific sectors of the public, including the media.