Question $1$

You are the Site Investigator at a large research centre. A draft protocol has come to you $($for comments$)$ that describes planned enrolment of adolescents in a trial exploring the safety and acceptability of a microbicide gel.

You review the section on Stakeholder Engagement and the corresponding budget and are unsure how to react. It reads as follows:

$$Stakeholder engagement is considered a fundamental and critical step in ethically acceptable clinical trials. Stakeholder engagement responsibilities will be met by the establishment of a Community Advisory Board who will meet on a monthly basis. The following stakeholders will be invited: representatives of local adolescent organisations, local care facilities, local religious organisations, and local political organisations.

What comments will you provide on this section? Choose the best answer:

That certain stakeholders $($most notably representatives of parents and adolescents$)$ are missing and so the Community Advisory Board should be larger and more inclusive.

That additional stakeholder engagement activities need to be added to the Community Advisory Board plans, such as regular awareness$-$raising forums with key constituencies, and joint prevention activities in the community. A portion of the budget should be dedicated to these activities.

That, given the limited budget, Community Advisory Board membership should be reserved for stakeholders who can help ensure the endorsement, approval, and smooth implementation of the trial in this geographical community. Saved funds could then go to other important expenses such as GCP training for staff.