A draft protocol that was to be implemented in the site was send to the CAB as is common they were expected to fill a questionnaire that asks whether the protocol answers a scientific that is relevant to the site, and whether if they qualified they would participate in the study. the CAB noted that Phase I IND protocol planned to enroll 18 subjects. They disliked the use of world subject because it make people like object that can not exercise any right. They insisted this be substituted with either volunteers or participants. This was changed to participants,
When a protocol is send to the site in the final form, to comply with the stakeholder engagement guidelines the protocol will be presented to the CAB to review informed Consent document this has been our practice. We have now learned that other stakeholders targeted likely to be affected by research ought to be reached, and their research literacy build so that they can be able to make informed opinion about planned research. It will be easy to have their buy in and help in addressing misconceptions.
