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Posted by jdeese25 on 27 Sep 2011 at 15:20 GMT
We applaud the authors’ effort to generate discussion regarding ethics in the HIV PrEP trials. However, the data collection and analysis methods detract from the strength of the authors’ conclusions. Most significantly, the 101-item checklist developed does not necessarily represent items that one would expect to find in the target documents – i.e., protocol, consent, registry and report. For example, in FEM-PrEP, IRB written procedures were collected and reviewed for all reviewing IRBs and DHHS assurance documentation obtained to ensure competence of ethics review despite that this is not discussed in the protocol or participant consent form. On the contrary, the checklist is so finely tuned that it is more reasonable to look for such items in trial Procedures Manuals, Standard Operating Procedures, etc. In addition, prioritization of items would be very useful given the length of the checklist. While the authors clearly state their objective is to evaluate reporting only in the target documents; we question how much weight this approach adds to the discussion. A more meaningful analysis may have included an in-depth review of additional trial procedural documents.