[Santorra]

In terms of having a negative impact on a particular protocol, our site has not had many issues when it comes to a stakeholder being less than fully or minimally involved. The closest occurrence that I can think of would be when we invited a city council member to one of our UCAB (United Community Advisory Board) meetings–both because she had not been present at a meeting in some time and because results of the HIV/AIDS 2020 summit and the protocol for the AMP (Antibody Mediated Prevention) Study were going to be discussed. This particular council member is very active in her district and takes pride in looking out for the best interest of those living there; especially since residents in some areas within her district are considered as marginalized or having a low socioeconomic status. Although she agreed to come to the meeting, she showed up late and missed a great deal of the background information about the AMP Study and missed the HIV 2020 discussion entirely. She did, however, hear one of our PIs speak briefly about funding the study. She then began asking questions about how much participants who decided to join would get paid and, she didn’t like the answer. When our PI asked how much she thought we should pay participants per visit, she stated something to the effect of $200 to $300 citing that $75-$100 per visit was too low for people in her community to get for joining an “HIV study”, especially when [our university] has billions of dollars. Although we understood her sentiment, she assumed that because we were affiliated with a university, that that meant we had plenty of money to compensate participants. She forgot about the cost of study materials, the study drug, and other costs associated with developing and implementing a clinical trial (and that we’re not funded by the university itself). An open dialogue about compensation and ethics during a clinical trial began after that, which is great; however, in the end, the councilwoman told us that she couldn’t, in good faith, recommend such a low-paying trial to people in her community. I am not really sure if she ended up expressing her point of view to her constituents because she has not been to another meeting and, as I mentioned, there has not been a negative impact on any particular protocol thus far in terms of recruitment. I do think, however, that not having a mutual understanding with such an important stakeholder could eventually lead to repercussions.