Informed consent in trials of genetically modified mosquitoes – an author and reviewer in conversation – Part 2 - F1000 BlogsF1000 Blogs

"One of our goals, in writing our article, was to make the point that only a minority of individuals who have interests in the conduct and outcomes of the trials are likely to be research subjects, according to the criteria of the regulations, and only under quite predictable and narrow circumstances. It is in these circumstances, and only in these circumstances, that the regulatory requirement of informed consent should apply....

One of the main complicating features of trials that go beyond the normal individual research subject paradigm, is that there are likely to be stakeholders who stand to have their interests set back in various ways, i.e., who stand to be harmed, by the conduct and/or outcomes of the trial, but who fall outside the scope of the regulatory definition of human subject. And many of these interests will be non-obvious to IRBs, especially when they are remote from the study sites...."