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I am happy that my paper provoked a response from the Health Research Authority (HRA) and that they have taken the opportunity to clarify this area—I want to respond in part to some of their comments, while accepting that some are accurate.1 ,2
While I am gladdened that generic advertising must now be submitted for review for stage 1 clinical trials since 2013 (there was some crossover between the original conception of the paper and this time period), I have to say this is at best only partially reassuring.
First, this is only partially reassuring because of the focus on stage 1 clinical trials—of course, non-specific trial recruitment can be used for all sorts of studies not only stage 1 clinical trials, so it would appear there is still a substantial regulatory gap to be filled here.
It is also worth noting that currently the online ethics approval application is at best unclear about providing copies of generic advertising to the approving research ethics committee since plausibly this is not recruitment literature for ‘this study’ an investigator may well mistakenly not submit it. Hence, it would be good to further clarify this on the Integrated Research Application Service (IRAS) form to avoid confusion.
But more importantly, I am a bit concerned with the decisions that seem to be being made given the norms that I suggested in the paper are well established, it seems difficult to equate these with the adverts that were described in the paper, whether the committee looked at these or not. Taking, for example, the trials4us website that has, we are told, been reviewed—there are requests to volunteer your friends for money, offers of payment for participation (not compensation but payment) and strong suggestions that by doing so you are helping people—all things that typically are not allowed by Research Ethics Committees during direct recruitment. Typically, this kind of advertising would be considered coercive and misleading and thus to invalidate informed consent.
Given this, I wonder what norms The Phase 1 Generic Advert Review Group is operating with and how the HRA guidelines were formulated. This is not to suggest that these norms and guidelines are necessarily wrong—there is after all a body of literature arguing against the standard Research Ethics Committee (REC) take on inducements in research. Nonetheless, the disharmony between the decisions of this group and standard judgements made by RECs is disquieting, and a broader discussion of this would be valuable I think.
This leaves open the broader question I raised in my paper—should we harmonise the norms of direct and indirect recruitment and, if we should, which direction should we move in?
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