Hazir, please correct me if I'm wrong, but I think we're using the term 'payer issue' in a different context. My understanding from your post is that you think payers (which, in most of Europe, boil down to governments) are not interested in paying for the upfront cost of PrEP so they have intentionally slowed regulatory approval of Truvada for this indication. IMO that's vaguely conspiratorial and probably incorrect; most of the interactions I've had with regulatory agencies in this vein gives me very little reason to believe that there is that level of political interference in the process (though I know the US system much better than the EU system).
When I say it's a payer problem, I mean to say that Truvada should in principle be available in the EU for PrEP as an off-label use - physicians can look at the data on its efficacy themselves and prescribe Truvada for PrEP even without official sanction of that indication (at least I assume this is so; US doctors routinely use/prescribe off-label therapies and are fully in their rights to do so). When I say it's a payer issue, I mean that I assume national payers (generally the government) won't subsidize the cost of PrEP without European approval of that specific indication, which is taking a bit longer than you'd like. But it's not a regulatory issue per se unless I was to believe that approval was being delayed for political reasons.
But to be honest I haven't followed this story with any level of interest, so take what I say with a grain of salt.
Hmm. There's definitely a grain of truth here, but he's being intentionally obtuse (probably for comic effect). Most of the bureaucratic things he complains about have excellent reasons for existing, even for an ostensibly low risk study like the one he describes. And he bellyaches about this 22 page form he needs to fill out, when vast swaths of it could be filled out with a simple N/A - and, even better, his institution even HAD a shorter version for precisely this kind of purpose. It's not their fault that he didn't do the basic legwork to figure out what he needed to do - in my experience, it's reasonably well laid out on the various IRB websites/forms/etc. for any given institution.
I have done a lot of work on animal studies, including getting protocols approved, and it's almost as laborious a process, involving lots of training, large numbers of forms, and a back-and-forth with the IACUC (which is essentially the animal version of an IRB). The considerations are different - obviously consent and protecting personal information are not issues with animals - but there's still a lot of bureaucracy even for ostensibly simple studies. I've found that in general, the process can take a bit of time but is relatively painless if two conditions are met: 1) you do your homework and 2) your institution's IACUC is doing their job, which is to help researchers craft protocols that meet statutory requirements. It sounds like in this case neither condition was met; maybe the institution had relatively little experience running human subjects research, or the clinician scientist was particularly obtuse (clinicians are notorious for being pretty awful at putting together a good research study and following through appropriately), but it clearly resulted in a suboptimal outcome. That is not the norm for a well-run institution.
He claims that the system is rigged against the little guy who doesn't have an army of compliance people to jump through regulatory hoops. To an extent he's right (and big companies do tend to welcome regulations that increase the barrier to entry in their market), but IRBs and the associated legal requirements have not generally been driven by these concerns, but rather by pretty reasonable concerns about human subject welfare and the ethical challenges of experimenting on humans. And some of the concerns he pooh-poohs - such as privacy issues - are very much problems that would effect human subjects even for ostensibly low risk studies.
There are a lot of great resources for IRBs for the 'little guy' - essentially contract IRB organizations that work with small companies and institutions that want to run human subjects research. They work very hard to streamline the process as much as possible in the framework of the law, and could easily whip up a protocol and get it rapidly approved for the little guy. Maybe it would have been better for the author's clearly small-scale IRB to outsource this function to someone who knows what they're doing.
There's obviously scope to try to loosen some of the more onerous requirements for very low risk studies like those described by the author; no one really questions the value of an IRB for the kind of work Flixy or I might be doing. And I think it makes sense to make a 'fast track' IRB category specifically for this kind of work. But that doesn't mean that you shouldn't be trained in appropriate research practices, get informed consent, or worry about patient privacy, or go through some sort of review process.