Should IRBs get out of the advertising business?

A general rule of baseball is that runners are safe while touching a base.¹ It is the space between bases where they are most at risk of being called out. Naturally, that space is where umpires dedicate most of their attention.

A less-discussed rule is that no one can move a base. The safety of the base is not portable! The bases always maintain the exact same 90 feet² of separation. It’s pretty easy to see how the game’s structure might fall apart if a runner could simply pick up first base, tuck it under her arm, and stroll safely to second.

Noted baseball ethicist Louis “Sweet Lou” Piniella demonstrating the problematic nature of nonstationary bases

In the US, IRBs are entities registered specifically to “review and monitor biomedical research” involving humans³. They are focused on research activities only. If a CRA lies about her salary to the waitstaff at Applebee’s and then leaves a bad tip, we may not like it, but we can agree the IRB was not empaneled to review and monitor her behavior.

And in fact, IRB oversight is limited to specific research activities. If a research tech vendor lies on its tax returns, that’s not an IRB issue - even if 100% of their revenue came as a result of research. What researchers do as people and what research institutions do as businesses are generally out of scope. These are safe bases to stand on, at least from the IRB perspective.

---

One place where this distinction begins to break down, however, is in clinical trial advertising. You can divide trial ads into two groups:

1. Ads for specific individual trials. These are subject to IRB review and approval.

2. Ads for trial sites, trial databases, or trial matching services. These are “general” ads and the underlying business/service is the “safe base” that makes them not appropriate for IRB review

Here’s the problem: there’s really no clear line separating these two groups, and the people who create ads in group #2 have realized it. And they are picking up their base and slowing walking towards group #1.

We are witnessing a proliferation of ads that clearly flout IRB rules, and get away with it, simply by not directly specifying a particular trial - even when they clearly appear to be advertising a particular trial.

It’s a pretty simple progression, where ads slowly become more specific but stay safe:

• Consider joining clinical trials

• Consider joining trials for people with lupus

• Consider joining treatment trials for lupus

• Consider joining add-on treatment trials for lupus

• Join an add-on treatment trial for lupus

And you end up here:

When I clicked on this ad, it quickly became clear that this site was recruiting for a single study - so it should (in some sense of “should”) have been reviewed by an IRB.

But it also seems clear that no IRB approved this ad - the big red $3000! kind of gives that away.⁴

The site has picked up the “generic site ad” base and walked all the way through the “study specific” regulatory zone. And there does not appear to be anything that the umpires can do in this situation.

---

So where does this leave us?

It feels like the current two-tier system can’t last long. Bypassing the IRB is cheaper, faster, and has a lot fewer pesky rules to worry about! So even if people feel that IRB review is better, competition and market forces would seem to push hard against that as a standard practice. And it absolutely does seem like no-IRB ads are proliferating.

It would be great, I suppose, if regulators gave IRBs a clearer mandate to review these ads. But that would also require them to expand IRBs remit into business operations, and it would need some kind of enforcement mechanism over those operations. And not to be cynical … but that’s a huge lift, and FDA hasn’t even updated its nonbinding guidance in 27 years.

Absent that, it would fall to another regulator to take an interest in policing these ads. And that’s not the FDA, as they only are empowered to regulate treatment claims, which these ads clearly are not. So that leaves the FTC, I guess?

A final option would be to get IRBs out of the ad review game entirely. That might leave us with worse ads overall, but it would focus efforts back on the informed consent process - arguably where they should be focused anyway.

1. Of course there are exceptions! It is very hard to think of baseball rules that do not have exceptions. But for present purposes we can stick with the general case.

2. Well … like research, the declared measurement of the basepaths is very clean, but the actual implementation gets weird, inconsistent, and a little messy.

3. Also, yes, there are exceptions and variations here! We’ll just talk about the FDA flavor of IRBs for now.

4. This is explicit in the FDA guidance: “Advertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.”