Does a commercial relationship necessarily hamper ethical review?
In the US, around 70% of clinical trials are reviewed by commercial/independent Institutional Review Boards (IRBs). These are normally paid by the trial sponsors and could, it can be argued, be under pressure to give favourable reviews. After all, in an open market, why chose an IRB that might give your trial a hard time?
The situation is massively different in the UK, where Ethics Committees (ECs), are either run by the NHS directly or by universities and hospitals themselves.
Non-commercial IRBs do exist in the US – also associated with hospitals or universities, but these have a reputation among many sponsors of being “less-efficient.” Of course, this could just be another way of saying “more difficult to work with.”
There is consolidation within the commercial IRB sector, with larger IRB, or even private equity firms, snapping up smaller IRBs.
So why bring this up now?
In June, the US National Institutes of Health announced that virtually all US-funded trials carried out at multiple research centres must start to use single IRBs. Only a few non-commercial IRBs are large enough to take on trials like these, so this could be a further boost for commercial IRBs.
Maybe, I’m just being; does the data actually point to a problem with commercial IRBs?
Between 2008 and 2014, the US FDA reported twice as many violations and problems with commercial IRBs as with non-profit boards. However, given the fact that 70% of IRB count as commercial ones, I’d be really surprised if they didn’t!
Understandably, commercial (they prefer the term “independent”) IRBs maintain that they provide a faster and more effective service than hospitals and universities without compromising quality.
It’s certainly true that larger independent IRBs can have access to have more advanced technology, which can in turn allow them to have better oversight of multi-site.
Ultimately, it is hard to judge the relative performance of IRBs because they don’t tend to publicise exactly how they make their assessments. Although the FDA is supposed to oversee the work of IRBs it doesn’t have sufficient staff to do so for a significant number of the thousands of studies in the US each year.
One of the strengths of systems like Infonetica’s Ethics Review Manager, is that is lets committees formalise their decision-making processes. They can ensure that different types of application automatically go to different committees for approval and can generate a clear audit trail showing precisely how each decision was taken.
Ethics Review Manager is used by many committees in the UK and a growing number of commercial and non-commercial ones in the US and Canada – maybe the other “independent” IRBs should take note! Read more [here]