My industry is about to undergo some serious changes. Thousands of people in jobs like mine will have their workloads almost completely diminish, if not disappear altogether, by the end of May next year. In some of the most sweeping changes to federal regulations regarding research in my lifetime, the local review of multicenter studies that are federally funded in some way (read: nearly all of them) will be centralized to a reviewer of the sponsor’s choosing. In their best interest, they’ll select one that will be mostly likely to give a favorable review, which is not something that people in my industry are necessarily known for.
I work for an institutional review board (or IRB), which is an independent body charged with reviewing research to ensure the rights and welfare of subjects are protected. This responsibility has merged with being the watchdog to ensure that projects that are conducted, are done so in accordance with the various applicable laws and regulations. You can imagine how popular it makes us, in general. We get a bad reputation, because, at the end of the day, there’s very little any group of people actually agree on, even if you’re given a framework of laws and rules to work under. These changes in the law are mostly our own doing, because each IRB is different, and ours is known to be one of the pickiest in the country. We historically take a strongly conservative approach to the interpretations of the rules, which, as you can imagine, makes some people trying to move through a bureaucracy rather irritated. I suppose that this sort of sentiment has finally reached powerful ears.
What no one wants to point out about these changes is two-fold. The first being how many people that it will put out of a job. I imagine this is a matter of pride, because we are ethicists by trade, and we don’t think of ourselves. Except that we do, because my mortgage company doesn’t accept anything other than funds to pay the bills. The second is how much these changes benefit big pharma. In an election year, I imagine that tons of money went into powerful pockets to ensure that this approval process for medicines reaching market faster gets streamlined. Putting money and pressure on an already exhausted system only puts people at risk, if you ask me. I could cite any number of drugs that were rushed to market, only to find out that they shouldn’t have been, because the long term side-effect data hadn’t yet shown total efficacy or worse, neglected to warn us of serious complications.
So, explanations aside, what it comes down to, for me at least, is that my boss has let slip that he’s going to have a very difficult time justifying a full office after these new changes go into place. We have seen a significant slowing in production in the last year or so, unsurprisingly coinciding with the announcement of these new changes to the law. Any pharma company trying to get a new drug to market would save themselves millions of dollars in what they deem to be redundant review by simply waiting it out a year or so. I can’t say I blame them. Have your study reviewed once, or 500 times? No brainer if you ask me.
The changes go into place in May, and our fiscal year ends June 30. If I still have a job, I’ll know by then, hopefully. But considering I’m one of the higher expenditures on the capital budget and one with less tenure than the others, I’ll likely be the first cut. Of course, no one’s come right out and told me this. I doubt I’d hear it directly from anyone until it’s too late to do anything about it. The panic is slowly moving within our department. The others are doing what they can to undermine each other, each trying to prove their worthiness for being last man standing on the sinking ship. Frankly, the entire department could be eliminated and outsourced to a commercial group. I’m sure a financially intelligent person reading the budget for full time employees and resources versus outsourcing to a commercial IRB would be foolish not to cut our non-profit generating toxic family loose into the sea of futility.