Predicting What Sites Will Perform
I am Dr. Jeff Kingsley and this is another edition of Riding in Cars With Researchers! We are doing a series for you right now on how you can predictively choose sites that will perform for you on everything that you need over time. As I said in the last edition, “Will they always perform every single time, on every single point?” No. But that doesn’t mean they aren’t professional baseball players, they aren’t professional research sites. Last time we talked about infrastructure. High degrees of infrastructure implementation allows a high degree of predictability that those sites will perform for you. Today we are going to talk about bureaucracy.
Bureacracy in Research
You can find sites that have a lot of infrastructure but they’ve, in fact, become very slow and sluggish….very bureaucratic. Some, not all, academic medical centers have become very bureaucratic. They’ve become slow. Those sites will tend to underperform for you. So what do you need to look for? Local IRBs. A local IRB is a red flag. Is it a hard stop? No. It’s a red flag that you are dealing with an old-fashioned bureaucratic organization. It’s going to have slower turn around times for you and less of a nimble attitude towards your unique needs for your research protocol.
What else should you look for in bureaucracy? In contract and budget negotiation, do the negotiators require two or three layers of approval with each round of negotiations? That’s a clear sign of a highly bureaucratic organization. It’s a strong sign that that organization will be slow, will not pivot to unique needs of your research protocol, and will not perform consistently on your research protocol in a way that you need from a site. Are these hard stops? No. Are there examples of organizations that have to use a local IRB but are, in fact, not very bureaucratic? Absolutely. Are there examples of sites that have policies that require a couple of layers of approval, yet they are not very bureaucratic? Yes. Is it common? No.
Dig Deeper in Site Selection Process
Use these signs as evidence you might be dealing with a bureaucratic organization. And use it as a reason for you to dig deeper in your site selection process. It’s not a hard stop, but a reason to ask more questions. And if you find high degrees of bureaucracy, it’s not just in contract and budget. It’s not going to be just in regulatory. It will be baked into the culture of that organization. It tends not to be siloed into one section of the organization. You can anticipate that there will be high degrees of bureaucracy in that organization. Consider it in your site selection process. It’s that balancing point between bureaucracy/processes and great implementation of infrastructure. The balancing point between the two is the sweet spot for you in choosing the right sites.
Low infrastructure equals low performance and high bureaucracy equals low performance. The balancing point in between is what you need to look for.
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