👋 Hello Clin Oops Pros,
If you’re reading this newsletter you probably know what an IRB is.
In fact, you’ve probably complained about an IRB. Or two.
Unfortunately, much like Gandalf, there is no way around IRBs (nor should there be).
So today, let’s talk about IRBs and how to make things smooth for your trials.
1. The Role of IRBs
OK, so we’re poking a bit of fun here.
But at the heart of any clinical trial involving human subjects is an IRB. These committees are the gatekeepers of ethical and regulatory standards, ensuring the welfare and rights of participants are protected.
They review your study design, assess potential risks and benefits, and keep a watchful eye on the trial's conduct.
Simply put, make sure research is done ethically. This is critical work.
2. Types of IRBs
There are several types of IRBs out there:
Local/University IRBs: Usually found at universities or hospitals, they're part of the institution conducting the research.
Central IRBs: These independent bodies review research protocols for multiple institutions. They're the go-to for multi-site studies.
Commercial IRBs: These are for-profit organizations that can be used by institutions that don't have their own IRB or by sponsors who want to outsource the review process.
Specialty IRBs: These are the subject matter experts in specific areas of research.
3. What’s up with university IRBs?
Working with local IRBs, particularly university-based ones, can sometimes feel like you're running a marathon uphill. Why? Several reasons:
Variability: Each IRB might interpret federal guidelines slightly differently, leading to inconsistencies. This leads to rework.
Resources: Local IRBs may not be as well-staffed or have the same level of administrative support as their central or commercial counterparts, potentially leading to slower review times.
Risk Aversion: Universities have reputations to protect, which can make local IRBs more conservative and stringent in their reviews.
4. How to work with IRBs
Getting your study through the IRB review process efficiently is a bit of an art.
Here are some quick tips:
Plan Ahead: Understand the IRB's submission requirements and deadlines to avoid any last-minute scrambles.
Clear Communication: Make sure your protocol submission is detailed and jargon-free.
Engage Early and Often: Establish a relationship with the IRB early in the study planning process.
Maintain Documentation: Keep documentation of all IRB communications and decisions. This can be useful for reference and for resolving any discrepancies.
Assign an IRB Captain: If you’ve got the resources, assign a dedicated IRB coordinator to handle the communications and paperwork with all IRBs.
And there you have it – a quick guide to navigating the world of IRBs.
Remember, the goal of all this is to ensure our research is conducted ethically and responsibly.
PS: Check out this conversation I had recently with Dan Sfera