Dr. Holly Fernandez Lynch

That's the company that is trying to get its product through the FDA approval pathway.

So that sponsor, before they can even start testing their drug in human beings, they have to go to FDA and

and file an application and say, here's what we're planning to do.

Here's how we're going to protect the research participants.

Here's our study design and why we think it's going to generate the evidence that you need, FDA, to decide whether we've met the standard for approval.

And FDA will grant approval of that application, allowing the company to begin doing their tests in people.

The other party that's involved is what's called an institutional review board or an IRB.

But really what their responsibility is, is to look after the rights and welfare of the people who are going to be enrolling in a research study.

So the IRB is evaluating the study based on the risks and benefits.

It wants to make sure that the benefits are reasonably likely to outweigh the risks.

The benefits that we're talking about, though, are not necessarily limited to benefits to the research participants, because the reason we do research is actually to generate knowledge for the benefit of other people, right, future patients who are not in that study.

The main difference between an academic IRB and one of these commercial IRBs is their structure.

So at a university IRB, there will be a committee of volunteers, right?

So it'll be some professors from that university and some outside individuals who are included on the committee.

But the key difference is that the commercial IRBs

it is the sole job of those IRB members to review protocols, right?

They're not also responsible for teaching and research and other service to their university.

This is all they do, right?

It's their full-time work.

So there's a benefit to that, right?