Screening visit (07.02 2019)
Today’s the day! After having spent years working in healthcare and medical research ethics, I’m finally getting a chance to participate in a clinical trial. My screening visit is in just a few hours.
A clinical trial is a way to test medical (or dental) products, to try to weed out any that don’t work very well. Or products that could do more harm than good. These trial have to be finished before a new prescription medicine or medical device can be sold. Before it can be used for, or by, patients.
There are a lot of government regulations – laws & rules – about how to run these research projects. One of them is that each planned project has to be approved – before it can start.
Most governments rely on something called a Research Ethics Board (REB) to approve, or reject, each research plan. In the US, the name for these is an Institutional Review Board (IRB). For some IRBs, the “I” stands for “Independent“.
The members of the REB/IRB work like a government committee, with votes and written notes about each meeting and decision. There may be a government employee on a REB/IRB, but in most parts of the world that’s not needed.
I used to manage a REB/IRB, so I know how they run! The members will read about the research study, and ask lots of questions, before deciding if it can be approved.
They might meet with the researchers. Sometimes they’ll decide that some things have to be changed, before it can start. Then they’ll review the whole project again, once the changes have been made.
To be able to make those decisions, the REB/IRB has to read a lot of documents. Examples are the research ‘protocol’ and ‘product monograph’. The protocol is a step-by-step plan; what the researchers want to do, and how.
The product monograph is different. It gives technical details of the product to be tested; how it’s supposed to work, and what it’s for.
Another very important research document, that the REB/IRB has to approve, is the informed consent form. It’s usually called an ICF or ICD; for ‘informed consent’ and then form or document. Giving consent, or consenting to something, means agreeing to it.
Informed consent happens before a research participant can start in a clinical trial. And it keeps going all through the study. The researchers have to keep checking that a person still agrees to be in the research project. At each step of the study.
(There are some times when this only happens after a study, but the REB/IRB has to say it’s okay to do that – before it happens! Maybe a new product that can only be used on patients who’ve been shot, and aren’t conscious or awake to give their consent.)
The ICF gives a short explanation of the protocol and product monograph. Most clinical trial documents are written for doctors & scientists, so have a lot of scientific terms and words.
The ICF is written without those scientific words, so research participants who aren’t doctors can understand it. And sometimes doctors are participants in clinical trials – because they get sick, too.
Research participants are the volunteers who’ll be testing the product. That might mean taking an experimental medicine, like a pill. Or having a surgeon use an experimental tool (device), during a surgery.
One of the things a REB/IRB will do is read the ICF. An REB/IRB has to have a member who’s not a scientist or doctor. That person will very carefully read the ICF from a research participant perspective. To be sure it’s understandable.
The REB I managed had every member review each ICF. I’d ask them to read it from the point of view of someone they knew – who might be asked to be in a research study. I’d always imagine my grandmother reading the ICF. A colleague would imagine her dad.
This was my way to remind all the REB members that research participants are… people. Our friends, colleagues, even loved ones.
And today, because of a disease I was struck with almost 3 years ago, I’ll be reading an ICF again. But this time as a research participant!
If I qualify for the study, that is. That’s the point of my screening visit today, to find out if there’s any reason I can’t be in the study. Maybe a medication I’m taking, or something in my medical history, will mean that I can’t participate.
Stay tuned! In the meantime, here’s the poster for the clinical trial I might be in: