Okay, so switching topics, I'm going to talk about the IRB or the Institutional Review Board. And I think the best way to talk about it is this story that came out in the early 2000's. Of of a young lady where she was enrolled in a clinical study and she died from the drug used in that, used in this clinical study looking at it for asthma. Unfortunately, they blamed the researcher. They, they actually also put some onus on the IRB Review Board at the time, and on the institution John Hopkins. So a little bit of background, 24-year old healthy adult, she's given two doses of, of a medication listed here. And this was gosh an old drug used in the 50s for high blood pressure, but it was removed because it didn't work. For this clinical study they're using this drug to study the mechanism of it in asthma. Unfortunately, as she was given two doses, couple days later she, she developed a fever. She later developed respiratory kidney failure, and she died. So what happened? So one of the first things that, that was, described in this, this, article. Was that there was very, there was inadequate avi-, evidence that the drug was safe. There ware actually publications in the early 50's of using that, the same medication, hexamethonium. And it actually caused rare cases of fatal lung disease, yet that was never included in the informed consent. It was never communicated from the to the, to the subjects that were enrolled in the study, so that was unfortunate. Investigator didn't obtain the proper regulatory approval he needed a investigational new drug application or an IND. And I don't want to give to much detail of an IND because next week you're going to have a lecture on regulatory components. regarding drug, drug development so but. Take a message, this is a big a huge a huge no no if you will in terms of not having an IND. It's required to have an IND before you start your phase one clinical study if you're looking doing that. So it's a, significant, significant finding. The other thing was the informed consent form. It was misleading and inadequate. I alluded to this earlier, but it didn't state that the drug could cause severe side effects. So you're not, there wasn't, there wasn't a full disclosure of what you know about the safety of this medication. And it didn't state that the drug was even used clinically, wasn't even being used clinically. So that, unfortunately, was not communicated. So what's the, what is the IRB? So, they're basically your I would say your shield, if you will. They're a formal approval process where they approve the protocol, the informed consent, and the clinical trial. It's re, required for all clinical trials, regardless of the phase, if it's one, two, three or four. Its independent and I think that's a key word governing body comprised of health care professionals and a patient advocate. And their role is to say alright is this study valid? Is there maintenance of ethical integrity? And what is the level of patient safety risk in essence? If you don't have an IRB approval you don't do your study. So, they are required to review the informed consent form, and to approve the language that's in the informed consent form. So the process of informed consent is that essentially it's a mechanism to communicate and disclose. The study and, and information of the study, before a subject decides to participate. So there are requirements of what has to be in you informants informed. I've listed some of them here, it's not all-inclusive. But you need you purpose, your background, study of procedures, in terms of number of visits. How much blood's going to be collected, like your total volume of blood being collected compensation for possible injury. And the process of that is that when a subject comes and say they're interested in the study. They're, it, it's on a written paper copy of an informed consent. They review it And they're provided that consent form. Any questions that may come up from the subject or, or addressed and answered at that time. But before anything is even done, before you can even touch the subject in terms of let's say for a blood draw or do a vital sign check, run an EKG. They have to provide written informed consent prior to any study procedure. I think a key point here, is that it's, it's not a binding contract. It, it's very easy where if you look at the language of an informed consent where it's like wow, this could be overwhelming. And it's very formal process, it's documented, it's you know, signed and dating. But it's important to communicate to subjects that it's not, It does not imply that once you're in you have to finish the study. So that's important to know. Is that a study, a civic has the right to withdraw at any time they feel. They have to move and they can't participate anymore or they're no longer interested. They have that ability to say you know what? I don't wan't to participate. Thanks. And they can be removed. I think this last example is really, shows you the challenge of trying to create the content of the informed consent form. It has to be kind of, you know, know your audience, right, it has to be in an eight grade, reading level comprehension. So I just have an example. Where, you know, all of us probably, consciously or unconsciously, when you are experts or know something really well. Your level of how you describe it is going to be very different from someone that's like de novo or knows nothing about it. So, a lot of these informed consent forms, the content is being developed by someone. that's either hired as a contractor by the pharmaceu-, pharmaceutical company. Or it's actually done by folks who are in the clinical operations department in the pharma company. So they, they know a lot more about this drug. So let me give you an example. So, I can see someone in, who works from a pharmaceutical company, and they know so much about it. They would probably say now, myostatin is a member of the transforming growth factor b superfamily. And encompasses a large group of secreted growth and differentiated factors, dot dot dot. So, all of it's true. It's factual. It's correct. But know your audience, right. So, rather than saying this very wordy, you know, scientifically-sounded statement, you want something that's still transparent. But short and sweet. So the alternative is, myostatin is a regulative muscle growth that is present in muscle. Essentially you've taken all the nomenclature if you will, the difficult terminologies, potential for confusion just. And you've really just kind of simplified it into a single sentence.