Now we’re going to get into some other topics of clinical research. So we’re going to talk about ethics and IRB’s (Institutional Review Boards). Sometimes they are also referred to as Independent Ethics Committees (IECs). It keeps coming up as you can see in these chapters and IRB’s govern every single clinical trial so there’s probably hundreds of IRB’s and they vary. Some are local which are the IRB’s that the universities and academic centers and hospitals must use because they have their own IRB’s. And then there’s central IRB’s. These can be used by a variety of research clinics based on whether the pharmaceutical company or the CRO, which we’re going to get into what that is later, based on who they choose to be the IRB. The central IRB, for the private clinics that don’t need to use local IRB’s and we’ll explain the difference between central and local IRB’s in a later chapter, but for now we’re going to talk about what an IRB is.
IRBs are also known as IECs “Independent Ethics Committees”.
2.1 Safety of the study participants
The function of the IRB is to ensure that every study participant is safe while they’re in a clinical trial. Furthermore they ensure that their research clinics and drug companies conducting the clinical trials are respecting the rights of the study participants as determined by the FDA and Good Clinical Practice (GCP) guidelines. Every clinical trial is overseen by an IRB. Before a trial even begins enrolling study volunteers, the IRB ensures that no human being will be put under any unnecessary risk.
Ensure that the study participants are safe during a clinical trial
For example, and this is important, if a drug company is testing a cancer drug for late stage cancer, the IRB ensures that all study participants will either receive the study drug and/or the best standard of treatment that has already been approved. This prevents these types of trials from using placebo alone. And therefore putting trial participants under unnecessary risk and immediate danger if they should be randomly assigned to the placebo.
So basically, the IRB’s role is to make sure that the study participant’s rights are being maintained and honored during the study and the IRB must approve the study before it even begins and what they usually look for, is to make sure that no unnecessary risk or no unnecessary harm is brought to the study participants. And they also look to make sure that vulnerable groups are not being enrolled, e.g. economically disadvantaged people, people who can’t read, people who otherwise can’t make their informed decision about joining the clinical trial should not be enrolled, etc. And what the IRB’s do is they make sure that the study drugs, if there is a placebo involved, that the placebo does not cause unnecessary harm to the study participant. In the United States, it is illegal to use placebo in any clinical trial that involves a life-threatening medical condition, such as cancer.
2.2 Clinical trials and ethics in third world countries
Cancer is a perfect example. In the United States and many countries, you are not allowed to use placebos. We can use our study drugs and we can use current standard of treatment for life-threatening conditions. This is where a lot of pharmaceutical sponsors went overseas to India and other third world countries and use placebo on life-threatening conditions because in the United States it’s not allowed. However, lately some of the clinical trials in India were being shut down by the Indian government because they caught on to this also. So anyway that’s the IRB’s job.
2.3 The Tuskegee Incident
This all kind of stems back to the “Tuskegee incident” which was in Alabama. It was a study where the majority of people enrolled were African-American males who had syphilis and some who did not have syphilis. If you Google Tuskegee incident you can read in depth what happened.
Basically, the majority of the study participants were African-American males. They were used for a clinical trial and they were not told it was related to syphilis. The ones who had syphilis were not told they even had the disease. They were told that they’re doing a study to stop “bad blood”, but in reality the researchers were looking to see how syphilis progresses and a lot of these people even died. The point is that a lot of these people could have been informed about what the study was actually all about, and could have actually been given treatment because penicillin became available during the course of the study. Penicillin treats syphilis but the researchers didn’t do that. They just kept the patients or the study participants unaware of the fact that they had syphilis and needless to say many people died and this was a turning point in research because from that point on we had IRB’s and that’s really good.
Most likely something horrible like the Tuskegee incident will never happen again.
2.4 Independent perspective
It’s really important to have IRB’s. It really gives clinical trials some ethical ground. The IRB’s are independent of the drug companies. They are independent of the researchers. They are composed of board members, of doctors, community leaders, people who have an understanding of clinical trials and of medicine, but who are also looking out for the rights. That’s their main purpose – is to look out for the rights of the clinical trial participants so each time there’s an informed consent, the IRB’s number is on there so the study participant can call the IRB and receive further information.
The IRB will also routinely audit research clinics to make sure that they’re doing the informed consent the proper way and we’re going to get into how to do that in another chapter. For now, just know that IRB is there. They’re in charge of any clinical trial. An IRB is in charge of and their main objective is to watch out for the safety and the rights of the patients, and to make sure that no unnecessary risks or harm is brought to the study participants because of the experiment. And sometimes protocols have to be changed because the IRB’s get involved and they say, “no this is too risky, change the protocol”. That’s their function and as a researcher you’re going to become very familiar with IRB’s when you do your studies. So let’s move on to our next chapter, Which will be about “the Rights of study participants”.
So by now you should have a good idea of the different phases of clinical trials, things like that. We’ve explained what the phases are and what type of study participants they enroll.