Now we’re going to talk about the rights of the study participants and you as a clinical researcher need to be aware that study participants have rights. This is the core of clinical trials. The first thing that a study participant is given when they come into a clinic is the Informed Consent.
3.1 Informed consent
The informed consent spells out everything about the clinical trial. It’s going to talk about the purpose for the study, why this study is being done, what are the known side effects, what are the procedures for the study, what are the emergency contact numbers. It’s going to talk about the IRB which we have discussed before in a separate chapter – what the IRB is, what the purpose of the IRB is and it’s going to tell them their rights.
3.2 Rights of the study participants
Now every single study participant has rights and we’re going to get into this topic a little bit more and in a future post, but every single study participant has the right to be fully informed of the risks of the trials, and must give full informed consent. They can stop participating at any time for any reason, or no reason at all, and they can refuse any research procedure done. These are basic human rights in clinical trials.
So for study participants, it’s best that they are fully informed about the details of the study and the research clinic also has the right to withdraw the study participant for any reason. So let’s say that you are a researcher and you’ve enrolled a participant in your study for the high blood pressure study and you noticed that it’s causing a weird side effect in that person or something that you just don’t think that patient should deal with. Even if that patient wants to continue in the study you can withdraw him/her and actually you should withdraw him if it’s putting his or her health at risk. These are things IRB’s look at which we keep talking about and we’re going to get into.
3.3 Regional and geographical differences
Now every country, and even state, has their own variation of bill of rights. But no matter where you live, research clinics must follow good clinical practice and we’re going to have a topic on this too – GCP which the FDA enforces.
3.4 Study participants are de-identified according to GCP
Good Clinical Practice Guidelines pretty much have the bill of rights covered as well. You also must respect your patient’s and study participant’s privacy. In the US, this is governed by HIPAA. This is the reason why study participants that are enrolled in a study they are de-identified. So you may get their name and signature on the informed consent and you might have their address on file, their phone number on file, their social security number etc. But the study sponsor, the drug company will never be able to see who that person was and they shouldn’t because they are de-identified. So this is why they are given numbers, unique identifying numbers. So the study sponsor may see their initials and their date of birth, and the rest is a number. It’s not a social security number because that would identify them. It’s a unique study number assigned for the purpose of the clinical trial and we’re going to get into what a screening visit is and what randomization visits are as well. But for now I think the next chapter we could focus on IRB’s since I keep talking about them so much.
In the next chapter we’re going to discuss how unwanted side effects are being handled during a clinical trial. Continue to read more about adverse events (AEs) and serious adverse events (SAEs).