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Steps that I'll be discussing in this session, which would be good clinical practice for the GCP and the declaration of the Helsinki. So the good clinical practice and the declaration of Helsinki, they, these are the two types of frameworks that form the ethical uh and the regulatory backbone of modern clinical research, especially within the NHS. So my goal for this session today is to give you an idea of, of what good clinical practice is, what are the and and how they're applied in research settings and also touch up on the Declaration of Helsinki and why that was um implemented and what are the different components of the Declaration of Helsinki? So let's start off with good clinical practice. So again, GCP is an internationally recognized um set of ethical and scientific quality standards for clinical trials. It guides how trials are designed, how they're conducted, monitored and reported to ensure the safety and wellbeing of participants while also maintaining scientific integrity. So the purpose of good clinical practice is pretty straightforward. It's about making sure that the research data is reliable and that we protect those who participate in clinical trials. And essentially GCP is the foundation for ethical research. So GCB has some core principles and they're based on a couple of core principles. So there are four ones that I'm going to be touching upon, mainly the first one would be ethical conduct. So that basically means that every clinical trial should be grounded or, or should be grounded in ethical principles, which means that we respect the participants and we adhere to the frameworks that we set, set to make sure that the participants are safe when we conduct the clinical trials. The second one is informed consent, which means that participants must know what the research is about what the the clinical trials entails and they should be given the opportunity to give us their voluntary consent. Third thing is the clinical sorry scientific validity. So research should be based on sound science, which means they should be, we should be able to get a meaning meaningful result, a meaningful er conclusion out of the research that we're planning. And the last is risk benefit ratio. So any potential harm to the participant must be minimized and justified by a possible benefit to the participant and to the society overall. So these are the four main concepts or principles of good clinical practice. And whenever we conduct a study, we always make sure that we're following the good clinical practice principles that are set up by them. Now, there are some key components of good clinical practice. So to put those um core principles into practice. Good clinical practice has given us some specific components that is quality assurance and control. That basically means, um, we do things to make sure that the data that we gather is accurate and it's also reliable and it's maintained that way throughout the entire trial. The next is safety monitoring. So that means we're constantly looking at the participants health and we're looking to see whether they've got any side effects from any of the medications that we might be trialing them or, and we're, we're constantly monitoring them for their safety purposes and lastly adhering to the protocol. So any protocol that we set at the beginning of the clinical trial, we should make sure that we're following that protocol, we're following the study's blueprint and sticking to that makes our trial consistent and also credible. So these are the three key components that the good clinical practice proposes to any researcher who wants to do a clinical trial or, or any sort of research. Now, how is good clinical practice is sort of applied in the NHS in the NHS? The good clinical practice is especially very relevant. The NHS plays a major role in conducting and supporting clinical research and the way we, the way we make sure that we're compliant with the good clinical practice is very crucial for this. So in the UK, we've got a number of regulatory framework bodies, organizations like um M HRA, which is the medicine and healthcare products, regulatory agencies. And they basically oversee um they, they look at clinical trials and they make sure that uh any all the clinical trials are conducted within the framework that they set to make sure that we provide a high quality of data to make sure that the patients or the participants that are involved are also um monitored in terms of their safety. And we've also got other authorities or regulatory bodies like for example, the Health Research Authority hra they make sure that the ethical standards are maintained and followed. So together these frameworks ensure that the NHS maintains high level of transparency, accountability and quality within the research. So that's what the clinical practice is about. The second part of this talk would be about the Declaration of Helsinki. So this is basically a declaration of Kansi was a cornerstone document for ethical standards in medical research. It was something that was adopted after the second World War in 1964 by the World M Medical Association and it gets updated several times and it has been updated since then. So the declaration sets out ethical principles that apply to research, which involves humans. And what the declaration basically says is that we prioritize the rights and the wellbeing of the human participants over the benefit of the study that we're doing. The goal is to make to prevent uh any exploitation. And we also, and also at the same time to make sure that there is scientific advancement and it's basically the scientific advancement or whatever we're trying to find out from the research. It it it benefits both the participants and also the society as as a whole. So the key principles of Declaration of Helsinki, they also emphasize on a couple of principles. The first thing that they put forth is respect for individuals, that means participants, health, well being and their welfare would always be given a priority over our aim and objective of our study. Second is informed consent is again another big pillar in Declaration of Helsinki, which basically states that all participants should be given the opportunity to fully understand the risks and the benefits of the clinical trial that they are getting involved in. Third one is risk management which says that researchers must take every step to minimize risk as much as we can and ensure that there is a proportionate to the potential benefits. And finally, it would be the posttrial access. So to be beneficial treatments, meaning participants should have access to successful treatments after a trial concludes a principle aimed at fair treatment for all involved. Not another port of um which which basically focuses both the declaration of Helsinki and the good clinical practice. What both of them focus mainly on is informed consent. So what is informed consent and what it involves? So this is basically a critical area of focus in both good clinical practice and declaration of Helsinki. True informed consent. It involves several steps. First is we are ensuring that there is voluntary participant so that there's basically the the human subjects or the participants are voluntarily participating in our study. And we provide full disclosure of the research details. We tell them what the research is about what, what we're trying to find out what our aims and objectives are. What the drug that we're trialing is. What are the side effects of it? And what are the side effects that we know? What are the side effects? We are not sure of what we are trying to find out from the drug. And the main thing is we make sure we respect the participants right to withdraw from the study at any time. So that means if you start a patient or on a trial and halfway through, they say they don't want to take part, you should be happy to accept that as a researcher as well. Sometimes when you try to, you know, um pin down a very informed consent there, it can be quite difficult because it's not always straightforward. So some of the common challenges that you can face when you're trying to give an informed consent is the complex, the complexity of the information in a way that our scientific uh you know, concepts can be complex to understand. We have to make sure that we explain what we're trying to do, what the drug can do to the body in a way that's easy for the patient to understand, have to be in simple languages. And another thing is when we're trying to reach out um to a lot of people so that they can take part in our study, sometimes we can have people from various backgrounds, from various cultures, taking part. So to address each of those in terms of culture barrier and language barrier, it can be quite hard. Some people from some regions may understand what you're saying. Some of them may not understand what you're saying. So that can be a quite a difficult situation to handle but always ensuring that every single person, every single participant in your study has completely understood. Um what the study entails, what it's about is really essential. And the last thing is ensuring that vulnerable groups are quite protected, that can be sometimes a quite challenging and informed consent as well. So addressing these challenges is key to making sure that your research is ethically sound. So what are the ethical considerations that we need to be thinking about when it comes to clinical research? Protection of vulnerable populations is very important because some patients, maybe, you know, they can be more susceptible to coercion or they can have difficulty in understanding their rights confidentiality must be maintained vigorously throughout the entire clinical trial throughout the study to make sure that the participants health information remains very secure and does not unprotected throughout the entire study and lastly being transparent and reporting every single outcome is very essential. It's vital research studies are reported honestly, even if they don't show what you have, what you thought, what you had expected to come out, even if it's not an expected outcome, it's important that you report it honestly. So that you make sure to, to avoid any kind of um mislead in the future studies. It's important to be as transparent with your results. Now, now that I've talked about all the theory behind the good clinical practice and declaration of health. How do we sort of apply it now, applying informed consent, applying, maintaining safety, putting participants safety first can be a bit difficult, but it's very essential and it involves various roles and various responsibilities. You need to create members within the team, assign them different roles to make sure that we maintain good clinical practice principles and we cover all the components. So we usually have investigators or those, you know, the main investigator who is conducting the study must make sure that the study protocol um is followed and that the participants rights are protected throughout the entire clinical trials. Sponsors p you know, um authorities who are sponsoring provide must provide necessary resources so that you can utilize it to protect your uh participants. And they should also ensure that they are compliant with the regulatory framework and the ethical framework, Research Ethics and Ethics Committee or the R EC. They should conduct an independent review of the research to make sure it meets all the essential ethical standards. So regular good clinical practice training is also important because that ensures that the every member of the team, every member of the research team is uh has understood what good clinical practice is and they can be updated on the regulatory requirements and the best practice. So all of this training, regular training is essential to make sure that we always maintain high standards in research. So II think I've covered various parts of good clinical practice, what it means and also the declaration of Helsinki, all of them mainly focus on making sure that our clinical research is ethically sound. We're not doing any harm to the patient. We're trying to maximize the benefits. We are protecting the participants, we're protecting their rights, we're protecting their safety while also making sure that the study that we do give us the maximum outcome. So the take home points from the from good clinical practice and the declaration of Helsinki would be, they form the ethical foundations of all clinical practice and they focus on respect consent, risk, benefit analysis and transparency. And within the NHS, this is much more important because it ensures that the research that we're conducting is safe for all the patients within the NHS. So I hope you were able to get some sort of an idea about good clinical practice and what it means. It's not this topic is not something that you should essentially know, uh, when you're working in the NHS at a junior level. But it is important. You get an idea, um especially when you're working with um other members of the team, within the research team, you should be able to understand what good clinical practice is and what the declaration of Helsinki is. Um And if you've looked at my previous videos, I have talked about um a course that you can do, which is a good clinical practice course. It's an online course and it's in the NIH R website, I'll put the link on the chat box for all of you who are interested. So it's an online course. You do get a free certification that goes towards your CPD points. Um And it's something really good to have in your CV as well if you're applying for jobs. So do check them out and um and you, well, you can learn much more about good clinical practice as well. So thank you for your time today. Um If you've got any questions, feel free to pop them in the chat box, I can answer it or if you think um you might have questions later on, feel free to send me a message or email me as well. So we do have a couple of more um sessions coming up which will focus on how to critically appraise or do an appraisal of a paper, how to write up a research paper. What are the different opportunities that you can have within research in the NHS or outside the NHS? Um And the last part would be about just a very interesting topic about what fraud in research basically means. So, thank you for your time and I hope to see you in another session. Thank you.