[MUSIC] In this video we're going to talk about a Historical Perspective on Human Subjects Research. To give you a background on why some of the regulations that exist were created and what researchers really need to think about when they're doing research or when they're doing quality improvement. So it's important to consider these issues, because for a time, there's been a real tension between the advancement of scientific knowledge and the ethical conductive research. And these issues grow more and more as we develop more sophisticated ways of doing research. And it's important always to keep them in mind. In addition, it's important to ensure that the rights and welfare of human subjects and research are maintained and protected. So that the public trust in the research enterprise is ongoing. If the public does not trust research, then we're going to find that when we're doing research, people are going to be less willing to be research subjects. But even more importantly that as tour knowledge of healthcare and quality improvement grows, people may be less likely to trust the results of the work that is done by research and quality improvement teams. Which could actually put them at a risk of harm due to insufficient healthcare if they don't trust research evidence. So when we talk about ethics, ethics in a nutshell, is knowing the difference between what you have a right to do and what is right to do. Especially in a research environment or in a quality improvement environment, we are often working with patients and others who have trust in us and expect that we will behave in an ethical manner toward them. And it's important that we do so. So whenever you're doing research or quality improvement really important to keep in mind that knowing what you should be doing rather than what you may do. Some historical example that give us some pause and really can help us to think about why these things are important is, during World War II for instance. We know that a number of German physicians conducted painful and often deadly experiments on thousands of prisoners in concentration camps without their consent. Some of these examples are quite horrific and came out during the trials that those physicians were put through following the war. In addition, in the US Public Health Service beginning in 1932, there's a famous Tuskegee Airmen studies that were done in the Tuskegee Institute. And that was a study that recorded the natural history of syphilis. So the study initially involved 600 Black men approximately a little more than half of whom had syphilis and little less than half who did not. And since it was a natural history study, these patients did not actually receive treatment for the syphilis. In fact, they were observed to see what happened in late stages of the disease. And this went on for quite a long time before the results of this study were known. The study was conducted without the benefit of their informed consent and as a result, there were a great deal of trials etc that were conducted to get to the bottom of what happened here. And regulations promulgated to work to ensure that breaches like this did not occur in the future. The history of ethics and research actually though does go back earlier to the Nuremberg Code which was the resulted of the Nuremberg War Crimes Trials, that I referred to in the previous slide. After those trials, the court determined what were the rules for Permissible Medical Experiments. And while these weren't codified into law they did for many years provide direction for what researchers and others should be considering when they did research. So the first of these is a requirement for voluntary consent, which lives with us today. Research must have scientific merit. It was determined during the Nuremberg War Trials. Some of the research that was conducted there really did not have scientific merit and should not have been conducted and would not have been conducted under normal circumstances. That the benefits of research must outweigh the risk. And finally that subjects must have the ability to terminate the participation in a research project at any time. And so, this is really we see the start of the development of research ethics and these principles inform everything that comes after them with respect to the ethical conduct of research and quality improvement. In 1964 the World Medical Association at it's meeting came up with what's called the Declaration of Helsinki. It's a very famous, again, it's actually a document that really by some, it's considered to be the beginning of research ethics and the ethical conduct of research and the rules that follow. But what it did was it provided guidance for physicians who were undertaking biomedical research involving human subjects. And it resulted in three principles, again these are still with us today. That you need to have a risk benefit ratio when you're considering whether something should be done such that the benefits should outweigh the risks. Or and if not that at least the risks should be minimal. But really what you want to see is that a benefit, even if it's not realized by the subjects, but rather it may be a benefit that is realized by humanity or human kind. That there is a weighing of that risk benefit ratio. It was one of the first to consider that the review of research should be done by an independent committee to really look at these ethical things and to understand what those risk benefit ratio is. And confirm that its research was doing and that the risk benefit ratio is a fair one and again worth doing. And finally, and importantly begins to talk about informed consent of research subjects. So that, not that they're just voluntary, but that they're understanding what it is that they're being asked to do. Why they're being asked to do this. So what's the purpose of the research? What's the result that the research team expects to achieve and do they or do they not, having that information, want to participate? When we consider the development of research ethics in the United States, in 1978 the Belmont report was issued. And this is a result of the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It resulted in three basic principles of the ethical conduct of research involving human subjects that are really key to what the rules for research are in the United States. How review takes place and what we should be considering as we're planning and carrying out research and also, by extension, quality improvement. So we need to have respect for persons. And what this assumes is that people should be able to make voluntary and autonomous decisions about what they will and will not do. And that's again where this notion of informed consent comes in. So that we're going to say here for respect for persons, we're going to inform them about what we're asking them to do. We're going to inform them what the risks are of what we are asking them to do. And then we're going to allow them to make their own decision about whether or not they'll participate. So again, we want to see that informed consent. The next is beneficence which really means to do good, sometimes it's considered to be to not do harm. But what beneficence really talks about is that risk-benefit ratio or that risk-benefit analysis. That's an important part of looking at what are the risks to the people who we are asking to participate in our research and or who will participate in our quality improvement initiatives? And then what are the benefits that we can expect to achieve? Is it a benefit to the person? Is it a benefit to society? And do those benefits outweigh the risks? The last principle is one of justice. Justice really talks about ensuring there is an equal burden that's shared by all for the risks and the benefits. And when we talk about an equal burden, what that really means in part is that there's a fair chance that anyone can be a part of the research or anyone in the particular population of interest could be a subject in the research. And that we're not sort of cherry picking who will and will not be asked to participate.
