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in kind of the name of science and in health are pretty, quite astounding. So we’re going to explore that. And then we’re going to talk about why the Belmont report is so important, especially as we’re moving into the realm of AI. You know, AI is being utilized in health care to make decisions for providers. What is the you know what are the ramifications of that, as far as privacy, as far as lots of different whole host of things. So anyway, we’re going to just kind of start with the history, so sit back and relax. It’s a little worrisome, isn’t it? I think we really need to kind of pump the brakes a little bit and and see what we’re dealing with. especially in healthcare. Prior to 19 0 6, when the Pure Food and Drug Act was passed, there were no regulations regarding the ethical use of human subjects in research. There were no consumer regulations, no food and drug administration, no common rule, and no institutional Review Board. A well-known chapter in the history of research with human subjects opened on December 9, th 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war, crimes and crimes against humanity. Among the charges were that German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent. Most of the subjects of these experiments died, or were permanently crippled. As a result. as a direct result of the trial. The Nuremberg code was established in 1948, stating that the voluntary consent of the human subject is absolutely essential, making it clear that subjects should give consent, and that the benefits of research must outweigh the risks. although it did not carry the force of law. The Nuremberg code was the 1st international document which advocated voluntary participation and informed consent. In the late 19 fifties Thalidomide was approved as a sedative in Europe. It was not approved in the United States by the FDA. The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus. Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babies were born with severe deformities due to Thalidomide. Us. Senate hearings followed, and in 1962, the so-called Kefauver amendments to the Food Drug and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety. For the 1st time drug manufacturers were required to prove to FDA the effectiveness of their products before marketing them. An equally well-known chapter in history occurred during a research project conducted by the Us. Public health service. 600 low-income African American males, 400 of whom were infected with syphilis, were monitored for 40 years. Free medical examinations were given, however, subjects were not told about their disease. even though a proven cure, penicillin became available in the 19 fifties. The study continued until 1972, with participants being denied treatment. In some cases, when subjects were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many subjects died of syphilis during the study. The study was stopped in 1973 by the Us. Department of Health Education and Welfare. In 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. The Declaration governs international research, ethics and defines rules for research combined with clinical care and non-therapeutic research. The Declaration of Helsinki was revised in 1975, 1983, 1989 and 1996, and is the basis for good clinical practices used today. Issues addressed in the Declaration of Helsinki include research with humans should be based on the results from laboratory and animal experimentation. Research protocols should be reviewed by an independent committee prior to initiation, informed consent from research participants is necessary. Research should be conducted by medically or scientifically qualified individuals. and risks should not exceed benefits. Finally. the Belmont Report was published in 1979, with attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. The report is a statement of the basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. The Belmont report established 3 basic ethical principles, respect for persons, beneficence and justice, which are the cornerstones for the regulations involving human subjects. Okay, so when you hear that. What surprised you? You know what really kind of stood out that you know. To me it amazes me that they found a cure for syphilis, and they kept that that going, knowing that those men had syphilis, why didn’t they just go ahead and give them the cure? Why did they keep going with that right? They were studying people who already had syphilis, but if they had a cure for it, why in the world would you keep something going like that. If you had a cure, why, why would you do that to me? That’s the most ethical. It does. It leads to total mistrust. So that’s why. You know. And if you go read about some of the Nazi experiments oh, my goodness, they they are atrocious, some of them. So that is, historically, where a lot of our informed consent, you know, patients have. Yeah, they did. It is very, very sad, knowing that there was a cure for it. That’s what that is what is so sad to me. So And if you really go read about it, some of the wives were infected because they didn’t know so it really kind of kept moving you know, through the families and so forth. So it’s just an atrocious unethical really, punishable by law, right to me. So now that we’ve looked at some of the historical context, that kind of resulted in the Belmont report. Let’s talk about They were trying to figure out what it did. You know, we didn’t know a lot about it at that time, so but it’s still, you know, if you have a a a cure for something, and you can help somebody, why in the world, unless they consent to it. But still you. this is so unethical. Think about the Hippocratic oath. Do no harm right for for providers and researchers that’s not our goal. So I don’t know. There’s there’s a lot of problems when you go really read through the entire thing. So some of it is just totally astounding. Yeah. And they’re trying different drugs. But syphilis, we know. You know, if there was no cure for it, you would eventually die, and then they spread it to other people, too, because they didn’t know they were infected with it. So that is just so. Think about, you know the wives, maybe the children, you know it. Just it’s just yeah. It’s not It’s something that really kind of it hits you hard when you, when you read stuff like that, it went on until I think it closed out in 1972. And if you go look, they actually got some some awards. You know recognition. I think it was in 1995 that there were monetary awards given to the family members of those poor souls. So you know. all right. So when we talk about consent. Right? Those men did they? They consented to you know, to a study. But wow! There’s just so much, you know, and that’s why we had good intention. Yep, our mental hospitals were too exactly. They had people just they would just admit them right. They just go go put them in there. In fact, they were some a big story. I don’t know. It’s in Louisiana. I think it was, if you, if you remember Governor Long. his brother. I think they had him committed to a mental institution, so he couldn’t run, or something like that. They didn’t give the wow. So there’s a there’s a ton of stuff like this, right? So we really need to revisit and and look at. You know, if we don’t look at things that happened historically, then we’re bound to repeat them again is the way I look at it, and if we don’t show this, if we don’t look at it. And if we don’t all say, Okay, this was this was terrible. We can’t let this happen again. You know, we have to talk about it. We have to put it to the forefront so that everyone it remains aware of it. So let’s talk about consent now a little bit more. Wow! Yep, so there’s a lot of things that that are out there that you can. That that really kind of you know, go against the grain, right? So let’s kind of delve a little further. Now sit back and relax another, you know, 4 min or so. and this one is a little longer. Today we’re going to talk about the Belmont report, one of the most important documents, arguably the most important document in the field of modern bioethics. In this video we’ll talk briefly about the history of the report, define human research and then briefly explore the core principles of the report. In our later videos, we’ll delve more deeply into those concepts and their background. The Belmont Report was compiled in 1978 and published in 1979 by the National Commission for the protection of human subjects, of biomedical and behavioral research which we’ll just call the Commission. The Commission was tasked with creating ethical principles for human research. That is any research where humans play a role as subjects from cutting-edge medical treatment to genetics, to psychology. While the report wasn’t the 1st document on human research, the Nuremberg trials of Nazi war criminals, for example, laid out principles for ethical research on human subjects. It was positioned at a crucial historical moment with emerging human research horizons in the Tuskegee syphilis study, which ended shortly before the formation of the Commission. Researchers tracked the progression of untreated syphilis in infected black men, but they neither told those men about their diagnosis nor its implications, and they withheld treatment for the sake of watching the disease progress. New questions were arising in fetal research, genetics and psychology about what researchers could ethically do to their subjects in the name of science. And so in 1974, the National Research Act created the Commission to provide expert insight into the boundaries and principles for ethical research on human subjects, from philosophers, medical doctors, psychologists, and theologians. Among others. Almost everyone mentioned in this video served the Commission as a consultant and published papers in the Appendix which we’ll discuss in later videos. No, most videos will just jump right into the 3 principles of the Belmont report right here. But we aren’t most ethics classes. We’re interested in moral philosophy, not just a quick set of rules. We want to know why these are the rules, not just what they are to do, that we’re going to go back to the originary question of the reports. How do we define and ethically navigate research on human subjects? And why does this matter for future healthcare professionals, especially if we don’t plan to do research for most of the rest of this video, we’re going to define what research even means in the context of healthcare. We can start with an easy opposition from Robert Levine. A patient is a client of a healthcare professional, who will by definition have the patient’s best interests in mind. SUMMARIZE THIS POST

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