 Here we are going to discuss balancing benefit and risk. We have been talking about risk-benefit ratio and many other similar topics in a very earlier days of these lectures. Now we have to see that how we can balance the benefits and risks. The incidents of obvious disregard for the welfare of the participants have led to closer scrutiny of potential risks before allowing a research project to go forward. It is very important that before initiating a research project, it should be seen well that the participants who are included in that research will benefit from this research and what are the risks? A horrendous example involves the government-sponsored Tuskegee study. Tuskegee study was one of a very important and highlighted unethical research which was being done way back in the 1930s. It says that poor black, cephalitic men in Alabama were left largely untreated for the purpose of understanding how this ravaging disease progressed. Cyphil is a disease in which a different kind of rashes appear on our skin and mostly all over the body and genitals. And it creates a lot of distress and pain in any person who got that. Now, that disease is spread more than contact. To treat this disease, some specific medical treatment is given. But to study this, what could be the impact of this? How does it disturb people psychologically? What impact does it have on their lives? A very unethical experiment was designed in which about 400 people were involved with cyphals. And some of them were helped with treatment. Just to see what impact would it have on their lives if they were not treated. Which is very, very unethical. And in those 400 people, because of contact, females were also affected by cyphals. And the counterpart that was produced with them was about 19 children. And almost 49 women also being engaged in this disease because of this experiment. And a lot of people died from it. So, the unethical practices like this, which are only part of a medical experiment or some psychological impacts of medicine, or disease, if they are not prevented, what is the impact of that? And to see that in which human rights are at risk, they are considered to be very unethical. And these days, we cannot even think of having any such experiment designed, whether it is with prisoners or with some other vulnerable population. This is not considered to be justified. One high-profile case includes medical research at prestigious institutions where experts' own assessment of risk or information provided to potential participants was ultimately deemed insufficient, resulting in deaths and major impairment of volunteers. Basically, the biggest problem in this experiment was that no informed consent was taken. To participate in this research first, they were not told about the loss of information. And medical research is very important to take care of this. The pros and cons of that research are fully informed of a contract, as we discussed earlier, and we should inform our participants. Then calculating a risk-benefit ratio, it's a crucial, although often very tricky, that what is the risk and what is the benefit. In general, if the project is considered substantial and vital, the amount of accepted risk can be higher. If we specifically talk about the era of COVID, then in the era of COVID, because suddenly there was a disease where so much research and treatments were not available, then whatever medicines were available, whatever vaccines were available, although there were no prolonged researches on them, because there was no time for them, but they were largely introduced to the market by seeing their benefits, and the general population was applied. So this is also one way we can see the risk and benefit ratio, because if they were not given vaccines, then the risk was very fatal that COVID could be life threatening. So it's very easy for us to understand the risk-benefit ratio here, because compared to this, a vaccine that is comparatively safe considered and maybe has some long-term effects, then it's better as compared to having a disease, because of which you can instantly die. Especially if the participants themselves might benefit from some type of intervention. Now risk and benefit assessment. If risk are known to be low and considerable benefits may result research is likely to be approved. This is very simple formula. If the risk is low, then the research will be approved. But when known risks are high and the likelihood of benefits are low or unknown, the research will not be likely to receive approval. This is also understandable when the risk is high and the research is low, then the research will not be approved. Except perhaps when the individuals are in an irresistible state and there are no other ways to help them. Exactly giving you the example of COVID vaccination, where one side is afraid to die from COVID, and the other side is insured from vaccination, then there is an inevitable state where you prefer to accept it. Then as one gets closer to the middle, moderate risk and moderate potential for benefits, the decision becomes more complex. As research initiates, progresses, and things are more clear, then this decision becomes more complex. The risk and benefit are clearly standing in front of you. And the requirements for the consent forms that participants understand even become more critical. As we are talking about, one of the vaccinations was tried, like the vaccinations for hepatitis B were given, then the treatments for hepatitis C were given, and the treatments were changed over the course of time. Research keeps telling that this treatment is better than the treatment. As time to time, research on COVID vaccinations will be found out which vaccination is better than other vaccinations. So, you know, this is a part in which a person has to go through. But looking at the risk-benefit ratio, at the moment of that time, the researcher has to decide whether he should go for the approval of that research, or whether he is going to stop that research.