[MUSIC] Hi, in this module, I'm going to be talking about the protection of research subjects. That is, how it is that we seek to ensure that the people who participate in our research studies do not suffer or experience adverse consequences, as a result of having helped us by participating in our study. Let me back up and give you some background on what we mean when we talk about the protection of subjects in social research. We basically have a consensus now that the risks of subjects in studies, in any kind of study, medical, social science, etc. The risks associated with participating in a study should not outweigh the likely benefits of the research. Now for almost all social science research, I think it's safe to say that we have an agreement that only minimal risk to participants is acceptable. There is little social science research that might be so promising in terms of its ability to save lives or somehow transform and improve society. That it would somehow justify anything other than the absolute minimum risk to the people that are kind enough to take the time to participate in our studies. By contrast, for biomedical research, things can get more complex. You may be talking about curing cancer or curing some other fatal disease, in which case, we may think that some higher level of risk, the risk of side effects from a drug that is being tried out. That risk may be acceptable because of the potential pay off in terms of the lives that might be saved and so forth. Now the basic principles for human subjects' protections evolved in The United States and elsewhere especially during the 1970s. In the United States the basic principles that are now at least universal in North America and many other places were laid out in what is known as the Belmont Report in 1979. The application of these principles, which I'll mention in just a second, really focused initially on medical research, because of some scandals that I'll talk about later. But as time has gone on, we have come to appreciate the importance of paying attention to these principles when it comes to social science research. So the basic principles are respect for persons, are we showing appropriate respect for the autonomy of the people who are taking the time to participate in our studies? Beneficence, are we seeking to benefit society overall? Are there benefits to be associated with the research that outweigh the risks that may accrue to particular participants? Finally, justice, is the benefit of the research broadly spread? And are the, you might say, penalties or the risks associated with participating in the research also broadly distributed? If we think that they're not evenly distributed, if they're not balanced, then we may have a problem. Now let me talk about each of these three principles in a little more detail to clarify what we mean when we talk about them. The first, respect for persons, again, this means respecting people's autonomy, taking them seriously as people who can make choices and make decisions. Here are one of the most important things that we focus on, is what we refer to as informed consent. Are the people in our studies, when they participate, are they doing so voluntarily? Do they understand the risks that may be associated with participating in the study? This requires special consideration when we are thinking about studies that may involve people, I'll give examples later, who may not be able to give consent freely the way that most people can. Beneficence, so, our general goal is to maximize possible benefits, minimize potential harms. So we don't want to conduct research, where the potential harm to the research subjects somehow outweighs the value of anything that we might learn as a result of conducting the study. And justice, from what groups are the subjects for the study being recruited? And what groups will the results of the study benefit? I think we would agree that there's some inequity if, for example, we are recruiting subjects from one particular group to conduct our research and perhaps putting them at some risk. In order to conduct research that may be of benefit to some completely different group that is not involved in participating in the research. So, these are all basic principles that emerged out of the Belmont Report, in which we have to think about as we assess the potential consequences of our studies for the participants in our research. I want to give you some background about why we care about this so much. So these consistent standards for the protection of research subjects are actually relatively recent, essentially emerging as I mentioned or taken more seriously starting in the 1970s. Well into the mid-20th century, researchers in the United States and elsewhere were subject to very little oversight when it came to the ways that they dealt with the people that participated in their studies. There were scandals and controversies that led to the recognition of need for standards to make sure that the interest of research subjects were protected. That they would not be harmed unduly as a result of participating in a research study. The Belmont report was the first step in laying out a set of consistent principles for protecting research subjects' interests. The standards now continue to evolve as new methodologies develop and as new risks are recognized. Let me review some of the scandals and controversies to help clarify why this issue is so serious and how bad can things go wrong in the absence of these kinds of standards. One of the worst examples of the violation of the interests of researcher subjects was the famous Tuskegee Experiment. In the 1930s, African American men, who had been diagnosed with syphilis, were left untreated for decades to observe the progression of the disease. As you probably know, syphilis is a terrible disease. In its later stages, it can cause madness, eventually, death. These men, though, were left untreated. They were not told of a cure when it became available. This all became public in the early 1970s, several decades later. And it was one of the scandals that, in fact, led to the need for a commission that produced the Belmont Report. The Stanford Prison Experiment, in this famous experiment, research subjects were divided into guards and prisoners in a simulated prison. The idea was to understand the dynamics of prison life and the interaction between guards and prisoners. The experiment quickly went out of control when the people who had been assigned to be, quote, guards, began behaving in a notorious and unpleasant fashion, mistreating the prisoners. And, indeed, conversely the prisoners began to become violent, or, in some cases, experience psychological harm. The experiment was allowed to continue, even when it was clear that it was completely out of control, and it was harming the people that were involved in it. The Tea Room Trade, this brought to our attention the need for privacy and confidentiality standards. A researcher studying men who had sex with strangers anonymously in public places misrepresented himself to his subjects and failed to disclose that he was conducting research. Putting the privacy and the confidentiality of his subjects at risk and putting them at great risk. And if their identities had become public, many of them would have experienced terrible loss and terrible suffering. So what we think about in terms of the actual risks associated with social science research, we generally think of them as being different from the ones that we are concerned about when it comes to medical research. So as we know, subjects in a medical study, we have to accept the possibility that they may suffer physical harm because of side effects or mishaps when they are administered novel drugs or given novel therapies. This is something that is accepted, and the people that review medical studies to assess the risks for human subjects have to think very carefully about these issues. It's very complex. For social science research, broadly speaking, the main concern, or the issues that come up most commonly, are what we refer to as informed consent and the preservation of confidentiality. In some cases, we may also worry about the risk of psychological harm as a possible consideration as a result of participating in certain kinds of studies. The risk of physical harm that we worry about for medical research is mostly indirect. Perhaps a violation of confidentiality that results in information being leaked that puts a subject at risk of physical harm. But it's rarely a direct concern. So to help assess whether or not proposed studies comply with standards for the protection of research subjects, most institutions in North America, and indeed elsewhere, now have what we call Institutional Review Boards, or the equivalent. The basic procedure is that researchers planning a study involving human subjects submit their protocol, their plan, for review to their institution's IRB. The IRB will review the protocol to assess the risks to subjects and how they balance with the benefit's potential of the research and how they comply with the other principles that I just talked about earlier. The boards are typically made up of both experts in research, as well as lay people who clearly do not have a stake in the outcome of the research. The IRB may come back and require changes, changes to the protocol to help safeguard the interests of the subjects. Now normally, an IRB is not suppose to comment on the design of the research, except as it affects the risks to human subjects. Or they normally do not comment on the topic, although there are sometimes exceptions. The IRB normally is supposed to be specifically focused on the wellbeing of the subjects in the study, seeking to protect their interests. Now obviously, in something like this, and when you think about the diversity of different types of research topics, the diversity of research methodologies, these issues are all very complex. And in the remaining modules, I'll talk about some of the specific issues related to social science research in a bit more detail, as well as some of the issues that come up in international research.