Speaker 1: Hello. If you're thinking about participating in a research study, you may have a lot of questions. Informed consent is the process researchers use to give you the information you need about the study and to answer your questions so you can decide if you want to participate. The Federal Office for Human Research Protections, or OHRP, made this video to explain the informed consent process. There are many reasons that might make you think about joining a research study. Perhaps you want to help other patients or society. Or maybe you hope that joining a research study will allow you to try out a new medicine for your condition. However, participating in research can have risks. While you might receive benefits from being in the research, it is also possible that you could be harmed or have other unwanted consequences. For example, volunteers in a clinical trial testing a new drug might benefit from more medical attention for their condition, but they might also experience harmful side effects of the new drug that researchers didn't know about. So before you decide to volunteer for research, you should have information about the study so that you can consider the reasons for why you might or might not want to participate. Informed consent is the process you go through to get this information and make your decision. Through the consent process, researchers will explain the study to you in detail to help you understand what they will do and what you would need to do while participating in the study. Sometimes researchers will explain the information to you orally, but they will usually also give you the information in writing to review and keep. This is called the consent form. You should read it carefully. If you don't understand the information or if you have questions, ask the researchers to explain it to you. It is their job to answer all of your questions. If you would feel more comfortable reading the consent form or asking questions in a different language, ask for an interpreter or a translated version of the document. It is important for you to understand how participating in the study might affect you. The consent form should tell you why researchers are doing the study and what they are trying to find out. It should also tell you why they are asking you to participate. For example, maybe researchers are testing a new therapy because they have reasons to believe that this new therapy has fewer side effects. Or perhaps they are studying a new way to provide assistance for people with the same illness, so they may be asking you to join because you have this illness. Finally, the consent form should also tell you what you would have to do in the study and how much time it would take. The consent form should also tell you about the risks and benefits to you if you participate in the study. It is important that you know how being in the study could affect your health. If there are risks to you, you should know how researchers will minimize these risks and how they will monitor your health during the study. Researchers should answer any questions you have. Of course, risks from participating in research studies are not always just about your health. For example, in a study about illegal drug use, there is a risk that sensitive information about volunteers could get out. This could damage their reputations or create legal problems for them. The consent form should explain how researchers plan to keep your participation confidential and protect the information you provide from getting out. It should also say whether researchers plan to use the information you provide in other research studies. As for benefits, if you join a medical study, you might benefit from better monitoring of your condition. However, there may or may not be other medical benefits. For clinical trials that test new medications or medical procedures, people sometimes think that joining a trial means they will automatically get a new and better treatment. But it is important to remember that the reason researchers are doing the research is to find out if the new treatment is better. They don't know yet. The consent form should make it clear what benefits you might expect from participating in the research or if there are no benefits that you will receive directly. For this kind of clinical trial, researchers should explain what they know so far about the new treatment and how it is different from the regular medical care that you get. The consent form should let you know if there are other treatment options for you without joining the research. You can discuss these options with your regular medical doctor as you consider whether to participate in the study. Considering these options and thinking about how being in the study might affect you will help you make a decision about whether to participate. The consent form should also tell you how researchers plan to do the study. For example, in a clinical trial that is testing a new treatment, oftentimes not all participants will get the new treatment. Clinical trials often assign volunteers to different treatment groups randomly. Some volunteers get the new treatment and others do not. The decision about who is in each group is often done randomly, like flipping a coin. This means that as a volunteer, you cannot choose which group you are in and you might not get the treatment that you want. You may not even find out which treatment you got until the study is over. So if you have a strong preference for one of the treatments, you might not want to join this type of study. The consent form should describe all of this clearly, so you can consider the reasons you might or might not want to join. Remember that participation in research is voluntary. This means that if a researcher asks you to participate in a research study, it is up to you. You can agree to participate or you can say no. You should face no negative consequences for saying no. And if you say yes, you can still change your mind later, even after the study has started. Informed consent is about giving you all the information you need to make a decision about participating in a research study. Use the information you get to think through how participating in the study or not would affect you. It is about helping you make a decision that works for you. If you choose to participate, you can sign the consent form. If you choose not to participate, you don't have to sign the form or do anything else. OHRP has created a website called About Research Participation to help you learn more about participating in research. The website has many helpful resources, including videos that cover topics such as what research is, how research is different from medical care, and what clinical trials are. You can also find a list of questions that you can print out and take with you to remember what to ask the researchers when you meet with them. To print this list of questions and see other information about research participation, check out the OHRP website at www.hhs.gov forward slash about dash research dash participation.