Information For Participants Welcome to the website of the UCLA Office for Protection of Research Subjects (OPRS). This page was created for members of the public.
UCLA is committed to protecting the rights and welfare of people who volunteer for research. Volunteers are also known as "subjects" or "participants." This page has basic information about research and about the rights of research participants. We hope this information will help you make informed choices if:
TABLE OF CONTENTS (click a topic name to go straight to the topic, or scroll down to read the entire page) What is research? WHAT IS RESEARCH? Research is an organized way of collecting information to help understand problems and test ideas for the benefit of society. UCLA faculty, students and staff do research in many different areas. Humans might participate in research about things like:
You may have heard the phrase "clinical trial." That is a name for research about health and illness in people, especially when the research compares treatments or uses experimental drugs or devices. A drug or device is called "experimental" when the U.S. Food and Drug Administration (FDA) has not approved it for any use. A drug or device is also "experimental" when the FDA has not approved it to treat the illness that is being studied. [Click here to return to the Table of Contents] Participants help researchers in many different ways. Depending on the goals of the research, participants might be asked to do things like:
[Click here to return to the Table of Contents] HOW DOES UCLA PROTECT PARTICIPANTS? It is a privilege to involve people in research. UCLA takes this privilege very seriously. Federal regulations, state laws and University of California policies require that UCLA protect the rights and welfare of research participants. The sections below describe some of these requirements. Everyone at UCLA is responsible for following these requirements. Every participant receives the same high level of protection. This is true no matter who pays for the research or where the research actually takes place. [Click here to return to the Table of Contents] WHO REVIEWS AND APPROVES RESEARCH AT UCLA? One way that UCLA protects participants is by having special committees review most research involving people. These committees are called Institutional Review Boards, or IRBs. UCLA has 5 IRBs of its own. UCLA sometimes relies on the IRBs of other organizations. UCLA IRBs include both scientists and people who are not scientists. Most of the members are UCLA faculty and staff. There are also members from the community who do not have any ties to UCLA. IRB review and approval must happen before the research starts. An IRB must make sure that:
An IRB can require changes to research, or even not allow research, to protect participants. When an IRB approves a researcher's plan (called a protocol), the researcher must follow that plan exactly. UCLA also has other committees to review specific issues. Examples of these issues include financial conflicts of interest, cancer research, the safe use of x-rays and other radiation, and the use of stem cells. The IRBs work closely with these other committees to help protect participants. If you are asked to join research, but you are not sure if it is approved, you can contact the UCLA Office for Protection of Research Subjects (OPRS) to check. OPRS is an office that helps the IRBs. [Click here to return to the Table of Contents] WHO WATCHES OVER RESEARCH WHILE IT IS BEING DONE? The IRB stays involved even after it approves research. If a researcher wants to change the plan, an IRB has to review and approve the changes first (unless changes are needed right away to protect participants from harm). When problems come up, researchers must report those problems to the IRB. The IRB must also review the research at least once a year to make sure that it is going as planned. Some sponsors (organizations that cover the costs of research) inspect the research they support. The government can also inspect researchers and IRBs to make sure that participants are being protected and that regulations are being followed. Sometimes medical research studies use special committees to look at detailed information about the research while the research is going on. These committees follow special rules for stopping a study. A study might be stopped if it meets its goals early or if it looks like the study will not meet its goals. This can also happen if safety problems come up more often than expected or if problems are more serious than expected. [Click here to return to the Table of Contents] WHAT RIGHTS DO I HAVE AS A PARTICIPANT? It is your decision whether or not you want to participate. In most cases you do not have to decide right away. You have the right to make this decision without any pressure. There will not be any consequences if you refuse. You do not have to participate in any research offered by your doctor. To help you make an informed decision, you have the right to receive information about the study. Information will almost always be given to you in writing (written study information is called an "informed consent form" or "research information sheet"). The information must always be in a language you can understand. The type of information you will get is described in the next section below. If you do not understand something, the study team must explain it for you in a way that you can understand. You have the right to ask questions at any time and to have your questions answered. If you decide to participate, you will be asked to sign and date the informed consent form. You have the right to receive a copy of the signed and dated written consent form. You also have the right to leave the research at any time. If you leave the research, your decision will not affect your relationship with UCLA or UCLA Medical Center, or any rights or benefits to which you are entitled. [Click here to return to the Table of Contents] WHAT INFORMATION SHOULD THE RESEARCHER GIVE TO ME? The researcher will usually give you the information listed below. Some of the information below will only be given to you for medical studies.
If you are concerned about any issue or you do not feel like you have enough information, tell the researcher at any time before, during or after the research. While you are participating, you also have the right to be given new information that comes up. This information might include changes to what you will be asked to do, new risks or new treatment options. If you are given new information, you will be asked if you are still willing to stay in the research. [Click here to return to the Table of Contents] WHAT WILL HAPPEN IF I VOLUNTEER FOR RESEARCH AT UCLA? You will be presented with information about the study. This is called the informed consent process. Members of the study team, including the researchers, will discuss this information with you. They will usually ask you questions to make sure that you understand the information. Once you understand the information and decide to participate, you will be asked to sign the consent form. You might also be asked to sign other documents, such as a form giving permission to use your medical records. Before you go through informed consent, the researchers might ask some basic questions about you. This is to see if you might qualify to participate. If you answer questions before giving informed consent, the researchers might still need more information about you after you give informed consent. This will be done to make sure that you qualify. If you are in medical research, this might include a physical examination, blood tests or other procedures. Even if you give informed consent, you are not guaranteed a place in the research. In some cases, researchers can accept anyone who volunteers. In other cases, researchers can accept only a certain number of people or only people who fit exactly what they are looking for. If you do not qualify, it does not mean something is wrong with you. It just means that the study was not for you. There might be other studies that you qualify for. If you qualify for a study, you will go through the exact steps of the approved research plan. What you undergo during the research should be exactly what is described in the consent form. What will happen (and for how long) depends on the goals of the research. Sometimes researchers will be able to work around your schedule. In other studies, visits might have to happen at very specific times. All of this should be explained to you during the informed consent process. [Click here to return to the Table of Contents] WHAT ARE THE BENEFITS OF PARTICIPATING? Researchers are searching for new information and new answers to problems. Because of this, most research is not intended to provide you with direct benefits. Research can also have serious risks. When you participate in research, you are mostly contributing to scientific progress and helping society. Research is not the same as treatment. In medical research, many of the drugs, devices and procedures being tested are experimental. This means that they have not been proven to work. There may be unknown risks. Although being in a medical study might help you, nobody can guarantee a direct benefit for you. [Click here to return to the Table of Contents] WILL I BE PAID FOR PARTICIPATING? Payment will be explained to you during the informed consent process. Some studies do not have the resources to pay you. Other studies might pay you for the time and effort it takes to participate. The money is usually only enough to cover expenses (parking, transportation, meals, etc.) and maybe for some of the time you spend away from work. The payment should not be enough to convince you to take risks that you normally would not take. If you leave before the end of the research, you will usually be paid for that portion of the research you complete. [Click here to return to the Table of Contents] HOW DO I PROTECT MY RIGHTS IF I VOLUNTEER? The most important thing to do is take an active role and communicate with the study team before, during and after the research. You should always ask questions if you are not clear about something, if you are curious about something, or if it seems like the research plan is different from what you were told. You have a right to have your questions answered. Take your time making decisions about whether or not to participate. You should seek the advice of trusted family members, friends or healthcare professionals before and during the research. If you feel uncomfortable with what you are doing, or if you think you might be experiencing changes in your health (whether good or bad), let the study team know so that they can help you. Always keep in mind that participation in research is voluntary. If you feel like you are being pressured to join or stay in a study, you can always say no. You can leave the research at any time for any reason, and you do not have to explain your decision. You can also contact the UCLA Office for Protection of Research Subjects (OPRS) with questions about your rights, or any problems or complaints about your experience with research at UCLA. [Click here to return to the Table of Contents] WHAT HAPPENS IF I LEAVE A STUDY? You always have the right to leave the research at any time and for any reason, and you do not have to explain your decision to anyone. For example, you might feel less comfortable than you thought you would, or maybe the research takes up too much of your time. Nobody should pressure you into staying in the research if you do not want to. You do not have to, but you might want to discuss any problems with the researcher before leaving. They might not be able to do anything if the research plan is not flexible, but it might be helpful for them to know why you can not continue. If you leave a medical study, you might be asked to come back once or twice for some extra safety tests. This is to make sure that you are not having any problems related to the study. You do not have to come back, but it is usually important for your safety that you do. [Click here to return to the Table of Contents] WHAT HAPPENS WHEN THE STUDY ENDS? When you complete everything (or if you leave early), that is usually the end of your participation. The consent form might describe extra contact with the study team after the study. The researcher might send you information about your participation, including any new information that might affect your health. If you were taking an experimental drug, sometimes you may be able to continue taking the drug. You might be asked if you are willing to be contacted about other research in the future. At the end of the study, the researchers put together all the information they have collected. They will analyze that information. They might be able to publish the results in scientific journals, present the results at conferences and use the results to get grants for more research. Sometimes the study information from UCLA will be combined with information from other places doing the same study. If a drug company paid for the research, the company might use the information to help get a product approved by the U.S. Food and Drug Administration. [Click here to return to the Table of Contents] WHERE CAN I FIND RESEARCH?
[Click here to return to the Table of Contents] WHERE CAN I FIND MORE GENERAL INFORMATION ABOUT RESEARCH?
[Click here to return to the Table of Contents] HOW CAN I GET MORE INFORMATION ABOUT MY RIGHTS OR DISCUSS A PROBLEM? If you are already participating in research, you are encouraged to communicate with your research team first, especially if you are experiencing medical problems. You can also contact the UCLA Office for Protection of Research Subjects (see contact information below) for help if:
If you contact OPRS, every precaution will be taken to maintain your confidentiality. If you report a problem, we might need to reveal your name or other information about you in order to investigate the problem. A representative from OPRS will contact you before revealing information about you. You may contact OPRS by phone, fax, mail or e-mail. UCLA Office for Protection of Research Subjects Telephone: 310.825.8714 [Click here to return to the Table of Contents] Last Revised: February 11, 2008 |
