Answer: Under federal law, an IRB is a group of scientific and non-scientific individuals who review research studies that involve human subjects. The IRB may approve, require changes in or disapprove the research to fulfill its responsibility to help protect the rights and welfare of human subjects. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. If the IRB approves the research, the IRB continues to review the ongoing research after it starts. It is important to understand that IRB approval does not mean that a research project is safe or that it is right for you. When an IRB approves research, it means that the members of the IRB believe that the research is acceptable to present to people like you for your consideration. However, you need to carefully look at the details of the research and decide whether it is right for you. Answer: The Food and Drug Administration or "FDA" is an agency of the United States government charged with, among other things, the oversight of the development of investigational drugs and medical devices. Question: What is a clinical trial? Answer: A clinical trial is a research study involving human subjects designed to answer specific questions. The question varies from study to study. The research protocol clearly states the question to be asked and discusses all of the tests and procedures that will be done during the research study. The U.S. government requires that, before a drug or a device can be sold in the U.S., it must be studied in research and the results must show that it is relatively safe and effective for its intended use in humans. If you decide to enter a research study, be sure you know what question the research is trying to answer. Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of subjects may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Doctors and other health professionals conduct the studies according to federal, state, and local laws designed to protect people involved in research. For more information please see the following link: http://www.fda.gov/oashi/clinicaltrials/clintrialdoc.html Question: Who pays for the research to be done? Answer: The sponsor pays for the research to be done. All research has a sponsor. The sponsor may be a government agency like the National Institutes of Health (NIH), a pharmaceutical or device company, a public institution like a University or Medical College, or an individual person. Answer: The protocol is the "blueprint" for how the study will be conducted. All the details of the study are described in the protocol. The principal investigator and other research staff must follow the protocol. If the protocol is not followed, the results of the research study may not be useful enough to answer the questions the research is trying to answer. Question: What is a Principal Investigator or PI? Answer: The principal investigator (PI) is the person responsible for conducting a research project at one or more locations. The PI is usually a medical doctor. Your own physician may be the PI for a research study or the principal investigator could be a physician who only conducts research studies. PI’s often have other professionals assisting with the research study. The PI’s research team may include sub-investigators, research coordinators and research nurses. Even if there are other doctors on the research team, the PI is the person ultimately responsible for ensuring that the research is being done according to the protocol. Question: What is a research subject? Answer: A research subject may be either a healthy individual or a patient who is taking part in a research study. Question: Who protects a research subject? Answer: The subject has an obligation to learn about the research study they are considering, ask questions of the investigator, and weigh the risk and benefits prior to independently making a choice of whether to take part. Investigators (PI’s), sponsors, ethical review boards or IRBs, and regulatory agencies (such as the Food & Drug Administration and Office for Human Research Protections) also help protect the subject. Each group plays a unique role in the protection of subjects, but by working together, they can accomplish what no single group can do alone.
Question: Why would I be considered a subject/participant and not a patient? Answer: The requirement in research to follow a protocol is what makes a research study different from the medical care patients receive from their personal doctor. When people are in research studies they are subjects. When people see their regular doctor for medical care, they are patients. For a patient, the treating doctor uses his or her clinical judgment to do what is best for each patient. A patient may be started on one course of treatment, then switched to another treatment if the doctor determines that the patient is not improving, or is experiencing side effects. What a doctor does for his or her patient depends on what will be best for the patient. On the other hand, when a person participates in a research study as a subject, the PI must follow the study protocol and provide only the medical care that is specified in the protocol. Consequently the tests and medicines given to the subject may be different than the doctor would give to his or her patient. There are several things commonly done in research studies that are not done in regular medical care, such as randomization, blinding, and use of placebo. It is important to know and remember that there is a difference between being a patient and being a research subject. Question: What is informed consent? Answer: Federal law requires that people considering taking part in a research study must be given sufficient information about the study before they agree to participate. This is known as the informed consent process. If the individual agrees to participate, he/she must sign an informed consent document, which states:
Question: Who can answer my questions before I agree to take part? Answer: Before signing the informed consent document, the subject should discuss the study in detail with the PI or a study staff member. This discussion must take place in private, and the subject must be given enough time to make a decision. In most studies the subject should be allowed to take the consent document home for further discussion with others such as family and primary care physicians. In addition, the study doctor and/or staff must answer all questions to the subject's satisfaction. Examples of questions to ask may include:
Only you can decide whether a clinical trial is right for you. Only you can balance the benefits and risks and determine which are more important to you. Question: What is my responsibility as a participant in the study? Answer: You will be expected to show up for all scheduled appointments, call the study personnel if you have a bad reaction, and follow the study related instructions given to you. You may also be expected to go in for many more visits than you would have with regular care. Therefore, you may have extra costs, such as parking, babysitting and time off work. Question: What are my rights as a study participant? Answer: You have several rights as a research subject:
Question: When should I contact the IRB? Answer: If you have questions about the conduct of the study or your rights as a research participant, you should contact the IRB at the number listed in the informed consent document. If you have questions about a research related injury, contact the study doctor. Question: What are some of the reasons others participate in research studies? Answer: There are many reasons why a person may choose to be in a research study. If you are considering joining a research study, you should think about what your reasons and goals are for joining and discuss them with friends, family, a trusted health care provider and with the principal investigator or other study personnel. Talking with these people should help you determine if your reason(s) for joining the study agrees with what may happen as a result of your participation and the question the research is trying to answer. The following are examples of reasons why people join research studies:
Question: Where can I find out more about clinical research studies? More information about clinical research studies is available form your doctor. E&I has also provided some useful links to to other internet sites. ![]() |
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