Before you agree to be in a research study, you should understand all of the information presented in the informed consent document. However, the informed consent document is not meant to replace the discussion that should occur between you, a friend, family member, or your family doctor and the research team. If your family doctor is part of the research study, you may discuss your care with another doctor who is not part of the research study. You are encouraged to ask as many questions as necessary before, during, and after taking part in any research study. The study doctor and other members of the research team will help you understand the information so that you can make a decision about whether or not you want to participate.
You should consult your informed consent document concerning if, when, and how much you will be paid for your participation in the study. If you believe there is an issue as to how much you are going to be paid, or when, please first contact the study doctor or research team with your concerns. If you do not believe your concerns were appropriately addressed, please contact Salus IRB.
Look in your informed consent document to see if, when, and how much you will be paid for your participation in the study. You may contact the study doctor or research team at the phone number listed in the informed consent document. Sometimes it takes a few weeks after a study is over for all of the participants to be paid. The study doctor or research team can tell you when you should expect to receive payment.
All studies are different. In some studies, participants are paid, and in other studies they are not paid. You will be told whether or not you will be paid, how you will be paid, and how much you will be paid before you are asked to decide if you want to participate. Some people participate in research studies because of the potential benefits to them from the research or because they want to help doctors learn more about medicine or procedures and not because they will be paid.
The study doctor can stop your participation at any time if he/she believes it is in your best interest not to continue. Your participation in a research study can be stopped if you do not follow the procedures listed in the informed consent document or the study doctor’s instructions. Salus IRB, the study sponsor, and/or the United States Food and Drug Administration (FDA) or the Department of Health and Human Services (DHHS) may also stop the entire study if they believe it is in the best interest of the participants.
In case of an emergency, please call 911. If it is not an emergency, please contact the study doctor or research team as soon as possible according to the instructions in the informed consent document. If you believe something happened because of negligence on the part of the study doctor or research team, the informed consent document does not prevent you from seeking legal aid.
If you agree to participate in the study and sign the informed consent document, you may still change your mind for any reason, at any time. It is important that you contact the study doctor or research team to inform them that you changed your mind. Depending on what kind of study you are in, they may need to perform some tests or ask you some questions to make sure that you withdraw from the study safely.
The informed consent document should tell you if it is possible for you to view the results of the research study. Some studies do not allow participants to view their results until the entire study is complete and all data is analyzed. Please note that in some cases, this may take a very long time. In some cases, you may contact the study doctor or research team to get results concerning your participation in the study.
Any time you have questions during the study, you may call the study doctor at the number provided to you in the informed consent document. If you cannot get in touch with the study doctor, or if he/she does not return your phone calls in a timely manner, you may contact Salus IRB.
You may contact Salus IRB any time before, during, or after your participation, with questions, comments, concerns, or to offer input or to obtain information.