1. What is an “IRB”? IRB stands for either an “Institutional Review Board” (such as a hospital or a university) or an “Independent Review Board” (not in an institution such as a hospital or university).

An IRB is a group of people (or a “Board”) who review research to make sure that it will be done safely, and to make sure that the rights, safety, and welfare of research participants are protected. The members of the Boards are usually physicians, and may also be psychologists, pharmacists, and members of the clergy. There may also be other members of the community such as teachers or home makers who do not have scientific backgrounds. IRBs follow the rules of the United States Department of Health and Human Services and the Food and Drug Administration (FDA). IRBs were formed to make sure that people are never involved in research studies without their knowledge or permission, and without first understanding what their participation will require, and what may happen to them in the research study. The Study Doctor could not conduct this research without approval from an IRB. Before approving a study, the IRB considers:

the possible risks of the study
the possible benefits of the study
the ways the Study Doctor will protect the privacy of participants in the study
the way the Study Doctor will make sure that the research participants are fully informed of their rights

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2. What does RCRC IRB do for me? RCRC IRB is dedicated to protecting the rights and welfare of research participants. The Members of the Board review the Informed Consent Document to make sure it provides enough information about the research in terms you can understand so that you can decide whether or not you want to participate. They also review the research plan. If the Board feels the research plan is safe, they will approve it. Sometimes they make changes to it so that it can be conducted more safely. About one year later they will review it again.
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3. What is “Informed Consent”? The Study Doctor or a member of the study staff will discuss the study with you and explain the information in the Informed Consent Document. If you feel you have enough information to make a decision about your participation, this is considered “informed consent”. Even if you decide to participate now, you may change your mind later and decide not to continue in the study. Taking part in this study is your choice; you do not have to take part in this study. Before you make your decision, you should have all of your questions answered so that you will know the following:

the purpose of the study and what is being tested
the procedures to be followed, and any drug or device that will be used
any risks or discomforts that are known and can be expected
any potential benefits, that can reasonably be expected
any alternative treatment options that are available, and their relative risks and benefits
how to seek medical care if there are complications
anything you do not understand in terms that you do understand
that you have the right to withdraw your consent at any time
that the Study Doctor or study sponsor may withdraw your consent at any time
that you will be given a copy of the signed and dated written informed consent document
that you will be given the opportunity to decide to consent or not to consent to a research study without the intervention of anyone, without fraud, deceit, duress, coercion, or undue influence.

Once you have had all your questions answered and are ‘Informed’ about all the information above, you are then able to decide if you want to be in the study and give ‘consent’ to take part. If you decide to participate in the research study and sign the Informed Consent Document, you should keep it in a safe place. If you have questions about the research related procedures you can read about them in this document, or contact the Study Doctor at the number in this document.
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4. Who should I talk to before I choose to participate? Before you agree or disagree to be in a research study, you should understand all of the information presented in an Informed Consent Document. However, the Informed Consent Document is not meant to replace the discussion that should occur between you, a friend, family member, your family doctor and the research staff. If your family doctor is part of this research study, you may discuss your care with another doctor who is not part of this 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 staff will help you understand the information so that you can make a decision about whether or not you want to participate.
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5. How much money will I be paid? 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, please first contact the Study Doctor or study staff with your concerns. If you do not believe your concerns were appropriately addressed, please let us know and we may be able to help.
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6. When should I receive the money?You should 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 study staff at the phone number listed on the informed consent, to ensure your payment is going to be given to you as scheduled. Sometimes it takes a few weeks after a study is over for all of the participants to be paid. The Study Doctor or study staff can tell you when you will receive payment.
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7. Why am I not getting paid to participate? 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 they want to help doctors learn more about medicine or procedures and not because they will be paid.
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8. Why was my participation in the study stopped? The Study Doctor can stop your participation at any time, if he/she believes it is in your best interest not to continue. Also, your participation in a research study can be stopped if you do not follow the procedures listed in the Informed Consent Document. RCRC IRB, the study Sponsor, and/or the United States Food and Drug Administration (FDA) may also stop the entire study if they believe it is in the best interest of the participants.
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9. I had something bad happen, who should I talk to? In case of an emergency, please call 911. If this is not an emergency, please contact the Study Doctor or study staff as soon as possible according to the instructions in the Informed Consent Document that you signed. If you believe something happened because of negligence of the Study Doctor or study staff, the Informed Consent Document does not prevent you from seeking legal aid.
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10. What if I change my mind after I start the study? 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 study staff to let them know 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 are safe.
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11. Will I be told the results of the study? 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 study staff to get results concerning your participation in the study.

12. What if I can’t get in touch with the Study Doctor? Any time you have questions during the study you may call your Study Doctor at the number provided to you on the Informed Consent Document. If you ever 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 RCRC IRB.
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13. What if I have other questions, comments, or concerns? You may call RCRC IRB at 800 688-2132 or e-mail us any time before, during, or after your participation, with questions, comments, or concerns. RCRC IRB wants to ensure that your rights, safety, and welfare are protected.
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