What will I be told about the study?

All medical research is done with volunteers who participate by their choice. Researchers use a process called informed consent to make sure that volunteers understand what will happen during and after the research study, the risks and benefits, and other information about the study. The goal of the informed consent process is to make sure you understand what you are agreeing to do.

If the study is easy to explain, the informed consent process may consist of a discussion between you and the researcher. If the study is more complex, the researcher may give you written information to take home. Either way, you will have a chance to ask questions about the study. You can also put off a final decision until you have a chance to talk to your physician or health care provider, family, or friends. The researcher also will remind you that if you want to drop out of the study at any time, for any reason, you are free to do so. After your questions have been answered to your satisfaction, and if you decide you want to participate, you will be asked to sign a form to document the informed consent process. You will be given a copy of the signed form.

During the informed consent process you should learn:

1. what kind of information the research study is looking for;
2. why you qualify for the study;
3. what will happen to you in the study, and what you will be expected to do and when;
4. what the investigational treatment or intervention is (if any);
5. when the study is a clinical trial, if there is a chance that you will receive a placebo (inactive treatment) and not the investigational treatment;
6. how long the study will last;
7. what are the risks (chances of being harmed) and benefits (chances of being helped);
8. what alternative treatments are available (if any);
9. if there will be any costs to you or your health insurance company for being in the study;
10. who will have access to your medical and other personal information;
11. who is responsible for paying for treatment if you are injured as a result of being in the study;
12. who is paying for the study;
13. if study volunteers will be paid for being in the study, and how much;
14. if your expenses (parking, transportation, child care) will be paid;
15. whom to contact if you have questions about the study.