Federal law says that all research involving humans requires informed consent. What this means is that the researcher must thoroughly explain the study and how it affects you – especially risks or discomforts – before you agree to participate. The researcher must also tell you about any changes during the course of the study, such as newly discovered risks or side effects. Informed consent applies to the whole study, no matter how long it takes to complete. So, you are always assured that you are kept informed.
If you do agree to participate in a study, you can always decide to withdraw from the study at any time, for any reason. Do not be afraid to ask any question if you do not understand. Feel free to discuss your participation in the research study with family and friends to get their advice. Sign the informed consent only if you are comfortable with what you have read.
