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What is a research study?
A research study is designed to answer a question about a medical condition or illness. Scientists and doctors do research to better understand how and why things happen.
Do I have to take part in a research study?
Taking part in research is always your choice. If you choose to be in a study and change your mind, you can drop out of the study at any time.
What are some questions I should ask before I decide to participate in a research study?
- What is the purpose of the research study?
- What other options do I have?
- Are there certain medicines or foods that I can’t take?
Are there risks in a research study?
The study doctor or study staff will discuss the Informed Consent Document with you. It will list any known risk in the research study.
What protections are in place for research subjects?
Each research study involving human subjects must be reviewed for scientific guidelines and safety and ethical conduct of the study. An Institutional Review Board (IRB), a group not associated with the research study, reviews it to determine if it is safe and appropriate for the study doctor to conduct the research study. You will also be given an Informed Consent Document which will fully explain the study.
What is an Institutional Review Board (IRB)?
An Institutional Review Board (IRB) is a group of people responsible for reviewing research studies involving human beings, The IRB reviews research studies to make sure the safety, rights, and welfare of human subject are protected.
What is informed Consent?
Informed consent is the process of being provided information and answers about the research study. Informed consent begins when the study doctor or study staff member tells you about a research study. Then, you will be given an Informed Consent Document or Children’s Assent Document. The study doctor or study staff member will discuss the document with you. You should ask questions about anything you don’t understand.
What if I want to stop taking part in the research study?
You can stop taking part in a research study at any time. You should tell the study doctor and study staff so you can be safely removed from the study.
What happens to my records from the research study? Who can see them?
The information about you in the research study records is private. The groups that may look at your records are:
- The study sponsor
- The study doctor and study staff
- The Institutional Review Board
- The United States Food and Drug Administration (FDA)
- The Department of Health and Human Services (DHHS) Office for Human Research
Human Research Protections (OHRP)
These groups need access to your study records to make certain that the study is conducted legally and safely.
What are my responsibilities as a research subject?
- Keep all scheduled study visits
- Ask questions to ensure understanding at any point during the study
- Truthfully answer all questions regarding your health and your taking part in the study
- Take your study medication as directed, if applicable
- Notify the study staff regarding any side effects or hospitalizations that may have occurred between the study visits
- Promptly notify the study staff of any problems or concerns
- Promptly notify the study doctor or study staff you decide to drop out of the study
Call to today to find out about our current and future studies (615) 835-4709.
