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What is a research study?

A research study is conducted in people to evaluate a new investigational medical drug, food, or device. The purpose of research studies is to find new and improved methods of treating different diseases, and their symptoms, in the future.

What is a clinical investigator?

A clinical investigator is a medical researcher conducting a research study. Researchers are usually doctors, nurses, pharmacists, or other medical professionals.

Are research studies safe?

Research studies are typically conducted by a trained medical professional. An Institutional Review Board (IRB) reviews all research studies. This is a committee made up of doctors, ethicists, and members of the general public and administrators. This group helps to ensure that the rights of research participants are protected. Your regular doctor is responsible for your well-being and you may want to speak with your doctor before agreeing to participate in a study as there are possible risks associated with participation. Whenever you agree to enter a study, you are given the name and telephone number of a contact in your study physician's office who will answer your questions as well as a contact for the IRB whom you can contact if you have questions or concerns.

Why do people participate in a research study?

There are many reasons people take part in research studies. It gives individuals a chance to receive investigational study drugs or medical devices not available to the public. Studies are performed to test if the investigational study drug or device works, and if it is safe.

Often, the process of collecting information in the study will allow the study doctor to find out more about the disease and its effects.

Lastly, a study may not benefit participants directly, but the information gathered may be of help to other individuals in the future with the same condition. Many study participants derive satisfaction knowing they may be a part of the effort to potentially reduce the suffering of other people in the future.

How will I know if I am eligible for a research study?

You can find out about research studies from many sources. There are often advertisements in your doctor's office. Many research studies are posted on the internet and can be an excellent source of information. Each study has certain requirements for participation. Your study doctor will take a medical history from you and may request additional testing to determine if you are eligible according to the criteria for the study.

What is an informed consent?

Anyone agreeing to participate in a research study is required to sign an informed consent document. The informed consent document provides the details about the study and explains the potential risks and benefits. In addition, the informed consent document explains your rights and responsibilities. This document will tell you what study drug may be given, what kind of side effects might occur, and who to contact if you have questions or concerns.

What if I have a hard time getting to and from the study appointments due to transportation issues?

Talk with the study team (doctor and staff) at the study site. They may be able to help assist with transportation issues.

How will my rights and medical safety as a study participant be protected during the research study?

Research studies must follow strict ethical and legal standards. In addition, the global and country health authorities regulate clinical research with built-in safeguards to protect study participants.

Can I stop participating in the research study before the study is completed?

Yes. Participants can withdraw from the study at any time. If you wish to withdraw from the study, you will be asked to notify the study team, give your reasons for stopping the study, and follow through with the study exit process.

For additional information on clinical trials, please visit www.clinicaltrials.gov