Patient Safety, Rights and Responsibilities

Clinical research is impossible without the generous and selfless participation of patients. The MUSC Digestive Disease Center is dedicated to safe, ethical and professional behavior when conducting a clinical trial. Therefore, it is very important that patients understand their rights and what to expect if they decide to participate in a clinical research study.

Safety

Once U.S. Food and Drug Administration (FDA) or National Institutes of Health (NIH) has given approval for a research study of a medication, device, procedure to start, the individual hospital or research center must then receive another approval from an Institutional Review Board (also called an IRB).

There are a few things to consider before participating in a research study:

Check with your personal doctor, as he/she can be a good source of information regarding the risks and benefits of participating in a clinical trial.

Have a good understanding about your current state of health. You will be told about the known side effects and other health risks of the treatment(s), but not all of the risks can be known when you decide to participate in a trial. Also, be sure you report all the normal medications you are taking, including vitamins and herbal.

Ask lots of questions before you make a decision whether or not to participate in a clinical trial. If possible, read the information given to you about the study. Ask if you can take it home to read if you need more time. Sometimes it is helpful to make a list of questions in advance to ask the study coordinator or doctor.

Rights

Informed Consent

Before you decide to participate in a clinical trial, a research coordinator, clinician or physician will discuss the research study with you. This discussion will include a detailed explanation of the purpose of the trial and the type(s) of treatment to be studied, your chances of receiving a given treatment, the known risks and benefits of each treatment, and any costs related to the study that you may be responsible for paying.

You will always be given a chance to ask any questions you may have and enough time to make an informed decision. If you decide to participate in a clinical research study, you will be required to review and sign an Informed Consent document (the consent form), which will also let you know whom to contact for more information and fully explains your rights during the trial.

Confidentiality

In addition to signing an Informed Consent, you will also be given a form called a HIPAA (Health Insurance Portability and Accountability Act) authorization. You will be asked to review and sign this form before you can participate in a clinical trial.

Right to Withdraw From a Study

Your participation in a clinical trial is totally voluntary. You are not obligated to participate and you have the right to withdraw from a study at any time.

For more information on your rights, read about the Code of Federal Regulations Title 21.

Responsibilities

Study Requirements

The study coordinator and/or doctor will discuss the study with you to make sure: (i) all questions were answered to your satisfaction; (ii) you voluntarily agreed to enroll in the study; and (iii), you accept the responsibilities involved with being a research subject on this particular study.

When you sign an informed consent you are agreeing to enroll in a clinical trial and attend all study visits. It also means you agree to follow the requirements of the study.

You will always have the right to withdraw from the study at any time.