HOW ARE MY RIGHTS PROTECTED IF I AM IN A CLINICAL RESEARCH STUDY?

LAWS

You may be worried about being in a clinical research study. You may have heard about some subjects that were not treated with respect. There are many laws to try to prevent this. At Slocum-Dickson Medical Group, we will do our best to make sure that each person’s rights and welfare are protected, whether or not you decide to be in a clinical research study. We will follow the rules – not just because they are the rules – but because it is the ethical way to treat the people who trust us to take care of them.

A STUDY MUST BE APPROVED

Before we can start a clinical research study, it has to be reviewed and approved by a group of people called an “Institutional Review Board”. Members include

• scientists (doctors, nurses, or researchers) who understand the disease and the investigational drug and
• “lay people” (clergy, teachers, people who study ethics, or other community members) who understand how patients feel.

This committee has many responsibilities.

1. To decide if the investigational drug is safe.
2. To confirm that subjects on the study are getting the care they need.
3. To make sure the study is scientifically designed so that it will be able to answer the question. If it is not designed properly, all of the subjects who agreed to be on the study would have wasted their time and put themselves at risk for no reason.
4. To check that the informed consent form contains the important information needed by a potential subject.
5. To review any advertisements to make sure they are not coercive.

GIVING YOU THE INFORMATION YOU NEED

Another way to protect your rights is to make sure that you have all of the information you need to make your decision about being in a clinical research study. We use an informed consent form to give you this information. Take your time reading it. Do not feel rushed to get through it while you are in the office. In most cases, you are encouraged to take the information home and re-read it. Write your questions down and make sure someone working on the study answers them. If you can’t think of any questions, maybe some of these will help start the discussion.

• How will the doctor make sure I stay safe while I am on the study?
• Is there anything I can not do while I am on the study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• Who will pay for the treatment?
• How will I know that the treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?
• What are the medical credentials and experience of the researchers and other study personnel?
• Will participants be able to take their regular medications while in the clinical trial?
• What support is available for participants and their families?

Once you have signed the form and started the study, the process is not over. You can ask questions at any time. If new information is learned, someone working on the study will share it with you.

PROTECTING YOUR PRIVACY

We realize that your privacy is important. If you are in a clinical research study, your confidentiality is respected. A few more people than normal will need to see your medical records, but generally they can only see this information in the office. Details about how your privacy will be protected will be described in the written materials you are given about the study.

THE DECISION IS UP TO YOU

The biggest way to protect your rights is to make sure you know that clinical research studies are voluntary. You do NOT have to be in a study. If you start a study, you always have the right to quit at any time. Deciding to be in a clinical research study is a very personal decision. We will respect your choice.