Frequently Asked Questions

Should I participate in a Clinical Trail?

Clinical trials are a critical tool for improving our understanding and treatment of illnesses and disease. Anyone may be eligible to participate in clinical trials. As a potential clinical trial subject, you may be asked if you’re willing to participate in a clinical trial that is specific to your health needs or diagnosis. You may also be asked to participate in research that is not necessarily a clinical trial, such as donating blood or tissue for a genetic study. People volunteer to be in clinical trials for different reasons: In hopes of improving their own health To access treatments that may be new and not yet widely available To help others by contributing to medical advances

What are the potential risks I may face by participating in a clinical trial?

There may be unpleasant, serious or even life-threatening side effects You may not benefit directly You may have to set aside time for travel to the study site, treatments, hospital stays and complex procedures

How I will be protected during clinical trial?

Federal and local regulations exist to protect volunteers in clinical trials. Federal regulations are determined by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) at the Department of Health and Human Services. Local regulations are determined by the University of Chicago Medicine Institutional Review Board (IRB).

What is the institutional review board or IRB?

Clinical trials must follow guidelines set forth by the FDA and/or OHRP, as well as the IRB. Before a clinical trial can begin, the IRB reviews the researchers’ proposal to ensure that the rights and well-being of those participating will be protected. Our Biological Sciences Division IRB consists of community volunteers, scientists and other institutional representatives. You can contact our IRB at any time regarding your rights as a clinical trial volunteer:

What is a informed consent?

All of the known risks associated with a particular trial will be discussed with you before the start of the study. This is called the informed consent process, and this information will be included in a document from the study’s research staff. After this information has been provided to you and your questions have been answered, you’ll be asked to give your voluntary consent to participate by signing a form that has been approved.

How do I find a clinical trial that is right for me?

Each clinical trial has different enrollment requirements, and your doctor can help you identify suitable trials. The following questions can also help you decide on whether a study is right for you: What’s the purpose of the study? Why am I being invited to participate in the study? How long will the study last? Where will the study take place? What will be done as part of the study? What will I have to do during the study? What are the risks? What are the possible benefits? Are other treatments or alternatives available? Who will see the information that is collected about me? What happens if I am injured during the study? What type of follow up is there after the study? Will I have to pay for any part of the study? You can use this printable worksheet (PDF) version of these questions to discuss them with your doctor. You’ll find many of the answers to these questions in the consent form you’ll be asked to sign.

What if I choose not to participate or change my mind?

Participating in clinical research is voluntary. If you decide not to, or if you withdraw your consent while volunteering for a study, your care at CTN will not be affected.

What is a Confidential Disclosure Agreement (CDA)?

A Confidential Disclosure Agreement (CDA), sometimes known as a “Confidentiality Agreement” or “Non-Disclosure Agreement,” is a legally enforceable contract that ensures the confidentiality of information that one party discloses to another party. A signed CDA may be required before an industry sponsor agrees to disclose its proprietary information (e.g., the study protocol) to an investigator. The CTN team is responsible for reviewing, negotiating and executing CDAs related to the evaluation of industry-supported clinical trials conducted at Yale. Faculty members are not authorized to sign CDAs for industry-funded clinical trials; all terms are negotiated and signed by OSP.

What are the Phases of Clinical Trials?

Phase I - Researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II - The study drug or treatment is given to a larger group of people (hundreds) to see if it is effective and to further evaluate its safety. Phase III - The study drug or treatment is given to large groups of people (hundreds to thousands) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV - Studies conducted after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

What are the benefits of participating in a clinical trial?

By participating in a clinical trial, you not only gain access to cutting-edge & expert care, but you are participating in a potential medical breakthrough that could help many more people in the future. During treatment, you will be monitored closely by top physicians and researchers. Should the medical treatment being tested in the clinical trial be effective, you will be one of the first people to reap the benefits before it is released to the public.

What if my condition worsens during a clinical trial?

Patients that are participating in a clinical trial are constant care by expert doctors and researchers who make the health and safety of the patient their priority. Constant communication and regular check-ins between the patient and the researcher are highly encouraged. If you do not feel well at any point during the trial, talk to the research team and your physician immediately to decide what the best next steps are.

What happens when the study is over?

After the study is completed, the data is then collected, analyzed, and shared with experts and several government agencies for the drug approval process. Participants can continue to take the medication, should it help, but they are not required to continue with any other phases of the trials. Each clinical trial has a different set of rules about what happens after the trial is over, so be sure to talk to your research team.

How is my privacy protected?

As much as possible, your identifiable information (name, birth date, address, contact information, etc.) is kept private from most members of the research team. No identifiable information is shared outside the research team without your knowing consent. Only authorized staff members of the research team can view the data at any time during, and after, the clinical trial. Privacy policies of the clinical trial are described the informed consent document.

What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

Plan ahead and write down possible questions to ask. Ask a friend or relative to come along for support and to hear the responses to the questions. Bring a tape recorder to record the discussion to replay later. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.