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