At ChristianaCare, all studies are first approved by the Institutional Review Board, a special committee that reviews and oversees all research projects to ensure that participants’ rights and welfare are protected. The IRB includes doctors, nurses and other health care professionals, research scientists and community members.
The IRB reviews each study to make sure it is safe and reasonable to ask for volunteers and that any associated risks are as small as possible. The IRB continues to monitor the study as it progresses to make sure volunteers are protected.
Participation in any medical research trial is completely voluntary. During the course of the study, you may be told of new findings, benefits or risks. At that time, you may decide to leave the study. It is your choice to participate or to leave a study at any time, including after the study has started or during follow-up.
If you do not wish to take part in a study or if you decide to stop participating after the study has begun, know that your decision will in no way interfere with the quality of medical care you receive.
When you volunteer to join a clinical trial, you will be asked to give your informed consent. Your signature on the informed consent form says that you voluntarily agree to participate and that you understand the key facts about the research study, including what will take place in the study and how it might affect you. A research nurse will discuss the research study with you, answer any questions you may have and help you fill out the informed consent form. You may need approval from both your primary-care physician and your specialist (if you have one) to participate in a clinical research study.
Your medical records and your study records will be kept confidential. Information about your medical or study records will only be given to the researchers conducting the study or to those responsible for making sure the study is safe and following approved procedures. These groups would include members of the research staff, the Institutional Review Board, the company or group funding the study and the appropriate government agencies who oversee the study. Your records can provide important information to these review groups about whether the study is following acceptable research practices.