Request An Appointment
816-836-2200
Kansas City's Premiere Digestive Health Specialists
Request An Appointment
816-836-2200
Kansas City's Premiere Digestive Health Specialists
The consent form that you sign to participate in a clinical research trial is similar to the form you sign to give consent for medical procedures such as surgery or diagnostic testing. However, when consenting to participate in a clinical trial you need to approach the process as more than just simply signing a piece of paper.
The informed consent for a clinical trial contains all the information about the trial that is currently available and relevant to your participation. The document will outline the reason for the trial, what the investigational drug or device is intended to do, and the potential benefits and risks of taking the drug or using the device. The informed consent document will also describe the treatment process and include information about study visits and procedures or tests that are completed during these visits. Finally, the informed consent will list known side effects of the drug or device and outline alternatives to participating.
First, you must read the informed consent document completely and make sure you understand the information it contains. If you don’t understand something, ask questions until you are clear on the information. Take your time when reading the information so you can fully absorb the information. It’s even a good idea to “sleep on” the information for a night to give you time to process the information and formulate questions for your doctor or research staff. You can also share the informed consent with a family member or friend in order to get their opinions or to see if they come up with questions you may not have thought of yet.
Second, you must understand that informed consent is an ongoing process. Just because you sign consent to participate in a research trial does not mean you must finish the trial. You can withdraw consent to participate at any time for any reason. Also, as the study progresses you may have more questions, and as part of continued informed consent you have the right to get answers before any procedures are done. The informed consent is a process, a process that is ongoing and interactive between you, the study staff and your physician. Throughout the trial the study team will update you if they receive any new information regarding the trial, and before, during and after participation you can ask questions, request more information or start conversations regarding the trial and the drug.