What is “informed consent”?
Before taking part in a study, each person will get a consent form that contains important written information about the study. It is important to read and understand the information in this form. The researcher or member of the research team will also talk to the person about the information contained in the form. The person should be sure all of his or her questions are answered before signing the consent form. A signed consent form is not a contract-a participant can leave a study at any time.
Informed Consent is the process by which a physician helps a patient arrive at an informed decision regarding treatment options. Sometimes this is very simple and straightforward, such as the decision to apply a cast for a broken bone. Other times it can be extraordinarily difficult, like choosing among various ways of treating cancer. The physician must help the patient understand the disease he/she faces and the risks and benefits of the various modalities. The patient’s hopes and fears must be addressed as well as psychological factors and family expectations. The patient must be aided in coming to an understanding of what this disease means in his/her life at this time. The physician should not hesitate to call on other sources of support and expertise and the patient should be encouraged to seek other opinions and points of view. The physician should help the patient realize that there is often no “right” answer, but only multiple trade-offs as they negotiate these complex decisio
Informed consent is the process by which a potential study participant is provided with information about the study and treatment before deciding whether or not to participate in the trial. It includes an explanation of what is involved in the trial, the duration of the study, the frequency and length of the required visits, as well as the known risks and benefits associated with the study treatment. Participation in a clinical trial is completely voluntary. All questions about the study should be answered to the patient’s satisfaction before an informed consent form (ICF) is signed. Patients have the right to refuse participation or to withdraw their consent at any time during the study without penalty. The wishes and best interest of the patient are considered at all times and, throughout the trial, participants will be provided with any new information that may affect their decision to continue their participation in the study. In addition, the study physician may withdraw a patient
Federal law says that all research involving humans requires informed consent. What this means is that the researcher must thoroughly explain the study and how it affects you – especially risks or discomforts – before you agree to participate. The researcher must also tell you about any changes during the course of the study, such as newly discovered risks or side effects. Informed consent applies to the whole study, no matter how long it takes to complete. So, you are always assured that you are kept informed. If you do agree to participate in a study, you can always decide to withdraw from the study at any time, for any reason. Do not be afraid to ask any question if you do not understand. Feel free to discuss your participation in the research study with family and friends to get their advice. Sign the informed consent only if you are comfortable with what you have read.
Informed consent means that if you elect to participate in the trial, you fully understand the risks and benefits of the treatment and freely elect to take part. Informed consent for clinical trials is just one part of a larger system in place to safeguard people who want to help researchers evaluate new practices that may improve treatment, supportive care, screening, and prevention, while perhaps benefiting from these new methods. This system ensures that clinical trials are conducted ethically, without undue risk to participants. Even after you give your consent, you can leave a clinical trial at any time.
