It is mandatory that every participant signs a consent form for ethical and legal purposes. Signed consent demonstrates that you understand the process you are about to embark on, the potential benefits and risks, and your rights and responsibilities. Before completing the consent form, the study coordinator will go over regulations, schedules, risks and benefits, compensation, treatment, all other details related to the trial, and any questions you might have.
Signed consent implies that you will provide study coordinators with accurate information about your medical condition and history, and that you will follow study rules and regulations appropriately. Failing to do so could result in early termination or harm. Participants will be frequently reminded about aspects of the consent form throughout the study. It is wise to postpone signing the consent form until the study coordinator clarifies any concerns or doubts you might have.
Signing the consent form does not waive the responsibilities of the investigators and the research team. Participant safety is our priority at all times; ethical and professional care is a fundamental right of each patient. Another essential right is the option to withdraw from the study at any time for any reason. However, if withdrawal might result in harm, investigators are obliged to inform you of potential consequences and provide you with the care you require. If injury or harm occurs as a result of the study, appropriate and adequate steps will be taken at no cost to you. Consenting to partake in a clinical trial does not void your legal rights or liberate the investigator from his or her legal, professional, or ethical responsibilities.
Participating in clinical trials is also associated with some risks. Your safety is our primary concern and we make sure that you are properly informed of all limitations:
- Clinical research is an experimental design and cannot guarantee that the medications being tested are better than the ones already available
- Like with all medications, there is a chance that you will experience side effects, and since the medication will be in the process of investigation, some side effects might not be known
- You are unable to choose which treatment you will receive, nor are you guaranteed to receive the medication over the placebo
- Frequent clinic visits might be required
Kindly keep in mind, frequent visits and other inconveniences are minor compared to the significant results that a medication might provide for a better quality of life. A chance to receive a treatment that has the potential to diminish your suffering makes the process a positive and worthwhile experience.