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 as a Healthy Volunteer is also associated with some risks. Your safety is our primary concern and we make sure that you are completely informed of all limitations:
- There are potential medical risks and side effects involved with the medication being tested
- Some studies might be lengthy while others might require overnight stays and will not allow contact with persons outside of the clinic
Despite the time requirement and the risk of side effects, which is present with any medication on or off the market, you will contribute greatly to medical advancements that ensue from clinical trials. Compensation provided for a volunteer’s time is also a great incentive.