THE RESEARCH VOLUNTEER’S PERSPECTIVE
Research volunteers are presented with an informed consent form before deciding whether or not to participate in a clinical trial. Informed consent is the process of learning all of the facts and details from the consent form and discussing the participants’ questions with the study staff & study doctor prior to the start of any study procedures. The volunteer is encouraged to discuss this information with family members as well as their personal physician. When the volunteer is satisfied that they have all of the necessary information to make their decision and would like to participate, the informed consent form is signed and a copy is given to the volunteer as a reference throughout the trial. The informed consent process continues even after the form has been signed and the trial is underway. If any new information becomes available it will be presented to the study volunteer in a timely manner, sometimes in the form of an updated consent form. Informed consent is not a contract and the participant may withdraw at any time for any reason. In this case, the research site should be notified as soon as possible to complete the volunteer’s participation in a safe and orderly manner.
The Research Process
All new medications are required to be adequately & successfully tested on the population of people who will ultimately use those medications, in order for the medication to be approved by the Food &Drug Administration (FDA). For example, a new asthma medication must be tested on people with asthma to show that it effectively treats asthma and to document what types of side effects, if any, may be experienced. New medications are only submitted to the FDA after completing the phases of clinical trials. The early stages (Phase 1 & 2) test a new drug or treatment on small groups of people to determine a safe dosage range, identify side effects & test efficacy. Later stages (Phase 3 & 4) test the drug in large groups of people to confirm its safety & effectiveness, monitor side effects and compare it to commonly used treatments. Every clinical research trial must follow a rigorous scientific protocol to objectively ascertain if a medicine is effective & safe in a significant portion of the study participants. WSCR, Inc. conducts each study with strict adherence to the protocol to ensure the safety of participants & to collect meaningful data about the drug in development. The FDA will then review all of the research data in order to decide whether or not to approve the new drug or treatment.
The physicians and study coordinators at Western States Clinical Research, Inc. are required by law to maintain your privacy at all times. We will not disclose your personal or medical information to any outside parties. After taking part in the informed consent process & if the decision to participate in a clinical research study is right for you, some of your medical information will be used for study purposes but your identity will remain protected.