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According to federal regulation, every clinical trial  Clinical Trial (Clinical Study)A scientific study involving human participants to determine the safety and efficacy of new therapies or new ways of using known treatments. in the U.S. must be approved and monitored by an Institutional Review Board  Institutional Review BoardA committee of physicians, statisticians, researchers, community advocates, and others chosen by an institution to initially approve and periodically review research projects involving human participants. Federal law requires this to ensure protection of participants’ safety, rights and welfare. (IRB)  IRBA committee of physicians, statisticians, researchers, community advocates, and others chosen by an institution to initially approve and periodically review research projects involving human participants. Federal law requires this to ensure protection of participants’ safety, rights and welfare. . An IRB is an independent committee of doctors, community advocates, and others, mandated to ensure that the clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. trial is ethical and that the rights of study participants are protected.

Federal guidelines require that all participants in clinical trials be given complete information about the trial before they agree to take part. This is known as informed consent.  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial. Before you decide to enter a trial, a member of the research team will go through the informed consent document  Informed Consent DocumentDescribes potential risks and benefits to study participants, and details about the study itself, such as its purpose, duration, required procedures, and key contacts. Although participants must sign the document in order to enroll in a clinical trial, informed consent is not a contract, and the participant may withdraw from the trial at any time. (consent form) to explain what will happen during the trial and what will be expected of you. You can expect the staff member to tell you about the purpose and length of the trial, potential benefits and risks, confidentiality of the study and alternative treatments that might be available. It’s important to ask any questions you might have about your participation before signing the form. The process can be a lengthy one, but its purpose is to help you understand the trial fully, help you decide whether or not to participate and to understand what you will be required to do.

If you feel comfortable with the protocol  ProtocolA plan that is the basis for the conduct of a clinical trial ensuring the health of participants, and the solutions to specific research questions. A protocol describes what types of people may participate in the trial, the schedule of tests, procedures, medications and dosages, and the length of the study. for the study, you must sign the informed consent form in person with a staff member as a witness before being screened for the study. After volunteering to join a clinical trial, the research team (this usually consists of doctors, nurses and sometimes social workers and other healthcare professionals) will give you instructions and monitor your health and reactions to the treatment throughout the trial.

Informed consent also emphasizes that your participation is voluntary and that you may leave the trial at any time, and that all aspects of your involvement in the study are confidential. However, if you decide to leave a trial, it is important to let the research team know that you are leaving and your reason. Your responsibility to inform the research team before you leave the study will enhance your health and safety, provide important information about the study design or treatment and help analyze the data at the study’s conclusion.