Rights Responsibilities and Protections
Each clinical trial has a protocol or road map that explains how it will work. The protocol will explain what the trial will do, how the clinical trial will be carried out, and why each part of the study is necessary. All clinical trials are regulated by federal rules.
Federal rules help ensure that clinical trials are run in an ethical manner. Your rights and safety are protected through a variety of measures:
Informed Consent Helps Patients Make Best Decisions About Clinical Trial Participation
Informed consent is the process by which a patient learns about a clinical trial. The point of informed consent is to give the patient the information he or she needs to make a good decision about whether or not to join a clinical trial.
It is important that individuals considering taking part in a clinical trial understand the purpose of the study, the procedures and schedule involved, the possible risks and benefits, and the alternatives to participation in the trial. A patient’s doctor or members of the research team will provide the patient with a written explanation of the clinical trial, known as the Informed Consent document.
Review Panels Ensure That Clinical Trials Are Safe and Ethical
All clinical trials at University Hospitals Seidman Cancer Center are subject to careful review and approval by two review panels.
A scientific review panel is made up of experts who review a clinical trial before it starts accepting patients to ensure that it is based on sound science. All cancer clinical trials at UH Seidman Cancer Center must go through this review.
Various groups of medical and health care experts must review and approve clinical trials before they begin, one of them being an independent institutional review board (IRB).
The IRB reviews all clinical trials and approves only those that address medically important questions. It is the IRB’s job to look at research studies and make sure they are safe and ethical. Physicians must wait for IRB approval before starting a clinical trial.
Ongoing Monitoring Protects Patients Throughout a Clinical Trial
Another way to ensure that a clinical trial adheres to safety and ethical standards is through ongoing monitoring.
Along with the IRB, a data and safety monitoring board (DSMB) will monitor the trial to help ensure safety. The DSMB is an independent committee made up of statisticians, doctors and other experts. The DSMB makes sure that any risks associated with being in the study are minimized as much as possible. It also ensures that the data are sound and stops a trial if safety concerns come up, or as soon as its objectives have been met.
A patient’s research team will include a dedicated research nurse, physician, and other health care specialists who will help with the research plan for the patient.
Information about all of our patients taking part in a clinical trial is kept strictly confidential. Medical records are kept secure and information regarding a patient’s participation is never made public. There are strict federal regulations about privacy related to a patient’s medical care. Before deciding to take part in a clinical trial, patients will be told exactly who will have access to this information.