Frequently Asked Questions about Clinical Trials
Carefully planned clinical trials test new medical advances for safety and efficacy, making possible future improvements in everyday clinical practice and health-care decision making.
What is a protocol?
The protocol is the trial method. It has been studied and approved by an oversight committee called the institutional review board (IRB).
What is an Institutional Review Board (IRB)?
An Institutional Review Board (often abbreviated as "IRB") is a committee or panel comprised of medical and non-medical members who study and properly consider all clinical protocols involving human subjects. The IRB assesses:
- the risks to the subjects
- the anticipated benefits to the subjects and others
- the importance of the knowledge that may reasonably be expected to result
- the informed consent process to be employed
Who serves on Stanford’s IRB?
Stanford University's IRB is called the "Administrative Panels on Human Subjects in Medical Research." Stanford has three panels, each of which meets 11 times a year.
Panel A, for example, has 10 voting members: six faculty physicians, a nurse, a pharmacist; a minister, and a graduate student. There are eight alternate voting members. Non-voting members include four administrators, one staff member, and a legal counsel.
The purpose of the Administrative Panels on Human Subjects in Medical Research (IRB) is to assure the University's compliance with federal regulations of research activities. The Panels review all proposals involving the use of human subjects in medical research. They assess current policies and their implementation and may recommend new policies within the Panels' province. Stanford University and the IRB are guided by the ethical principles regarding all research that involves humans as subjects regardless of whether the research is subject to Federal regulation or with whom conducted or source of support (i.e., sponsorship).
The involvement of human subjects in research is not permitted until an appropriate IRB has reviewed and approved the research protocol and informed consent has been obtained from each human subject of Biomedical and Behavioral Research.
WHO participates in clinical trials?
Participants are adult and/or pediatric subjects, who may be healthy or with disease, depending on the study. Trial subjects volunteer for a clinical study and sign an informed consent form. Subjects have the option to withdraw at any point. In some clinical trials, patients may be reimbursed for their participation.
WHY participate in a clinical trial?
Subjects might volunteer for a clinical trial to receive a promising new therapy before it is generally available to the public. Others may want to help scientific advancement. Another benefit is that medical treatments in a clinical trial are routinely made available at no charge to the patient, family, or insurance company.
Are clinical trials safe?
Patients considering participating in a clinical trial should discuss it with their physician and/or medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.
The patient's rights and safety are protected in two important ways. First, any physician awarded a research grant by a private company or the National Institutes of Health must obtain approval from an Institutional Review Board before conducting the study. The review board, usually composed of physicians and lay people, is charged with examining the study's protocol to ensure that a patient's rights are protected, and that the study does not present undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.
Where can I get more information on clinical trials?
- There is an extensive FAQ on clinical trials on the ClinicalTrials.gov website.
- Bulletin boards and notices in doctors' offices, newspapers and radio stations regularly provide brief descriptions and contact information for clinical trials. Searching the Internet for information about a disease or condition will yield news on where and what clinical research activity is ongoing.
- If you don't find the information you are looking for regarding clinical studies at Stanford University Medical Center, you can contact Spectrum at (650) 498-7425 (49-TRIAL).