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IRB Committees: Balancing Medical Policy, Ethics and Statistics

Introduction The underlying premise of an ethical clinical study involving human subjects is that the study is reasonably safe, and that participants fully understand and consent to the procedures or treatments they will receive. Subjects must be free (e.g., without coercion, deceit, duress, fraud, or force) and competent (e.g., do not manifest impaired decision-making ability, or lack of maturity due to age, disease, or fetal/embryo status) to choose whether or not to participate, and may opt to withdraw from the study at any point without prejudice, financial loss, or embarrassment. Patients must be informed of any potential or expected risks or discomforts known or believed to be associated with the study, and be advised of any appropriate alternatives to the study. Prior to enrolling in the study, a patient must be clearly and completely informed of remedial medical treatment and compensation, if any, available to them, if complications should arise during the course of the study, or following the completion of the study (if they are believed to be consequent to the study). The confidentially of a patient’s medical condition and care must be respected at all times by attending staff in their communications with outside individuals (e.g., friends, classmates), groups (e.g., insurance agencies, employers), the press, or anyone not directly involved in the care of the patient. Patient charts and computerized medical records must also be securely maintained to protect the privacy of participants in the study and their immediate families. Should tissue samples or bodily fluids be extracted from patients in the study, they must be informed of and agree to their intended use, whether now or in the future, and be told of the study policy regarding when and if test results will be made available to them.