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By Rochelle L. Goodson, Co-Director QRTI
Consenting of subjects prior to their enrollment in a clinical trial is one of the most fundamental and well established requirements of clinical research. Physicians and the study staff consider it a routine task, yet inadequate informed consent issues remain one of the most common deficiencies cited by monitors, auditors, and inspectors.
Although the Informed Consent Form (ICF) serves as the mechanism for obtaining a signed and dated document, the process itself must be appropriately administered and documented. The ICF should be used as a springboard for providing information to facilitate a potential subject’s decision-making with regard to participating in a clinical research trial. In addition to answering the subject’s questions, the process should enable the consenters to ascertain that a potential subject understands the content of the consent.
Perhaps the real challenge is an honest evaluation of whether or not the goal of obtaining the subject’s dated signature on an ICF undermines the intent of the process, i.e., to assure the subjects’ rights, safety, and welfare. Circumstances, such as a small study staff, nonclinically trained staff, an overly-committed Principal Investigator, and tight or overly ambitious enrollment deadlines, are among the most common situations that encourage poor consenting practices.
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