Retina Today - Clinical Trials for the Retina Specialist: Informed Consent: A Pivotal Piece in a Trial (July/August 2011)

摘要

When a patient appears to be eligible to participate in a clinical trial, it is necessary to obtain and document his or her informed consent before proceeding with any studyspecific screening procedures. The informed consent process is the primary and among the most critical aspects of human participant protections in the entirety of clinical trial execution. The process itself involves four specific elements, all of which must be documented: disclosure and comprehension, the informational components; and competence and voluntary choice, the consent components. INFORMED CONSENT PROCESS Institutional review boards (IRBs)/ethics committees (ECs), clinical investigators, and sponsors of clinical research share joint responsibility for ensuring that the informed consent process is conducted properly and professionally, but the responsibility of actually obtaining informed consent is ultimately the investigatora??s alone. The US Food and Drug Administration (FDA) states: a??Informed consent is more than just a signature on a form, it is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions and measures of subject understanding.a??1 The tangible outcome of this process is the establishment of proper documentation to satisfy legal and regulatory requirements. The foundations, however, are central among the basic fundamentals of ethical conduct and research practice. These internationally accepted standards were first set forth in the 1964 Declaration of Helsinki and remain recognized to this day. From a practical perspective, the informed consent process is also a chance to launch good patient-practitioner communication and develop positive rapport with potential subjects. In sum, the consent process should serve as the basis for a meaningful exchange between the investigator and the subject. INFORMED CONSENT ELEMENTS1 Although the FDA does not explicitly require the clinical investigator to personally conduct the consent interviews, he or she is responsible for ensuring that proper informed consent is obtained from each subject before the subject is allowed to participate in a clinical study. The IRB-approved informed consent form (ICF) used to document consent may be either of the following: a full, written document or a short form that states the relevant information has been presented orally to the subject. It is not uncommon to see a high frequency of these short forms used in retina studies because many potential subjects for these trials have severely compromised visual acuity. In this case, an impartial witness must be present during the informed consent discussion. After the ICF and any other IRB-approved supplemental information has been provided to, read by, and explained to the subject (and/or the subjecta??s legally authorized representative) and the subject consents to participate, the subject is asked to sign and date the ICF. The witness should also sign and date the consent form to attest that the information in the consent form was accurately presented to the subject. In the context of an investigational drug, biologic or device study, the ICF must also contain a statement that the study involves research; this differentiates it from consent forms used for standard medical procedures. Additionally, this must be supplemented by an explanation of the purpose of the study, an outline of the study visit schedule and procedures, the number of subjects expected to be enrolled in the study, and identification of any investigational products. It is important that the information be in terms that the subject can understand. Taking the time to thoroughly review terms or procedures that may be unfamiliar to the subject (e.g. randomization, placebo control, tonometry) are crucial to ensuring the subject is truly