OM t of c.iii - Vision Research Coordinating Center - Washington ...

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2/1/99 Chapter 4 Recruitment, Education, Consent page 4-1 Chapter 4 Patient Education, Informed Consent, and Patient Recruitment 4.1 Patient Education and Informed Consent The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study requires that written consent be obtained from each patient prior to enrollment in the study. The patient is asked to sign the Clinic’s own institution-approved consent form only after eligibility has been established and after patient education has been completed. The signed informed consent is kept by the Participating Clinic in locked patient files located in the individual CLEK Clinic. The Data Monitoring and Oversight Committee and the CLEK Study Executive Committee review consent forms periodically to assure adherence to CLEK Study standards. Each Clinic Principal Investigator is responsible for obtaining approval of his or her Clinic’s consent form and approval for conducting the CLEK Study from the local institutional review board. (See sample at the end of this chapter.) A copy of each Clinic’s approved consent form and documentation of approval must be submitted to the Study Chairman before patients can be enrolled in the CLEK Study. Each Participating Clinic will receive an annual reminder that its Human Subjects approval is due to be renewed two months before the annual expiration date. All patients in the CLEK Study should understand the purpose of the study, the need for his or her commitment to long-term follow-up, and costs and reimbursements. All of the patient education and informed consent activities require the participation of the Clinician. The time required for these activities should not be underestimated. In the event that a CLEK patient needs to be seen at a Participating Clinic other than the one he or she originally enrolled at, the patient will need to sign an informed consent form at the Clinic at which he or she is to be seen. 4.2 Patient Education Once the Clinician has examined the patient, completed the Eligibility Form, and determined the patient’s eligibility, the following procedures must be followed: • Keratoconus is explained to the patient and to his or her family, if necessary. • Each patient reads the informed consent form. The form is then explained, and time is allowed for the patient to ask questions. • The CLEK Study, the need for long-term follow-up, and costs and reimbursements are explained.
2/1/99 Chapter 4 Recruitment, Education, Consent page 4-2 • The patient is given the opportunity to view the CLEK Study Recruitment Video. This presentation is designed to give the patient an overview of the Study and provide him or her with the perspective that this is a national study. • The patient should not be subjected to any pressure; if the patient would like to consider the Study and return at a later time, that is quite acceptable. • All the patient’s questions must be answered. If an answer is not known, the Clinician should admit frankly that it is not known and follow-up should be promised. The Participating Clinician calls Dr. Zadnik, CLEK Study Chairman at (510) 643-0568, to obtain the answer and then responds to the patient. • The CLEK Study’s status as a large, national, multi-center program is emphasized. No analytical results will be available for months to years. Each patient should be reminded of the importance of his or her individual efforts. • After the patient signs the informed consent form, the form is copied, and the patient receives the copy. The original informed consent form is filed at the Participating Clinic. 4.3 Special Consent Procedures for Minors Because the inclusion criterion for age includes minors ages 12 years and over, special procedures are outlined here for obtaining informed consent from minors’ guardians who are eligible for the CLEK Study. The minor must provide signed assent. All procedures to be performed and eye drops to be used in the CLEK Study are within the realm of ordinary clinical contact lens practice. Great care must be taken to explain the effects of the drops and testing procedures to both minors eligible for the Study and their parents. Particular benefit may accrue to minors enrolled in the Study since there is a tendency for keratoconus patients diagnosed in the second decade of life to progress faster. Each CLEK Participating Clinic will meet its individual Institutional Review Board’s requirements on informed consent for minors. 4.4 Costs and Reimbursements to Patients Keratoconus patients enrolled in the CLEK Study are not charged for Studyrelated examinations and tests and receive $20 reimbursement per Study visit. All other routine eye care, including contact lens services and materials and surgical care, is the responsibility of the patient, his or her doctor, and his or her insurance provider. If the procedure is part of the CLEK Study protocol (ie, contained on the CLEK Examination
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