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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.