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

2/1/99 Chapter 2 Study Design page 2-20
2.10 Human Subjects Considerations
The CLEK Study is limited to keratoconus patients who have corneal irregularity
and slit lamp signs of keratoconus. There are no limitations based on gender, ethnic
group, race, or religious affiliation.
Because the inclusion criterion for age includes minors older than age 12 years,
special procedures are outlined in Chapter 4 of this Operations Manual for obtaining
informed consent from minors who are eligible for the CLEK Study. All procedures to
be performed and eye drops to be used in the CLEK Study are considered standard
clinical practice. Great care is 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.
The research data consist of written records, corneal photographs, and
fluorescein pattern photographs. All materials are kept in locked file cabinets and are
available only to the investigators and coordinators at the various Clinics, the CLEK
Photography Reading Center, the Coordinating Center, and the Data Monitoring and
Oversight Committee. No material will be published or released with a patient’s name,
medical record number, social security number, or other identifier. Data at the Clinic
retain patient identifiers. With the patient’s permission, the Chairman’s Office will
maintain a patient name and address list for reimbursement and mailing purposes, but
the list will not be linked to CLEK Study patient ID numbers.
After determining that a Study candidate has satisfied the eligibility
requirements, the Clinician discusses participation in the CLEK Study with the Study
candidate. Each Study candidate signs an Informed Consent Form or Decline to
Participate Form after a discussion of keratoconus and the study. A detailed
explanation of the informed consent procedure is in Chapter 4, “Patient Education,
Informed Consent, and Patient Recruitment.” The individual retains a copy of the
signed consent form, and the original signed form is retained at the Clinic. In order to
protect patient confidentiality, the signed consent form is not sent to the Coordinating
Center. The signed consent form is a very important legal document and is subject to
audit at site visits.
The patient’s name, social security number, and address are supplied to the
Study Chairman’s office in order to process patient reimbursement, but they are not be
attached to the patient’s Study identification number to preserve confidentiality.
Reimbursement forms are supplied to each Clinic. Patients will complete them and mail
them to Dr. Zadnik in an addressed, stamped envelope so that check disbursement will
be processed.
The data and the progress of the Study are monitored on an ongoing basis by the
Coordinating Center and annually by the Data Monitoring and Oversight Committee.