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

2/1/99 Chapter 4 Recruitment, Education, Consent page 4-8
9. RISKS TO STUDY PARTICIPANTS
CLEK Study Sample Consent Form
page 2
The risks to Study participants is the same as for any other patient with keratoconus: corneal
swelling, corneal abrasion, corneal scarring, corneal thinning, corneal vascularization, decrease
in contact lens comfort and wearing time, reduction in visual acuity, redness, and infection of the
eye. There may be discomfort and tearing the Study participants during the fitting of contact
lenses. Vision, especially near vision, will usually be blurred for several hours after the pupils
have been dilated.
10. ALTERNATIVES TO PARTICIPATION IN THE STUDY
The alternative to participation in the Study is to not participate in the Study, and to have routine
eye care by an optometrist and/or ophthalmologist.
11. STUDY PARTICIPANT REMOVAL
Study participants are strongly encouraged to return for scheduled eye examinations. Participants
who do not return for scheduled eye examinations may be removed from the Study.
12. STUDY PARTICIPANT’S RIGHT TO REFUSE TO PARTICIPATE OR WITHDRAW
Study participants may refuse to participate or withdraw from the Study at anytime without
jeopardizing, in any way, their medical treatment at this institution in the present or future.
Should significant new findings develop during the course of the research that may relate to the
Study participant’s willingness to continue participation, that information will be provided to the
Study participant.
13. STUDY PARTICIPANT’S RIGHT TO PRIVACY
The results of the Study may be published, but the privacy of Study participants will be protected
and they will not be identified in any way. All data from the Study will be maintained in
confidentiality in two locations: (1) each Study participant’s medical record, and (2) a separate
record of visits and photographs in which each Study participant is identified by a number code.
All data files will be maintained and pooled data analyzed at a central Coordinating Center at
Washington University in St. Louis, Missouri. At no time will the Coordinating Center know the
identity of Study participants, since all information kept there will be by number code only.
Study participants are asked to provide their name and address to the Study Chairman in order to
receive reimbursement for Study visits and to receive Study newsletters. The Study Chairman
will not be able to link the names of Study participants with their number code or Study data.
14. RELEASE OF INFORMATION
The medical records related to the Study are available to the National Eye Institute.