For example:

Uterine fibroids are a condition that affect many women. From 20 to 40 percent of women age 35 and older have uterine fibroids of significant size. African-American women are at higher risk for fibroids: as many as 50 percent have fibroids of significant size. Fibroids are a common cause of symptoms such as abnormal menstrual bleeding, lower abdominal (pelvic) pain and discomfort, and frequent urination and constipation.

The Cardiovascular and Interventional Radiology Research and Education Foundation (CIRREF) in collaboration with the Duke Clinical Research Institute (DCRI) is conducting a research study to gather information to demonstrate the safety and effectiveness of uterine artery embolization (UAE) for treatment of uterine fibroids and to understand how effective UAE is in meeting the needs of patients with uterine fibroids. The UAE that you are scheduled to undergo is not a part of this study. This study is designed to study the impact of this procedure on fertility and quality of life.

B. Study Procedure [including a statement that the registry data is entered by site study personnel and transmitted to the study center at the DCRI (a third party) over the Internet via secure web-based forms].

For example:

Over 4000 patients per year will be involved with this research study. Dr.___________________ is involved to gather information that will be used to improve the care of women with symptomatic uterine fibroids. The information collected will include information about your uterine fibroids and fertility history, your UAE procedure and in-hospital events. You will also be contacted at around 30 days from your UAE procedure to collect information about how you have been doing and any events you have experienced since being discharged from the hospital.

Data collected about your fibroids and UAE procedure will be entered onto secure web-based forms by site study personnel and submitted over the Internet to the registry database at the study center.

C. Time Involvement

For example:

Your involvement in the study is limited to collection of information about your uterine fibroids, fertility history and UAE procedure and a brief 30-day follow-up contact.

D. Statement of voluntary participation.

For example:

Participation in this study is completely voluntary. You may decide not to take part in this study without altering your medical care. If you decide not to participate or to discontinue participation in the study, treatment of your uterine fibroids will occur as you and your personal doctor have decided. Your current quality of care will not be affected in any way by your participation or refusal to participate in this study.

E. Statement of rights of refusal.

For example:

If you choose to participate, you have the right to refuse to answer any questions you wish.

F. Statement regarding risks and benefits.

For example:

There is no direct benefit to you as an individual from participating.

G. Statement regarding access to data.

All information that you provide will be kept confidential. Your name and any identifying information will be kept separate from your medical history and procedure information. If results of this study are reported in medical journals or at any scientific meetings, your identity will not be revealed. The United States Food and Drug Administration (FDA) will have access to procedure information in order to help monitor and improve UAE safety. Monitors from the study sponsor may also inspect procedure data. All identifying data will be kept anonymous.

H. Explanation of whom to contact for questions about the research.

If you choose to be a part of this study, you will need to read this form completely. After you have signed it, you and Dr.______________________ will complete the first set of forms and go on with your treatment plan. If there are any questions concerning this research study, please call Dr. _______________ at __________________, or _________________ (the study coordinator) at _______________. Please keep a copy of this form for your information.

I. Signatures.

I have read the informed consent and Dr. _____________________ has answered any questions I may have about participation in the FIBROID Registry. I agree to participate in this study.

Signed: 

Date:

Witness: 

Date: