Attachment7 - Other Study Docs

ATTACHMENT 7

REDS - II Donor Iron Status Evaluation (RISE) Study

Study Membership Card

Front

< LOGO > REDS Donor Iron Study

< Insert Name of Blood Center >

Name:_______________________

Birth date:____________________                               

Donor ID:____________________

Dear Donor: Please remember that you indicated you would donate at

least ___times per year over the two year study period.

Please bring this card with you each time you donate and

present it to the staff prior to making your donation.

Back

Dear Donor: Thank you for joining this important study.  When you donate blood again, please call one of our recruitment staff at XXX-XXX-XXXX to make an appointment. You can record your appointments below. 

Locations for your donation:

1) ____________________________

2) ____________________________

Blood Center Staff:  This donor is part of an iron research study.  Please follow your procedures for these donors. If you have questions, please contact the research staff at your center for guidelines at xxxxx befor

RISE REMINDER POSTCARD FOR INTERIM PHASE FOLLOW-UP VISITS

RISE REMINDER POSTCARD FOR FINAL PHASE FOLLOW-UP VISITS

<Blood Center Name>

REDS-II Donor Iron Status Evaluation (RISE) Study

Reminder – Final Study Visit

Dear Donor,

Thank you for donating blood for patients in your community, and also for agreeing to participate in the REDS-II Donor Iron Status Evaluation (RISE) Study. This study monitors Iron levels in donors over a 2 year period. The two year period is nearing the end, and <Blood Center Name> would like to schedule a final research donation. Since an extra tube of blood needs to be collected at this final research donation, a research coordinator needs to be present at your donation. You may schedule a convenient donation time by calling <Phone number>.

Thank you.

Invitation to Participate Brochure

Introduction

For a number of years, blood donation has been known to lower body iron stores, although usually not to levels that are believed to be of major health significance. This is because iron in the body is primarily found in the red cells of the blood (actually in the main oxygen carrying protein, hemoglobin, within the red cells). You can lose iron for reasons other than blood donation. For example, before menopause, women lose blood during their menses; pregnant women need to provide iron to their developing child; and some people may lose blood due to health conditions such as intestinal bleeding.

Blood donors who do not have enough iron in their body may have a low hemoglobin level in their blood, a condition called anemia. When you have anemia, you may be tired, have problems exercising, and may have other health problems. It is for this reason that blood centers routinely screen for anemia in persons who try to donate and require all donors to have a minimum hemoglobin level in their blood before they can donate blood.

Whether there is health significance for persons with a low level of iron in their body if this level is not low enough to cause anemia is uncertain. Some research suggests that a slightly low iron level can cause mild problems, such as being tired and difficulty concentrating while other research suggests that having a slightly low iron level may be beneficial and decrease heart and blood vessel disease.

As a blood donor you already know the vital role that your blood donation plays in saving the lives of others. By participating in the REDS Donor Iron Status Evaluation (RISE) Study, you can also play a vital role in the research that helps keep frequent blood donors healthy. The information contained in this brochure can help you decide if you would like to participate in this important study.

The RISE Study is designed to answer questions about how iron and hemoglobin levels change in blood donors over time. Iron is a necessary part of hemoglobin which is the part of the red blood cell that carries oxygen from your lungs to other parts of the body. This study is designed to look at how blood donation and personal characteristics may affect levels of iron and hemoglobin in a person’s blood. Information from the study will also help us evaluate which laboratory tests are best for monitoring donor’s iron levels, the best frequency for blood donation, and how genetic factors may influence iron and hemoglobin levels.

Who is being asked to participate in the REDS Donor Iron Status Evaluation (RISE) Study?

Two groups of donors are being asked to participate in the study for 1 ½-2 years. One group consists of frequent donors who have given blood at this center regularly in the past year. The other group includes donors who either have never given blood before or have not done so in the past 2 years but who, we hope, will now agree to give regularly.

We need to study both types of donors in order to understand how blood donation influences iron and hemoglobin levels. You will need to qualify for blood donation today to participate in the study.

What will be required of me if I decide to enroll in the REDS Donor Iron Status Evaluation (RISE) Study?

First you will be required to read and sign a consent form to participate in the study. This consent form will explain in greater detail than this brochure what the study requirements are. It will also contain information on your rights as a study participant and how your privacy is protected. You should read the consent form carefully before enrolling in the study and only sign it if you meet the study requirements, want to participate and have all your questions answered by the study staff.

The main requirement of the study will be to continue donating blood during the next two years. Most people involved in the study will be asked to donate twice a year for the next two years. Men who were frequent donors before enrolling will be asked to donate 3 times per year. This will be explained again in the consent form for the study. Because of the study requirements, you can only donate blood during this study at a limited number of sites, preferably at the donation site where you enroll in the study.

After enrolling, you will be asked to fill out a brief questionnaire about yourself that should take no more than 10 minutes to complete. The questionnaire will ask you about your previous blood donations, dietary habits, whether you take iron supplements or vitamins with iron, and your smoking habits. Women will also be asked about their menstrual cycle and blood loss during menstruation and their history of pregnancy. You will then be asked to donate blood as you normally would. At the time of your donation today and until your final visit, when samples are taken from your donation for routine blood testing, an additional 2-3 teaspoons of your blood may be taken to be used for laboratory tests that measure your iron stores.

After approximately a year and a half you will be recruited by the research staff to give a final set of blood samples which will be used to check your iron levels and complete another survey. You can donate blood at the same time, but the final visit will need to be specially scheduled. The final visit will need to be scheduled within 2-3 months of your receiving a reminder notification letter.

Before you leave, you will be given a membership card identifying you as a participant in the RISE Study. You can use the contact information on this card to arrange for your next donation. The card will also let you know where you can donate while you are enrolled in the study and remind you (if you already made an appointment) when you agreed to next donate blood. But, first of all, you should show this card to the blood center staff when you come in to donate so they are reminded that you are a study participant!

Please note, that if at any time after you are enrolled and successfully donate, you are asked not to donate blood because your hemoglobin level becomes too low, you are still asked to continue participating in the study. Although you will not be able to donate that day, you will be asked to provide blood samples to check your iron levels on the day you are deferred. The blood center will give you advice on how quickly you can return to donate. It is also important that you do NOT donate to another blood center during the two year study. You will be given instructions about how you can schedule donations but the donations should be made at the site where you enrolled or another site which is participating in the research.

What tests will be performed on my blood sample for the research study?

Your blood samples will be tested for several indicators of your body’s iron stores. Your blood will be analyzed using newer testing designed to detect early iron deficiency. Some people, depending on how their body uses available iron, may be more likely to have too little iron while others may be more likely to have too much. Because of this we will also analyze your genes related to iron metabolism to find out how your body uses iron.

A small portion of the blood collected on your visits will be frozen and stored for possible later use. These samples will only be used if other tests for iron status or iron genetic markers are developed. The researchers will not use your blood for any other purpose without your written consent.

Will anyone be able to link my survey answers or blood test results back to me?

Your information will be kept confidential. Details of how we keep your information private are in the consent form.

Who are the REDS-II Donor Iron Status Evaluation (RISE) Study researchers?

The REDS-II Donor Iron Status Evaluation (RISE) Study researchers are part of a larger group of researchers participating in the REDS-II study, sponsored by the National Institutes of Health, National Heart, Lung and Blood Institute. If you have not already received information about the REDS-II study we will be happy to provide it to you now.

Who do I contact if I have questions about the study?

<INSERT BLOOD CENTER NAME AND CONTACT INFORMATION>