Invitation to participate brochure

ATTACHMENT 3

Invitation to Participate Brochure
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 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 Donor Iron 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 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.
A third group of donors who are deferred because of low hemoglobin at their first
donation will also be asked to participate by completing only the initial assessment.
We need to study all three types of donors in order to understand how blood
donation influences iron and hemoglobin levels.
What will be required of me if I decide to enroll in the REDS Donor Iron 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 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 REDS Donor Iron 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.
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 first visit will be frozen and stored
for possible later use. The 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 Donor Iron Study researchers?
The REDS Donor Iron 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?