Consent and letters

ATTACHMENT 4

ATTACHMENT 4.1

Informed Consent
You are asked to participate in a research study, called the REDS Donor Iron Study,
which is being conducted at the ______________ Blood Center under the supervision of
Dr. ______________. This study is part of a larger network of blood safety research
called REDS (Retrovirus Epidemiology Donor Study) funded by the National Heart,
Lung and Blood Institute. The REDS Donor Iron Study will assess how blood donation
and personal characteristics may affect levels of iron and hemoglobin in a person’s blood.
Information from the study will help us evaluate which laboratory tests are best for
monitoring donors’ iron and hemoglobin levels, the best frequency for blood donation,
and how some personal characteristics such as your diet, use of mineral supplements, or
smoking may influence iron levels and the ability to donate blood. We will also assess in
women donors how menstrual periods affect their iron levels and ability to donate blood.

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.

Overview of the Study
Why was I asked to participate?
We are asking for your participation in this study because: [One box below to be
checked by Research staff]
______You are new to blood donation and have never donated blood.
______You have not donated blood in the last two years before today.
______You are a man who has donated at least 3 times in the last 12 months (not
including today). Double red cell donations count as two donations.
______You are a woman who has donated at least 2 times in the last 12 months (not
including today). Double red cell donations count as two donations.
______You are new to blood donation or have not donated blood in the last two years,
and have a hemoglobin level today that is not high enough for you to give blood.
What do I need to do to participate?
If your hemoglobin level is high enough today for you to donate, we are asking you to
participate in this study for approximately 2 years during which time we will assess your
hemoglobin and/or iron levels each time you come to donate.
For the study to accomplish its goals, it is important that you understand we would like
you to donate blood to the ____________ Blood Center as frequently as you can over the
next two years (you are eligible to donate blood every 8 weeks or double red cells, using
a special blood collection method, every 16 weeks). 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. You will also receive
reminders from the research staff at __________ Blood Center to donate blood while you
are enrolled in the study. You will also receive routine recruitment calls from the Blood
Center.
We would like you to donate at least as often as checked below (double red cell donations
count as two donations): [Research staff to check the appropriate box below]
______ If you are new to blood donation and have never donated blood, you agree to
donate blood at least twice a year for the next two years (4 more donations after today
over the next two years)

______ If you have not donated blood in the last two years before today, you agree to
donate blood at least twice a year for the next two years (4 more donations after today
over the next two years)
______ If you are a man who has donated at least 3 times in the last 12 months (not
including today), you agree to continue to donate at least three times a year for the next
two years (6 more donations after today over the next two years)
______ If you are a woman who has donated at least 2 times in the last 12 months (not
including today), you agree to continue to donate at least two times a year for the next
two years (4 more donations after today over the next two years)
If your hemoglobin level is NOT high enough today for you to donate, we are asking
for you to participate in this study only today so your iron levels and personal
characteristics can be assessed once.

What you can expect if you participate in this study
At each donation visit, including today, you will be evaluated as usual by regular Blood
Center staff to determine if you are eligible to donate. This will include a hemoglobin
screening test to check for anemia.
If you are eligible, you will then donate blood as normal. When samples are taken from
your donation for routine blood testing, an additional three teaspoons (15 ccs) of blood
will be taken to check your iron and hemoglobin levels. At the donations between the
first and last, only two teaspoons (10ccs) of blood will be taken. The samples between the
first and last donations may be used to check on your iron levels later, but the decision on
whether these will be tested will be made at the end of the study. The iron tests that will
be done on the blood samples you provide today when you enroll in the study will
include checking your genetic material (your DNA) for genes that may make you likely
to have too little iron or too much body iron. (No other genetic tests other than those
related to iron or hemoglobin will be done on your DNA). At today’s donation and at the
end of the study, we will also check your count of red blood cells, white blood cells and
platelets (the different cells in your blood).
At today’s donation, you will be asked to complete a 10 minute survey about your blood
donation history, your diet, your use of iron supplements and aspirin, your smoking
history, and, for women, your pregnancy and menstrual history. You will also be asked to
complete a shorter survey (5 minutes) at the end of the study to check if there have been
any changes in your use of vitamins and iron supplements, your smoking habits, and, for
women, your menstrual history. These are all factors that are expected to influence your
body’s iron stores. Some of these questions may be sensitive, but it is important they be
answered fully and accurately for you to participate in the study.

If you are told you cannot donate blood
If you are told you cannot donate blood today because your hemoglobin level is too low,
we will ask you to provide three teaspoons of blood for the research tests and to complete
the 5-10 minutes survey. However, you will not be asked to participate in the follow-up
study for the next two years. You should ask the Blood Center staff when you can next
try to donate blood.
If you can give blood today but cannot at some point in the next two years because your
hemoglobin level is too low, we will ask you at that time to provide three teaspoons of
blood for the research tests. You should ask the Blood Center staff when you can next
attempt to donate blood. You are still being asked to continue to participate in the study
until it ends.
If you cannot donate blood for a reason other than hemoglobin during the next two years,
your participation in this study will end but you will be asked to provide a final sample of
three teaspoons of blood and to complete the survey one last time. The regular Blood
Center staff will provide you further information on why you cannot donate blood at that
time, whether you can donate blood in the future and whether this means anything for
your health.
Your blood test results
In general, the iron research test results will not be available until late in the study. Since
iron loss is a known effect of blood donation in many donors and the ________Blood
Center will routinely let you know if your hemoglobin level is too low when you donate,
we do not plan to share with you the results of any research test that may show this
expected iron loss, although, upon request we will share these results with you and your
physician (if you identify one) when they are available.
Certain research test results however may be important to your health. You (and your
physician if you identify one) will be notified if these test results are abnormal and may
be of potential medical concern

Sample Repository
If you agree to participate in this study, samples of your blood will be frozen and saved
indefinitely in a repository for future research on iron stores. Future testing on these
saved samples will be done only to check body iron and hemoglobin levels and may
include additional tests of your genetic material if new genes are identified that tell us
how your body absorbs and keeps iron or sets hemoglobin levels. No other genetic tests
other than those related to iron or hemoglobin will be done on your DNA. The testing
may be done at other laboratories, but your identity (name, address) will remain coded
and only be known to the research staff at the _____________ Blood Center. All
proposed testing on saved samples will be subject to review and approval by the Blood
Center’s Institutional Review Board, which has the responsibility to protect the rights of

research study subjects, the REDS-II study, and representatives of the National Institutes
of Health.

What are the risks and benefits of participating in this study?
Risks: Other than the known risks of blood donation (Insert individual Center’s “What
You Must Know” that describe these risks to blood donors) the only additional risks of
participation in this research study are:

1) If extra blood draws are needed: pain, bruising, and rarely infection.
2) Small additional blood loss: Rarely, the extra 2-3 teaspoons of blood drawn for
the study at each blood donation could aggravate iron loss.
3) Information risk: If I request my results or am notified of a serious health
implication from the testing, this information could be upsetting, although it could
also represent a benefit to me.
4) Genetic testing: Knowing that you have a genetic or inherited abnormality in how
your body absorbs iron could cause distress to you and your family, although it
could also represent a benefit to you or your family.
5) Confidentiality: Participation in research may involve loss of privacy, but
information about me will be handled as confidentially as possible by the
investigators. My name and address information will be kept locked in a locked
file at my local blood center, and other study data will have a code number instead
of my name. Representatives from the funding agency, the National Institutes of
Health, may review information about me to check on the study. My name will
not be used in any published report about this study.
While we will make every attempt to keep the results of this study confidential,
confidentiality cannot be guaranteed. To provide additional protection of your privacy,
the blood center has obtained a Certificate of Confidentiality in accordance with Section
301(d) of the Public Health Service Act. This certificate will prevent study staff from
being forced to disclose information that may identify you by court order or other legal
action. This protection lasts forever (even after death) for all study participants. Any
results of the study, such as scientific publications, will be reported as summaries that
will not reveal your identity.
Benefits: Although you will not directly benefit from participating in this study, this
study may benefit other donors like you in the future, by helping ______________Blood
Center develop donor-specific guidelines on how often one can safely donate blood. You
will not be paid to participate in the study.

Non Consent/Withdrawal from the study
Whether you choose to participate or not in this study will not affect your opportunity to
donate blood today nor any rights or privileges you may have with the __________
Blood Center. If you decide to participate in the REDS Donor Iron Study, but change

your mind later you may withdraw at any time or elect not to provide a study blood
sample or complete one of the questionnaires. In the case that you are unwilling to
provide samples or complete surveys as outlined in this consent, we may decide to
withdraw you from the study. You may also request to have your samples withdrawn
from the sample repository. Withdrawal from the research study will not affect your
relationship with __________ Blood Center or your previous or future blood donations.

Subjects’ Rights
Your decision whether or not to take part in this study is voluntary. It will not change
your future relationship with ___________Blood Center in any way. You are free to end
your participation at any time without harm to your rights or your future relationship with
_________________Blood Center.

If you are injured
[Each Center to insert their own wording- One example given below]
In the event that you suffer physical injury as a direct result of your participation in this
research activity, the ____________Blood Center will assume responsibility for making
immediate medical care available to you. This care will be provided without charge if
you notify Dr. ______________________ (Principal Investigator’s or designee’s name
and telephone number) within fifteen days of the date of the injury or appearance of
symptoms, and consent to the care offered. There is no provision for monetary
compensation to you at the expense of ____________________ Blood Center for such
things as lost wages, disability, injury or discomfort resulting to you from such physical
injury. Further information concerning treatment and payment of medical expenses in
the event of an injury may be obtained from _________________________________
(Principal Investigator’s or designee’s name and telephone number).

Contact Person
If you have any questions, please ask us now. If you have any additional questions later,
contact Dr. _____________at_____________ who will be happy to answer them. If you
have questions about your rights as a research subject, call___________________(local
IRB). If you decide to participate, you will be given a copy of this form to keep.

Consent Authorization
My signature indicates that I have read the above explanation of this research project. I
have been given the opportunity to ask questions of ________________ and my
questions have been answered. The potential risks and benefits have been explained to
me. Based on this information, I have voluntarily decided to participate in this research
study. I understand that I have the option to withdraw from the study without penalty at
any time after signing this form.

_____________________________________
Printed or Typed Name
__________________________________
Signature of the participant

______________________________
Date

___________________________________
Witness Name and Signature

______________________________
Date

ATTACHMENT 4.2

Targeted mailing for Interim Visits

Feeling like you need to donate?
Dear Donor,
Thank you for donating blood for patients in your community, and
also for agreeing to participate in the REDS-II Donor Iron Study.
This study monitors Iron levels in donors over a 2 year period. If
you’ve donated recently, thank you very much! If you haven’t
donated recently, would you please seriously consider doing so,
both for patients that need blood products and researchers that
need data from your donation?
You may schedule a convenient donation time by calling
, or simply stop by any of our permanent
collection sites.
Thank You!

ATTACHMENT 4.3

Targeted mailing for Final Visit

Feeling like you need to donate?

Dear Donor, thank you for donating blood for patients in your
community, and also for agreeing to participate in the REDS-II
Donor Iron Study. This study monitors Iron levels in donors over
a 2 year period. The two year period is nearing the end, and we
would like you 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 , or simply stop by any of our permanent
collection sites.
Thank You!